Diabetes Mellitus, Non-Insulin-DependentPhase 1NCT01105429
Single Ascending Dose Study of BMS-820132 in Patients With Type 2 Diabetes
A Phase 1 study testing BMS-820132 in people with Diabetes Mellitus, Non-Insulin-Dependent, run by Bristol-Myers Squibb at 3 sites in United States.
Trial summary
BMS-820132 is an investigational new drug being developed by BMS for treating Type 2 diabetes. The purpose of this study is to test the safety/tolerability (potential side effects) of single doses of the investigational new drug, as well as the amount of study drug in the blood, in subjects with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Non-Insulin-Dependent
- What is being tested?
- BMS-820132
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2010to Oct 2010
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females of childbearing potential (willing to use an acceptable method of contraception), or females of non-childbearing potential (i.e., post-menopausal or surgically sterile)
- Diagnosis of type 2 diabetes treated with metformin monotherapy on a stable regimen for at least 2 months
- Body Mass Index (BMI) of 18 to 40 kg/m2
- Fasting glucose in the range of 100-250 mg/dL
- Hemoglobin A1c (HbA1c) in the range of 6.5% -9.5%
Who cannot join
- Clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Any significant acute or chronic medical illness other than stable and well controlled hypertension, microalbuminuria, dyslipidemia, or depression
- Past history of diabetic ketoacidosis and/or C-peptide < 1.0 ng/mL, hyperosmolar nonketotic syndrome, lactic acidosis, or recurrent hypoglycemia
- Any major surgery within 4 weeks of study drug administration
- Any gastrointestinal surgery that could impact upon the absorption of study drug
- Smoking more than 10 cigarettes per day
Show all 10Show fewer
- Recent drug or alcohol abuse
- Women who are pregnant or breastfeeding
- Positive urine screen for drugs of abuse
- Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibody
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Profil Institute For Clinical Research, Inc. (Picr)
Chula Vista, California, 91911
Clinical Pharmacology Of Miami Inc.
Miami, Florida, 33014
Elite Research Institute
Miami, Florida, 33169
About this study
Official title: Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-820132 in Subjects With Type 2 Diabetes on Background Therapy of Metformin
BMS-820132 is an investigational new drug being developed by BMS for treating Type 2 diabetes. The purpose of this study is to test the safety/tolerability (potential side effects) of single doses of the investigational new drug, as well as the amount of study drug in the blood, in subjects with type 2 diabetes.
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Being tested
- BMS-820132, Placebo
- 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-820132Drug
Oral Solution, Oral, 0.3 mg, once daily, 1 day
BMS-820132Drug
Oral Solution, Oral, 1.0 mg, once daily, 1 day
BMS-820132Drug
Oral Solution, Oral, 3 mg, once daily, 1 day
BMS-820132Drug
Oral Solution, Oral, 10 mg, once daily, 1 day
BMS-820132Drug
Oral Solution, Oral, 30 mg, once daily, 1 day
BMS-820132Drug
Oral Solution, Oral , 75 mg, once daily, 1 day
BMS-820132Drug
Oral Solution, Oral, 150 mg, once daily, 1 day
BMS-820132Drug
Oral Solution, Oral, 300 mg, once daily, 1 day
BMS-820132Drug
Capsule, Oral, (TBD), once daily, 2 days
PlaceboDrug
Oral Solution, Oral, 0mg, once daily, 1 day
PlaceboDrug
Capsule, Oral, (TBD), once daily, 2 days
| Study group | Role | What they receive |
|---|---|---|
| BMS-820132 (0.3 mg) or Placebo | Active comparator | Not described Receives: Drug: BMS-820132; Drug: Placebo |
| BMS-820132 (1.0 mg) or Placebo | Active comparator | Not described Receives: Drug: BMS-820132; Drug: Placebo |
| BMS-820132 (3 mg) or Placebo | Active comparator | Not described Receives: Drug: BMS-820132; Drug: Placebo |
| BMS-820132 (10 mg) or Placebo | Active comparator | Not described Receives: Drug: BMS-820132; Drug: Placebo |
| BMS-820132 (30 mg) or Placebo | Active comparator | Not described Receives: Drug: BMS-820132; Drug: Placebo |
| BMS-820132 (75 mg) or Placebo | Active comparator | Not described Receives: Drug: BMS-820132; Drug: Placebo |
| BMS-820132 (150 mg) or Placebo | Active comparator | Not described Receives: Drug: BMS-820132; Drug: Placebo |
| BMS-820132 (300 mg) or Placebo | Active comparator | Not described Receives: Drug: BMS-820132; Drug: Placebo |
| BMS-820132 (TBD) or Placebo | Active comparator | Not described Receives: Drug: BMS-820132; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments
Measured: Within 5 days of study drug administration
Secondary outcomes (3)
Exposure to the investigational drug and its metabolites
Measured: Within 2 days after study drug administration
Pharmacodynamic activity of the investigational drug on biomarkers
Measured: Within 2 days after study drug administration
Excretion of the investigational drug and metabolites from the body
Measured: Within 2 days after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Non-Insulin-DependentStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105429
- Sponsor's protocol ID
- MB122-002
- Status last verified
- Nov 2010
- First submitted
- 13 Apr 2010
- Last updated
- 9 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-820132 in Subjects With Type 2 Diabetes on Background Therapy of Metformin
- ClinicalTrials.gov ID
- NCT01105429
- Acronym / sponsor ID
- MB122-002
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 16 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.
BMS-820132 is an investigational new drug being developed by BMS for treating Type 2 diabetes. The purpose of this study is to test the safety/tolerability (potential side effects) of single doses of the investigational new drug, as well as the amount of study drug in the blood, in subjects with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| BMS-820132 (0.3 mg) or Placebo | Active comparator | Drug: BMS-820132, Drug: Placebo |
| BMS-820132 (1.0 mg) or Placebo | Active comparator | Drug: BMS-820132, Drug: Placebo |
| BMS-820132 (3 mg) or Placebo | Active comparator | Drug: BMS-820132, Drug: Placebo |
| BMS-820132 (10 mg) or Placebo | Active comparator | Drug: BMS-820132, Drug: Placebo |
| BMS-820132 (30 mg) or Placebo | Active comparator | Drug: BMS-820132, Drug: Placebo |
| BMS-820132 (75 mg) or Placebo | Active comparator | Drug: BMS-820132, Drug: Placebo |
| BMS-820132 (150 mg) or Placebo | Active comparator | Drug: BMS-820132, Drug: Placebo |
| BMS-820132 (300 mg) or Placebo | Active comparator | Drug: BMS-820132, Drug: Placebo |
| BMS-820132 (TBD) or Placebo | Active comparator | Drug: BMS-820132, Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females of childbearing potential (willing to use an acceptable method of contraception), or females of non-childbearing potential (i.e., post-menopausal or surgically sterile)
- Diagnosis of type 2 diabetes treated with metformin monotherapy on a stable regimen for at least 2 months
- Body Mass Index (BMI) of 18 to 40 kg/m2
- Fasting glucose in the range of 100-250 mg/dL
- Hemoglobin A1c (HbA1c) in the range of 6.5% -9.5%
Key exclusion criteria (10 listed)
- Clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Any significant acute or chronic medical illness other than stable and well controlled hypertension, microalbuminuria, dyslipidemia, or depression
- Past history of diabetic ketoacidosis and/or C-peptide < 1.0 ng/mL, hyperosmolar nonketotic syndrome, lactic acidosis, or recurrent hypoglycemia
- Any major surgery within 4 weeks of study drug administration
- Any gastrointestinal surgery that could impact upon the absorption of study drug
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-820132Oral Solution, Oral, 0.3 mg, once daily, 1 day | Drug | BMS-820132 (0.3 mg) or Placebo |
| BMS-820132Oral Solution, Oral, 1.0 mg, once daily, 1 day | Drug | BMS-820132 (1.0 mg) or Placebo |
| BMS-820132Oral Solution, Oral, 3 mg, once daily, 1 day | Drug | BMS-820132 (3 mg) or Placebo |
| BMS-820132Oral Solution, Oral, 10 mg, once daily, 1 day | Drug | BMS-820132 (10 mg) or Placebo |
| BMS-820132Oral Solution, Oral, 30 mg, once daily, 1 day | Drug | BMS-820132 (30 mg) or Placebo |
| BMS-820132Oral Solution, Oral , 75 mg, once daily, 1 day | Drug | BMS-820132 (75 mg) or Placebo |
| BMS-820132Oral Solution, Oral, 150 mg, once daily, 1 day | Drug | BMS-820132 (150 mg) or Placebo |
| BMS-820132Oral Solution, Oral, 300 mg, once daily, 1 day | Drug | BMS-820132 (300 mg) or Placebo |
| BMS-820132Capsule, Oral, (TBD), once daily, 2 days | Drug | BMS-820132 (TBD) or Placebo |
| PlaceboOral Solution, Oral, 0mg, once daily, 1 day | Drug | BMS-820132 (0.3 mg) or Placebo, BMS-820132 (1.0 mg) or Placebo, BMS-820132 (10 mg) or Placebo, BMS-820132 (150 mg) or Placebo, BMS-820132 (3 mg) or Placebo, BMS-820132 (30 mg) or Placebo, BMS-820132 (300 mg) or Placebo, BMS-820132 (75 mg) or Placebo |
| PlaceboCapsule, Oral, (TBD), once daily, 2 days | Drug | BMS-820132 (TBD) or Placebo |
Primary outcome
Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments
Time frame: Within 5 days of study drug administration
3 secondary outcomes
Exposure to the investigational drug and its metabolites
Time frame: Within 2 days after study drug administration
Pharmacodynamic activity of the investigational drug on biomarkers
Time frame: Within 2 days after study drug administration
Excretion of the investigational drug and metabolites from the body
Time frame: Within 2 days after study drug administration
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 9 Mar 2011.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-820132 in people with Diabetes Mellitus, Non-Insulin-Dependent, run by Bristol-Myers Squibb at 3 sites in United States.
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 5 inclusion and 10 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 9 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments (time frame: Within 5 days of study drug administration). 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 9 Mar 2011.