A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.

Study Overview
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Brief Summary
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This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea combination therapy. Patients will be randomized to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to continued prestudy metformin treatment. The anticipated time on study treatment is 2+ years, and the target sample size if 500+ individuals.

Official Title
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A Multicenter, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naïve Type 2 Diabetic Patients Inadequately Controlled With Metformin and Sulphonylurea Combination Therapy

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Drug: insulin glargine
* Drug: metformin
* Drug: taspoglutide
* Drug: taspoglutide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients, 18-75 years of age; type 2 diabetes treated with a stable dose of metformin and sulphonylurea for at least 12 weeks; C-peptide (fasting) >=1.0ng/mL; HbA1c >=7.0% and <=10.0% at screening; BMI >=25 (>23 for Asians) and <=45kg/m2 at screening; stable weight +-5% for at least 12 weeks prior to screening. Exclusion Criteria: history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months; evidence of clinically significant diabetic complications; symptomatic poorly controlled diabetes; clinically symptomatic gastrointestinal disease; myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months; known hemoglobinopathy or chronic anemia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Active Comparator: insulin glargine<br>insulin glargine starting dose 10 IU daily in addition to continued prestudy metformin treatment | Drug: insulin glargine<br>* starting dose 10 IU daily<br>Drug: metformin<br>* As prescribed<br>|
| Experimental: taspoglutide 10 mg<br>taspoglutide 10 mg once weekly in addition to continued prestudy metformin treatment | Drug: metformin<br>* As prescribed<br>Drug: taspoglutide<br>* 10 mg once weekly<br>|
| Experimental: taspoglutide 10 mg/20 mg<br>taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) in addition to continued prestudy metformin treatment | Drug: metformin<br>* As prescribed<br>Drug: taspoglutide<br>* 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline in HbA1c |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fasting plasma glucose; change from baseline in body weight; responder rates for HbA1c (target <=7.0%, <=6.5%); incidence of hypoglycemia; change from baseline in lipid profile. |  | 24 weeks | 
| Relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test. |  | 24 weeks | 
| Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies |  | Throughout study |