A Dose-Titration Study of GK Activator (2) in Patients With Type 2 Diabetes.

Roche

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: GK Activator (2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00366379

BC19800

Details and patient eligibility

About

This study will assess the efficacy, safety and tolerability of increasing doses of GK Activator (2) in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their previous antidiabetic therapy, patients will receive GK Activator (2) orally, twice a day for 12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a target fasting glucose level (FPG) of <100mg/dL. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Enrollment: 127 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, 18-75 years of age;
• type 2 diabetes mellitus treated with one oral antihyperglycemic agent for >=3 months prior to screening.

Exclusion criteria

• type 1 diabetes mellitus;
• treatment with insulin, PPAR agonists or systemic corticosteroids during the 3 months prior to screening;
• women who are pregnant, breast-feeding or not using adequate contraceptive methods.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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127 participants in 5 patient groups

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

Experimental group

Treatment:

Drug: GK Activator (2)