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NCT Number: NCT00809705

A Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 Diabetes

This 3 arm, placebo-controlled study will investigate the effect of Taspoglutide on gastric emptying in patients with type 2 diabetes. Patients will be randomized into one of 3 groups to receive a)10mg Taspoglutide sc weekly for 12 weeks b)10mg Taspoglutide sc weekly for 4 weeks followed by 20mg Taspoglutide sc weekly for 8 weeks or c) placebo sc weekly for 12 weeks, with all injections administered in the abdomen.Gastric emptying will be assessed by a paracetamol test at intervals during the study. The anticipated time on study treatment is 3 months, and the target sample size is <100 individuals.

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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–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult patients, 18-75 years of age;
  • type 2 diabetes mellitus, treated with stable oral antidiabetic drug therapy for >=3 months prior to screening;
  • stable weight +/-10% for >=3 months before screening.

Exclusion criteria

  • type 1 diabetes mellitus;
  • acute gastrointestinal symptoms at screening and/or day -1;
  • clinically relevant cardiovascular, bronchopulmonary, gastrointestinal or neurological disease.

Treatment and study plan

Placebo

Drug

sc once weekly for 12 weeks

taspoglutide

Drug

10mg sc once weekly for 4 weeks, followed by 20mg sc once weekly for 8 weeks

Primary outcomes

  1. Tmax, log (AUC), log(Cmax)of paracetamol

    Time frame: Days -1, 1, 5, 29, 33, 78 and 82

Secondary outcomes

  1. Adverse events, laboratory parameters, vital signs

    Time frame: Throughout study

  2. renal function (creatinine clearance, urine volume and electrolytes)

    Time frame: Throughout study

  3. Multiple dose pharmacokinetics of Taspoglutide

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Investigate the Effect of Taspoglutide on Gastric Emptying Measured by a Paracetamol Test After Single Dose and After Multiple Doses in Patients With Type 2 Diabetes

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 17, 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.

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