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CompletedNCT01046422Updated Oct 12, 2015

Safety Study of BMS-770767 in Subjects With Type 2 Diabetes

A Phase 2 interventional study of BMS-770767 and BMS-770767 in Diabetes Type 2, sponsored by Bristol-Myers Squibb. Completed at 18 sites in 4 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-10-12.

Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

03

In context

Diabetes Mellitus

10,926 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 76 is close to the median of 80 across 8,368 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
76 participants (actual)

Study arms

  • Experimental
    BMS-770767 ± metformin (Treatment A)

    Drug: BMS-770767 · Drug: Metformin

  • Experimental
    BMS-770767 ± metformin (Treatment B)

    Drug: BMS-770767 · Drug: Metformin

  • Experimental
    BMS-770767 ± metformin (Treatment C)

    Drug: BMS-770767 · Drug: Metformin

  • Experimental
    BMS-770767 ± metformin (Treatment D)

    Drug: BMS-770767 · Drug: Metformin

  • Placebo comparator
    Placebo ± metformin (Treatment E)

    Drug: Placebo · Drug: Metformin

Interventions

  • DrugBMS-770767

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

  • DrugBMS-770767

    Capsule, Oral, 50mg, Active, Daily, 28 days

  • DrugBMS-770767

    Capsule, Oral, 150mg, Active, Daily, 28 days

  • DrugBMS-770767

    Capsule, Oral, 50mg BID, Active, Daily, 28 days

  • DrugPlacebo

    Capsule, Oral, 0mg, Daily, 28 days

  • DrugMetformin

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

06

What researchers measure

Primary outcomes

  1. Fasting Plasma Glucose Improvement

    Time frame: Within seven days following dosing

Secondary outcomes

  1. Mean daily glucose (3-day 7 pt-fingerstick)

    Time frame: Within 28 days following dosing

  2. Four (4)-hour post-prandial glucose AUC

    Time frame: Within 28 days following dosing

  3. HbA1C

    Time frame: Within 28 days following dosing

  4. Lipid profiles

    Time frame: Within 28 days following dosing

07

Study locations

18 sites
  • Marina Raikhel, Md
    Lomita, California 90717, United States
  • Nevada Alliance Against Diabetes
    Las Vegas, Nevada 89101, United States
  • Local Institution
    Caboolture, Queensland 4510, Australia
  • Local Institution
    Meadowbrook, Queensland 4131, Australia
  • Local Institution
    Daw Park, South Australia 5041, Australia
  • Local Institution
    Geelong, Victoria 3220, Australia
  • Local Institution
    Nedlands, Western Australia 6009, Australia
  • Local Institution
    Winnipeg, Manitoba R3P 1R9, Canada
  • Local Institution
    Mount Pearl, Newfoundland and Labrador A1N 1W7, Canada
  • Local Institution
    Brampton, Ontario L6T 3J1, Canada
  • Local Institution
    Toronto, Ontario M4G 3E8, Canada
  • Local Institution
    Charlottetown, Prince Edward Island C1A 5Y9, Canada
  • Local Institution
    Drummondville, Quebec J2B 7T1, Canada
  • Local Institution
    Lachine, Quebec H8S 2E4, Canada
  • Local Institution
    Laval, Quebec H7T 2P5, Canada
  • Local Institution
    Montreal, Quebec H3J 2V5, Canada
  • Local Institution
    Incheon, 405-760, Korea, Republic of
  • Local Institution
    Suwon, 443-721, Korea, Republic of
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01046422
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Jan 12, 2010
Start date
May 2010
Primary completion
Jan 2011
Completion
Jan 2011
Last update
Oct 12, 2015

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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