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

Hoffmann-La Roche127 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

127

Conditions

Diabetes Mellitus Type 2

Interventions

GK Activator (2)DRUG

25-200mg po bid for 20 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (21)

Unnamed facility

Chandler, Arizona, United States

Unnamed facility

Oviedo, Florida, United States

Unnamed facility

Nampa, Idaho, United States

Outcomes

Primary Outcomes

Percentage of patients at each dose who achieve FPG <100mg/dL.

Time frame: Throughout study

Secondary Outcomes

Mean change in HbA1c and FPG from baseline to endpoint; absolute/relative changes in lipid profile.

Time frame: At intervals throughout study

AEs, laboratory parameters.

Time frame: Throughout study

Data from ClinicalTrials.gov

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