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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03199053
Registration number
NCT03199053
Ethics application status
Date submitted
22/06/2017
Date registered
26/06/2017
Titles & IDs
Public title
Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus (T2DM) Aged 10 to Below 18 Years Old
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Scientific title
A 26 Week, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase 3 Trial With a 26 Week Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 5 and 10 mg, and Saxagliptin 2.5 and 5 mg in Pediatric Patients With Type 2 Diabetes Mellitus Who Are Between 10 and Below 18 Years of Age
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Secondary ID [1]
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0
2015-005042-66
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Secondary ID [2]
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D1680C00019
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
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Condition category
Condition code
Metabolic and Endocrine
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dapagliflozin
Treatment: Drugs - Saxagliptin
Treatment: Drugs - Placebo
Experimental: Low dose Dapagliflozin - Oral route. Start with a low dose of dapagliflozin administered once daily and remain on the low dose regardless of your HbA1c at week 12.
Experimental: Low dose/high dose Dapagliflozin - Oral route. Start with a low dose of Dapagliflozin administered once daily and up titrate to the high dose Dapagliflozin administered once daily if HbA1c \>= 7% at week 12
Experimental: Low dose Saxagliptin - Oral route. Start with a low dose of saxagliptin administered once daily and remain on the low dose regardless of your HbA1c at week 12
Experimental: Low dose/high dose Saxagliptin - Oral route. Start with a low dose of saxagliptin administered once daily and up titrate to the high dose if HbA1c \>= 7% at week 12
Placebo comparator: Placebo arm - Oral route. Placebo tablets administered for 52 weeks
Treatment: Drugs: Dapagliflozin
Tablets, Oral, 5mg , Once daily Tablets, Oral, 10mg, Once daily
Treatment: Drugs: Saxagliptin
Tablets, Oral, 2.5mg Once daily Tablets, Oral, 5mg, Once daily
Treatment: Drugs: Placebo
Matching placebo to dapagliflozin 5mg and 10 mg/saxagliptin 2.5 mg and 5 mg, Tablets, oral, Once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Dapagliflozin Versus Placebo: Adjusted Mean Change From Baseline in HbA1c at Week 26
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Assessment method [1]
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on multiple imputation washout (MI-WO) within each arm using the data from placebo participants with Week 26 data.
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Timepoint [1]
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Baseline and Week 26
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Primary outcome [2]
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Saxagliptin Versus Placebo: Adjusted Mean Change From Baseline in HbA1c at Week 26
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Assessment method [2]
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
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Timepoint [2]
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Baseline and Week 26
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Secondary outcome [1]
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Dapagliflozin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26
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Assessment method [1]
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Dapagliflozin participants were weighted as follows: participants who had HbA1c \< 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c \>= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c \>= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
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Timepoint [1]
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Baseline and Week 26
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Secondary outcome [2]
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Saxagliptin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26
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Assessment method [2]
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Saxagliptin participants were weighted as follows: participants who had HbA1c \< 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c \>= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c \>= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
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Timepoint [2]
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Baseline and Week 26
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Secondary outcome [3]
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Dapagliflozin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26
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Assessment method [3]
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Dapagliflozin participants were weighted as follows: participants who had HbA1c \< 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c \>= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c \>= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
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Timepoint [3]
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Baseline and Week 26
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Secondary outcome [4]
0
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Saxagliptin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26
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Assessment method [4]
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Saxagliptin participants were weighted as follows: participants who had HbA1c \< 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c \>= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c \>= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
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Timepoint [4]
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Baseline and Week 26
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Secondary outcome [5]
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Dapagliflozin Versus Placebo: Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
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Assessment method [5]
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
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Timepoint [5]
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Baseline and Week 26
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Secondary outcome [6]
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Saxagliptin Versus Placebo: Adjusted Mean Change From Baseline in FPG at Week 26
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Assessment method [6]
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
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Timepoint [6]
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Baseline and Week 26
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Secondary outcome [7]
0
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Dapagliflozin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26
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Assessment method [7]
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0
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Dapagliflozin participants were weighted as follows: participants who had HbA1c \< 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c \>= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c \>= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
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Timepoint [7]
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Baseline and Week 26
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Secondary outcome [8]
0
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Saxagliptin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26
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Assessment method [8]
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0
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Saxagliptin participants were weighted as follows: participants who had HbA1c \< 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c \>= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c \>= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
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Timepoint [8]
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Baseline and Week 26
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Secondary outcome [9]
0
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Dapagliflozin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26
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Assessment method [9]
0
0
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Dapagliflozin participants were weighted as follows: participants who had HbA1c \< 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c \>= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c \>= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
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Timepoint [9]
0
0
Baseline and Week 26
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Secondary outcome [10]
0
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Saxagliptin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26
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Assessment method [10]
0
0
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Saxagliptin participants were weighted as follows: participants who had HbA1c \< 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c \>= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c \>= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
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Timepoint [10]
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0
Baseline and Week 26
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Secondary outcome [11]
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Percentage of Participants With Baseline HbA1c = 7% Who Achieved HbA1c < 7% at Week 26
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Assessment method [11]
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A logistic regression model adjusting for sex, age group, background antidiabetes medication and Baseline HbA1c was used. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
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Timepoint [11]
0
0
Baseline and Week 26
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Secondary outcome [12]
0
0
Low-dose/High-dose Versus Placebo (Weighted): Percentage of Participants With Baseline HbA1c = 7% Who Achieved HbA1c < 7% at Week 26
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Assessment method [12]
0
0
A weighted logistic regression model adjusting for sex, age group, background antidiabetes medication and Baseline HbA1c was used. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Participants were weighted as follows: participants who had HbA1c \< 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c \>= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c \>= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
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Timepoint [12]
0
0
Baseline and Week 26
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Secondary outcome [13]
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Low-dose Versus Placebo (Weighted): Percentage of Participants With Baseline HbA1c = 7% Who Achieved HbA1c < 7% at Week 26
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Assessment method [13]
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0
A weighted logistic regression model adjusting for sex, age group, background antidiabetes medication and Baseline HbA1c was used. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Participants were weighted as follows: participants who had HbA1c \< 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c \>= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c \>= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
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Timepoint [13]
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Baseline and Week 26
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Secondary outcome [14]
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Low-dose Versus Uptitration to the High Dose: Adjusted Mean Change From Baseline in HbA1c at Week 26
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Assessment method [14]
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
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Timepoint [14]
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0
Baseline and Week 26
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Secondary outcome [15]
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Low-dose Versus Uptitration to the High Dose: Adjusted Mean Change From Baseline in FPG at Week 26
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Assessment method [15]
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
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Timepoint [15]
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Baseline and Week 26
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Secondary outcome [16]
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Dapagliflozin Low-dose Versus Uptitration to the High Dose: Percentage of Participants With Baseline HbA1c = 7% Who Achieved HbA1c < 7% at Week 26
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Assessment method [16]
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A Fisher's exact test was used and unadjusted difference in percentage of participants and Clopper-Pearson CIs presented using imputed data. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
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Timepoint [16]
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Baseline and Week 26
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Secondary outcome [17]
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Saxagliptin Low-dose Versus Uptitration to the High Dose: Percentage of Participants With Baseline HbA1c = 7% Who Achieved HbA1c < 7% at Week 26
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Assessment method [17]
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A Fisher's exact test was used and unadjusted difference in percentage of participants and Clopper-Pearson CIs presented using imputed data. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
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Timepoint [17]
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Baseline and Week 26
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Eligibility
Key inclusion criteria
* Signed Written Informed Consent
* Target Population
* Previously diagnosed with Type 2 Diabetes Mellitus by World Health Organization/ADA criteria
* HbA1c between 6.5% and 10.5% obtained at screening.
* Currently on diet and exercise and stable dose of at least 1000 mg metformin (IR or XR) for a minimum of 8 weeks, or stable dose of insulin for a minimum of 8 weeks, or a stable combination of at least 1000 mg metformin (IR or XR) and insulin for a minimum of 8 weeks prior to randomization. For those children on insulin, investigators will confirm that attempts at removing insulin from the subject's therapeutic regimen had been previously made but had not been successful.
* Age and Reproductive Status
* Male and female patients eligible if 10 years of age, up to but not including 18 years of age at the time of enrollment/screening. At least 30% of total subjects will be between the ages of 10 and 14 years and at least one third, but no more than two thirds, female subjects.
* Women of childbearing potential must have a negative pregnancy test within 24 hours prior to the start of study drug.
* Women must not be breastfeeding.
* Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs: saxagliptin, and dapagliflozin, plus 5 half-lives of study drugs or 30 days (whichever is longer), plus 30 days (duration of ovulatory cycle) for a total of 60 days post treatment completion.
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Minimum age
10
Years
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Target Disease Exceptions
* Presence of Type 1 diabetes, as demonstrated by Preexisting diagnosis of Type 1 diabetes,
* Previous diagnosis of monogenic etiology of Type 2 diabetes
* Diabetes ketoacidosis (DKA) within 6 months of screening
* Current use of the following medications for the treatment of diabetes, or use within the specified timeframe prior to screening for the main study:
* Eight weeks: sulfonylureas, alpha glucosidase inhibitors, metiglinide, oral or injectable incretins or incretin mimetics, other antidiabetes medications not otherwise specified.
* Sixteen weeks: thiazolidinediones, DPP-4 inhibitors (with no reported medication related AEs related to DPP-4 inhibitors), sodium glucose cotransporter-2 (SGLT-2) inhibitors (with no reported medication related AEs related to SGLT-2 inhibitors)
* Initiation or discontinuation of prescription or non-prescription weight loss drugs within 8 weeks of screening. Use of prescription or non-prescription weight loss drugs must be stable during the study.
* Medical History and Concurrent Diseases
* Pregnant, positive serum pregnancy test, planning to become pregnant during the clinical trials, or breastfeeding
* History of unstable or rapidly progressive renal disease
* History of unresolved vesico-ureteral reflux
* History of or current, acute or chronic pancreatitis
* History of hemoglobinopathy, with the exception of sickle cell trait or thalassemia minor; or chronic or recurrent hemolysis
* Malignancy within 5 years of the screening visit (with the exception of treated basal cell or treated squamous cell carcinoma)
* Replacement or chronic systemic corticosteroid therapy, defined as any dose of systemic corticosteroid taken for > 4 weeks within 3 months prior to the Day 1 visit
* Physical and Laboratory Test Findings
* Abnormal renal function,
* An abnormal thyroid-stimulating hormone (TSH) value at enrollment will be further evaluated for free T4. Subjects with abnormal free T4 values will be excluded.
* Hematuria (confirmed by microscopy at screening) with no explanation as judged by the Investigator up to randomization.
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2× upper limit of normal (ULN), or clinically significant hepatic disease.
* Serum total bilirubin (TB) > 2x ULN unless exclusively caused by Gilbert's syndrome
* Positive serologic evidence of current infectious liver disease including anti hepatitis A virus (HAV) (IgM), hepatitis B surface antigen (HBsAg), or anti hepatitis C virus (HCV). Patients who have isolated positive anti-hepatitis B surface antibodies may be included.
* Anemia of any etiology
* Volume-depleted subjects.
* Allergies and Adverse Drug Reaction
* Known allergy, sensitivity or contraindication to any study drug or its excipient/vehicle
* Other Exclusion Criteria
* Subject is currently abusing alcohol or other drugs or has done so within the last 6 months prior to the screening visit.
* Prisoners or subjects who are involuntarily incarcerated. (Note: under certain specific circumstances a person who has been imprisoned may be included or permitted to continue as a subject. Strict conditions apply and Sponsor/designee approval is required.)
* Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
* Psychiatric or cognitive disorder that will, in the opinion of investigators, limit the subject's ability to comply with the study medications and monitoring.
* Subjects who have contraindications to therapy as outlined in the saxagliptin and dapagliflozin Investigator Brochure or local package inserts.
* Participation and receiving IP in another clinical study during the prior 3 months
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/10/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
3/01/2024
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Sample size
Target
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Accrual to date
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Final
256
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Blacktown
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Recruitment postcode(s) [1]
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0
2148 - Blacktown
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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0
United States of America
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0
Connecticut
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0
United States of America
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Florida
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0
United States of America
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Georgia
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United States of America
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Idaho
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United States of America
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New Jersey
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Ciudad de Buenos Aires
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Argentina
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San Miguel de Tucuman
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Argentina
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San Miguel de Tucumán
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Brazil
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Brasilia
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Brazil
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Curitiba
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Brazil
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Fortaleza
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Brazil
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Passo Fundo
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Brazil
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Porto Alegre
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Brazil
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Ribeirão Preto
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Brazil
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Santa Maria
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Brazil
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Sao Paulo
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Canada
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Quebec
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Chile
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Santiago
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Colombia
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Armenia
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Colombia
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Barranquilla
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Finland
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Tampere
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India
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Ahmedabad
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India
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Aurangabad
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India
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Bangalore
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India
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Bikaner
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India
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Chandigarh
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0
India
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Taiping
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Ufa
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Manisa
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Dnipro
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Kyiv
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London
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United Kingdom
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United Kingdom
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Nottingham
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Funding & Sponsors
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Name
AstraZeneca
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Summary
Brief summary
The primary objective of this study is to determine if there will be a greater mean reduction from baseline in glycated hemoglobin (HbA1c) achieved after 26 weeks of oral double-blind add-on therapy of dapagliflozin or saxagliptin compared to placebo in paediatric T2DM patients with HbA1c levels of 6.5 to 10.5% on diet and exercise and metformin, insulin, or metformin plus insulin.
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Trial website
https://clinicaltrials.gov/study/NCT03199053
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Contacts
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/53/NCT03199053/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/53/NCT03199053/SAP_003.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03199053