A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone.

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00744367

Enrollment

326

Registered

2008-09-01

Start date

2008-10-31

Completion date

2010-11-30

Last updated

2016-08-05

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 of taspoglutide on glycemic control (as assessed by HbA1c) in patients with type 2 diabetes mellitus inadequately controlled with metformin plus pioglitazone, compared to placebo after 24 weeks of treatment. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg once weekly, taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) or placebo, in addition to their continued stable metformin plus pioglitazone treatment. 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 1-2 years, and the target sample size is 100-500 individuals.

Interventions

DRUGmetformin

\>1500 mg/day or maximum tolerated dose (MTD)

DRUGpioglitazone

\>= 30 mg/day

DRUGplacebo

sc once weekly

DRUGtaspoglutide

10 mg 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 75 Years

Healthy volunteers

Inclusion criteria

* adult patients, 18-75 years age; * type 2 diabetes receiving pioglitazone (\>= 30 mg/day) and metformin (\>= 1500 mg/day) for at least 12 weeks prior to screening; * HbA1c \>=7.0% and \<=10.0% at screening; * BMI \>= 25 (\>23 for Asians) and \<=45 kg/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; * 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%); responder rates for body weight; beta cell function.	24 weeks
Safety: adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.	Throughout the study

Countries

Brazil, Canada, Costa Rica, France, Germany, Guatemala, Mexico, Puerto Rico, United States

Outcome results

None listed

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