A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.

Diabetes Mellitus Type 2 Clinical Trial

Official title:

A Multicenter, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naïve Type 2 Diabetic Patients Inadequately Controlled With Metformin and Sulphonylurea Combination Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755287
• Other study ID #: BC20965
• Secondary ID: 2008-001855-23
• Status: Completed
• Phase: Phase 3
• First received: September 17, 2008
• Last updated: July 27, 2016
• Start date: November 2008
• Est. completion date: December 2010

Study information

• Verified date: July 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 to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea combination therapy. Patients will be randomized to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to continued prestudy metformin treatment. The anticipated time on study treatment is 2+ years, and the target sample size if 500+ individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1072
• Est. completion date: December 2010
• Est. primary completion date: December 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 treated with a stable dose of metformin and sulphonylurea for at least 12 weeks;

• C-peptide (fasting) >=1.0ng/mL;

• HbA1c >=7.0% 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;

• 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.

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:
• insulin glargine
starting dose 10 IU daily
• metformin
As prescribed
• taspoglutide
10 mg once weekly
• taspoglutide
20 mg once weekly (after 4 weeks of taspoglutide 10 mg 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,  Austria,  Belgium,  Brazil,  Canada,  Czech Republic,  Finland,  France,  Germany,  Greece,  Guatemala,  Hong Kong,  Hungary,  Italy,  Korea, Republic of,  Mexico,  New Zealand,  Peru,  Poland,  Portugal,  Puerto Rico,  Russian Federation,  Serbia,  Spain,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change from baseline in HbA1c		24 weeks	No
Secondary	Change from baseline in fasting plasma glucose; change from baseline in body weight; responder rates for HbA1c (target <=7.0%, <=6.5%); incidence of hypoglycemia; change from baseline in lipid profile.		24 weeks	No
Secondary	Relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test.		24 weeks	No
Secondary	Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies		Throughout study	No