Type 2 Diabetes MellitusPhase 2NCT00814372
Evaluate Safety and Effectiveness of MBX-102 in Type 2 Diabetes Patients With Poor Glycemic Control on Metformin
A Phase 2 study testing MBX-102, Actos and Metformin in people with Type 2 Diabetes Mellitus, run by Gilead Sciences at 26 sites in 2 countries.
Trial summary
To define the relative efficacy, safety and tolerability profiles of oral daily MBX-102 at daily doses of 400 and 600 mg vs. placebo and Actos® 30 mg (up-titrated to 45 mg after 8 weeks) when administered for up to 24 weeks in patients inadequately controlled with a stable dose of metformin (≥ 1500 mg/day). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- MBX-102, Actos and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 26 sitesin 2 countries
- Study dates
- Dec 2008to Feb 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
- Patients with type 2 diabetes who have been on metformin for the last 6 months and are taking a stable dose of metformin (≥ 1500 mg/d) as monotherapy for at least the last 3 months
- Male or female, 18-70 years of age
- All female patients must be surgically sterile or post-menopausal (at least 40 years of age with no history of menses for at least 2 years; or any age with no history of menses for at least 6 months and serum FSH ≥ 40 mIU/mL) or must agree to use two medically accepted methods of contraception including a barrier method. Depo contraceptives are excluded.
- Female patients must not be pregnant or lactating
- BMI ≥ 26 (patients of Asian Indian origin ≥ 22) kg/m2
- HbA1c ≥ 7.5%, ≤ 10.5%
- FPG ≥ 120 mg/dL, ≤ 240 mg/dL
Who cannot join
- History of diabetes secondary to pancreatitis or pancreatectomy
- Any history of ketoacidosis
- History of insulin use within last one year (insulin use while hospitalized is acceptable)
- Weight loss > 10 pounds in the three months prior to screening visit
- History of TZD use (Actos® or Avandia®) within 6 months of screening visit
- History of TZD discontinuation due to side effect or lack of efficacy
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
India21 sites
Bangalore Diabetes Centre
Bangalore
Diacon Hospital Diabetes & Research Centre
Bangalore
M. S. Ramaiah Memorial Hospital
Bangalore
St. John's Medical College & Hospital
Bangalore
Dr. V. Seshiah Diabetes Care & Research Institute
Chennai
Kamineni Hospitals Pvt, Ltd.
Hyderabad, Andhra Pradesh, 50008
Mediciti Hospital
Hyderabad
Medwin Hospital
Hyderabad
Diabetes Thyroid Hormone Research Institute Pvt. Ltd.
Indore
Fortis Hospital
Jaipur
Bharti Research Institute of Diabetes & Endocrinology
Karnāl
Amrita Institute of Medical Sciences
Kochi
Diabetes Action Centre
Mumbai, 400067
BYL Nair Hospital
Mumbai
PD Hindhuja National Hospital
Mumbai
Gandhi Endocrinology & Diabetes Centre
Nagpur
All India Institute of Medical Sciences
New Delhi
Deenanath Mangeshkar Hospital & Research Centre
Pune
Diabetes Care & Research Centre
Pune
Health & Research Centre
Trivendrum
Christian Medical College
Vellore
United States5 sites
Providence Clinical Research
Burbank, California, 91505
Nevada Alliance Against Diabetes
Las Vegas, Nevada, 89101
American Institute of Research
Los Angeles, California, 90017
DGD Research, Inc.
San Antonio, Texas, 78229
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 2 Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Study to Evaluate the Safety and Efficacy of MBX-102/JNJ-39659100 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy
To define the relative efficacy, safety and tolerability profiles of oral daily MBX-102 at daily doses of 400 and 600 mg vs. placebo and Actos® 30 mg (up-titrated to 45 mg after 8 weeks) when administered for up to 24 weeks in patients inadequately controlled with a stable dose of metformin (≥ 1500 mg/day).
Read the detailed description
Approximately 240 patients will be randomized in this study, 60 to each of two MBX-102 treatment groups (400 and 600 mg daily), 60 to placebo, and 60 to the Actos® group. Patients in the Actos® group will receive Actos® 30 mg/daily for the first eight weeks of the treatment phase and Actos® 45 mg/daily for the last 16 weeks of the treatment phase. Patients in the MBX-102 400 mg group and MBX-102 600 mg group will continue MBX-102 400 mg and 600 mg, respectively for the full 24 weeks. All study medication will be over-encapsulated; thus, each patient will take two blinded capsules each day containing either placebo, MBX-102 or Actos®. This sample size provides the minimum number expected to ensure a power of at least 90% in detecting a difference of 0.64% in HbA1c between the placebo and experimental treatment, using a two-tailed, two-sample t-test with type 1 error of 0.05, when the pooled standard deviation is ≤ 1.0%, and the discontinuation rate is ≤ 12.5%.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- MBX-102, Placebo, Actos, Metformin
- 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.
MBX-102Drug
capsule
PlaceboDrug
matching placebo
ActosDrug
over-encapsulated to match MBX-102 and placebo
MetforminDrug
greater than or equal to 1500 mg/kg day
| Study group | Role | What they receive |
|---|---|---|
| MBX-102 400 | Experimental | Not described Receives: Drug: MBX-102; Drug: Metformin |
| MBX-102 600 | Experimental | Not described Receives: Drug: MBX-102; Drug: Metformin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Metformin |
| Actos | Active comparator | 30-45 mg Receives: Drug: Actos; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from baseline and compared to placebo
Measured: 24 weeks
Secondary outcomes (1)
Change in fasting plasma glucose (FPG) from baseline and vs. placebo
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: MBX-102 did not meet the target efficacy profile of HbA1c change.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas Denham, M.D., Principal investigator, dgd Research, Inc.Thomas W. Littlejohn, M.D., Principal investigator, Piedmont Medical Research AssociatesMichael Guice, M.D., Principal investigator, American Institute of ResearchK. M. Prasanna Kumar, MD, Principal investigator, M. S. Ramaiah Memorial HospitalVeerasamy Seshiah, MD, Principal investigator, Dr. V. Seshiah Diabetes Care & Research InstituteSanjay Kalra, MD, Principal investigator, Bharti Research Institute of Diabetes & EndocrinologySailesh Lodha, MD, Principal investigator, Fortis HospitalAriachery C Ammini, MD, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814372
- Sponsor's protocol ID
- M102-20814
- Status last verified
- Mar 2015
- First submitted
- 22 Dec 2008
- 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
- A Phase 2 Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Study to Evaluate the Safety and Efficacy of MBX-102/JNJ-39659100 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy
- ClinicalTrials.gov ID
- NCT00814372
- Acronym / sponsor ID
- M102-20814
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: MBX-102 did not meet the target efficacy profile of HbA1c change.
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 24 Dec 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.
To define the relative efficacy, safety and tolerability profiles of oral daily MBX-102 at daily doses of 400 and 600 mg vs. placebo and Actos® 30 mg (up-titrated to 45 mg after 8 weeks) when administered for up to 24 weeks in patients inadequately controlled with a stable dose of metformin (≥ 1500 mg/day).
Detailed description
Approximately 240 patients will be randomized in this study, 60 to each of two MBX-102 treatment groups (400 and 600 mg daily), 60 to placebo, and 60 to the Actos® group. Patients in the Actos® group will receive Actos® 30 mg/daily for the first eight weeks of the treatment phase and Actos® 45 mg/daily for the last 16 weeks of the treatment phase. Patients in the MBX-102 400 mg group and MBX-102 600 mg group will continue MBX-102 400 mg and 600 mg, respectively for the full 24 weeks. All study medication will be over-encapsulated; thus, each patient will take two blinded capsules each day containing either placebo, MBX-102 or Actos®. This sample size provides the minimum number expected to ensure a power of at least 90% in detecting a difference of 0.64% in HbA1c between the placebo and experimental treatment, using a two-tailed, two-sample t-test with type 1 error of 0.05, when the pooled standard deviation is ≤ 1.0%, and the discontinuation rate is ≤ 12.5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MBX-102 400 | Experimental | Drug: MBX-102, Drug: Metformin |
| MBX-102 600 | Experimental | Drug: MBX-102, Drug: Metformin |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Metformin |
| Actos | Active comparator | Drug: Actos, Drug: Metformin30-45 mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with type 2 diabetes who have been on metformin for the last 6 months and are taking a stable dose of metformin (≥ 1500 mg/d) as monotherapy for at least the last 3 months
- Male or female, 18-70 years of age
- All female patients must be surgically sterile or post-menopausal (at least 40 years of age with no history of menses for at least 2 years; or any age with no history of menses for at least 6 months and serum FSH ≥ 40 mIU/mL) or must agree to use two medically accepted methods of contraception including a barrier method. Depo contraceptives are excluded.
- Female patients must not be pregnant or lactating
- BMI ≥ 26 (patients of Asian Indian origin ≥ 22) kg/m2
Key exclusion criteria (6 listed)
- History of diabetes secondary to pancreatitis or pancreatectomy
- Any history of ketoacidosis
- History of insulin use within last one year (insulin use while hospitalized is acceptable)
- Weight loss > 10 pounds in the three months prior to screening visit
- History of TZD use (Actos® or Avandia®) within 6 months of screening visit
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-102capsule | Drug | MBX-102 400, MBX-102 600 |
| Placebomatching placebo | Drug | Placebo |
| Actosover-encapsulated to match MBX-102 and placebo | Drug | Actos |
| Metformingreater than or equal to 1500 mg/kg day | Drug | Actos, MBX-102 400, MBX-102 600, Placebo |
Primary outcome
Change in HbA1c from baseline and compared to placebo
Time frame: 24 weeks
1 secondary outcome
Change in fasting plasma glucose (FPG) from baseline and vs. placebo
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: MBX-102 did not meet the target efficacy profile of HbA1c change.). Results are not available in the source record.
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.
Douglas Denham, M.D. principal investigator
dgd Research, Inc.
Thomas W. Littlejohn, M.D. principal investigator
Piedmont Medical Research Associates
Michael Guice, M.D. principal investigator
American Institute of Research
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MBX-102, Actos and Metformin in people with Type 2 Diabetes Mellitus, run by Gilead Sciences at 26 sites in 2 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 7 inclusion and 6 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: stopped early, 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 26 sites in India, 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 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 was stopped early (reason given: MBX-102 did not meet the target efficacy profile of HbA1c change.). Results are not available in the source record.
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 from baseline and compared to placebo (time frame: 24 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.