A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes

A Multicenter, Randomized, Double Blind (Double Dummy), Active Controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Pioglitazone in Type 2 Diabetes Patients Inadequately Controlled on Therapy With Sulfonylurea or Metformin Plus Sulfonylurea

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00909597

Enrollment

756

Registered

2009-05-28

Start date

2009-05-31

Completion date

2010-11-30

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 double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy. After an initial screening period, patients will be randomized to one of 3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, and the target sample size is 500+ individuals.

Interventions

DRUGpioglitazone

30mg po once daily for 4 weeks, followed by 45mg once daily

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 75 Years

Healthy volunteers

Inclusion criteria

* adult patients, 18-75 years of age; * type 2 diabetes mellitus; * treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for \>=12 weeks prior to screening; * HbA1c \>=7.0% and \<=10% at screening; * stable weight +/-5% for \>=12 weeks prior to screening.

Exclusion criteria

* type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes; * clinically significant diabetic complications; * clinically symptomatic gastrointestinal disease; * \>3 episodes of severe hypoglycemia within 6 months before screening.

Design outcomes

Primary

Measure	Time frame
Absolute change from baseline in HbA1c	24 weeks

Secondary

Measure	Time frame
Proportion of patients achieving target HbA1c <=6.5%, <=7%	weeks 24, 52 and 104
Absolute/percentage change from baseline in body weight; responder rate for body weight; absolute/percentage change from baseline in waist and hip circumference;absolute/percentage change from baseline in fasting plasma glucose	weeks 24, 52 and 104
Adverse events; laboratory parameters; cardiovascular events	At each clinic visit up to 106 weeks

Countries

Australia, Brazil, Canada, Costa Rica, France, Germany, Mexico, New Zealand, Peru, Poland, Puerto Rico, Russia, Slovakia, South Africa, Spain, Thailand, Ukraine, United Kingdom, United States

Outcome results

None listed

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