Treatment Intensification With Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Inadequately Controlled on Sitagliptin and Metformin | RxWiki

Treatment Intensification With Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Inadequately Controlled on Sitagliptin and Metformin

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Diabetes Diabetes Mellitus, Type 2
Intervention	Drug: biphasic insulin aspart 30 Drug: biphasic insulin aspart 30 Drug: sitagliptin Drug: metformin
Phase	Phase 4
Sponsor	Novo Nordisk A/S
Responsible Party	Novo Nordisk A/S
ClinicalTrials.gov Identifier	NCT01519674
First Received	January 24, 2012
Last Updated	October 22, 2013
Last verified	October 2013

Tracking Information[ + expand ][ + ]

First Received Date	January 24, 2012
Last Updated Date	October 22, 2013
Start Date	June 2012
Estimated Primary Completion Date	October 2013
Current Primary Outcome Measures	Change from baseline in HbA1c (glycosylated haemoglobin) [Time Frame: Week 0, week 24] [Designated as safety issue: No]
Current Secondary Outcome Measures	Responder for HbA1c, proportion of subjects achieving pre-defined HbA1c targets [Time Frame: After 24 weeks of treatment] [Designated as safety issue: No] Change from baseline in fasting plasma glucose (FPG) [Time Frame: Week 0, week 24] [Designated as safety issue: No] Prandial plasma glucose (PPG) increments at each meal (breakfast, lunch and dinner) and overall mean increment [Time Frame: After 24 weeks of treatment] [Designated as safety issue: No] Adverse Events (AEs) [Time Frame: Weeks 0-24] [Designated as safety issue: No] 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 [Time Frame: Weeks 0-24] [Designated as safety issue: No] Change from baseline in Patient Reported Outcome by use of the Treatment Related Impact Measure - Diabetes [Time Frame: Week 0, week 24] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Treatment Intensification With Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Inadequately Controlled on Sitagliptin and Metformin
Official 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
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Diabetes Diabetes Mellitus, Type 2
Intervention	Drug: biphasic insulin aspart 30 BIAsp 30 will be injected subcutaneously (under the skin) twice daily. Individually adjusted dose. Drug: biphasic insulin aspart 30 BIAsp 30 will be injected subcutaneously (under the skin) once daily. Individually adjusted dose. Drug: sitagliptin Subjects will continue on their pre-trial sitagliptin treatment. Drug: metformin Subjects will continue on their pre-trial metformin treatment.
Study Arm (s)	Active Comparator: BIAsp 30 twice daily + sitagliptin + metformin Active Comparator: BIAsp 30 twice daily + metformin Active Comparator: BIAsp 30 once daily + sitagliptin + metformin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	582
Estimated Completion Date	October 2013
Estimated Primary Completion Date	October 2013
Eligibility Criteria	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 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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Argentina, Australia, Brazil, Greece, India, Korea, Republic of, Malaysia, Portugal, Thailand, Turkey

Administrative Information[ + expand ][ + ]

NCT Number	NCT01519674
Other Study ID Numbers	BIASP-3963
Has Data Monitoring Committee	No
Information Provided By	Novo Nordisk A/S
Study Sponsor	Novo Nordisk A/S
Collaborators	Not Provided
Investigators	Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Verification Date	October 2013

Locations[ + expand ][ + ]

Argentina	Buenos Aires, Argentina, B1704ETD
Australia, New South Wales	Broadmeadow, New South Wales, Australia, 2292
Brazil	Porto Alegre, Brazil, 90035-170
Greece	Athens, Greece, 17562
India, Karnataka	Bangalore, Karnataka, India, 560043
Korea, Republic of	Seoul, Korea, Republic of, 110-744
Malaysia	Penang, Malaysia, 10459
Portugal	Lisboa, Portugal, 1649-035
Thailand	Bangkok, Thailand, 10400
Turkey	Istanbul, Turkey, 34360