A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin

Roche

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: Metformin; Drug: GK Activator (2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00266253

BM18249

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 6 patient groups

1

Experimental group

Treatment:

Drug: Metformin

Drug: GK Activator (2)

2

Experimental group

Treatment:

Drug: Metformin

Drug: GK Activator (2)

3

Experimental group

Treatment:

Drug: Metformin

Drug: GK Activator (2)

4

Experimental group

Treatment:

Drug: Metformin

Drug: GK Activator (2)

5

Experimental group

Treatment:

Drug: Metformin

Drug: GK Activator (2)

6

Active Comparator group

Treatment:

Drug: Metformin