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.

Phase 3

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: metformin; Drug: insulin glargine; Drug: taspoglutide

• Registration Number: NCT00755287
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-17
• Study First Submitted QC: 2008-09-17
• Study First Posted: 2008-09-18
• Study Start: 2008-11
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2016-07
• Disposition First Submitted: 2016-07-26
• Disposition First Submitted QC: 2016-07-26
• Last Update Submitted: 2016-07-27
• Disposition First Posted: 2016-07-28
• Last Update Posted: 2016-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1072

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
taspoglutide 10 mg	taspoglutide	taspoglutide 10 mg once weekly in addition to continued prestudy metformin treatment
taspoglutide 10 mg	metformin	taspoglutide 10 mg once weekly in addition to continued prestudy metformin treatment
insulin glargine	insulin glargine	insulin glargine starting dose 10 IU daily in addition to continued prestudy metformin treatment
insulin glargine	metformin	insulin glargine starting dose 10 IU daily in addition to continued prestudy metformin treatment
taspoglutide 10 mg/20 mg	metformin	taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) in addition to continued prestudy metformin treatment
taspoglutide 10 mg/20 mg	taspoglutide	taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) in addition to continued prestudy metformin treatment

Primary Outcome Measures

Name	Time	Method
Absolute change from baseline in HbA1c	24 weeks

Secondary Outcome Measures

Name	Time	Method
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