A Study of Taspoglutide in Type 2 Diabetic Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 2
• Intervention / Treatment: Drug: Placebo; Drug: taspoglutide; Drug: taspoglutide

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, 41460

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Placebo; sc for 4 days; Drug: taspoglutide; 300micrograms/day sc for 2 days; Drug: taspoglutide; 800 micrograms/day sc for 2 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incremental area under insulin concentration time curve relative to basal insulin concentration	First 10 minutes after glucose bolus

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events, laboratory parameters	Throughout study
Incremental area under insulin concentration time curve relative to basal insulin concentration	10-120 minutes after glucose bolus

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: December 18, 2008
• First Submitted That Met QC Criteria: December 18, 2008
• First Posted (Estimate): December 19, 2008

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Glucagon-Like Peptide 1
• Other Study ID Numbers: BP21844; 2008-003582-97