DiabetesPhase 2NCT01035879
Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of MBX-2982 Administered Daily for 4 Weeks as Monotherapy in Patients With Type 2 Diabetes
A Phase 2 study testing MBX-2982 and Sitagliptin in people with Diabetes, run by Gilead Sciences at 14 sites in 3 countries.
Trial summary
To define the relative efficacy, safety and tolerability profiles of oral daily MBX-2982 at three different daily doses vs. placebo and sitagliptin 100 mg when administered for up to 4 weeks in patients that are treatment-naive or taking a single anti-diabetic medication (non-TZD, non-injectable). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes
- What is being tested?
- MBX-2982 and Sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 14 sitesin 3 countries
- Study dates
- Dec 2009to Aug 2010
- 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
- History of type 2 diabetes of at least 3 months duration
- Treatment-naïve (not on any anti-diabetic medication) or treated with a single anti-diabetic agent (excluding insulin, exenatide or other GLP-1 analogs, pioglitazone or rosiglitazone)
- HbA1c 7.0-8.5% (inclusive) at screening
- BMI ≥ 26 kg/m2 for patients recruited from U.S or Georgia or ≥ 22 kg/m2 for patients recruited from India
Who cannot join
- Any history of type 1 diabetes or diabetic ketoacidosis
- History of major upper GI surgery
- Evidence or history of clinically significant GI illness including dyspepsia, PUD, nausea, diarrhea, malabsorption, etc.
- History of outpatient insulin use within last 1 year (insulin use while hospitalized is acceptable)
- Weight loss > 10 pounds (4.5 kg) in the 3 months prior to screening visit or use of weight loss medications (prescription or OTC) within 30 days of screening
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
India7 sites
Gokula Metropolis Research, MS Ramaiah Memorial Hospital
Bangalore, 560 054
Medisys Clinisearch India Pvt Ltd
Bangalore, 560043
Hormone Care Research Centre
Ghaziabad, 201002
Diabetes Thyroid Hormone Research Institute Pvt Ltd
Indore, M.P., 452001
Bharti Research Institute of Diabetes and Endocrinology
Karnāl, Haryana, 132001
Bangalore Endocrinology & Diabetes Research Centre
Malleshwaram, 560 003
Gandhi Endocrinology & Diabetes Centre
Rāmdaspeth, Nagpur, 10
United States4 sites
United Medical Associates
Binghamton, New York, 13901
Nevada Alliance Against Diabetes
Las Vegas, Nevada, 89101
Impact Clinical Trials
Los Angeles, California, 90036
dgd Research, Inc., a Cetero Research Co.
San Antonio, Texas, 78229
Georgia3 sites
Healthy Life Clinical Diagnostic Center
Tbilisi, 0144
Georgian Diabetes Center
Tbilisi, 0159
Medulla Chemotherapy and Immunotherapy Clinic
Tbilisi, 0186
About this study
Official title: Phase 2, Randomized, Double-Blind, Placebo and Active-Comparator Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of MBX-2982 Administered Daily for 4 Weeks as Monotherapy in Patients With Type 2 Diabetes
To define the relative efficacy, safety and tolerability profiles of oral daily MBX-2982 at three different daily doses vs. placebo and sitagliptin 100 mg when administered for up to 4 weeks in patients that are treatment-naive or taking a single anti-diabetic medication (non-TZD, non-injectable).
Read the detailed description
Approximately 100 patients will be randomized in this study, 20 to each of of the three MBX-2982 treatment groups, 20 to placebo, and 20 to the sitagliptin group. Patients will be taking 3 tablets and 1 capsule daily. This sample size provides the minimum number expected to ensure a power of at least 80% to detect a 20% decrease in the weighted mean glucose level associated with an extended mixed meal tolerance test (with 2 standardized meals) relative to placebo after 4 weeks of daily treatment with MBX-2982, assuming a drop-out rate of 20% and a common SD of 25%.
- Conditions
- Diabetes
- Being tested
- MBX-2982, Sitagliptin, placebo
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBX-2982Drug
tablets and capsule once daily
MBX-2982Drug
tablets and capsule once daily
MBX-2982Drug
tablets and capsule once daily
SitagliptinDrug
tablets and capsule once daily
placeboDrug
tablets and capsule once daily
| Study group | Role | What they receive |
|---|---|---|
| MBX-2982 25 mg | Experimental | Not described Receives: Drug: MBX-2982 |
| MBX-2982 100 mg | Experimental | Not described Receives: Drug: MBX-2982 |
| MBX-2982 300 mg | Experimental | Not described Receives: Drug: MBX-2982 |
| Sitagliptin 100 mg | Active comparator | Not described Receives: Drug: Sitagliptin |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of MBX-2982 on the absolute and percent change from baseline and placebo in mean weighted average of 14-point blood glucose levels associated with a standardized breakfast and lunch
Measured: 4 weeks
Secondary outcomes (1)
Evaluate the effect of MBX-2982 on additional glycemic parameters.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Roberts, MD, Study director, Metabolex, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01035879
- Sponsor's protocol ID
- M2982-20920
- Status last verified
- Mar 2015
- First submitted
- 17 Dec 2009
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Randomized, Double-Blind, Placebo and Active-Comparator Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of MBX-2982 Administered Daily for 4 Weeks as Monotherapy in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01035879
- Acronym / sponsor ID
- M2982-20920
- Conditions
- Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 Dec 2009 (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.
To define the relative efficacy, safety and tolerability profiles of oral daily MBX-2982 at three different daily doses vs. placebo and sitagliptin 100 mg when administered for up to 4 weeks in patients that are treatment-naive or taking a single anti-diabetic medication (non-TZD, non-injectable).
Detailed description
Approximately 100 patients will be randomized in this study, 20 to each of of the three MBX-2982 treatment groups, 20 to placebo, and 20 to the sitagliptin group. Patients will be taking 3 tablets and 1 capsule daily. This sample size provides the minimum number expected to ensure a power of at least 80% to detect a 20% decrease in the weighted mean glucose level associated with an extended mixed meal tolerance test (with 2 standardized meals) relative to placebo after 4 weeks of daily treatment with MBX-2982, assuming a drop-out rate of 20% and a common SD of 25%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MBX-2982 25 mg | Experimental | Drug: MBX-2982 |
| MBX-2982 100 mg | Experimental | Drug: MBX-2982 |
| MBX-2982 300 mg | Experimental | Drug: MBX-2982 |
| Sitagliptin 100 mg | Active comparator | Drug: Sitagliptin |
| Placebo | 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 (4 listed)
- History of type 2 diabetes of at least 3 months duration
- Treatment-naïve (not on any anti-diabetic medication) or treated with a single anti-diabetic agent (excluding insulin, exenatide or other GLP-1 analogs, pioglitazone or rosiglitazone)
- HbA1c 7.0-8.5% (inclusive) at screening
- BMI ≥ 26 kg/m2 for patients recruited from U.S or Georgia or ≥ 22 kg/m2 for patients recruited from India
Key exclusion criteria (5 listed)
- Any history of type 1 diabetes or diabetic ketoacidosis
- History of major upper GI surgery
- Evidence or history of clinically significant GI illness including dyspepsia, PUD, nausea, diarrhea, malabsorption, etc.
- History of outpatient insulin use within last 1 year (insulin use while hospitalized is acceptable)
- Weight loss > 10 pounds (4.5 kg) in the 3 months prior to screening visit or use of weight loss medications (prescription or OTC) within 30 days of screening
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 |
|---|---|---|
| MBX-2982tablets and capsule once daily | Drug | MBX-2982 25 mg |
| MBX-2982tablets and capsule once daily | Drug | MBX-2982 100 mg |
| MBX-2982tablets and capsule once daily | Drug | MBX-2982 300 mg |
| Sitagliptintablets and capsule once daily | Drug | Sitagliptin 100 mg |
| placebotablets and capsule once daily | Drug | Placebo |
Primary outcome
Evaluate the effect of MBX-2982 on the absolute and percent change from baseline and placebo in mean weighted average of 14-point blood glucose levels associated with a standardized breakfast and lunch
Time frame: 4 weeks
1 secondary outcome
Evaluate the effect of MBX-2982 on additional glycemic parameters.
Time frame: 4 weeks
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 18 Sep 2026.
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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.
Brian Roberts, MD study director
Metabolex, Inc.
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 MBX-2982 and Sitagliptin in people with Diabetes, run by Gilead Sciences 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 5 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 18 Sep 2026. 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 India, United States, Georgia. 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?
Evaluate the effect of MBX-2982 on the absolute and percent change from baseline and placebo in mean weighted average of 14-point blood glucose levels associated with a standardized breakfast and lunch (time frame: 4 weeks). 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 18 Sep 2026.