A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A 12-week Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate Safety, Tolerability, and Efficacy of GRC 8200, a New Oral DPP -IV Inhibitor, in Patients With Type 2 Diabetes Mellitus.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00836940
• Other study ID #: GRC 8200-301
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 3, 2009
• Last updated: September 23, 2009
• Start date: June 2008
• Est. completion date: October 2009

Study information

• Verified date: September 2009
• Source: Glenmark Pharmaceuticals Europe Ltd. (R&D)
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of IndiaIndia: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The study is aimed at evaluating efficacy and safety of GRC 8200 in type 2 diabetes mellitus patients.

The study involves six weeks of wash out period and two weeks run in period for patients currently on mono-therapy and a two week run in period only for drug naïve patients.

This is a placebo controlled study. One of the five treatment arms is placebo. The duration of treatment is 12 weeks.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 480
• Est. completion date: October 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients =30 years of age

• At screening, females of non-childbearing potential or females of childbearing potential with adequate contraception

• Has an established clinical diagnosis of type 2 diabetes mellitus for at least 3 months prior to the screening period

• Is being treated for diabetes either with diet and exercise alone, or on monotherapy with any of the antidiabetic drugs

• Has an HbA1c value at screening between 6.5% and 10%

Exclusion Criteria:

• Has type 1 diabetes

• Is a female who is lactating or is pregnant

• Has a history of acute metabolic diabetic complications

• Has clinically significant disease other than type 2 diabetes mellitus

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• GRC 8200
Capsules, 25 to 100mg, once/ twice a day, 12 weeks

Locations

Country	Name	City	State
India	Glenmark Investigational site	Mumbai

Sponsors (1)

Lead Sponsor	Collaborator
Glenmark Pharmaceuticals Europe Ltd. (R&D)

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c compared with placebo at the end of 12 week treatment period		12 weeks	No
Secondary	Change in HbA1c from baseline at the end of 4 and 8 weeks of treatment		4 and 8 weeks	No
Secondary	Fasting plasma glucose and fasting serum insulin		12 weeks	No
Secondary	Plasma glucose 2 hours post glucose challenge (OGTT)		12 weeks	No
Secondary	HOMA-IR		12 weeks	No
Secondary	HOMA-B		12 weeks	No
Secondary	Change in serum lipids		12 weeks	No
Secondary	Body weight		12 weeks	No
Secondary	Waist circumference		12 weeks	No