A Study to Compare Taspoglutide and Insulin Glargine in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Sulfonylurea Combination Therapy

Study Overview
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Brief Summary
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This randomized, open-label, parallel arm study will compare the safety, tolerability and effect on glycemic control of taspoglutide versus insulin glargine in insulin-naïve patients with type 2 diabetes mellitus inadequately controlled on merformin and sulfonylurea combination therapy. Patients will be randomized to receive either taspoglutide 10mg subcutaneously (sc) weekly, or taspoglutide 10mg sc weekly for 4 weeks followed by 20mg sc weekly, or insulin glargine at an initial dose of 10 international units sc daily. Metformin treatment will be continued in all patients throughout the study, whereas sulfonylurea will be discontinued before starting study treatment. Anticipated time on study treatment is 24 weeks, with an option to continue the assigned treatment for another 28 weeks. Target sample size is 500-600 patients.

Official Title
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A Multi-center, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naive 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 mellitus, treated with stable dose of metformin and sulfonylurea for >/= 12 weeks prior to screening HbA1c 7-10% at screening body weight stable (+/-5%) for >/= 12 weeks prior to screening fasting C-peptide >/=1ng/ml treatment-naïve for insulin Exclusion Criteria: diagnosis or history of type 1 diabetes mellitus or secondary forms of diabetes acute metabolic diabetic complications or evidence of clinically significant diabetic complications clinically symptomatic gastrointestinal disease history of chronic pancreatitis or acute idiopathic pancreatitis >3 episodes of severe hypoglycemia within 6 months prior to screening miocardial infarcion, unstable angina pectoris, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within 6 months prior to screening any treatment with exenatide, exendin analogues, GLP-1 or its analogues

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 |
| --- | --- |
| Experimental: 1<br> | Drug: metformin<br>* as prescribed<br>Drug: taspoglutide<br>* 10mg sc weekly, 24 (-52) weeks<br>|
| Experimental: 2<br> | Drug: metformin<br>* as prescribed<br>Drug: taspoglutide<br>* 10mg sc weekly the 1st 4 weeks followed by 20mg sc weekly, 24 (-52) weeks<br>|
| Active Comparator: 3<br> | Drug: insulin glargine<br>* initial dose 10 international units (IU) sc daily, titrated according to the mean FPG, 24 (-52) weeks<br>Drug: metformin<br>* as prescribed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control assessed by HbA1c |  | week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma glucose, incidence of hypoglycemia, proportion of patients achieving target HbA1c |  | week 24 | 
| Body weight, lipid profile (triglycerides, total cholesterol, LDL and HDL cholesterol, LDL/HDL ratio) |  | week 24 | 
| Safety and tolerability: Adverse events (including hypoglycemia), vital signs, laboratory parameters |  | throughout study, laboratory assessments weeks 12, 24, 32 and 52 | 
| Meal tolerance test (in a subset of patients): Glucose, insulin, C-peptide, glucagon values |  | week 24 |