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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00423501
First received: January 17, 2007
Last updated: May 13, 2009
Last verified: May 2009
History of Changes
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
 Drug: GLP-1
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Absolute change from baseline in HbAlc [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute change from baseline in FPG, fructosamine, body weight, fasting insulin, C-peptide, glucagon. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Changes in lipid profile [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, primary pharmacokinetic parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 306
Study Completion Date: November 2007
Arms Assigned Interventions
Experimental: 1 Drug: GLP-1
5mg sc weekly
Experimental: 2 Drug: GLP-1
10mg sc weekly
Experimental: 3 Drug: GLP-1
20mg sc weekly
Experimental: 4 Drug: GLP-1
10mg sc every 2 weeks
Experimental: 5 Drug: GLP-1
20mg sc every 2 weeks
Placebo Comparator: 6 Drug: Placebo
sc weekly

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423501

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35205
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, 79705
United States, Virginia
Richmond, Virginia, United States, 23249
Australia
Adelaide, Australia, 5000
Sydney, Australia, 2050
Bulgaria
Dimitrovgrad, Bulgaria, 6400
Pleven, Bulgaria, 5800
Ruse, Bulgaria, 7002
Sofia, Bulgaria, 1606
Sofia, Bulgaria, 1233
Varna, Bulgaria, 9010
China
Hong Kong, China
Germany
Bad Lauterberg, Germany, 37431
Berlin, Germany, 10115
Görlitz, Germany, 02826
Hannover, Germany, 30167
Mainz, Germany, 55116
Neuss, Germany, 41460
Nürnberg, Germany, 90402
Guatemala
Guatemala City, Guatemala, 01015
Latvia
Riga, Latvia, 1002
Lithuania
Kaunas, Lithuania, 3036
Klaipeda, Lithuania, 92304
Vilnius, Lithuania, 08661
Mexico
Guadalajara, Mexico, 44340
Guadalajara, Mexico, 44650
Mexico City, Mexico, 14610
Mexico City, Mexico, 11650
Mexico City, Mexico, 14080
Mexico City, Mexico, 03100
Monterrey, Mexico, 64460
Pachuca, Mexico, 42090
Romania
Brasov, Romania, 500365
Bucharest, Romania, 020475
Bucharest, Romania
Bucharest, Romania, 050452
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00423501     History of Changes
Other Study ID Numbers: BC20688
Study First Received: January 17, 2007
Last Updated: May 13, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 21, 2013