Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03199053
Registration number
NCT03199053
Ethics application status
Date submitted
22/06/2017
Date registered
26/06/2017
Date last updated
17/04/2024
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
Query!
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
Query!
Secondary ID [1]
0
0
2015-005042-66
Query!
Secondary ID [2]
0
0
D1680C00019
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
0
0
Query!
Condition category
Condition code
Metabolic and Endocrine
0
0
0
0
Query!
Diabetes
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Dapagliflozin Versus Placebo: Adjusted Mean Change From Baseline in HbA1c at Week 26
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline and Week 26
Query!
Primary outcome [2]
0
0
Saxagliptin Versus Placebo: Adjusted Mean Change From Baseline in HbA1c at Week 26
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline and Week 26
Query!
Secondary outcome [1]
0
0
Dapagliflozin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline and Week 26
Query!
Secondary outcome [2]
0
0
Saxagliptin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline and Week 26
Query!
Secondary outcome [3]
0
0
Dapagliflozin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline and Week 26
Query!
Secondary outcome [4]
0
0
Saxagliptin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline and Week 26
Query!
Secondary outcome [5]
0
0
Dapagliflozin Versus Placebo: Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Query!
Assessment method [5]
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.
Query!
Timepoint [5]
0
0
Baseline and Week 26
Query!
Secondary outcome [6]
0
0
Saxagliptin Versus Placebo: Adjusted Mean Change From Baseline in FPG at Week 26
Query!
Assessment method [6]
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.
Query!
Timepoint [6]
0
0
Baseline and Week 26
Query!
Secondary outcome [7]
0
0
Dapagliflozin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26
Query!
Assessment method [7]
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 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.
Query!
Timepoint [7]
0
0
Baseline and Week 26
Query!
Secondary outcome [8]
0
0
Saxagliptin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26
Query!
Assessment method [8]
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 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.
Query!
Timepoint [8]
0
0
Baseline and Week 26
Query!
Secondary outcome [9]
0
0
Dapagliflozin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26
Query!
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.
Query!
Timepoint [9]
0
0
Baseline and Week 26
Query!
Secondary outcome [10]
0
0
Saxagliptin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26
Query!
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.
Query!
Timepoint [10]
0
0
Baseline and Week 26
Query!
Secondary outcome [11]
0
0
Percentage of Participants With Baseline HbA1c = 7% Who Achieved HbA1c < 7% at Week 26
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
Baseline and Week 26
Query!
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
Query!
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.
Query!
Timepoint [12]
0
0
Baseline and Week 26
Query!
Secondary outcome [13]
0
0
Low-dose Versus Placebo (Weighted): Percentage of Participants With Baseline HbA1c = 7% Who Achieved HbA1c < 7% at Week 26
Query!
Assessment method [13]
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 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.
Query!
Timepoint [13]
0
0
Baseline and Week 26
Query!
Secondary outcome [14]
0
0
Low-dose Versus Uptitration to the High Dose: Adjusted Mean Change From Baseline in HbA1c at Week 26
Query!
Assessment method [14]
0
0
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.
Query!
Timepoint [14]
0
0
Baseline and Week 26
Query!
Secondary outcome [15]
0
0
Low-dose Versus Uptitration to the High Dose: Adjusted Mean Change From Baseline in FPG at Week 26
Query!
Assessment method [15]
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.
Query!
Timepoint [15]
0
0
Baseline and Week 26
Query!
Secondary outcome [16]
0
0
Dapagliflozin Low-dose Versus Uptitration to the High Dose: Percentage of Participants With Baseline HbA1c = 7% Who Achieved HbA1c < 7% at Week 26
Query!
Assessment method [16]
0
0
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.
Query!
Timepoint [16]
0
0
Baseline and Week 26
Query!
Secondary outcome [17]
0
0
Saxagliptin Low-dose Versus Uptitration to the High Dose: Percentage of Participants With Baseline HbA1c = 7% Who Achieved HbA1c < 7% at Week 26
Query!
Assessment method [17]
0
0
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.
Query!
Timepoint [17]
0
0
Baseline and Week 26
Query!
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.
Query!
Minimum age
10
Years
Query!
Query!
Maximum age
18
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
11/10/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
3/01/2024
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
256
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Research Site - Blacktown
Query!
Recruitment postcode(s) [1]
0
0
2148 - Blacktown
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Connecticut
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Idaho
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
New Jersey
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Tennessee
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Texas
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Virginia
Query!
Country [10]
0
0
Argentina
Query!
State/province [10]
0
0
Buenos Aires
Query!
Country [11]
0
0
Argentina
Query!
State/province [11]
0
0
Caba
Query!
Country [12]
0
0
Argentina
Query!
State/province [12]
0
0
Ciudad de Buenos Aires
Query!
Country [13]
0
0
Argentina
Query!
State/province [13]
0
0
San Miguel de Tucuman
Query!
Country [14]
0
0
Argentina
Query!
State/province [14]
0
0
San Miguel de Tucumán
Query!
Country [15]
0
0
Brazil
Query!
State/province [15]
0
0
Brasilia
Query!
Country [16]
0
0
Brazil
Query!
State/province [16]
0
0
Curitiba
Query!
Country [17]
0
0
Brazil
Query!
State/province [17]
0
0
Fortaleza
Query!
Country [18]
0
0
Brazil
Query!
State/province [18]
0
0
Passo Fundo
Query!
Country [19]
0
0
Brazil
Query!
State/province [19]
0
0
Porto Alegre
Query!
Country [20]
0
0
Brazil
Query!
State/province [20]
0
0
Ribeirão Preto
Query!
Country [21]
0
0
Brazil
Query!
State/province [21]
0
0
Santa Maria
Query!
Country [22]
0
0
Brazil
Query!
State/province [22]
0
0
Sao Paulo
Query!
Country [23]
0
0
Canada
Query!
State/province [23]
0
0
Quebec
Query!
Country [24]
0
0
Chile
Query!
State/province [24]
0
0
Santiago
Query!
Country [25]
0
0
Colombia
Query!
State/province [25]
0
0
Armenia
Query!
Country [26]
0
0
Colombia
Query!
State/province [26]
0
0
Barranquilla
Query!
Country [27]
0
0
Finland
Query!
State/province [27]
0
0
Tampere
Query!
Country [28]
0
0
India
Query!
State/province [28]
0
0
Ahmedabad
Query!
Country [29]
0
0
India
Query!
State/province [29]
0
0
Aurangabad
Query!
Country [30]
0
0
India
Query!
State/province [30]
0
0
Bangalore
Query!
Country [31]
0
0
India
Query!
State/province [31]
0
0
Bikaner
Query!
Country [32]
0
0
India
Query!
State/province [32]
0
0
Chandigarh
Query!
Country [33]
0
0
India
Query!
State/province [33]
0
0
Coimbatore
Query!
Country [34]
0
0
India
Query!
State/province [34]
0
0
Hyderabad
Query!
Country [35]
0
0
India
Query!
State/province [35]
0
0
Kolkata
Query!
Country [36]
0
0
India
Query!
State/province [36]
0
0
Kozhikode
Query!
Country [37]
0
0
India
Query!
State/province [37]
0
0
Nashik
Query!
Country [38]
0
0
India
Query!
State/province [38]
0
0
Pune
Query!
Country [39]
0
0
India
Query!
State/province [39]
0
0
Visakhapatnam
Query!
Country [40]
0
0
Israel
Query!
State/province [40]
0
0
Haifa
Query!
Country [41]
0
0
Italy
Query!
State/province [41]
0
0
Ancona
Query!
Country [42]
0
0
Italy
Query!
State/province [42]
0
0
Napoli
Query!
Country [43]
0
0
Italy
Query!
State/province [43]
0
0
Roma
Query!
Country [44]
0
0
Korea, Republic of
Query!
State/province [44]
0
0
Daejeon-si
Query!
Country [45]
0
0
Korea, Republic of
Query!
State/province [45]
0
0
Incheon
Query!
Country [46]
0
0
Korea, Republic of
Query!
State/province [46]
0
0
Wonju-si
Query!
Country [47]
0
0
Malaysia
Query!
State/province [47]
0
0
George Town
Query!
Country [48]
0
0
Malaysia
Query!
State/province [48]
0
0
Ipoh
Query!
Country [49]
0
0
Malaysia
Query!
State/province [49]
0
0
Johor Bahru
Query!
Country [50]
0
0
Malaysia
Query!
State/province [50]
0
0
Klang
Query!
Country [51]
0
0
Malaysia
Query!
State/province [51]
0
0
Kota Kinabalu
Query!
Country [52]
0
0
Malaysia
Query!
State/province [52]
0
0
Kuala Lumpur
Query!
Country [53]
0
0
Malaysia
Query!
State/province [53]
0
0
Kuching
Query!
Country [54]
0
0
Malaysia
Query!
State/province [54]
0
0
Melaka
Query!
Country [55]
0
0
Malaysia
Query!
State/province [55]
0
0
Putrajaya
Query!
Country [56]
0
0
Malaysia
Query!
State/province [56]
0
0
Seremban
Query!
Country [57]
0
0
Malaysia
Query!
State/province [57]
0
0
Seri Manjung
Query!
Country [58]
0
0
Malaysia
Query!
State/province [58]
0
0
Taiping
Query!
Country [59]
0
0
Mexico
Query!
State/province [59]
0
0
Boca del Rio
Query!
Country [60]
0
0
Mexico
Query!
State/province [60]
0
0
Celaya
Query!
Country [61]
0
0
Mexico
Query!
State/province [61]
0
0
Ciudad Madero
Query!
Country [62]
0
0
Mexico
Query!
State/province [62]
0
0
Cuernavaca
Query!
Country [63]
0
0
Mexico
Query!
State/province [63]
0
0
Culiacán
Query!
Country [64]
0
0
Mexico
Query!
State/province [64]
0
0
Durango
Query!
Country [65]
0
0
Mexico
Query!
State/province [65]
0
0
Guadalajara
Query!
Country [66]
0
0
Mexico
Query!
State/province [66]
0
0
Juriquilla
Query!
Country [67]
0
0
Mexico
Query!
State/province [67]
0
0
Merida
Query!
Country [68]
0
0
Mexico
Query!
State/province [68]
0
0
Mexico
Query!
Country [69]
0
0
Mexico
Query!
State/province [69]
0
0
Monterrey
Query!
Country [70]
0
0
Mexico
Query!
State/province [70]
0
0
México, D.F.
Query!
Country [71]
0
0
Mexico
Query!
State/province [71]
0
0
San Juan del Rio
Query!
Country [72]
0
0
Mexico
Query!
State/province [72]
0
0
Veracruz
Query!
Country [73]
0
0
Mexico
Query!
State/province [73]
0
0
Zapopan
Query!
Country [74]
0
0
New Zealand
Query!
State/province [74]
0
0
Grafton
Query!
Country [75]
0
0
New Zealand
Query!
State/province [75]
0
0
Tauranga
Query!
Country [76]
0
0
New Zealand
Query!
State/province [76]
0
0
Wellington
Query!
Country [77]
0
0
Philippines
Query!
State/province [77]
0
0
Quezon City
Query!
Country [78]
0
0
Philippines
Query!
State/province [78]
0
0
San Fernando City
Query!
Country [79]
0
0
Poland
Query!
State/province [79]
0
0
Warszawa
Query!
Country [80]
0
0
Russian Federation
Query!
State/province [80]
0
0
Izhevsk
Query!
Country [81]
0
0
Russian Federation
Query!
State/province [81]
0
0
Moscow
Query!
Country [82]
0
0
Russian Federation
Query!
State/province [82]
0
0
Ufa
Query!
Country [83]
0
0
Taiwan
Query!
State/province [83]
0
0
Tainan City
Query!
Country [84]
0
0
Taiwan
Query!
State/province [84]
0
0
Taipei
Query!
Country [85]
0
0
Thailand
Query!
State/province [85]
0
0
Bangkok
Query!
Country [86]
0
0
Thailand
Query!
State/province [86]
0
0
Hat Yai
Query!
Country [87]
0
0
Turkey
Query!
State/province [87]
0
0
Aydin
Query!
Country [88]
0
0
Turkey
Query!
State/province [88]
0
0
Bursa
Query!
Country [89]
0
0
Turkey
Query!
State/province [89]
0
0
Eskisehir
Query!
Country [90]
0
0
Turkey
Query!
State/province [90]
0
0
Istanbul
Query!
Country [91]
0
0
Turkey
Query!
State/province [91]
0
0
Izmir
Query!
Country [92]
0
0
Turkey
Query!
State/province [92]
0
0
Kocaeli
Query!
Country [93]
0
0
Turkey
Query!
State/province [93]
0
0
Kurupelit
Query!
Country [94]
0
0
Turkey
Query!
State/province [94]
0
0
Manisa
Query!
Country [95]
0
0
Ukraine
Query!
State/province [95]
0
0
Dnipro
Query!
Country [96]
0
0
Ukraine
Query!
State/province [96]
0
0
Kyiv
Query!
Country [97]
0
0
Ukraine
Query!
State/province [97]
0
0
Vinnytsia
Query!
Country [98]
0
0
United Kingdom
Query!
State/province [98]
0
0
Birmingham
Query!
Country [99]
0
0
United Kingdom
Query!
State/province [99]
0
0
London
Query!
Country [100]
0
0
United Kingdom
Query!
State/province [100]
0
0
Middlesborough
Query!
Country [101]
0
0
United Kingdom
Query!
State/province [101]
0
0
Nottingham
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
AstraZeneca
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03199053
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03199053
Download to PDF