A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide Compared to Placebo, in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00744926

Enrollment

373

Registered

2008-09-01

Start date

2008-08-31

Completion date

2010-04-30

Last updated

2016-07-28

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 placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg sc once weekly, taspoglutide 20mg sc once weekly (after 4 weeks of taspoglutide 10mg sc once weekly) or placebo. After the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.

Interventions

DRUGplacebo

sc, once weekly

DRUGtaspoglutide

10mg sc, once weekly

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* adult patients, 18-80 years of age; * drug naive patients with type 2 diabetes uncontrolled with diet and exercise; * tested negative for anti-glutamic acid decarboxylase (anti-GAD) antibodies; * C-peptide (fasting) \>=1.0ng/mL * HbA1c \>=6.5% 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; * 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
Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.	Throughout study
Change from baseline in fasting plasma glucose; change from baseline in body weight.	24 weeks
Responder rates for HbA1c (target <=7.0%, <=6.5%); relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function.	24 weeks

Countries

Australia, Guatemala, Israel, Mexico, Peru, Romania, Russia, Slovakia, Taiwan, Ukraine, United States

Outcome results

None listed

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