A Study of Taspoglutide in Type 2 Diabetic Patients

Diabetes Mellitus Type 2 Clinical Trial

Official title:

A Double-blind, Crossover, Randomized, Placebo-controlled Study to Investigate the Effect of Two Different Doses of Taspoglutide IRF Administered as Continuous Subcutaneous Infusion on First- and Second-phase Insulin Secretion in Type 2 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00811460
• Other study ID #: BP21844
• Secondary ID: 2008-003582-97
• Status: Completed
• Phase: Phase 1
• First received: December 18, 2008
• Last updated: November 1, 2016
• Start date: November 2008
• Est. completion date: August 2009

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany:BfArM
• Study type: Interventional

Clinical Trial Summary

This crossover study will assess the effect of 2 doses of Taspoglutide on first- and second-phase insulin secretion in patients with type 2 diabetes. Patients will receive a continuous subcutaneous infusion of a)the Immediate Release Formulation (IRF)of Taspoglutide 300 micrograms/day for 2 days followed by Taspoglutide 800 micrograms/day for 2 days or b)saline placebo for 2+2 days. After a washout period of 10-15 days, patients will be crossed-over for further treatment;those receiving Taspoglutide in period 1 will receive placebo in period 2, and vice versa. On days 2 and 4 of each period, insulin secretion patterns will be assessed. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• adult patients, 18-65 years of age;

• type 2 diabetes mellitus;

• treated with diet and exercise alone, or in combination with stable metformin for at least 3 months prior to screening.

Exclusion Criteria:

• type 1 diabetes mellitus;

• type 2 diabetes duration of <3 months;

• treatment with any oral anti-hyperglycemic medication other than metformin monotherapy during last 3 months;

• treatment with insulin for >7 days within 6 months prior to screening.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover 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:
• Placebo
sc for 4 days
• taspoglutide
300micrograms/day sc for 2 days
• taspoglutide
800 micrograms/day sc for 2 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental area under insulin concentration time curve relative to basal insulin concentration		First 10 minutes after glucose bolus	No
Secondary	Incremental area under insulin concentration time curve relative to basal insulin concentration		10-120 minutes after glucose bolus	No
Secondary	Adverse events, laboratory parameters		Throughout study	No