A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus

Roche

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00266240

BM18248

Details and patient eligibility

About

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.

Enrollment: 267 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 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).

Exclusion criteria

• type 1 diabetes mellitus;
• women who are pregnant, breast-feeding or not using adequate contraceptive methods.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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267 participants in 5 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: GK Activator (2)

2

Experimental group

Treatment:

Drug: GK Activator (2)

3

Experimental group

Treatment:

Drug: GK Activator (2)

4

Experimental group

Treatment:

Drug: GK Activator (2)

5

Placebo Comparator group

Treatment:

Drug: Placebo