NCT01111955

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_2 diabetes-mellitus-type-2

Geographic Reach
3 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

October 12, 2015

Status Verified

September 1, 2015

Enrollment Period

6 months

First QC Date

April 26, 2010

Last Update Submit

September 23, 2015

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • 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

Study Arms (4)

BMS-823778 (2 mg)

ACTIVE COMPARATOR

\+ metformin

Drug: BMS-823778Drug: Metformin

BMS-823778 (10 mg)

ACTIVE COMPARATOR

\+ metformin

Drug: BMS-823778Drug: Metformin

BMS-823778 (20 mg)

ACTIVE COMPARATOR

\+ metformin

Drug: BMS-823778Drug: Metformin

Placebo

PLACEBO COMPARATOR

\+ metformin

Drug: PlaceboDrug: Metformin

Interventions

BMS-823778DRUG

Capsules, Oral, 2 mg, once daily, 28 days

BMS-823778 (2 mg)
PlaceboDRUG

Capsules, Oral, 0 mg, once daily, 28 days

Placebo
MetforminDRUG

Capsules, Oral, ≥ 1500 mg, once daily, 28 days

BMS-823778 (10 mg)BMS-823778 (2 mg)BMS-823778 (20 mg)Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Farid Marquez, Md

Hialeah, Florida, 33012, United States

Location

Capital Clinical Reserch Center

Olympia, Washington, 98502, United States

Location

Aurora Advanced Healthcare

Milwaukee, Wisconsin, 53209, United States

Location

Local Institution

Blacktown, New South Wales, 2148, Australia

Location

Local Institution

Box Hill, Victoria, 3128, Australia

Location

Local Institution

Freemantle, Western Australia, 6959, Australia

Location

Local Institution

Surrey, British Columbia, V4A 2H9, Canada

Location

Local Institution

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Local Institution

Bathurst, New Brunswick, E2A 4X7, Canada

Location

Local Institution

St. John's, Newfoundland and Labrador, A1A 3R5, Canada

Location

Local Institution

Thornhill, Ontario, L4J 8L7, Canada

Location

Local Institution

Mirabel, Quebec, J7J 2K8, Canada

Location

Local Institution

Québec, Quebec, G1N 4V3, Canada

Location

Local Institution

Saskatoon, Saskatchewan, S7K 7H9, Canada

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

BMS-823778Metformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2010

First Posted

April 28, 2010

Study Start

July 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

October 12, 2015

Record last verified: 2015-09

Locations

US(3)CA(8)AU(3)