A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.

Diabetes Mellitus Type 2 Clinical Trial

Official title:

Randomized, Active Controlled, Open Label Study to Compare Taspoglutide vs Exenatide as add-on Treatment to Metformin and/or Thiazolidinediones in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717457
• Other study ID #: BC21625
• Secondary ID: 2008-001856-36
• Status: Completed
• Phase: Phase 3
• First received: July 16, 2008
• Last updated: November 1, 2016
• Start date: July 2008
• Est. completion date: March 2011

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 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is >500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1189
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• 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 receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks;

• HbA1c >=7.0% and <=10% at screening;

• BMI >=25kg/m2 (>23kg/m2 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, diabetes resulting from pancreatic injury or secondary forms of diabetes;

• history of acute metabolic diabetic complications within the previous 6 months;

• evidence of clinically significant diabetic complications;

• known proliferative diabetic retinopathy;

• myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months;

• any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator;

• known hemoglobinopathy or chronic anemia;

• clinically significant gastrointestinal disease.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• exenatide
5mg twice daily for 4 weeks followed by 10mg twice daily
• taspoglutide
10mg once weekly
• taspoglutide
10mg once weekly for 4 weeks followed by 20mg 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,  Argentina,  Australia,  Brazil,  Canada,  Denmark,  Finland,  France,  Germany,  Greece,  Guatemala,  Israel,  Italy,  Korea, Republic of,  Mexico,  New Zealand,  Peru,  Puerto Rico,  Russian Federation,  South Africa,  Spain,  Sweden,  Switzerland,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c		24 weeks	No
Secondary	Fasting body weight		24 weeks	No
Secondary	Proportion of patients reaching target HbA1c <=7.0%, <=6.5%		24 weeks	No
Secondary	Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients.		24 weeks	No
Secondary	Beta cell function (proinsulin/insulin ratio)		24 weeks	No