Study MK0767 and Metformin in Type 2 Diabetic Patients (0... | NCT00543361

Studies
Study MK0767 and Metformin in Type 2 Diabetic Patients (0767-020)

NCT00543361

Sponsor

Merck Sharp & Dohme LLC

Status

Terminated

Last Update Posted

Jun 12, 2015Estimated

Enrollment

382Actual

Phase

Phase 3

Conditions

Diabetes Mellitus, Type 2

Interventions

MK0767
Comparator: placebo (unspecified)
Comparator: metformin

Countries

Not provided

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

Jun 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Dec 2003Actual

Completion Date

Dec 2003Actual

First Submitted Date

Oct 5, 2007

First Submission Date that Met QC Criteria

Oct 11, 2007

First Posted Date

Oct 15, 2007Estimated

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

Jun 11, 2015

Last Update Posted Date

Jun 12, 2015Estimated

Description Module

Brief Summary

The purpose of the study is to assess how MK0767, compared to Metformin, performs in lowering blood glucose levels in patients whose Type II diabetes is not controlled by diet and exercise.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

382Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description
MK0767	Drug	Duration of Treatment: 52 Weeks
Comparator: placebo (unspecified)	Drug	Duration of Treatment: 52 Weeks
Comparator: metformin	Drug	Duration of Treatment: 52 Weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
This study will assess the lipid lowering effectiveness of MK0767 compared to metformin over the course of 52 weeks.		over the course of 52 weeks

Secondary Outcomes

Measure	Description	Time Frame
MK0767 will be safe and well tolerated.		over the course of 52 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients are men and non-pregnant women ages 21 to 78 years
Patients either not on antihyperglycemic medications (>8 weeks), or being treated with a single oral antihyperglycemic agent & willing to discontinue therapy for the duration of the study

Exclusion Criteria:

Patient has history of type 1 diabetes mellitus and or history of ketoacidosis
Patients undergoing surgery within 30 days of Visit 1
Patients taking Warfin or Warfin-like anticoagulants
Patients on a weight loss program with on-going weight loss or starting an intensive exercise program within 4 weeks of Visit 1/Week 9

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

78 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

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

Intervention Browse Module

MeSH Terms

ID	Term
C487303	MK0767

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
MK0767-020
2007_627