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.

A Multicenter, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naïve Type 2 Diabetic Patients Inadequately Controlled With Metformin and Sulphonylurea Combination Therapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00755287

Enrollment

1072

Registered

2008-09-18

Start date

2008-11-30

Completion date

2010-12-31

Last updated

2016-07-29

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 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.

Interventions

DRUGinsulin glargine

starting dose 10 IU daily

DRUGmetformin

As prescribed

DRUGtaspoglutide

10 mg once weekly

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 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.

Design outcomes

Primary

Measure	Time frame
Absolute change from baseline in HbA1c	24 weeks

Secondary

Measure	Time frame
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

Countries

Australia, Austria, Belgium, Brazil, Canada, Czechia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Italy, Mexico, New Zealand, Peru, Poland, Portugal, Puerto Rico, Russia, Serbia, South Korea, Spain, Thailand, United Kingdom, United States

Outcome results

None listed

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