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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

An Open Label Study to Determine the Effect on Fasting Glucose Levels, and Safety, of Increasing Doses of GK Activator (2) in Patients With Type 2 Diabetes Not Optimally Controlled With One Previous Oral Antihyperglycemic Agent.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366379
• Other study ID #: BC19800
• Status: Completed
• Phase: Phase 2
• First received: August 16, 2006
• Last updated: November 1, 2016
• Start date: July 2006
• Est. completion date: June 2007

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• GK Activator (2)
25-200mg po bid for 20 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Estonia,  Latvia,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients at each dose who achieve FPG <100mg/dL.		Throughout study	No
Secondary	Mean change in HbA1c and FPG from baseline to endpoint; absolute/relative changes in lipid profile.		At intervals throughout study	No
Secondary	AEs, laboratory parameters.		Throughout study	No