NCT01046422

Brief Summary

The purpose of this study is to determine if BMS-770767 is safe, well tolerated, measure its levels in the blood (pharmacokinetics), and measure the levels of chemicals (biomarkers) that may be affected by this drug (pharmacodynamics) in a type 2 diabetes patient population

Trial Health

90
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2010

Shorter than P25 for phase_2

Geographic Reach
4 countries

18 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

January 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
8 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

8 months

First QC Date

January 11, 2010

Last Update Submit

September 23, 2015

Conditions

Diabetes Type 2

Outcome Measures

Primary Outcomes (1)

  • Fasting Plasma Glucose Improvement

    Within seven days following dosing

Secondary Outcomes (4)

  • Mean daily glucose (3-day 7 pt-fingerstick)

    Within 28 days following dosing

  • Four (4)-hour post-prandial glucose AUC

    Within 28 days following dosing

  • HbA1C

    Within 28 days following dosing

  • Lipid profiles

    Within 28 days following dosing

Study Arms (5)

BMS-770767 ± metformin (Treatment A)

EXPERIMENTAL
Drug: BMS-770767Drug: Metformin

BMS-770767 ± metformin (Treatment B)

EXPERIMENTAL
Drug: BMS-770767Drug: Metformin

BMS-770767 ± metformin (Treatment C)

EXPERIMENTAL
Drug: BMS-770767Drug: Metformin

BMS-770767 ± metformin (Treatment D)

EXPERIMENTAL
Drug: BMS-770767Drug: Metformin

Placebo ± metformin (Treatment E)

PLACEBO COMPARATOR
Drug: PlaceboDrug: Metformin

Interventions

BMS-770767DRUG

Capsule, Oral, 15mg, Active, Daily, 28 days

BMS-770767 ± metformin (Treatment A)
PlaceboDRUG

Capsule, Oral, 0mg, Daily, 28 days

Placebo ± metformin (Treatment E)
MetforminDRUG

Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days

BMS-770767 ± metformin (Treatment A)BMS-770767 ± metformin (Treatment B)BMS-770767 ± metformin (Treatment C)BMS-770767 ± metformin (Treatment D)Placebo ± metformin (Treatment E)

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with type 2 diabetes with inadequate glycemic control and treated with either diet and exercise alone, or with stable doses (≥ 1500mg/d) of metformin for at least 8 weeks prior to screening
  • HbA1c ≥ 7.0% and ≤ 10.0% with FPG ≤ 240mg/dL (13.3 mmol/dL)

You may not qualify if:

  • Women of childbearing potential
  • History of diabetic ketoacidosis or hyperosmolar nonketotic coma
  • Significant cardiovascular history
  • History of unstable or rapidly progressing renal disease
  • Impaired renal function defined by a serum creatinine \> 1.4mg/dL (124 µmol/L) for women and \>1.5mg/dL (133 µmol/L) for men
  • Active liver disease and /or significant abnormal liver function defined as AST \> 3X ULN and/or ALT \> 3XULN and /or serum total bilirubin \> 2.0mg/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Marina Raikhel, Md

Lomita, California, 90717, United States

Location

Nevada Alliance Against Diabetes

Las Vegas, Nevada, 89101, United States

Location

Local Institution

Caboolture, Queensland, 4510, Australia

Location

Local Institution

Meadowbrook, Queensland, 4131, Australia

Location

Local Institution

Daw Park, South Australia, 5041, Australia

Location

Local Institution

Geelong, Victoria, 3220, Australia

Location

Local Institution

Nedlands, Western Australia, 6009, Australia

Location

Local Institution

Winnipeg, Manitoba, R3P 1R9, Canada

Location

Local Institution

Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada

Location

Local Institution

Brampton, Ontario, L6T 3J1, Canada

Location

Local Institution

Toronto, Ontario, M4G 3E8, Canada

Location

Local Institution

Charlottetown, Prince Edward Island, C1A 5Y9, Canada

Location

Local Institution

Drummondville, Quebec, J2B 7T1, Canada

Location

Local Institution

Lachine, Quebec, H8S 2E4, Canada

Location

Local Institution

Laval, Quebec, H7T 2P5, Canada

Location

Local Institution

Montreal, Quebec, H3J 2V5, Canada

Location

Local Institution

Incheon, 405-760, South Korea

Location

Local Institution

Suwon, 443-721, South Korea

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

BMS-770767Metformin

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, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2010

First Posted

January 12, 2010

Study Start

May 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

October 12, 2015

Record last verified: 2015-09

Locations

CA(9)KR(2)US(2)AU(5)