A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus | NCT00836940

Studies
A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus

NCT00836940

Sponsor

Glenmark Pharmaceuticals Europe Ltd. (R&D)

Status

Unknown status

Last Update Posted

Sep 24, 2009Estimated

Enrollment

480Estimated

Phase

Phase 2

Conditions

Type 2 Diabetes Mellitus

Interventions

GRC 8200

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

May 2009Actual

Completion Date

Oct 2009Estimated

First Submitted Date

Feb 3, 2009

First Submission Date that Met QC Criteria

Feb 3, 2009

First Posted Date

Feb 4, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2009

Last Update Posted Date

Sep 24, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

480Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator		Drug: GRC 8200
2	Experimental	GRC 8200-25mg OD	Drug: GRC 8200
3	Experimental	GRC 8200-50mg OD	Drug: GRC 8200
4	Experimental	GRC 8200-50mg BD	Drug: GRC 8200
5	Experimental	GRC 8200-100mg OD	Drug: GRC 8200

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GRC 8200	Drug	Capsules, 25 to 100mg, once/ twice a day, 12 weeks	1 2 3 4 5

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in HbA1c compared with placebo at the end of 12 week treatment period		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in HbA1c from baseline at the end of 4 and 8 weeks of treatment		4 and 8 weeks
Fasting plasma glucose and fasting serum insulin		12 weeks
Plasma glucose 2 hours post glucose challenge (OGTT)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glenmark Investigational site		Mumbai			India

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided