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

Phase 3

Terminated

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

• Registration Number: NCT01051011
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-15
• Study First Submitted QC: 2010-01-15
• Study First Posted: 2010-01-18
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 370

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	metformin	-
2	taspoglutide	-
3	metformin	-
2	metformin	-
3	insulin glargine	-
1	taspoglutide	-

Primary Outcome Measures

Name	Time	Method
Glycemic control assessed by HbA1c	week 24

Secondary Outcome Measures

Name	Time	Method
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