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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
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
Secondary ID [1] 0 0
U1111-1125-0850
Secondary ID [2] 0 0
BIASP-3963
Universal Trial Number (UTN)
Trial acronym
SIT2MIX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Timepoint [1] 0 0
Week 0 to Week 24
Secondary outcome [1] 0 0
Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c < 7.0%)
Timepoint [1] 0 0
After 24 weeks of treatment
Secondary outcome [2] 0 0
Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c = 6.5%)
Timepoint [2] 0 0
After 24 weeks of treatment
Secondary outcome [3] 0 0
Change From Baseline in Fasting Plasma Glucose (FPG)
Timepoint [3] 0 0
Week 0 to Week 24
Secondary outcome [4] 0 0
Prandial Plasma Glucose (PPG) Increments at Breakfast
Timepoint [4] 0 0
After 24 weeks of treatment
Secondary outcome [5] 0 0
Prandial Plasma Glucose (PPG) Increments at Lunch.
Timepoint [5] 0 0
After 24 weeks of treatment
Secondary outcome [6] 0 0
Prandial Plasma Glucose (PPG) Increments at Dinner.
Timepoint [6] 0 0
After 24 weeks of treatment
Secondary outcome [7] 0 0
Prandial Plasma Glucose (PPG) Overall Mean Increment.
Timepoint [7] 0 0
After 24 weeks of treatment
Secondary outcome [8] 0 0
Adverse Events (AEs)
Timepoint [8] 0 0
Week 0 to Week 24
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
Week 0 to Week 24
Secondary outcome [10] 0 0
Change From Baseline in Patient Reported Outcome by Use of the Treatment Related Impact Measure - Diabetes.
Timepoint [10] 0 0
Week 0 to Week 24

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2013
Sample size
Target
Accrual to date
Final
582
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Broadmeadow
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Coffs Harbour
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Caba
Country [3] 0 0
Argentina
State/province [3] 0 0
Mar del Plata
Country [4] 0 0
Argentina
State/province [4] 0 0
Morón
Country [5] 0 0
Brazil
State/province [5] 0 0
Sao Paulo
Country [6] 0 0
Brazil
State/province [6] 0 0
Brasília
Country [7] 0 0
Brazil
State/province [7] 0 0
Curitiba
Country [8] 0 0
Brazil
State/province [8] 0 0
Fortaleza
Country [9] 0 0
Brazil
State/province [9] 0 0
Porto Alegre
Country [10] 0 0
Greece
State/province [10] 0 0
Alexandroupolis
Country [11] 0 0
Greece
State/province [11] 0 0
Athens
Country [12] 0 0
Greece
State/province [12] 0 0
Thessaloniki
Country [13] 0 0
India
State/province [13] 0 0
Andhra Pradesh
Country [14] 0 0
India
State/province [14] 0 0
Gujarat
Country [15] 0 0
India
State/province [15] 0 0
Karnataka
Country [16] 0 0
India
State/province [16] 0 0
Kerala
Country [17] 0 0
India
State/province [17] 0 0
Maharashtra
Country [18] 0 0
India
State/province [18] 0 0
Punjab
Country [19] 0 0
India
State/province [19] 0 0
Tamil Nadu
Country [20] 0 0
India
State/province [20] 0 0
Uttar Pradesh
Country [21] 0 0
India
State/province [21] 0 0
West Bengal
Country [22] 0 0
India
State/province [22] 0 0
New Delhi
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Goyang
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Jeonju
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Pusan
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Pyungchon-Dong 896, Dongan-Gu
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Seoul
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Suwon
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Ulsan
Country [30] 0 0
Malaysia
State/province [30] 0 0
Penang
Country [31] 0 0
Malaysia
State/province [31] 0 0
Seremban
Country [32] 0 0
Portugal
State/province [32] 0 0
Coimbra
Country [33] 0 0
Portugal
State/province [33] 0 0
Lisboa
Country [34] 0 0
Portugal
State/province [34] 0 0
Matosinhos
Country [35] 0 0
Portugal
State/province [35] 0 0
Porto
Country [36] 0 0
Thailand
State/province [36] 0 0
Bangkok
Country [37] 0 0
Thailand
State/province [37] 0 0
Chiang Mai
Country [38] 0 0
Thailand
State/province [38] 0 0
Khon Kaen
Country [39] 0 0
Turkey
State/province [39] 0 0
Antalya
Country [40] 0 0
Turkey
State/province [40] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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

TypeCitations or Other Details
Journal Linjawi S, Sothiratnam R, Sari R, Andersen H, Hior... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT01519674