Proof of Confidence Study of CCR2 Antagonist (BMS-741672)... | NCT00699790

Studies
Proof of Confidence Study of CCR2 Antagonist (BMS-741672) in Insulin Resistance

NCT00699790

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Oct 12, 2015Estimated

Enrollment

58Actual

Phase

Phase 2

Conditions

Type 2 Diabetes

Interventions

CCR2 Antagonist
Placebo

Countries

Russia

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 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Jun 17, 2008

First Submission Date that Met QC Criteria

Jun 17, 2008

First Posted Date

Jun 18, 2008Estimated

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

Sep 23, 2015

Certification/Extension First Submitted that Passed QC Review

Sep 23, 2015

Certification/Extension First Posted Date

Oct 12, 2015Estimated

Last Update Submitted Date

Sep 23, 2015

Last Update Posted Date

Oct 12, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 purpose of the study is to determine whether a CCR2 antagonist (BMS-741672) improves glucose homeostasis in drug-naive type 2 diabetic patients

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

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A1	Experimental		Drug: CCR2 Antagonist
A2	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CCR2 Antagonist	Drug	Tablets, Oral, 50 mg, once daily, 12 weeks	A1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in HbA1c		after 12 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
Other glycemic, atherosclerosis, lipid and mechanism-based biomarkers will be measured		throughout the 12 weeks of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Drug-naive Type 2 diabetics with a screening HbA1c of ≥ 7.5% and ≤ 10%
Screening FPG ≥ 140 mg/dL and ≤ 220 mg/dL
BMI ≤ 40 kg/m2

Exclusion Criteria:

Active tuberculosis
Symptoms of poorly controlled diabetes
History of diabetic ketoacidosis
Significant cardiovascular history or gastrointestinal disorders
History of unstable or rapidly progressing renal disease
Active liver disease and/or significant abnormal liver function
Abnormal chest x-ray at screening indicative of tuberculosis or other infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Dzerzhnsky		140090	Russia
Local Institution

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided