Diabetes Type 2Phase 2NCT01046422
Safety Study of BMS-770767 in Subjects With Type 2 Diabetes
A Phase 2 study testing BMS-770767 and Metformin in people with Diabetes Type 2, run by Bristol-Myers Squibb at 18 sites in 4 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- BMS-770767 and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 18 sitesin 4 countries
- Study dates
- May 2010to Jan 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
Canada9 sites
Local Institution
Brampton, Ontario, L6T 3J1
Local Institution
Charlottetown, Prince Edward Island, C1A 5Y9
Local Institution
Drummondville, Quebec, J2B 7T1
Local Institution
Lachine, Quebec, H8S 2E4
Local Institution
Laval, Quebec, H7T 2P5
Local Institution
Montreal, Quebec, H3J 2V5
Local Institution
Mount Pearl, Newfoundland and Labrador, A1N 1W7
Local Institution
Toronto, Ontario, M4G 3E8
Local Institution
Winnipeg, Manitoba, R3P 1R9
Australia5 sites
Local Institution
Caboolture, Queensland, 4510
Local Institution
Daw Park, South Australia, 5041
Local Institution
Geelong, Victoria, 3220
Local Institution
Meadowbrook, Queensland, 4131
Local Institution
Nedlands, Western Australia, 6009
United States2 sites
Nevada Alliance Against Diabetes
Las Vegas, Nevada, 89101
Marina Raikhel, Md
Lomita, California, 90717
South Korea2 sites
Local Institution
Incheon, 405-760
Local Institution
Suwon, 443-721
About this study
Official title: A Double-blind, Placebo-Controlled, Parallel-group, Randomized, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of BMS-770767 in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Either Diet and Exercise Alone or on a Background of Metformin
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
- Conditions
- Diabetes Type 2
- Being tested
- BMS-770767, Placebo, Metformin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-770767Drug
Capsule, Oral, 15mg, Active, Daily, 28 days
BMS-770767Drug
Capsule, Oral, 50mg, Active, Daily, 28 days
BMS-770767Drug
Capsule, Oral, 150mg, Active, Daily, 28 days
BMS-770767Drug
Capsule, Oral, 50mg BID, Active, Daily, 28 days
PlaceboDrug
Capsule, Oral, 0mg, Daily, 28 days
MetforminDrug
Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days
| Study group | Role | What they receive |
|---|---|---|
| BMS-770767 ± metformin (Treatment A) | Experimental | Not described Receives: Drug: BMS-770767; Drug: Metformin |
| BMS-770767 ± metformin (Treatment B) | Experimental | Not described Receives: Drug: BMS-770767; Drug: Metformin |
| BMS-770767 ± metformin (Treatment C) | Experimental | Not described Receives: Drug: BMS-770767; Drug: Metformin |
| BMS-770767 ± metformin (Treatment D) | Experimental | Not described Receives: Drug: BMS-770767; Drug: Metformin |
| Placebo ± metformin (Treatment E) | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Plasma Glucose Improvement
Measured: Within seven days following dosing
Secondary outcomes (4)
Mean daily glucose (3-day 7 pt-fingerstick)
Measured: Within 28 days following dosing
Four (4)-hour post-prandial glucose AUC
Measured: Within 28 days following dosing
HbA1C
Measured: Within 28 days following dosing
Lipid profiles
Measured: Within 28 days following dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startMay 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046422
- Sponsor's protocol ID
- MB117-003
- Other IDs
- 2009-014308-79, 2009
- Status last verified
- Sep 2015
- First submitted
- 11 Jan 2010
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-Controlled, Parallel-group, Randomized, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of BMS-770767 in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Either Diet and Exercise Alone or on a Background of Metformin
- ClinicalTrials.gov ID
- NCT01046422
- Acronym / sponsor ID
- MB117-003
- Conditions
- Diabetes Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 12 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BMS-770767 ± metformin (Treatment A) | Experimental | Drug: BMS-770767, Drug: Metformin |
| BMS-770767 ± metformin (Treatment B) | Experimental | Drug: BMS-770767, Drug: Metformin |
| BMS-770767 ± metformin (Treatment C) | Experimental | Drug: BMS-770767, Drug: Metformin |
| BMS-770767 ± metformin (Treatment D) | Experimental | Drug: BMS-770767, Drug: Metformin |
| Placebo ± metformin (Treatment E) | Placebo comparator | Drug: Placebo, Drug: Metformin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-770767Capsule, Oral, 15mg, Active, Daily, 28 days | Drug | BMS-770767 ± metformin (Treatment A) |
| BMS-770767Capsule, Oral, 50mg, Active, Daily, 28 days | Drug | BMS-770767 ± metformin (Treatment B) |
| BMS-770767Capsule, Oral, 150mg, Active, Daily, 28 days | Drug | BMS-770767 ± metformin (Treatment C) |
| BMS-770767Capsule, Oral, 50mg BID, Active, Daily, 28 days | Drug | BMS-770767 ± metformin (Treatment D) |
| PlaceboCapsule, Oral, 0mg, Daily, 28 days | Drug | Placebo ± metformin (Treatment E) |
| MetforminTablet, Oral, ≥ 1500mg, Active, Daily, 28 days | Drug | BMS-770767 ± metformin (Treatment A), BMS-770767 ± metformin (Treatment B), BMS-770767 ± metformin (Treatment C), BMS-770767 ± metformin (Treatment D), Placebo ± metformin (Treatment E) |
Primary outcome
Fasting Plasma Glucose Improvement
Time frame: Within seven days following dosing
4 secondary outcomes
Mean daily glucose (3-day 7 pt-fingerstick)
Time frame: Within 28 days following dosing
Four (4)-hour post-prandial glucose AUC
Time frame: Within 28 days following dosing
HbA1C
Time frame: Within 28 days following dosing
Lipid profiles
Time frame: Within 28 days following dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-770767 and Metformin in people with Diabetes Type 2, run by Bristol-Myers Squibb at 18 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Canada, Australia, United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Plasma Glucose Improvement (time frame: Within seven days following dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015; AzTrials last refreshed its copy on 6 Nov 2026.