Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes | RxWiki

Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes

Overview[ - collapse ][ - ]

Purpose	This trial is conducted in Asia, Europe and North America. This trial aims for comparison of the effect on the glycemic control in subjects with type 2 diabetes of basal insulin analogue with one oral anti-diabetic drug (OAD) versus oral anti-diabetic drug alone.
Condition	Diabetes Diabetes Mellitus, Type 2
Intervention	Drug: insulin detemir Drug: sitagliptin Drug: metformin Drug: sulphonylurea
Phase	Phase 3
Sponsor	Novo Nordisk A/S
Responsible Party	Novo Nordisk A/S
ClinicalTrials.gov Identifier	NCT00789191
First Received	November 10, 2008
Last Updated	June 26, 2012
Last verified	June 2012

Tracking Information[ + expand ][ + ]

First Received Date	November 10, 2008
Last Updated Date	June 26, 2012
Start Date	November 2008
Estimated Primary Completion Date	August 2009
Current Primary Outcome Measures	HbA1c (Glycosylated Haemoglobin A1c) [Time Frame: Week 26] [Designated as safety issue: No]
Current Secondary Outcome Measures	Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% [Time Frame: Week 26] [Designated as safety issue: No] Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia [Time Frame: Week 26] [Designated as safety issue: No]Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% [Time Frame: Week 26] [Designated as safety issue: No] Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia [Time Frame: Week 26] [Designated as safety issue: No]Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia Change in BMI (Body Mass Index) [Time Frame: Week 0, Week 26] [Designated as safety issue: No] Change in Body Weight [Time Frame: Week 0, Week 26] [Designated as safety issue: No] FPG (Fasting Plasma Glucose) [Time Frame: Week 26] [Designated as safety issue: No] Hypoglycemic Episodes [Time Frame: Weeks 0-26] [Designated as safety issue: No]Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L Hypoglycemic Episodes: Day Time [Time Frame: Weeks 0-26] [Designated as safety issue: No]Day time: Episodes between 6 pm and 11 am. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L Hypoglycemic Episodes: Night Time [Time Frame: Weeks 0-26] [Designated as safety issue: No]Night time: Episodes between 11 am and 6 pm. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L Self-measured 9-point Plasma Glucose Profile [Time Frame: Week 26] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes
Official Title	Effect of Detemir and Sitagliptin on Blood Glucose Control in Subjects With Type 2 Diabetes Mellitus
Brief Summary	This trial is conducted in Asia, Europe and North America. This trial aims for comparison of the effect on the glycemic control in subjects with type 2 diabetes of basal insulin analogue with one oral anti-diabetic drug (OAD) versus oral anti-diabetic drug alone.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
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: insulin detemir The detemir insulin dose is injected subcutaneously (under the skin) once daily in the evening and will be titrated (individually adjusted) weekly throughout the trial. Drug: sitagliptin The sitagliptin dose is 100 mg/ day and should be kept stable throughout the trial. Frequency of sitagliptin is once daily. Drug: metformin Metformin treatment with at least 1000 mg/ day. Dose and dosing frequency should remain unchanged throughout the trial. Drug: sulphonylurea Sulphonylurea (SU) dose and dosing frequency should initially remain unchanged. In case of hypoglycaemia SU dose may be reduced at the discretion of the investigator.
Study Arm (s)	Experimental: Comb Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment Active Comparator: Sita Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	222
Estimated Completion Date	August 2009
Estimated Primary Completion Date	August 2009
Eligibility Criteria	Inclusion Criteria: - Diagnosed with type 2 diabetes for at least 6 months before trial start - Treatment with at least 1000 mg metformin per day for at least 3 months - Insulin-naive (short-term insulin treatment of up to 14 days is allowed) - DPP-4 (dipeptidyl peptidase-4) inhibitor naive - HbA1c (glycosylated haemoglobin A1c) between 7.5-10.0% by central laboratory analysis - BMI (Body Mass Index) lesser than or equal to 45.0 kg/m2 - Able and willing to take one subcutaneous injection every day - Able and willing to perform mandatory SMPG (self measured plasma glucose) measurements Exclusion Criteria: - Known or suspected allergy or intolerance to any of the trial products or related products - Severe hypertension - Treatment with thiazolidinedione (TZD) or GLP-1 (glucagon-like peptide-1) analogues within 2 months prior to trial start - Cardiac disease, within the last 12 months - Impaired hepatic function - Impaired renal function - Proliferative retinopathy or macular oedema requiring acute treatment - Female of childbearing potential - Known or suspected abuse of alcohol, narcotics or illicit substances
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States, Canada, Finland, France, Hungary, Korea, Republic of, Slovakia, Turkey

Administrative Information[ + expand ][ + ]

NCT Number	NCT00789191
Other Study ID Numbers	NN304-3511
Has Data Monitoring Committee	No
Information Provided By	Novo Nordisk A/S
Study Sponsor	Novo Nordisk A/S
Collaborators	Not Provided
Investigators	Study Director: Tine Møller Jørgensen, M.Sc. Pharm Novo Nordisk A/S
Verification Date	June 2012

Locations[ + expand ][ + ]

Novo Nordisk Clinical Trial Call Center	Orange, California, United States, 92869
Novo Nordisk Clinical Trial Call Center	Santa Monica, California, United States, 90404
Novo Nordisk Clinical Trial Call Center	Dunwoody, Georgia, United States, 30338
Novo Nordisk Clinical Trial Call Center	Vestavia, Georgia, United States, 35209
Novo Nordisk Clinical Trial Call Center	West Seneca, New York, United States, 14224
Novo Nordisk Clinical Trial Call Center	Cincinnati, Ohio, United States, 45245
Novo Nordisk Clinical Trial Call Center	Dayton, Ohio, United States, 45439
Novo Nordisk Clinical Trial Call Center	Norristown, Pennsylvania, United States, 19401
Novo Nordisk Clinical Trial Call Center	Chattanooga, Tennessee, United States, 37411
Novo Nordisk Clinical Trial Call Center	Dallas, Texas, United States, 75246
Canada, British Columbia	Coquitlam, British Columbia, Canada, V3K 3P4
Finland	Pieksämäki, Finland, 76100
France	Narbonne, France, 11108
Hungary	Budapest, Hungary, H-1212
Korea, Republic of	Incheon, Korea, Republic of, 400-103
Slovakia	Bratislava, Slovakia, 831 01
Turkey	Izmit, Turkey, 41380