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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00809705
Recruitment Status : Completed
First Posted : December 17, 2008
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Placebo Drug: taspoglutide Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : December 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: taspoglutide
10mg sc once weekly for 12 weeks

Experimental: 2 Drug: taspoglutide
10mg sc once weekly for 4 weeks, followed by 20mg sc once weekly for 8 weeks

Placebo Comparator: 3 Drug: Placebo
sc once weekly for 12 weeks

Primary Outcome Measures :
  1. Tmax, log (AUC), log(Cmax)of paracetamol [ Time Frame: Days -1, 1, 5, 29, 33, 78 and 82 ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00809705

Berlin, Germany, 14050
Neuss, Germany, 41460
United Kingdom
London, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00809705     History of Changes
Other Study ID Numbers: BP21572
First Posted: December 17, 2008    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon-Like Peptide 1
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs