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

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.

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 2
• Intervention / Treatment: Drug: GK Activator (2)

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Phase 2

Contacts and Locations

Study Locations

• Estonia
  • Tallinn, Estonia, 10138
  • Tartu, Estonia, 50406
  • Tartu, Estonia, 51014
  • Tartu, Estonia, 50708
• Latvia
  • Jelgava, Latvia, 3001
  • Riga, Latvia, 1002
  • Riga, Latvia, 1038
• Mexico
  • Chihuahua, Mexico, 31238
  • Guadalajara, Mexico, 44340
  • Guadalajara, Mexico, 44650
  • Pachuca, Mexico, 42086
• United States
  • Arizona
    • Chandler, Arizona, United States, 85225
  • Florida
    • Oviedo, Florida, United States, 32765
  • Idaho
    • Nampa, Idaho, United States, 83687
  • Indiana
    • Evansville, Indiana, United States, 47714
  • Montana
    • Butte, Montana, United States, 59701
  • Ohio
    • Canton, Ohio, United States, 44718
  • Oregon
    • Portland, Oregon, United States, 97239
  • South Carolina
    • Greer, South Carolina, United States, 29651
  • Texas
    • Midland, Texas, United States, 79707
  • Virginia
    • Richmond, Virginia, United States, 23249

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: GK Activator (2); 25-200mg po bid for 20 weeks
Experimental: 2	Drug: GK Activator (2); 25-200mg po bid for 20 weeks
Experimental: 3	Drug: GK Activator (2); 25-200mg po bid for 20 weeks
Experimental: 4	Drug: GK Activator (2); 25-200mg po bid for 20 weeks
Experimental: 5	Drug: GK Activator (2); 25-200mg po bid for 20 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients at each dose who achieve FPG <100mg/dL.	Throughout study

Secondary Outcome Measures

Outcome Measure	Time Frame
AEs, laboratory parameters.	Throughout study
Mean change in HbA1c and FPG from baseline to endpoint; absolute/relative changes in lipid profile.	At intervals throughout study

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: August 16, 2006
• First Submitted That Met QC Criteria: August 18, 2006
• First Posted (Estimate): August 21, 2006

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: BC19800

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No