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.

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 2
• Intervention / Treatment: Drug: GK Activator (2); Drug: Metformin

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, 5000
  • Heidelberg, Australia, 3081
  • Sydney, Australia, 2050
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5N 3Y6
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
  • Ontario
    • London, Ontario, Canada, NGA 4V2
  • 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
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
  • California
    • Chula Vista, California, United States, 91910
    • Los Angeles, California, United States, 90057
  • Florida
    • Kissimmee, Florida, United States, 34741
    • Tampa, Florida, United States, 33603
  • Georgia
    • Lawrenceville, Georgia, United States, 30045
  • Kansas
    • Arkansas City, Kansas, United States, 67005
  • Michigan
    • Benzonia, Michigan, United States, 49616
  • Missouri
    • Springfield, Missouri, United States, 65804
  • Montana
    • Butte, Montana, United States, 59701
  • Ohio
    • Kettering, Ohio, United States, 45429
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
  • Oregon
    • Medford, Oregon, United States, 97504
  • Pennsylvania
    • Morrisville, Pennsylvania, United States, 19067
    • Philadelphia, Pennsylvania, United States, 19107
  • Tennessee
    • Memphis, Tennessee, United States, 38119
  • Washington
    • Bellevue, Washington, United States, 98004
    • Federal Way, Washington, United States, 98003

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HbA1c mean change from baseline compared with placebo.	Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
AEs, laboratory parameters.	Throughout study
Additional parameters of glycemic and lipid control.	Week 12
Pharmacokinetic and exposure-response relationship	Throughout study

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): March 1, 2007
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: December 15, 2005
• First Submitted That Met QC Criteria: December 15, 2005
• First Posted (Estimate): December 16, 2005

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: BM18249