Type 2 DiabetesPhase 1NCT00508287
Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes
A Phase 1 study testing BMS-686117 and Byetta in people with Type 2 Diabetes, run by Bristol-Myers Squibb at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of single doses of BMS-686117 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-686117 and Byetta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2007to Nov 2007
- 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
- Diagnosis of Type 2 diabetes for ≥ 3 months treated with metformin, thiazolidinedione, or sulfonylurea (either monotherapy or combination) or diet alone (drug naïve)
- Fasting plasma glucose: 126 - 240 mg/dL
- Hemoglobin A1c: 6 - 10%
- Estimated CrCl ≥ 60 mL/min
- ALT ≤ 1.5 x ULN and total bilirubin ≤ 2 x ULN
- Stable and well controlled hypertension and/or dyslipidemia
- Concomitant medications used for hypertension and/or dyslipidemia, thyroid hormone replacement therapy and low dose aspirin will be allowed if stable for at least 6 weeks
Who cannot join
- Women of childbearing potential
- Symptomatic diabetes with polyuria and/or polydipsia
- History of diabetic ketoacidosis or hyperosmolar nonketotic syndrome
- History of renal disease including diabetic nephropathy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
New Orleans Center For Clinical Research
Knoxville, Tennessee, 37920
Elite Research Institute
Miami, Florida, 33169
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: Randomized, Placebo-Controlled, Single-Dose, Crossover Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of single doses of BMS-686117
- Conditions
- Type 2 Diabetes
- Being tested
- BMS-686117, Byetta, 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-686117Drug
Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.
ByettaDrug
Injection solution, Subcutaneous, 5 mcg, Once daily, Single dose.
PlaceboDrug
Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: BMS-686117 |
| B | Active comparator | Not described Receives: Drug: Byetta |
| C | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: incidence of adverse events
Measured: from subject enrollment to study discharge
Secondary outcomes (2)
PK parameters: Cmax, Tmax, AUC(0-24h), AUC(INF) and T-HALF
Measured: from pre-dose to 24 hrs post-dose
PD Measures: Fasting and postprandial serum glucose (AUC), serum insulin, and plasma glucagon concentrations. Acetaminophen plasma concentrations will be measured after a single dose of acetaminophen
Measured: from pre-dose to 9 hrs post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2007 (estimated)
- Study startAug 2007
- Primary completionNov 2007
- Study completionNov 2007
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
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
- NCT00508287
- Sponsor's protocol ID
- MB110-005
- Status last verified
- Mar 2009
- First submitted
- 26 Jul 2007
- Last updated
- 16 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-Controlled, Single-Dose, Crossover Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00508287
- Acronym / sponsor ID
- MB110-005
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 27 Jul 2007 (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 evaluate the safety, pharmacokinetics and pharmacodynamics of single doses of BMS-686117
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: BMS-686117 |
| B | Active comparator | Drug: Byetta |
| C | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of Type 2 diabetes for ≥ 3 months treated with metformin, thiazolidinedione, or sulfonylurea (either monotherapy or combination) or diet alone (drug naïve)
- Fasting plasma glucose: 126 - 240 mg/dL
- Hemoglobin A1c: 6 - 10%
- Estimated CrCl ≥ 60 mL/min
- ALT ≤ 1.5 x ULN and total bilirubin ≤ 2 x ULN
Key exclusion criteria (4 listed)
- Women of childbearing potential
- Symptomatic diabetes with polyuria and/or polydipsia
- History of diabetic ketoacidosis or hyperosmolar nonketotic syndrome
- History of renal disease including diabetic nephropathy
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-686117Injection solution, Subcutaneous, 1 mg, Once daily, Single dose. | Drug | A |
| ByettaInjection solution, Subcutaneous, 5 mcg, Once daily, Single dose. | Drug | B |
| PlaceboInjection solution, Subcutaneous, 1 mg, Once daily, Single dose. | Drug | C |
Primary outcome
Safety: incidence of adverse events
Time frame: from subject enrollment to study discharge
2 secondary outcomes
PK parameters: Cmax, Tmax, AUC(0-24h), AUC(INF) and T-HALF
Time frame: from pre-dose to 24 hrs post-dose
PD Measures: Fasting and postprandial serum glucose (AUC), serum insulin, and plasma glucagon concentrations. Acetaminophen plasma concentrations will be measured after a single dose of acetaminophen
Time frame: from pre-dose to 9 hrs post-dose
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 16 Mar 2009.
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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-686117 and Byetta in people with Type 2 Diabetes, 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 7 inclusion and 4 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 16 Mar 2009. 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. 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 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: incidence of adverse events (time frame: from subject enrollment to study discharge). 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 16 Mar 2009.