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.

Sponsors

Lead Sponsor: Hoffmann-La Roche

Source Hoffmann-La Roche
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.

Overall Status Completed
Start Date November 2005
Completion Date March 2007
Primary Completion Date March 2007
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
HbA1c mean change from baseline compared with placebo. Week 12
Secondary Outcome
Measure Time Frame
Additional parameters of glycemic and lipid control. Week 12
AEs, laboratory parameters. Throughout study
Pharmacokinetic and exposure-response relationship Throughout study
Enrollment 220
Condition
Intervention

Intervention Type: Drug

Intervention Name: GK Activator (2)

Description: Escalating doses, po bid or qd for 12 weeks.

Intervention Type: Drug

Intervention Name: Metformin

Description: As prescribed, for 12 weeks

Eligibility

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

Gender: All

Minimum Age: 30 Years

Maximum Age: 75 Years

Healthy Volunteers: No

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

Australia

Canada

Germany

Spain

United Kingdom

United States

Verification Date

November 2016

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 6
Arm Group

Label: 1

Type: Experimental

Label: 2

Type: Experimental

Label: 3

Type: Experimental

Label: 4

Type: Experimental

Label: 5

Type: Experimental

Label: 6

Type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov