Type 2 DiabetesPhase 2NCT00699790
Proof of Confidence Study of CCR2 Antagonist (BMS-741672) in Insulin Resistance
A Phase 2 study testing CCR2 Antagonist in people with Type 2 Diabetes, run by Bristol-Myers Squibb at 12 sites in Russia.
Trial summary
The purpose of the study is to determine whether a CCR2 antagonist (BMS-741672) improves glucose homeostasis in drug-naive type 2 diabetic patients 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?
- CCR2 Antagonist
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 12 sitesRussia
- Study dates
- Feb 2009to Dec 2009
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Drug-naive Type 2 diabetics with a screening HbA1c of ≥ 7.5% and ≤ 10%
- Screening FPG ≥ 140 mg/dL and ≤ 220 mg/dL
- BMI ≤ 40 kg/m2
Who cannot join
- Active tuberculosis
- Symptoms of poorly controlled diabetes
- History of diabetic ketoacidosis
- Significant cardiovascular history or gastrointestinal disorders
- History of unstable or rapidly progressing renal disease
- Active liver disease and/or significant abnormal liver function
- Abnormal chest x-ray at screening indicative of tuberculosis or other infection
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Russia12 sites
Local Institution
Dzerzhnsky, 140090
Local Institution
Moscow, 105229
Local Institution
Moscow, 117036
Local Institution
Moscow, 125315
Local Institution
Nizhny Novgorod, 603126
Local Institution
Saint Petersburg, 190068
Local Institution
Saint Petersburg, 191015
Local Institution
Saint Petersburg, 194044
Local Institution
Saint Petersburg, 195271
Local Institution
Tyumen, 625023
Local Institution
Voronezh, 394066
Local Institution
Yaroslavl, 150023
About this study
Official title: A 12-Week Randomized, Double-Blinded Study to Evaluate the Effects of Daily Oral Doses of BMS-741672 in Drug-Naive Type 2 Diabetic Patients
The purpose of the study is to determine whether a CCR2 antagonist (BMS-741672) improves glucose homeostasis in drug-naive type 2 diabetic patients
- Conditions
- Type 2 Diabetes
- Being tested
- CCR2 Antagonist, Placebo
- Keywords
- Diabetes, NOS
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCR2 AntagonistDrug
Also called BMS-741672
Tablets, Oral, 50 mg, once daily, 12 weeks
PlaceboDrug
Tablets, Oral, 0mg, once daily, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Not described Receives: Drug: CCR2 Antagonist |
| A2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Measured: after 12 weeks of treatment
Secondary outcomes (1)
Other glycemic, atherosclerosis, lipid and mechanism-based biomarkers will be measured
Measured: throughout the 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startFeb 2009
- Primary completionDec 2009
- Study completionDec 2009
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 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
- NCT00699790
- Sponsor's protocol ID
- MB114-005
- Status last verified
- Sep 2015
- First submitted
- 17 Jun 2008
- 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 12-Week Randomized, Double-Blinded Study to Evaluate the Effects of Daily Oral Doses of BMS-741672 in Drug-Naive Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT00699790
- Acronym / sponsor ID
- MB114-005
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, NOS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 18 Jun 2008 (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 the study is to determine whether a CCR2 antagonist (BMS-741672) improves glucose homeostasis in drug-naive type 2 diabetic patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: CCR2 Antagonist |
| A2 | 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 (3 listed)
- Drug-naive Type 2 diabetics with a screening HbA1c of ≥ 7.5% and ≤ 10%
- Screening FPG ≥ 140 mg/dL and ≤ 220 mg/dL
- BMI ≤ 40 kg/m2
Key exclusion criteria (7 listed)
- Active tuberculosis
- Symptoms of poorly controlled diabetes
- History of diabetic ketoacidosis
- Significant cardiovascular history or gastrointestinal disorders
- History of unstable or rapidly progressing renal disease
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 |
|---|---|---|
| CCR2 AntagonistAlso: BMS-741672Tablets, Oral, 50 mg, once daily, 12 weeks | Drug | A1 |
| PlaceboTablets, Oral, 0mg, once daily, 12 weeks | Drug | A2 |
Primary outcome
Change in HbA1c
Time frame: after 12 weeks of treatment
1 secondary outcome
Other glycemic, atherosclerosis, lipid and mechanism-based biomarkers will be measured
Time frame: throughout the 12 weeks of treatment
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 Type 2 Diabetes
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
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CCR2 Antagonist in people with Type 2 Diabetes, run by Bristol-Myers Squibb at 12 sites in Russia.
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 3 inclusion and 7 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 12 sites in Russia. 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?
Change in HbA1c (time frame: after 12 weeks of treatment). 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.