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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00460941
First received: April 16, 2007
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This 4 arm study will evaluate the tolerability, efficacy and pharmacodynamics o f different doses of a GLP-1 analogue in patients with type 2 diabetes who are t reated with a stable dose of metformin. Patients will be randomized to receive e ither subcutaneous placebo, or subcutaneous GLP-1 analogue (at a dose of 20mg, o r a starting dose of 20mg escalating to either 30mg or 40mg), weekly. All patien ts will continue on their existing metformin treatment regimen throughout the st udy. 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: Placebo
Drug: taspoglutide
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 Titration Study to Investigate the Tolerability, Safety and Pharmacodynamic Profile of a GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients withdrawn because of gastrointestinal effects [ Time Frame: Week 9 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean changes in 24h blood glucose AUC, FPG, fructosamine, HbAlc, body weight, AEs, laboratory parameters. [ Time Frame: Week 9 ] [ Designated as safety issue: No ]

Enrollment: 133
Study Start Date: April 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: taspoglutide
20mg sc weekly
Experimental: 2 Drug: taspoglutide
20mg-30mg sc weekly
Experimental: 3 Drug: taspoglutide
20mg-40mg sc weekly
Placebo Comparator: 4 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:

  • male,and post-menopausal or surgically sterilized female, patients, 18-75 years of age;
  • type 2 diabetes mellitus, with stable metformin treatment for >=3 months;
  • HbA1c >=7.0% and <=9.5% at screening;
  • stable weight +/-10% for >=3 months before screening.

Exclusion Criteria:

  • type 1 diabetes mellitus;
  • clinically significant gastrointestinal disease;
  • 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;
  • previous exposure to GLP-1 or GLP-1 analogues.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460941

  Hide Study Locations
Locations
United States, Arkansas
Harrisburg, Arkansas, United States, 72432
Hot Springs, Arkansas, United States, 71913
Jonesboro, Arkansas, United States, 72401
United States, California
National City, California, United States, 91950
United States, Florida
Jacksonville, Florida, United States, 32216
United States, Kentucky
Madisonville, Kentucky, United States, 42431
United States, Maryland
Hyattsville, Maryland, United States, 20783
United States, North Carolina
Winston-salem, North Carolina, United States, 27103
United States, Texas
Dallas, Texas, United States, 75231
Dallas, Texas, United States, 75230
United States, Virginia
Richmond, Virginia, United States, 23294
Australia
Adelaide, Australia, 5000
Camperdown, Australia, 2050
France
Besancon, France, 25030
Corbeil Essonnes, France, 91106
Narbonne, France, 11108
Paris, France, 75877
Poitiers, France, 86021
Germany
Berlin, Germany, 10115
München, Germany, 80636
Neuss, Germany, 41460
Mexico
Chihuahua, Mexico, 31238
Culiacan, Mexico, 80020
Monterrey, Mexico, 64410
Tampico, Mexico, 89109
Peru
Lima, Peru, 31
Lima, Peru, 10
Lima, Peru, LIMA 29
Puerto Rico
Ponce, Puerto Rico, 00716
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: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00460941     History of Changes
Other Study ID Numbers: BC20728
Study First Received: April 16, 2007
Last Updated: August 26, 2014
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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014