A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00266253
First received: December 15, 2005
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This study will evaluate the efficacy, safety, tolerability, and pharmacokinetic s of GK Activator (2) in combination with metformin, compared to that of placebo (metformin monotherapy), in patients with type 2 diabetes mellitus. Patients wi ll continue on their stable dose of metformin and will be randomized to receive either GK Activator (2) or placebo. The anticipated time on study treatment is l ess than 3 months, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: GK Activator (2)
Drug: Metformin
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 Randomized Double-blind Study to Determine the Effect of GK Activator (2) on Efficacy (HbA1c), Safety, Tolerability and Pharmacokinetics 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:
  • HbA1c mean change from baseline compared with placebo. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Additional parameters of glycemic and lipid control. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Pharmacokinetic and exposure-response relationship [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 220
Study Start Date: November 2005
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: GK Activator (2)
Escalating doses, po bid or qd for 12 weeks.
Drug: Metformin
As prescribed, for 12 weeks
Experimental: 2 Drug: GK Activator (2)
Escalating doses, po bid or qd for 12 weeks.
Drug: Metformin
As prescribed, for 12 weeks
Experimental: 3 Drug: GK Activator (2)
Escalating doses, po bid or qd for 12 weeks.
Drug: Metformin
As prescribed, for 12 weeks
Experimental: 4 Drug: GK Activator (2)
Escalating doses, po bid or qd for 12 weeks.
Drug: Metformin
As prescribed, for 12 weeks
Experimental: 5 Drug: GK Activator (2)
Escalating doses, po bid or qd for 12 weeks.
Drug: Metformin
As prescribed, for 12 weeks
Active Comparator: 6 Drug: Metformin
As prescribed, for 12 weeks

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients 30-75 years of age;
  • type 2 diabetes mellitus;
  • individual maximal tolerated daily dose of metformin monotherapy for >=3 months prior to screening.

Exclusion Criteria:

  • type 1 diabetes mellitus;
  • any oral anti-hyperglycemic medication, other than metformin monotherapy, during last 3 months
  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: NCT00266253

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States, 85012
United States, California
Chula Vista, California, United States, 91910
Los Angeles, California, United States, 90057
United States, Florida
Kissimmee, Florida, United States, 34741
Tampa, Florida, United States, 33603
United States, Georgia
Lawrenceville, Georgia, United States, 30045
United States, Kansas
Arkansas City, Kansas, United States, 67005
United States, Michigan
Benzonia, Michigan, United States, 49616
United States, Missouri
Springfield, Missouri, United States, 65804
United States, Montana
Butte, Montana, United States, 59701
United States, Ohio
Kettering, Ohio, United States, 45429
United States, Oklahoma
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Medford, Oregon, United States, 97504
United States, Pennsylvania
Morrisville, Pennsylvania, United States, 19067
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Memphis, Tennessee, United States, 38119
United States, Washington
Bellevue, Washington, United States, 98004
Federal Way, Washington, United States, 98003
Australia
Adelaide, Australia, 5000
Heidelberg, Australia, 3081
Sydney, Australia, 2050
Canada, Alberta
Edmonton, Alberta, Canada, T5N 3Y6
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
London, Ontario, Canada, NGA 4V2
Canada, Quebec
Montreal, Quebec, Canada, H1T 2M4
Sherbrooke, Quebec, Canada, J1H 4J6
Germany
Bammental, Germany, 69245
Berlin, Germany, 10115
Essen, Germany, 45355
Giessen, Germany, 35385
Görlitz, Germany, 02826
Hamburg, Germany, 20249
Kuenzing, Germany, 94550
Mannheim, Germany, 68161
Nürnberg, Germany, 90402
Tann, Germany, 36142
Spain
Alzira, Spain, 46600
Bacarot Alicant, Spain, 03114
Baracaldo, Spain, 48903
Barcelona, Spain, 08036
United Kingdom
Dundee, United Kingdom, DD1 5LA
Frome, United Kingdom, BA11 1EZ
Glasgow, United Kingdom, G45 9AW
Liverpool, United Kingdom, L9 7AL
Motherwell, United Kingdom, ML1 3JX
Northwood, United Kingdom, HA6 2RN
Plymouth, United Kingdom, PL6 7TH
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00266253     History of Changes
Other Study ID Numbers: BM18249
Study First Received: December 15, 2005
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014