A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin
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.
1 other identifier
interventional
220
6 countries
47
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 diabetes-mellitus-type-2
Started Nov 2005
Typical duration for phase_2 diabetes-mellitus-type-2
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 15, 2005
CompletedFirst Posted
Study publicly available on registry
December 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedNovember 2, 2016
November 1, 2016
1.3 years
December 15, 2005
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c mean change from baseline compared with placebo.
Week 12
Secondary Outcomes (3)
Additional parameters of glycemic and lipid control.
Week 12
AEs, laboratory parameters.
Throughout study
Pharmacokinetic and exposure-response relationship
Throughout study
Study Arms (6)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
EXPERIMENTAL5
EXPERIMENTAL6
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- type 1 diabetes mellitus;
- any oral anti-hyperglycemic medication, other than metformin monotherapy, during last 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Unknown Facility
Phoenix, Arizona, 85012, United States
Unknown Facility
Chula Vista, California, 91910, United States
Unknown Facility
Los Angeles, California, 90057, United States
Unknown Facility
Kissimmee, Florida, 34741, United States
Unknown Facility
Tampa, Florida, 33603, United States
Unknown Facility
Lawrenceville, Georgia, 30045, United States
Unknown Facility
Arkansas City, Kansas, 67005, United States
Unknown Facility
Benzonia, Michigan, 49616, United States
Unknown Facility
Springfield, Missouri, 65804, United States
Unknown Facility
Butte, Montana, 59701, United States
Unknown Facility
Kettering, Ohio, 45429, United States
Unknown Facility
Tulsa, Oklahoma, 74104, United States
Unknown Facility
Medford, Oregon, 97504, United States
Unknown Facility
Morrisville, Pennsylvania, 19067, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
Memphis, Tennessee, 38119, United States
Unknown Facility
Bellevue, Washington, 98004, United States
Unknown Facility
Federal Way, Washington, 98003, United States
Unknown Facility
Adelaide, 5000, Australia
Unknown Facility
Heidelberg, 3081, Australia
Unknown Facility
Sydney, 2050, Australia
Unknown Facility
Edmonton, Alberta, T5N 3Y6, Canada
Unknown Facility
Vancouver, British Columbia, V5Z 1M9, Canada
Unknown Facility
London, Ontario, NGA 4V2, Canada
Unknown Facility
Montreal, Quebec, H1T 2M4, Canada
Unknown Facility
Sherbrooke, Quebec, J1H 4J6, Canada
Unknown Facility
Bammental, 69245, Germany
Unknown Facility
Berlin, 10115, Germany
Unknown Facility
Essen, 45355, Germany
Unknown Facility
Giessen, 35385, Germany
Unknown Facility
Görlitz, 02826, Germany
Unknown Facility
Hamburg, 20249, Germany
Unknown Facility
Künzing, 94550, Germany
Unknown Facility
Mannheim, 68161, Germany
Unknown Facility
Nuremberg, 90402, Germany
Unknown Facility
Tann, 36142, Germany
Unknown Facility
Alzira, 46600, Spain
Unknown Facility
Bacarot Alicant, 03114, Spain
Unknown Facility
Barakaldo, 48903, Spain
Unknown Facility
Barcelona, 08036, Spain
Unknown Facility
Dundee, DD1 5LA, United Kingdom
Unknown Facility
Frome, BA11 1EZ, United Kingdom
Unknown Facility
Glasgow, G45 9AW, United Kingdom
Unknown Facility
Liverpool, L9 7AL, United Kingdom
Unknown Facility
Motherwell, ML1 3JX, United Kingdom
Unknown Facility
Northwood, HA6 2RN, United Kingdom
Unknown Facility
Plymouth, PL6 7TH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2005
First Posted
December 16, 2005
Study Start
November 1, 2005
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
November 2, 2016
Record last verified: 2016-11