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

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Detemir and Sitagliptin on Blood Glucose Control in Subjects With Type 2 Diabetes Mellitus

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: insulin detemir
* Drug: sitagliptin
* Drug: metformin
* Drug: sulphonylurea


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comb<br>Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment | Drug: insulin detemir<br>* 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.<br>Drug: sitagliptin<br>* The sitagliptin dose is 100 mg/ day and should be kept stable throughout the trial. Frequency of sitagliptin is once daily.<br>Drug: metformin<br>* Metformin treatment with at least 1000 mg/ day. Dose and dosing frequency should remain unchanged throughout the trial.<br>|
| Active Comparator: Sita<br>Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment | Drug: sitagliptin<br>* The sitagliptin dose is 100 mg/ day and should be kept stable throughout the trial. Frequency of sitagliptin is once daily.<br>Drug: metformin<br>* Metformin treatment with at least 1000 mg/ day. Dose and dosing frequency should remain unchanged throughout the trial.<br>Drug: sulphonylurea<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (Glycosylated Haemoglobin A1c) |  | Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% |  | Week 26 | 
| Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia | Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia | Week 26 | 
| Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% |  | Week 26 | 
| Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia | Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia | Week 26 | 
| Change in BMI (Body Mass Index) |  | Week 0, Week 26 | 
| Change in Body Weight |  | Week 0, Week 26 | 
| FPG (Fasting Plasma Glucose) |  | Week 26 | 
| Hypoglycemic Episodes | Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L | Weeks 0-26 | 
| Hypoglycemic Episodes: Day Time | 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 | Weeks 0-26 | 
| Hypoglycemic Episodes: Night Time | 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 | Weeks 0-26 | 
| Self-measured 9-point Plasma Glucose Profile |  | Week 26 |