A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy. After an initial screening period, patients will be randomized to one of 3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, and the target sample size is 500+ individuals.

Official Title
-----------------
A Multicenter, Randomized, Double Blind (Double Dummy), Active Controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Pioglitazone in Type 2 Diabetes Patients Inadequately Controlled on Therapy With Sulfonylurea or Metformin Plus Sulfonylurea

Conditions
-----------------
Diabetes Mellitus Type 2

Intervention / Treatment
-----------------
* Drug: pioglitazone
* Drug: taspoglutide
* Drug: taspoglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, 18-75 years of age; type 2 diabetes mellitus; treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for >=12 weeks prior to screening; HbA1c >=7.0% and <=10% at screening; stable weight +/-5% for >=12 weeks prior to screening. Exclusion Criteria: type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes; clinically significant diabetic complications; clinically symptomatic gastrointestinal disease; >3 episodes of severe hypoglycemia within 6 months before screening.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pioglitazone<br> | Drug: pioglitazone<br>* 30mg po once daily for 4 weeks, followed by 45mg once daily<br>|
| Experimental: taspoglutide 10mg<br>taspoglutide 10mg sc weekly | Drug: taspoglutide<br>* 10mg sc once weekly<br>|
| Experimental: taspoglutide 10mg/20mg<br>taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly | Drug: taspoglutide<br>* 10mg sc once weekly for 4 weeks, followed by 20 mg sc once weekly<br>|

What is the study measuring?
-----------------
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 |
| --- | --- | --- |
| Proportion of patients achieving target HbA1c <=6.5%, <=7% |  | weeks 24, 52 and 104 | 
| Absolute/percentage change from baseline in body weight; responder rate for body weight; absolute/percentage change from baseline in waist and hip circumference;absolute/percentage change from baseline in fasting plasma glucose |  | weeks 24, 52 and 104 | 
| Adverse events; laboratory parameters; cardiovascular events |  | At each clinic visit up to 106 weeks |