A Study of a GLP-1 Analogue in Patients With Type 2 Diabetes Treated With Metformin.

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: NCT00423501
Recruitment Status : Completed
First Posted : January 18, 2007
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple doses and regimens of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue, 5mg, 10mg or 20mg weekly, or 10mg or 20mg every 2 weeks. All patients will continue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind, Placebo-controlled, Dose-ranging Study to Investigate the Effect on Glycemic Control, Safety, Pharmacokinetics and Pharmacodynamics of GLP-1 in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.
Study Start Date : February 2007
Primary Completion Date : November 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: taspoglutide
5mg sc weekly
Experimental: 2 Drug: taspoglutide
10mg sc weekly
Experimental: 3 Drug: taspoglutide
20mg sc weekly
Experimental: 4 Drug: taspoglutide
10mg sc every 2 weeks
Experimental: 5 Drug: taspoglutide
20mg sc every 2 weeks
Placebo Comparator: 6 Drug: Placebo
sc weekly

Primary Outcome Measures :
  1. Absolute change from baseline in HbAlc [ Time Frame: Week 8 ]

Secondary Outcome Measures :
  1. Absolute change from baseline in FPG, fructosamine, body weight, fasting insulin, C-peptide, glucagon. [ Time Frame: Week 8 ]
  2. Changes in lipid profile [ Time Frame: Week 8 ]
  3. AEs, laboratory parameters, primary pharmacokinetic parameters [ 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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • type 2 diabetes mellitus, with stable metformin treatment for >=3 months;
  • stable weight +/-10% for >=3 months before screening.

Exclusion Criteria:

  • type 1 diabetes mellitus;
  • treatment with any anti-hyperglycemic medication other than metformin monotherapy during last 3 months;
  • use of weight-lowering medications in the last 3 months;
  • uncontrolled hypertension.

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): NCT00423501

  Hide Study Locations
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Georgia
Woodstock, Georgia, United States, 30189
United States, Illinois
Chicago, Illinois, United States, 60607
Springfield, Illinois, United States, 62704-1433
United States, New York
Rochester, New York, United States, 14609
United States, Oregon
Portland, Oregon, United States, 97239
United States, Texas
Dallas, Texas, United States, 75246
Midland, Texas, United States, 79707
San Antonio, Texas, United States, 78229
United States, Virginia
Richmond, Virginia, United States, 23249
Adelaide, Australia, 5000
Camperdown, Australia, 2050
Dimitrovgrad, Bulgaria, 6400
Pleven, Bulgaria, 5800
Ruse, Bulgaria, 7002
Sofia, Bulgaria, 1233
Sofia, Bulgaria, 1606
Varna, Bulgaria, 9010
Bad Lauterberg, Germany, 37431
Berlin, Germany, 10115
Görlitz, Germany, 02826
Hannover, Germany, 30167
Mainz, Germany, 55116
Neuss, Germany, 41460
Nürnberg, Germany, 90402
Guatemala City, Guatemala, 01015
Hong Kong
Hong Kong, Hong Kong
Riga, Latvia, 1002
Kaunas, Lithuania, 51270
Klaipeda, Lithuania, 92304
Vilnius, Lithuania, 08661
Guadalajara, Mexico, 44340
Guadalajara, Mexico, 44650
Mexico City, Mexico, 03100
Mexico City, Mexico, 11650
Mexico City, Mexico, 14080
Mexico City, Mexico, 14610
Monterrey, Mexico, 64460
Pachuca, Mexico, 42086
Brasov, Romania, 500365
Bucharest, Romania, 020475
Bucharest, Romania, 050452
Bucharest, Romania
Cluj-napoca, Romania, 400006
Jud Covasna, Romania, 520064
Mures, Romania, 540011
Ploiesti, Romania, 100163
Satu Mare, Romania, 3900
Sibiu, Romania, 550245
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT00423501     History of Changes
Other Study ID Numbers: BC20688
First Posted: January 18, 2007    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
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists