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

Roche

Status and phase: Terminated; Phase 3

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: metformin; Drug: insulin glargine; Drug: taspoglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01051011

ZC22565

Details and patient eligibility

About

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.

Enrollment: 370 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

370 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: metformin

Drug: taspoglutide

Drug: taspoglutide

2

Experimental group

Treatment:

Drug: metformin

Drug: taspoglutide

Drug: taspoglutide

3

Active Comparator group

Treatment:

Drug: metformin

Drug: insulin glargine