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

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.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01051011

Enrollment

370

Registered

2010-01-18

Start date

2010-01-31

Completion date

2010-12-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

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.

Interventions

DRUGinsulin glargine

initial dose 10 international units (IU) sc daily, titrated according to the mean FPG, 24 (-52) weeks

DRUGmetformin

as prescribed

DRUGtaspoglutide

10mg sc weekly, 24 (-52) weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Glycemic control assessed by HbA1c	week 24

Secondary

Measure	Time frame
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

Countries

China, Hong Kong, Malaysia, Philippines, South Korea, Taiwan, Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026