Diabetes Mellitus, Type 2Phase 2NCT01111955
Safety Study of BMS-823778 in Subjects With Type 2 Diabetes
A Phase 2 study testing BMS-823778 and Metformin in people with Diabetes Mellitus, Type 2, run by Bristol-Myers Squibb at 14 sites in 3 countries.
Trial summary
The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on fasting plasma glucose (FPG). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- BMS-823778 and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 14 sitesin 3 countries
- Study dates
- Jul 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
- Type 2 diabetes mellitus
- Drug naive or on stable metformin therapy
- HbA1c 7-10%
- FPG ≤ 240mg/dL
Who cannot join
- 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
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
Canada8 sites
Local Institution
Bathurst, New Brunswick, E2A 4X7
Local Institution
Mirabel, Quebec, J7J 2K8
Local Institution
Québec, Quebec, G1N 4V3
Local Institution
Saskatoon, Saskatchewan, S7K 7H9
Local Institution
St. John's, Newfoundland and Labrador, A1A 3R5
Local Institution
Surrey, British Columbia, V4A 2H9
Local Institution
Thornhill, Ontario, L4J 8L7
Local Institution
Winnipeg, Manitoba, R3E 3P4
United States3 sites
Farid Marquez, Md
Hialeah, Florida, 33012
Aurora Advanced Healthcare
Milwaukee, Wisconsin, 53209
Capital Clinical Reserch Center
Olympia, Washington, 98502
Australia3 sites
Local Institution
Blacktown, New South Wales, 2148
Local Institution
Box Hill, Victoria, 3128
Local Institution
Freemantle, Western Australia, 6959
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-823778 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 assess the safety, tolerability and pharmacodynamic effects on fasting plasma glucose (FPG).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- BMS-823778, 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-823778Drug
Capsules, Oral, 2 mg, once daily, 28 days
BMS-823778Drug
Capsules, Oral, 10 mg, once daily, 28 days
BMS-823778Drug
Capsules, Oral, 20 mg, once daily, 28 days
PlaceboDrug
Capsules, Oral, 0 mg, once daily, 28 days
MetforminDrug
Capsules, Oral, ≥ 1500 mg, once daily, 28 days
| Study group | Role | What they receive |
|---|---|---|
| BMS-823778 (2 mg) | Active comparator | + metformin Receives: Drug: BMS-823778; Drug: Metformin |
| BMS-823778 (10 mg) | Active comparator | + metformin Receives: Drug: BMS-823778; Drug: Metformin |
| BMS-823778 (20 mg) | Active comparator | + metformin Receives: Drug: BMS-823778; Drug: Metformin |
| Placebo | Placebo comparator | + metformin Receives: Drug: Placebo; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowering of fasting plasma glucose (FPG) throughout the study to see if there is a decrease from baseline
Measured: Within 28 days following dosing
Secondary outcomes (2)
Pharmacokinetics (measuring trough concentrations)
Measured: On days 7, 14 and 28
Pharmacodynamics (measuring daily glucose, glucose AUC, HbA1c, lipid profiles, HPA markers, free testosterone, and SHBG)
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 posted28 Apr 2010 (estimated)
- Study startJul 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 Mellitus, 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, Care provider, Investigator
- Enrolment
- 62 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
- NCT01111955
- Sponsor's protocol ID
- MB121-002
- Status last verified
- Sep 2015
- First submitted
- 26 Apr 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-823778 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
- NCT01111955
- Acronym / sponsor ID
- MB121-002
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 28 Apr 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 assess the safety, tolerability and pharmacodynamic effects on fasting plasma glucose (FPG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BMS-823778 (2 mg) | Active comparator | Drug: BMS-823778, Drug: Metformin+ metformin |
| BMS-823778 (10 mg) | Active comparator | Drug: BMS-823778, Drug: Metformin+ metformin |
| BMS-823778 (20 mg) | Active comparator | Drug: BMS-823778, Drug: Metformin+ metformin |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Metformin+ metformin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes mellitus
- Drug naive or on stable metformin therapy
- HbA1c 7-10%
- FPG ≤ 240mg/dL
Key exclusion criteria (6 listed)
- 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
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-823778Capsules, Oral, 2 mg, once daily, 28 days | Drug | BMS-823778 (2 mg) |
| BMS-823778Capsules, Oral, 10 mg, once daily, 28 days | Drug | BMS-823778 (10 mg) |
| BMS-823778Capsules, Oral, 20 mg, once daily, 28 days | Drug | BMS-823778 (20 mg) |
| PlaceboCapsules, Oral, 0 mg, once daily, 28 days | Drug | Placebo |
| MetforminCapsules, Oral, ≥ 1500 mg, once daily, 28 days | Drug | BMS-823778 (10 mg), BMS-823778 (2 mg), BMS-823778 (20 mg), Placebo |
Primary outcome
Lowering of fasting plasma glucose (FPG) throughout the study to see if there is a decrease from baseline
Time frame: Within 28 days following dosing
2 secondary outcomes
Pharmacokinetics (measuring trough concentrations)
Time frame: On days 7, 14 and 28
Pharmacodynamics (measuring daily glucose, glucose AUC, HbA1c, lipid profiles, HPA markers, free testosterone, and SHBG)
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.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-823778 and Metformin in people with Diabetes Mellitus, Type 2, run by Bristol-Myers Squibb at 14 sites in 3 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 4 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 14 sites in Canada, United States, Australia. 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?
Lowering of fasting plasma glucose (FPG) throughout the study to see if there is a decrease from baseline (time frame: Within 28 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.