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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01519674
Registration number
NCT01519674
Ethics application status
Date submitted
24/01/2012
Date registered
27/01/2012
Date last updated
24/02/2017
Titles & IDs
Public title
Treatment Intensification With Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Inadequately Controlled on Sitagliptin and Metformin
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Scientific title
A 24 Week Randomised, Open Label, 3 Parallel-group Comparison of Once and Twice Daily Biphasic Insulin Aspart (BIAsp) 30 Plus Sitagliptin and Twice Daily BIAsp 30, All in Combination With Metformin in Insulin naïve Type 2 Diabetic Subjects Inadequately Controlled on Sitagliptin and Metformin
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Secondary ID [1]
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U1111-1125-0850
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Secondary ID [2]
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BIASP-3963
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Universal Trial Number (UTN)
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Trial acronym
SIT2MIX
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes
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Diabetes Mellitus, Type 2
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Condition category
Condition code
Metabolic and Endocrine
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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 - biphasic insulin aspart 30
Treatment: Drugs - biphasic insulin aspart 30
Treatment: Drugs - sitagliptin
Treatment: Drugs - metformin
Active comparator: BIAsp 30 BID + sitagliptin + metformin -
Active comparator: BIAsp 30 BID + metformin -
Active comparator: BIAsp 30 OD + sitagliptin + metformin -
Treatment: Drugs: biphasic insulin aspart 30
BIAsp 30 will be injected subcutaneously (under the skin) twice daily. Individually adjusted dose.
Treatment: Drugs: biphasic insulin aspart 30
BIAsp 30 will be injected subcutaneously (under the skin) once daily. Individually adjusted dose.
Treatment: Drugs: sitagliptin
Subjects will continue on their pre-trial sitagliptin treatment.
Treatment: Drugs: metformin
Subjects will continue on their pre-trial metformin treatment.
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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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Change From Baseline in HbA1c (Glycosylated Haemoglobin)
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Assessment method [1]
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Estimated mean change from baseline in HbA1c after 24 weeks of treatment.
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Timepoint [1]
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Week 0 to Week 24
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Secondary outcome [1]
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Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c < 7.0%)
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Assessment method [1]
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Proportion of subjects achieving HbA1c below 7.0% after 24 weeks of treatment
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Timepoint [1]
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After 24 weeks of treatment
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Secondary outcome [2]
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Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c = 6.5%)
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Assessment method [2]
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Proportion of subjects achieving HbA1c equal to or below 6.5% after 24 weeks of treatment.
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Timepoint [2]
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After 24 weeks of treatment
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Secondary outcome [3]
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Change From Baseline in Fasting Plasma Glucose (FPG)
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Assessment method [3]
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Estimated mean change from baseline in fasting plasma glucose (FPG)
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Timepoint [3]
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Week 0 to Week 24
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Secondary outcome [4]
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Prandial Plasma Glucose (PPG) Increments at Breakfast
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Assessment method [4]
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Estimated mean post prandial increments at breakfast after 24 weeks of treatment.
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Timepoint [4]
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After 24 weeks of treatment
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Secondary outcome [5]
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Prandial Plasma Glucose (PPG) Increments at Lunch.
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Assessment method [5]
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Estimated mean post prandial increments at lunch after 24 weeks of treatment.
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Timepoint [5]
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After 24 weeks of treatment
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Secondary outcome [6]
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Prandial Plasma Glucose (PPG) Increments at Dinner.
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Assessment method [6]
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Estimated mean post prandial increments at dinner after 24 weeks of treatment.
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Timepoint [6]
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After 24 weeks of treatment
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Secondary outcome [7]
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Prandial Plasma Glucose (PPG) Overall Mean Increment.
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Assessment method [7]
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Estimated overall mean post prandial increment after 24 weeks of treatment.
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Timepoint [7]
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After 24 weeks of treatment
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Secondary outcome [8]
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Adverse Events (AEs)
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Assessment method [8]
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Rate of AEs per 100 years of patient exposure. An adverse event was defined as treatment emergent if the event had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
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Timepoint [8]
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Week 0 to Week 24
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Secondary outcome [9]
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Number of Treatment Emergent Hypoglycaemic Episodes (Nocturnal and Day-time) Classified Both According to the American Diabetes Association (ADA) Definition and to an Additional Definition for Minor Episodes.
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Assessment method [9]
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Number of treatment emergent hypoglycaemic episodes. Treatment emergent hypoglycaemic episode: if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Nocturnal: Time of onset between 00:01 and 05:59 a.m. (both included). Additional minor hypoglycaemic episode: symptomatic or asymptomatic hypoglycaemia with blood glucose (BG) values \< 2.8 mmol/L (50 mg/dL) or plasma glucose (PG) \< 3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself.
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Timepoint [9]
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Week 0 to Week 24
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Secondary outcome [10]
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Change From Baseline in Patient Reported Outcome by Use of the Treatment Related Impact Measure - Diabetes.
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Assessment method [10]
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Estimated mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) 'total score' to end of trial. The score measured treatment satisfaction. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction.
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Timepoint [10]
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Week 0 to Week 24
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Eligibility
Key inclusion criteria
* Diagnosed with type 2 diabetes for a minimum of 6 months prior to screening (Visit 1)
* Stable treatment with a total daily dose of at least 1000 mg of metformin (with or without additional oral anti-diabetic drugs (OADs) treatment). The metformin dose must have been unchanged for at least 3 months prior to screening (Visit 1)
* Stable treatment with a total daily dose of at least 100 mg sitagliptin. The sitagliptin dose must have been unchanged for at least 3 months prior to screening (Visit 1)
* Subject is insulin-naïve (never previously treated with insulin). (However, short term insulin use due to intermittent illness of up to 14 days or insulin treatment for gestational diabetes is allowed)
* HbA1c (glycosylated haemoglobin) between 7.0 to 10.0 % (53-86 mmol/mol) (both inclusive) by central laboratory analysis demonstrating inadequate control on sitagliptin and metformin (with or without other OADs)
* Body Mass Index (BMI) below or equal to 40.0 kg/m^2
* Able and willing to eat at least 2 meals (breakfast and dinner) every day during the trial
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Minimum age
18
Years
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Maximum age
No limit
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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
* Treatment with thiazolidinedione (TZD) or glucagon-like-peptide-1 (GLP-1) receptor agonist within the last 3 months prior to screening (Visit 1)
* Cardiac disease within the last 6 months prior to screening (Visit 1), defined as: decompensated heart failure New York Heart Association (NYHA) class III or IV; unstable angina pectoris; or myocardial infarction
* Severe hypertension, systolic blood pressure equal to or above 180 mm Hg or diastolic blood pressure equal to or above 100 mm Hg, after 5 minutes rest in the sitting position using mean value of 3 measurements at screening (Visit 1)
* Anticipated change of dose of any systemic treatment with products, which in the trial physician's opinion could interfere with glucose metabolism (e.g., systemic corticosteroids)
* Clinically significant diseases (except for conditions associated with type 2 diabetes) which, in the trial physician's opinion may confound the results of the trial or pose additional risk in administering trial product(s)
* Impaired hepatic function as indicated by aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) above 2.5 times the upper normal range, according to central laboratory reference ranges
* Impaired renal function as indicated by serum creatinine levels equal to or above 133 micromol/L (1.5 mg/dL) for males and equal to or above 124 micromol/L (1.4 mg/dL) for females or estimated creatinine clearance below 60 mL/min, based on the Cockroft & Gault formula and according to local practise for metformin use
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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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
1/06/2012
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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
1/10/2013
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Sample size
Target
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Accrual to date
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Final
582
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Novo Nordisk Investigational Site - Broadmeadow
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Recruitment hospital [2]
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Novo Nordisk Investigational Site - Coffs Harbour
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Recruitment postcode(s) [1]
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2292 - Broadmeadow
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Recruitment postcode(s) [2]
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2450 - Coffs Harbour
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Country [2]
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Argentina
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State/province [2]
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Caba
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Country [3]
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Argentina
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State/province [3]
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Mar del Plata
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Country [4]
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Argentina
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State/province [4]
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Morón
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Country [5]
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Brazil
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State/province [5]
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Sao Paulo
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Country [6]
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Brazil
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State/province [6]
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Brasília
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Country [7]
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Brazil
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State/province [7]
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Curitiba
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Country [8]
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Brazil
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State/province [8]
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Fortaleza
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Country [9]
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Brazil
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State/province [9]
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Porto Alegre
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Country [10]
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Greece
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State/province [10]
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Alexandroupolis
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Country [11]
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Greece
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State/province [11]
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Athens
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Greece
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State/province [12]
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Thessaloniki
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India
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State/province [13]
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Andhra Pradesh
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Country [14]
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India
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State/province [14]
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Gujarat
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Country [15]
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India
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State/province [15]
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Karnataka
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Country [16]
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India
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State/province [16]
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Kerala
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Country [17]
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India
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State/province [17]
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Maharashtra
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Country [18]
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India
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State/province [18]
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Punjab
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Country [19]
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India
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State/province [19]
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Tamil Nadu
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Country [20]
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India
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State/province [20]
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Uttar Pradesh
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Country [21]
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India
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State/province [21]
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West Bengal
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Country [22]
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India
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State/province [22]
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New Delhi
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Country [23]
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Korea, Republic of
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State/province [23]
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Goyang
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Country [24]
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Korea, Republic of
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State/province [24]
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Jeonju
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Country [25]
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Korea, Republic of
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State/province [25]
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Pusan
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Korea, Republic of
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State/province [26]
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Pyungchon-Dong 896, Dongan-Gu
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Country [27]
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Korea, Republic of
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State/province [27]
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Seoul
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Country [28]
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Korea, Republic of
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State/province [28]
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Suwon
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Country [29]
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Korea, Republic of
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State/province [29]
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Ulsan
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Country [30]
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Malaysia
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Penang
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Country [31]
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Malaysia
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State/province [31]
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Seremban
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Country [32]
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Portugal
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State/province [32]
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Coimbra
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Portugal
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State/province [33]
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Lisboa
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Portugal
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State/province [34]
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Matosinhos
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Country [35]
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Portugal
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State/province [35]
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Porto
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Country [36]
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Thailand
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State/province [36]
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Bangkok
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Country [37]
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Thailand
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State/province [37]
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Chiang Mai
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Country [38]
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Thailand
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State/province [38]
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Khon Kaen
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Country [39]
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Turkey
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State/province [39]
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Antalya
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Country [40]
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Turkey
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State/province [40]
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Istanbul
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novo Nordisk A/S
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This trial is conducted in Asia, Europe, Oceania and South America. The aim of this clinical trial is to generate data demonstrating how to intensify diabetes treatment using BIAsp 30 (biphasic insulin aspart 30) by adding or substituting BIAsp 30 to sitagliptin in various regimens for type 2 patients inadequately controlled on sitagliptin and metformin (with or without other oral anti-diabetic drugs (OADs)). The trial is conducted as a phase 4 trial in the majority of the participating countries. However, in some countries the trial is conducted as phase 3b.
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Trial website
https://clinicaltrials.gov/study/NCT01519674
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Trial related presentations / publications
Linjawi S, Sothiratnam R, Sari R, Andersen H, Hiort LC, Rao P. The study of once- and twice-daily biphasic insulin aspart 30 (BIAsp 30) with sitagliptin, and twice-daily BIAsp 30 without sitagliptin, in patients with type 2 diabetes uncontrolled on sitagliptin and metformin-The Sit2Mix trial. Prim Care Diabetes. 2015 Oct;9(5):370-6. doi: 10.1016/j.pcd.2014.11.001. Epub 2014 Dec 3.
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Public notes
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Contacts
Principal investigator
Name
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Global Clinical Registry (GCR, 1452)
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Address
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Novo Nordisk A/S
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Linjawi S, Sothiratnam R, Sari R, Andersen H, Hior...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT01519674
Download to PDF