A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus
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
1 other identifier
interventional
267
7 countries
44
Brief Summary
This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral GK Activator (2), compared to placebo, in patients with type 2 diabetes mellitus. 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 P75+ for phase_2 diabetes-mellitus-type-2
Started Nov 2005
Typical duration for phase_2 diabetes-mellitus-type-2
44 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
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedNovember 2, 2016
November 1, 2016
1.5 years
December 15, 2005
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c mean change from baseline, compared to 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 (5)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
EXPERIMENTAL5
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- adult patients 30-75 years of age;
- type 2 diabetes mellitus for \>3 months before screening;
- treatment-naive, inadequately controlled diabetes despite diet and exercise, or inadequately controlled diabetes in patients on monotherapy or combination therapy (maximum of 2 oral anti-hyperglycemic medications).
You may not qualify if:
- type 1 diabetes mellitus;
- women who are pregnant, breast-feeding or not using adequate contraceptive methods.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Unknown Facility
Tucson, Arizona, 85723, United States
Unknown Facility
Pine Bluff, Arkansas, 71603, United States
Unknown Facility
Chula Vista, California, 91911, United States
Unknown Facility
Spring Valley, California, 91978, United States
Unknown Facility
West Hills, California, 91307, United States
Unknown Facility
Hollywood, Florida, 33021, United States
Unknown Facility
Atlanta, Georgia, 30308, United States
Unknown Facility
Binghamton, New York, 13901, United States
Unknown Facility
Fayetteville, North Carolina, 28304, United States
Unknown Facility
Statesville, North Carolina, 28625, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Springdale, Ohio, 45246, United States
Unknown Facility
Oklahoma City, Oklahoma, 73112, United States
Unknown Facility
Medford, Oregon, 97504, United States
Unknown Facility
Beaver, Pennsylvania, 15009, United States
Unknown Facility
Tipton, Pennsylvania, 16684, United States
Unknown Facility
Mt. Pleasant, South Carolina, 29464, United States
Unknown Facility
Plano, Texas, 75093, United States
Unknown Facility
Renton, Washington, 98055, United States
Unknown Facility
Dimitrovgrad, 6400, Bulgaria
Unknown Facility
Pleven, 5800, Bulgaria
Unknown Facility
Rousse, 7002, Bulgaria
Unknown Facility
Sofia, 1233, Bulgaria
Unknown Facility
Sofia, 1303, Bulgaria
Unknown Facility
Sofia, 1431, Bulgaria
Unknown Facility
Sofia, 1606, Bulgaria
Unknown Facility
Zagreb, 10000, Croatia
Unknown Facility
Guatemala City, 01015, Guatemala
Unknown Facility
Budapest, 1083, Hungary
Unknown Facility
Budapest, 1088, Hungary
Unknown Facility
Győr, 9024, Hungary
Unknown Facility
Kecskemét, 6000, Hungary
Unknown Facility
Chihuahua City, 31238, Mexico
Unknown Facility
Cuernavaca, 62250, Mexico
Unknown Facility
Durango, 34070, Mexico
Unknown Facility
Mexico City, 06700, Mexico
Unknown Facility
Mexico City, 11650, Mexico
Unknown Facility
Mexico City, 14050, Mexico
Unknown Facility
Mexico City, 14610, Mexico
Unknown Facility
Bialystok, 15-276, Poland
Unknown Facility
Gdansk, 80-757, Poland
Unknown Facility
Gorzów, 66-400, Poland
Unknown Facility
Krakow, 31-121, Poland
Unknown Facility
Wroclaw, 50-088, Poland
MeSH Terms
Conditions
Condition 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
May 1, 2007
Study Completion
May 1, 2007
Last Updated
November 2, 2016
Record last verified: 2016-11