A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Glenmark Pharmaceuticals Europe Ltd. (R&D).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Glenmark Pharmaceuticals Europe Ltd. (R&D)
ClinicalTrials.gov Identifier:
NCT00836940
First received: February 3, 2009
Last updated: September 23, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: GRC 8200
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Glenmark Pharmaceuticals Europe Ltd. (R&D):

Primary Outcome Measures:
  • Change from baseline in HbA1c compared with placebo at the end of 12 week treatment period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HbA1c from baseline at the end of 4 and 8 weeks of treatment [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • Fasting plasma glucose and fasting serum insulin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Plasma glucose 2 hours post glucose challenge (OGTT) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • HOMA-IR [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • HOMA-B [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in serum lipids [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: June 2008
Estimated Study Completion Date: October 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: GRC 8200
Capsules, 25 to 100mg, once/ twice a day, 12 weeks
Experimental: 2
GRC 8200-25mg OD
Drug: GRC 8200
Capsules, 25 to 100mg, once/ twice a day, 12 weeks
Experimental: 3
GRC 8200-50mg OD
Drug: GRC 8200
Capsules, 25 to 100mg, once/ twice a day, 12 weeks
Experimental: 4
GRC 8200-50mg BD
Drug: GRC 8200
Capsules, 25 to 100mg, once/ twice a day, 12 weeks
Experimental: 5
GRC 8200-100mg OD
Drug: GRC 8200
Capsules, 25 to 100mg, once/ twice a day, 12 weeks

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836940

Locations
India
Glenmark Investigational site
Mumbai, India
Sponsors and Collaborators
Glenmark Pharmaceuticals Europe Ltd. (R&D)
  More Information

No publications provided

Responsible Party: Dr Manmath Patekar, Glenmark Pharmaceuticals ltd
ClinicalTrials.gov Identifier: NCT00836940     History of Changes
Other Study ID Numbers: GRC 8200-301
Study First Received: February 3, 2009
Last Updated: September 23, 2009
Health Authority: India: Drugs Controller General of India
India: Institutional Review Board

Keywords provided by Glenmark Pharmaceuticals Europe Ltd. (R&D):
Type 2 diabetes mellitus
GRC 8200

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 19, 2014