Safety Study of BMS-823778 in Subjects With Type 2 Diabetes | NCT01111955

Studies
Safety Study of BMS-823778 in Subjects With Type 2 Diabetes

NCT01111955

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Oct 12, 2015Estimated

Enrollment

62Actual

Phase

Phase 2

Conditions

Diabetes Mellitus, Type 2

Interventions

BMS-823778
BMS-823778
BMS-823778
Placebo
Metformin

Countries

United States
Australia
Canada

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

Official Title

A Double-blind, Placebo-Controlled, Parallel-group, Randomized, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of BMS-823778 in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Either Diet and Exercise Alone or on a Background of Metformin

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

Jul 2010

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Apr 26, 2010

First Submission Date that Met QC Criteria

Apr 27, 2010

First Posted Date

Apr 28, 2010Estimated

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

Apr 25, 2012

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 this study is to assess the safety, tolerability and pharmacodynamic effects on fasting plasma glucose (FPG).

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

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BMS-823778 (2 mg)	Active Comparator	+ metformin	Drug: BMS-823778 Drug: Metformin
BMS-823778 (10 mg)	Active Comparator	+ metformin	Drug: BMS-823778 Drug: Metformin
BMS-823778 (20 mg)	Active Comparator	+ metformin	Drug: BMS-823778 Drug: Metformin
Placebo	Placebo Comparator	+ metformin	Drug: Placebo Drug: Metformin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-823778	Drug	Capsules, Oral, 2 mg, once daily, 28 days	BMS-823778 (2 mg)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lowering of fasting plasma glucose (FPG) throughout the study to see if there is a decrease from baseline		Within 28 days following dosing

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics (measuring trough concentrations)		On days 7, 14 and 28
Pharmacodynamics (measuring daily glucose, glucose AUC, HbA1c, lipid profiles, HPA markers, free testosterone, and SHBG)		Within 28 days following dosing

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetes mellitus
Drug naive or on stable metformin therapy
HbA1c 7-10%
FPG ≤ 240mg/dL

Exclusion Criteria:

History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study
Congestive heart failure
Active liver disease
Impaired renal function
Hepatitis C, B and HIV

This list is not inclusive; additional information is provided in the protocol

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 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
Farid Marquez, Md		Hialeah	Florida	33012	United States
Capital Clinical Reserch Center

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
C000624964	BMS-823778
D008687	Metformin

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided