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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01051011
• Other study ID #: ZC22565
• Status: Terminated
• Phase: Phase 3
• First received: January 15, 2010
• Last updated: November 1, 2016
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 370
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin glargine
initial dose 10 international units (IU) sc daily, titrated according to the mean FPG, 24 (-52) weeks
• metformin
as prescribed
• taspoglutide
10mg sc weekly, 24 (-52) weeks
• taspoglutide
10mg sc weekly the 1st 4 weeks followed by 20mg sc weekly, 24 (-52) weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

China,  Hong Kong,  Korea, Republic of,  Malaysia,  Philippines,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control assessed by HbA1c		week 24	No
Secondary	Fasting plasma glucose, incidence of hypoglycemia, proportion of patients achieving target HbA1c		week 24	No
Secondary	Body weight, lipid profile (triglycerides, total cholesterol, LDL and HDL cholesterol, LDL/HDL ratio)		week 24	No
Secondary	Safety and tolerability: Adverse events (including hypoglycemia), vital signs, laboratory parameters		throughout study, laboratory assessments weeks 12, 24, 32 and 52	No
Secondary	Meal tolerance test (in a subset of patients): Glucose, insulin, C-peptide, glucagon values		week 24	No