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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

A Randomized, Double-blind Study to Determine the Effect of GK Activator (2) on Efficacy (HbA1c), Safety, Tolerability and Pharmacokinetics in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00266240
• Other study ID #: BM18248
• Status: Completed
• Phase: Phase 2
• First received: December 15, 2005
• Last updated: November 1, 2016
• Start date: November 2005
• Est. completion date: May 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• GK Activator (2)
Escalating doses po bid
• Placebo
po bid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Bulgaria,  Croatia,  Guatemala,  Hungary,  Mexico,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c mean change from baseline, compared to placebo.		Week 12	No
Secondary	Additional parameters of glycemic and lipid control.		Week 12	No
Secondary	AEs, laboratory parameters.		Throughout study	No
Secondary	Pharmacokinetic and exposure-response relationship		Throughout study	No