Type 2 DiabetesPhase 1NCT01290575
Multiple Ascending Dose Study of BMS-820132 in Patients With Type 2 Diabetes
A Phase 1 study testing BMS-820132 in people with Type 2 Diabetes, run by Bristol-Myers Squibb at 5 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 multiple doses of the investigational new drug, as well as the amount of study drug in the blood and its effects on blood sugar,in… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- 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
- 67 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2011to Nov 2011
- 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 70 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 (at least 1500 mg/day for at least 6 months) on a stable regimen for at least 2 months.
- Body Mass Index (BMI) of 18.5 to 40 kg/m2.
- Fasting glucose in the range of 125-275 mg/dL.
- Hemoglobin A1c (HbA1c) in the range of 7.0% -11.0%.
- Fasting C-peptide > 1 ng/mL.
Who cannot join
- Clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations, and any significant acute or chronic medical illness other than stable and well controlled hypertension, microalbuminuria, dyslipidemia, depression, or hypothyroidism.
- History of diabetic ketoacidosis, hyperosmolar nonketotic syndrome, lactic acidosis, hypoglycemia (i.e., ≥ 1 self-reported episodes of hypoglycemia within the last 3 months or ≥ 2 self-reported episodes of hypoglycemia within the last 6 months), or hypoglycemia unawareness.
- 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.
- Recent drug or alcohol abuse.
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- 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 Human Immunodeficiency Virus (HIV)-1, -2 antibody.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Osborne Research Center
Little Rock, Arkansas, 72201
Clinical Pharmacology Of Miami Inc.
Miami, Florida, 33014
Mra Clinical Research
Miami, Florida, 33143
Dedicated Phase I, Inc.
Phoenix, Arizona, 85013
Cetero Research
San Antonio, Texas, 78229
About this study
Official title: Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-820132 in Subjects With Type 2 Diabetes Treated With Metformin Monotherapy.
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 multiple doses of the investigational new drug, as well as the amount of study drug in the blood and its effects on blood sugar,in subjects with type 2 diabetes.
Read the detailed description
Study Classification: Safety, Pharmacokinetics/dynamics
- Conditions
- Type 2 Diabetes
- Being tested
- Placebo, BMS-820132
- 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.
PlaceboDrug
capsule, Oral, 0.0mg, twice daily, 14 day
PlaceboDrug
Capsule, Oral, 0.0mg, once daily, 14 day
BMS-820132Drug
Capsule, Oral, 15mg, twice daily, 14 day
BMS-820132Drug
Capsule, Oral, 60mg, twice daily, 14 day
BMS-820132Drug
Capsule, oral, 150mg, twice daily, 14 day
BMS-820132Drug
Capsule, Oral, 300mg, twice daily, 14 day
BMS-820132Drug
Capsule, Oral, 450mg, twice daily, 14 day
BMS-820132Drug
Capsule, Oral, To be determined (TBD), once daily, 14 day
BMS-820132Drug
Capsule, Oral, 5 mg, twice daily, 14 day
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 BMS-820132 or placebo | Active comparator | Not described Receives: Drug: Placebo; Drug: BMS-820132 |
| Arm 2 BMS-820132 or placebo | Active comparator | Not described Receives: Drug: Placebo; Drug: BMS-820132 |
| Arm 3 BMS-820132 or placebo | Active comparator | Not described Receives: Drug: Placebo; Drug: BMS-820132 |
| Arm 4 BMS-820132 or placebo | Active comparator | Not described Receives: Drug: Placebo; Drug: BMS-820132 |
| Arm 5 BMS-820132 or placebo | Active comparator | Not described Receives: Drug: Placebo; Drug: BMS-820132 |
| Arm 6 BMS-820132 or placebo | Active comparator | Not described Receives: Drug: Placebo; Drug: BMS-820132 |
| Arm 7 BMS-820132 or placebo | Active comparator | Not described Receives: Drug: Placebo; Drug: BMS-820132 |
| Arm 8 BMS-820132 or placebo | Active comparator | Not described Receives: Drug: Placebo; Drug: BMS-820132 |
| Arm 9 BMS-820132 or placebo | Active comparator | Not described Receives: Drug: Placebo; Drug: BMS-820132 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments.
Measured: Throughout the study drug administration period (14 days)
Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments.
Measured: within 7 days after the final dose
Secondary outcomes (7)
Maximum observed plasma concentration (Cmax) of BMS-820132
Measured: Day 1 and Day 14
Time of maximum observed plasma concentration (Tmax) of BMS-820132
Measured: Day 1 and Day 14
Trough observed plasma concentration (Cmin) of BMS-820132
Measured: Day 1 through Day 14 (selected days)
Area under the plasma concentration-time curve over one dosing interval [AUC(TAU)] of BMS-820132
Measured: Day 1 and Day 14
Accumulation index (AI) of BMS-820132
Measured: Day 14
Half life (T-Half) of BMS-820132
Measured: Day 14
AUC(0-24 h) and postprandial AUC(0-4h) for biomarkers of glucose homeostasis
Measured: Day -1, Day 1, Day 7 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- 67 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
- NCT01290575
- Sponsor's protocol ID
- MB122-004
- Status last verified
- Mar 2012
- First submitted
- 2 Feb 2011
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-820132 in Subjects With Type 2 Diabetes Treated With Metformin Monotherapy.
- ClinicalTrials.gov ID
- NCT01290575
- Acronym / sponsor ID
- MB122-004
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 7 Feb 2011 (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 multiple doses of the investigational new drug, as well as the amount of study drug in the blood and its effects on blood sugar,in subjects with type 2 diabetes.
Detailed description
Study Classification: Safety, Pharmacokinetics/dynamics
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Arm 1 BMS-820132 or placebo | Active comparator | Drug: Placebo, Drug: BMS-820132 |
| Arm 2 BMS-820132 or placebo | Active comparator | Drug: Placebo, Drug: BMS-820132 |
| Arm 3 BMS-820132 or placebo | Active comparator | Drug: Placebo, Drug: BMS-820132 |
| Arm 4 BMS-820132 or placebo | Active comparator | Drug: Placebo, Drug: BMS-820132 |
| Arm 5 BMS-820132 or placebo | Active comparator | Drug: Placebo, Drug: BMS-820132 |
| Arm 6 BMS-820132 or placebo | Active comparator | Drug: Placebo, Drug: BMS-820132 |
| Arm 7 BMS-820132 or placebo | Active comparator | Drug: Placebo, Drug: BMS-820132 |
| Arm 8 BMS-820132 or placebo | Active comparator | Drug: Placebo, Drug: BMS-820132 |
| Arm 9 BMS-820132 or placebo | Active comparator | Drug: Placebo, Drug: BMS-820132 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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 (at least 1500 mg/day for at least 6 months) on a stable regimen for at least 2 months.
- Body Mass Index (BMI) of 18.5 to 40 kg/m2.
- Fasting glucose in the range of 125-275 mg/dL.
- Hemoglobin A1c (HbA1c) in the range of 7.0% -11.0%.
Key exclusion criteria (9 listed)
- Clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations, and any significant acute or chronic medical illness other than stable and well controlled hypertension, microalbuminuria, dyslipidemia, depression, or hypothyroidism.
- History of diabetic ketoacidosis, hyperosmolar nonketotic syndrome, lactic acidosis, hypoglycemia (i.e., ≥ 1 self-reported episodes of hypoglycemia within the last 3 months or ≥ 2 self-reported episodes of hypoglycemia within the last 6 months), or hypoglycemia unawareness.
- 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.
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 |
|---|---|---|
| Placebocapsule, Oral, 0.0mg, twice daily, 14 day | Drug | Arm 1 BMS-820132 or placebo, Arm 2 BMS-820132 or placebo, Arm 3 BMS-820132 or placebo, Arm 4 BMS-820132 or placebo, Arm 5 BMS-820132 or placebo, Arm 9 BMS-820132 or placebo |
| PlaceboCapsule, Oral, 0.0mg, once daily, 14 day | Drug | Arm 6 BMS-820132 or placebo, Arm 7 BMS-820132 or placebo, Arm 8 BMS-820132 or placebo |
| BMS-820132Capsule, Oral, 15mg, twice daily, 14 day | Drug | Arm 1 BMS-820132 or placebo |
| BMS-820132Capsule, Oral, 60mg, twice daily, 14 day | Drug | Arm 2 BMS-820132 or placebo |
| BMS-820132Capsule, oral, 150mg, twice daily, 14 day | Drug | Arm 3 BMS-820132 or placebo |
| BMS-820132Capsule, Oral, 300mg, twice daily, 14 day | Drug | Arm 4 BMS-820132 or placebo |
| BMS-820132Capsule, Oral, 450mg, twice daily, 14 day | Drug | Arm 5 BMS-820132 or placebo |
| BMS-820132Capsule, Oral, To be determined (TBD), once daily, 14 day | Drug | Arm 6 BMS-820132 or placebo, Arm 7 BMS-820132 or placebo, Arm 8 BMS-820132 or placebo |
| BMS-820132Capsule, Oral, 5 mg, twice daily, 14 day | Drug | Arm 9 BMS-820132 or placebo |
Primary outcome
Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments.
Time frame: Throughout the study drug administration period (14 days)
Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments.
Time frame: within 7 days after the final dose
7 secondary outcomes
Maximum observed plasma concentration (Cmax) of BMS-820132
Time frame: Day 1 and Day 14
Time of maximum observed plasma concentration (Tmax) of BMS-820132
Time frame: Day 1 and Day 14
Trough observed plasma concentration (Cmin) of BMS-820132
Time frame: Day 1 through Day 14 (selected days)
Area under the plasma concentration-time curve over one dosing interval [AUC(TAU)] of BMS-820132
Time frame: Day 1 and Day 14
Accumulation index (AI) of BMS-820132
Time frame: Day 14
Half life (T-Half) of BMS-820132
Time frame: Day 14
AUC(0-24 h) and postprandial AUC(0-4h) for biomarkers of glucose homeostasis
Time frame: Day -1, Day 1, Day 7 and Day 14
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 27 Mar 2012.
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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
5 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 Type 2 Diabetes, run by Bristol-Myers Squibb at 5 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 6 inclusion and 9 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 27 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments. (time frame: Throughout the study drug administration period (14 days)). The study lists 2 primary outcomes in all. 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 27 Mar 2012.