Type 2 DiabetesPhase 2/3NCT00353587
Safety and Efficacy Study of Metaglidasen in Type 2 Diabetes in Patients Suboptimally Controlled on Insulin
A Phase 2/3 study testing MBX-102 and Actos in people with Type 2 Diabetes, run by Gilead Sciences at 67 sites in 4 countries.
Trial summary
This is a multicenter, randomized, double-blind, placebo- and active comparator-controlled phase 2/3 study of three dose levels of MBX-102 (200, 400, 600 mg) given orally to patients with type 2 diabetes receiving concomitant therapy with insulin. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- MBX-102 and Actos
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 396 participants
- Where
- 67 sitesin 4 countries
- Study dates
- May 2006to Nov 2007
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes (as described by the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus24) treated with insulin alone (a stable dose of long and/or intermediate-acting insulin or pre-mixed insulin e.g., "70/30") ≥ 30 units/day for at least 3 months, but poorly controlled on their existing therapy
- Or, patients treated with insulin (as above) in combination with non-TZD hypoglycemic agents (e.g., a sulfonylurea, metformin, acrabose, or Byetta for at least 3 months, but poorly controlled on their existing therapy
- Or, patients treated with fixed doses of short-acting insulin in combination with intermediate-acting insulin for at least 3 months, but poorly controlled on their existing therapy
- Patients in last 2 categories must be willing to discontinue the use of OHA and/or short-acting insulin (or change to pre-mixed insulin) for at least 26 weeks.
- Male or female, 18-75 years of age
- Provide informed consent and agree to comply with study requirements
Show all 19Show fewer
- Current monotherapy insulin dose regimen ≥ 30 units/day (stable for 8-week Run-in/stabilization Period); or patients who need insulin dose adjustment must have a stabilized dose ≥ 30 units/day. Patients must not have taken TZDs within 5 months of screening
- All female patients must be surgically sterile, post-menopausal (at least 40 years of age with no history of menses for at least 2 years) or agree to use adequate contraception(s) that must include a barrier method (other methods may include oral contraceptives, double barrier methods, intra-uterine devices, or abstinence). Depo contraceptives are excluded
- Female patients must not be pregnant or lactating
- BMI 26-44 kg/m2
- Hemoglobin A1c must be ≥7.5%, ≤11.5% at both Screening and Visit 4
- Patients must have a FPG ≤ 220 mg/dl
- Patients must have liver function tests ≤ 2X the upper limits of normal for AST, ALT, and bilirubin, and ≤ 2.5X the upper limits of normal for ALP and GGT
- Patients must have serum creatinine ≤ 1.8 mg/dl for males and ≤ 1.5 mg/dl for females and BUN ≤ 40 mg/dl
- Fecal occult blood test must be negative
- All other clinical laboratory parameters must be within normal limits or considered not clinically significant for participation in this study, including: hematology, coagulation, other serum chemistry, and other urinalysis parameters
- TSH must be ≤ 3x ULN and patient clinically euthyroid in opinion of investigator. If TSH is > ULN but ≤ 3x ULN, and patient is clinically euthyroid, FT4 should be drawn and must be WNL
- Electrocardiogram (ECG) must be normal, or considered not clinically significant, for participation in this study
- Patients must have a blood pressure ≤ 160/90 mm/hg including hypertensive patients controlled with medication
Who cannot join
- Patients will be excluded from study participation if any of the following applies:
- History of diabetes secondary to pancreatitis or pancreatectomy
- Requirement for short-acting insulin during the study
- Weight loss > 10 pounds in the three months prior to study
- History of TZD use (Actos or Avandia) within 5 months of Screening Visit
- History of TZD discontinuation due to side effect or lack of efficacy
Show all 23Show fewer
- Prior history of endoscopically or radiographically documented peptic ulcer disease within last 5 years (unless patient had documented H. pylori infection with subsequent treatment and no recurrence)
- Prior history of GI bleeding within last 5 years (except for hemorrhoids or perianal disease)
- Known infection with the human immunodeficiency virus (HIV) or history of viral hepatitis type B or C
- History of congestive heart failure within last 5 years (NYHA Class III-IV)
- History of significant pulmonary disease, myocardial infarction, cerebrovascular accident, or nephrotic syndrome within last 1 year
- Elevated creatine phosphokinase (> 2X the upper limits of normal)
- Malignancy within the last 5 years (except resected basal cell carcinoma)
- Ongoing active infection, as evidenced by symptoms such as temperature > 38.5° C and/or clinically significant elevation in WBC count (i.e., not asymptomatic colonization)
- Change in treatment with lipid-lowering agent after screening visit
- Current or expected requirement for anticoagulant therapy [except for low- dose (≤ 325 mg/d) aspirin]
- Current or expected treatment with phenytoin
- Current or anticipated treatment with non-steroidal anti-inflammatory drugs (i.e., naproxen, ibuprofen, Vioxx, Celebrex, indomethacin, etc.). However, patients may take aspirin < 325 mg/day for cardiovascular prophylaxis
- Known hypersensitivity to NSAIDs
- Treatment with any other investigational therapy within the 30 days prior to Screening Visit
- History of illicit drug or alcohol abuse within last 1 year
- Current or expected treatment with systemic corticosteroids (except topical, ophthalmic, intra-articular, or inhaled at a dose < 1600 μg/day)
- Any other condition that compromises the ability of the patient to provide informed consent or to comply with the objectives and procedures of this protocol, as judged by the investigator.
Trial locations and contacts
67 sites in 4 countries.
67 sites in 4 countries
United States18 sites
Associated Pharmaceutical Research Center, Inc.
Buena Park, California, 90620
Cedar-Crosse Research Center
Chicago, Illinois, 60607
Optimed Research, LLC
Columbus, Ohio, 43235
Dallas Diabetes & Endocrine Center
Dallas, Texas, 75230
Radiant Research - Greer
Greer, South Carolina, 29651
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, 60031
Mercury Pharma Services
Houston, Texas, 77081
NEA Clinic
Jonesboro, Arkansas, 72401
The Intermed Group
Los Angeles, California, 90017
LAC/USC Medical Center
Los Angeles, California, 90033
International Research Associates, LLC
Miami, Florida, 33156
Diabetes Center of the Southwest
Midland, Texas, 79705
Olive Branch Research
Olive Branch, Mississippi, 38654
Suncoast Clinical Research, Inc.
Palm Harbor, Florida, 34684
Andres Patron DO PA
Pembroke Pines, Florida, 33026
McGuire VA Medical Center
Richmond, Virginia, 23249
National Clinical Research
Richmond, Virginia, 23294
Diabetes & Glandular Disease Research Associates, P.A.
San Antonio, Texas, 78229
India18 sites
Sterling Hospital
Ahmedabad
Kasturba Medical College Hospital
Attavar, Mangalore, 575001
St. John's Medical College Hospital
Bangalore, 560034
M.S. Ramaih Medical College & Hospital
Bangalore, 560054
Diacon Hospital
Bangalore
Sri Ramachandra Medical Centre
Chennai, 600 116
Dr. V. Seshiah Diabetes Care & Research Institute
Chennai
Bharti Research Institute of Diabetes & Endocrinology
Karnāl, Haryana
Amrita Institute of Medical Sciences
Kochi, Kerala, 682026
Apollo Gleneages/Dept. of Endocrinology
Kolkata
Diabetes Care and Research Center
Maharashtra, 411011
Kasturba Hospital
Manipal, 576104
Chowpatty Medical Center
Mumbai
Mediheights Healthcare Pvt. Ltd.
Mumbai
Nizam's Institute of Medical Sciences
Panjagutta, Hyderabad, Andhra Pradesh, 500082
KEM Hospital
Pune, 411 011
Kerala Institute of Medical Sciences
Trivandrum
Christian Medical College Hospital
Vellore, 632004
Argentina17 sites
Consultorio Integral de Atencion al Diabetico (CIAD)
Buenos Aires, B1708IFF
CIMEL
Buenos Aires, B1824KAJ
Centro de Atencion Integral en Diabetes, Endocrinologica y Metabolismo
Buenos Aires, B6740CWC
Fundacion CIDEA
Buenos Aires, C1121ABE
Sanatorio Municipal Dr. Julio Mendez
Buenos Aires, C1405CNF
Instituto Medico Especializado
Buenos Aires, C1405CWB
Hospital Thompson
Buenos Aires, CP1650
Clinica Dleta Zarate
Buenos Aires
Hospital Privado de Comunidad
Buenos Aires
Consultorios Asociados de Endocrinologia
Capital Federal
Instituto Latinoamericano de Investigaciones Clinicas
Córdoba, X5000BNB
Sanatorio Parque
Córdoba, X5000IKK
Fundacion Marcelino Rusculleda Batlle
Córdoba
Instituto de Clinica Medica y Diabetes
Mendoza, M5519XAC
Policlio Modelo de Cipoletti
Rio Negro, R8324BSS
Hospital San Bernardo
Salta, A4406CLA
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
San Juan Capital
Israel14 sites
Endocrinology Institute, Haemek Medical Center
Afula
Barzilai Medical Center
Ashkelon
Soroka Medical Center
Beersheba, 84101
Rambam Medical Center
Haifa, 31996
Linn Medical Center
Haifa, 34780
Wolfson Medical Center
Holon, 58100
Hadassah University Hospital
Jerusalem, 91120
Clalit Health Services
Jerusalem, 93106
Institution of Diabetes and Metabolism
Nahariya, 22100
Endocrinology & Diabetes Institute
Petah Tikva
Department of Endocrinology, Ziv Medical Center
Safed, 13091
Zamenhoff Medical Center
Tel Aviv, 64353
Institute of Metabolic Diseases
Tel Aviv
Assaf Haroffe Medical Center
Zrifin
About this study
Official title: Phase 2/3, Randomized, Double-blind, Placebo- and Active Comparator-controlled, Parallel, Multicenter Study to Determine Safety and Efficacy of Metaglidasen in Treatment of Type 2 Diabetes Suboptimally Controlled on Insulin
This is a multicenter, randomized, double-blind, placebo- and active comparator-controlled phase 2/3 study of three dose levels of MBX-102 (200, 400, 600 mg) given orally to patients with type 2 diabetes receiving concomitant therapy with insulin. Eligible patients will be adults with type 2 diabetes who are taking intermediate- and/or long-acting insulin or pre-mixed (e.g., "70/30") insulin, or a combination of insulin and one or two non-TZD hypoglycemic agents including sulfonylurea, metformin, acrabose or Byetta, but who are poorly controlled on their existing therapy. Preference for enrollment will be given to patients on insulin monotherapy. Patients treated with a combination of insulin and other hypoglycemic agent(s) must be willing and able to discontinue and washout of the hypoglycemic agent(s) for the entire duration of the study (in toto, approximately 28 weeks). Patients who are taking fixed doses of a short-acting insulin (e.g., not a "sliding scale") in combination with intermediate-acting insulin may qualify for the study if both the patient and investigator are willing to either change to pre-mixed insulin (e.g., 70/30) or discontinue use of the short acting insulin for at least 26 weeks. Patients treated with a sliding scale of short-acting insulin will not be eligible for enrollment.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo- and active comparator-controlled phase 2/3 study of three dose levels of MBX-102 (200, 400, 600 mg) given orally to patients with type 2 diabetes receiving concomitant therapy with insulin. Eligible patients will be adults with type 2 diabetes who are taking intermediate- and/or long-acting insulin or pre-mixed (e.g., "70/30") insulin, or a combination of insulin and one or two non-TZD hypoglycemic agents including sulfonylurea, metformin, acrabose or Byetta, but who are poorly controlled on their existing therapy. Preference for enrollment will be given to patients on insulin monotherapy. Patients treated with a combination of insulin and other hypoglycemic agent(s) must be willing and able to discontinue and washout of the hypoglycemic agent(s) for the entire duration of the study (in toto, approximately 28 weeks). Patients who are taking fixed doses of a short-acting insulin (e.g., not a "sliding scale") in combination with intermediate-acting insulin may qualify for the study if both the patient and investigator are willing to either change to pre-mixed insulin (e.g., 70/30) or discontinue use of the short acting insulin for at least 26 weeks. Patients treated with a sliding scale of short-acting insulin will not be eligible for enrollment.
Following any insulin dose adjustment during the first few weeks of the study, insulin dose and regimen should remain constant for the duration of the study.
No stand alone (e.g., other than pre-mixed) short- or ultrashort-acting insulin and/or sliding scale will be allowed for the entire duration of the study.
A minimum of 400 patients will be randomized in this study (approximately 80 to each of the five treatment arms). Additional patients may be enrolled as appropriate to replace screen failures and drop-outs during the initial period of the study.
- Conditions
- Type 2 Diabetes
- Being tested
- MBX-102, Placebo, Actos
- Keywords
- insulin sensitizer, type 2 diabetes, diabetes, glucose control
- 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.
MBX-102Drug
MBX-102 200 mg once daily for 16 weeks
MBX-102Drug
MBX-102 400 mg once daily for 16 weeks
MBX-102Drug
MBX-102 600 mg once daily for 16 weeks
PlaceboDrug
MBX-102 Placebo once daily for 16 weeks
ActosDrug
Actos 30 mg once daily for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| MBX-102 200 mg | Experimental | MBX-102 200 mg once daily for 16 weeks Receives: Drug: MBX-102 |
| MBX-102 400 mg | Experimental | MBX-102 400 mg once daily for 16 weeks Receives: Drug: MBX-102 |
| MBX-102 600 mg | Experimental | MBX-102 600 mg once daily for 16 weeks Receives: Drug: MBX-102 |
| Sugar Pill | Placebo comparator | Placebo comparator once daily for 16 weeks Receives: Drug: Placebo |
| Actos | Active comparator | Actos 30 mg once daily for 16 weeks Receives: Drug: Actos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate effects of MBX-102 administered orally at doses of 200, 400 and 600 mg daily for 16 weeks, on glucose control, as measured by HbA1c
Evaluate safety of MBX-102 with particular emphasis on endpoints of weight gain and edema
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2006 (estimated)
- Study startMay 2006
- 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 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353587
- Sponsor's protocol ID
- M102-20509
- Status last verified
- Apr 2015
- First submitted
- 14 Jul 2006
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2/3, Randomized, Double-blind, Placebo- and Active Comparator-controlled, Parallel, Multicenter Study to Determine Safety and Efficacy of Metaglidasen in Treatment of Type 2 Diabetes Suboptimally Controlled on Insulin
- ClinicalTrials.gov ID
- NCT00353587
- Acronym / sponsor ID
- M102-20509
- Conditions
- Type 2 Diabetes
- Keywords
- insulin sensitizer, type 2 diabetes, diabetes, glucose control
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 18 Jul 2006 (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.
This is a multicenter, randomized, double-blind, placebo- and active comparator-controlled phase 2/3 study of three dose levels of MBX-102 (200, 400, 600 mg) given orally to patients with type 2 diabetes receiving concomitant therapy with insulin. Eligible patients will be adults with type 2 diabetes who are taking intermediate- and/or long-acting insulin or pre-mixed (e.g., "70/30") insulin, or a combination of insulin and one or two non-TZD hypoglycemic agents including sulfonylurea, metformin, acrabose or Byetta, but who are poorly controlled on their existing therapy. Preference for enrollment will be given to patients on insulin monotherapy. Patients treated with a combination of insulin and other hypoglycemic agent(s) must be willing and able to discontinue and washout of the hypoglycemic agent(s) for the entire duration of the study (in toto, approximately 28 weeks). Patients who are taking fixed doses of a short-acting insulin (e.g., not a "sliding scale") in combination with intermediate-acting insulin may qualify for the study if both the patient and investigator are willing to either change to pre-mixed insulin (e.g., 70/30) or discontinue use of the short acting insulin for at least 26 weeks. Patients treated with a sliding scale of short-acting insulin will not be eligible for enrollment.
Detailed description
This is a multicenter, randomized, double-blind, placebo- and active comparator-controlled phase 2/3 study of three dose levels of MBX-102 (200, 400, 600 mg) given orally to patients with type 2 diabetes receiving concomitant therapy with insulin. Eligible patients will be adults with type 2 diabetes who are taking intermediate- and/or long-acting insulin or pre-mixed (e.g., "70/30") insulin, or a combination of insulin and one or two non-TZD hypoglycemic agents including sulfonylurea, metformin, acrabose or Byetta, but who are poorly controlled on their existing therapy. Preference for enrollment will be given to patients on insulin monotherapy. Patients treated with a combination of insulin and other hypoglycemic agent(s) must be willing and able to discontinue and washout of the hypoglycemic agent(s) for the entire duration of the study (in toto, approximately 28 weeks). Patients who are taking fixed doses of a short-acting insulin (e.g., not a "sliding scale") in combination with intermediate-acting insulin may qualify for the study if both the patient and investigator are willing to either change to pre-mixed insulin (e.g., 70/30) or discontinue use of the short acting insulin for at least 26 weeks. Patients treated with a sliding scale of short-acting insulin will not be eligible for enrollment.
Following any insulin dose adjustment during the first few weeks of the study, insulin dose and regimen should remain constant for the duration of the study.
No stand alone (e.g., other than pre-mixed) short- or ultrashort-acting insulin and/or sliding scale will be allowed for the entire duration of the study.
A minimum of 400 patients will be randomized in this study (approximately 80 to each of the five treatment arms). Additional patients may be enrolled as appropriate to replace screen failures and drop-outs during the initial period of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MBX-102 200 mg | Experimental | Drug: MBX-102MBX-102 200 mg once daily for 16 weeks |
| MBX-102 400 mg | Experimental | Drug: MBX-102MBX-102 400 mg once daily for 16 weeks |
| MBX-102 600 mg | Experimental | Drug: MBX-102MBX-102 600 mg once daily for 16 weeks |
| Sugar Pill | Placebo comparator | Drug: PlaceboPlacebo comparator once daily for 16 weeks |
| Actos | Active comparator | Drug: ActosActos 30 mg once daily for 16 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Type 2 diabetes (as described by the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus24) treated with insulin alone (a stable dose of long and/or intermediate-acting insulin or pre-mixed insulin e.g., "70/30") ≥ 30 units/day for at least 3 months, but poorly controlled on their existing therapy
- Or, patients treated with insulin (as above) in combination with non-TZD hypoglycemic agents (e.g., a sulfonylurea, metformin, acrabose, or Byetta for at least 3 months, but poorly controlled on their existing therapy
- Or, patients treated with fixed doses of short-acting insulin in combination with intermediate-acting insulin for at least 3 months, but poorly controlled on their existing therapy
- Patients in last 2 categories must be willing to discontinue the use of OHA and/or short-acting insulin (or change to pre-mixed insulin) for at least 26 weeks.
- Male or female, 18-75 years of age
Key exclusion criteria (23 listed)
- History of diabetes secondary to pancreatitis or pancreatectomy
- Requirement for short-acting insulin during the study
- Weight loss > 10 pounds in the three months prior to study
- History of TZD use (Actos or Avandia) within 5 months of Screening Visit
- History of TZD discontinuation due to side effect or lack of efficacy
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-102MBX-102 200 mg once daily for 16 weeks | Drug | MBX-102 200 mg |
| MBX-102MBX-102 400 mg once daily for 16 weeks | Drug | MBX-102 400 mg |
| MBX-102MBX-102 600 mg once daily for 16 weeks | Drug | MBX-102 600 mg |
| PlaceboMBX-102 Placebo once daily for 16 weeks | Drug | Sugar Pill |
| ActosActos 30 mg once daily for 16 weeks | Drug | Actos |
Primary outcome
Evaluate effects of MBX-102 administered orally at doses of 200, 400 and 600 mg daily for 16 weeks, on glucose control, as measured by HbA1c
Evaluate safety of MBX-102 with particular emphasis on endpoints of weight gain and edema
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 1 May 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
67 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MBX-102 and Actos in people with Type 2 Diabetes, run by Gilead Sciences at 67 sites in 4 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 19 inclusion and 23 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 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States, India, Argentina, Israel. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 effects of MBX-102 administered orally at doses of 200, 400 and 600 mg daily for 16 weeks, on glucose control, as measured by HbA1c. 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 1 May 2015.