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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909597
• Other study ID #: BC21893
• Secondary ID: 2009-009157-24
• Status: Completed
• Phase: Phase 3
• First received: May 27, 2009
• Last updated: November 1, 2016
• Start date: May 2009
• Est. completion date: November 2010

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 756
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• pioglitazone
30mg po once daily for 4 weeks, followed by 45mg once daily
• taspoglutide
10mg sc once weekly
• taspoglutide
10mg sc once weekly for 4 weeks, followed by 20 mg sc once weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change from baseline in HbA1c		24 weeks	No
Secondary	Proportion of patients achieving target HbA1c <=6.5%, <=7%		weeks 24, 52 and 104	No
Secondary	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	No
Secondary	Adverse events; laboratory parameters; cardiovascular events		At each clinic visit up to 106 weeks	No