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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:
ClinicalTrials.gov Identifier:
NCT00266253
First Posted: December 16, 2005
Last Update Posted: November 2, 2016
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.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of GK Activator (2) in combination with metformin, compared to that of placebo (metformin monotherapy), in patients with type 2 diabetes mellitus. Patients will 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 less 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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Additional parameters of glycemic and lipid control. [ Time Frame: Week 12 ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ]
  • Pharmacokinetic and exposure-response relationship [ Time Frame: Throughout study ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00266253


  Show 47 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00266253     History of Changes
Other Study ID Numbers: BM18249
First Submitted: December 15, 2005
First Posted: December 16, 2005
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
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs