Skip to main content
OpenTrials
Completed

NCT Number: NCT00811460

A Study of Taspoglutide 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

sc for 4 days

taspoglutide

Drug

300micrograms/day sc for 2 days

Primary outcomes

  1. Incremental area under insulin concentration time curve relative to basal insulin concentration

    Time frame: First 10 minutes after glucose bolus

Secondary outcomes

  1. Incremental area under insulin concentration time curve relative to basal insulin concentration

    Time frame: 10-120 minutes after glucose bolus

  2. Adverse events, laboratory parameters

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 19, 2008
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.