Type 2 Diabetes MellitusPhase 2NCT00422487
Safety and Tolerability Study of MBX-2044 in Patients With Type 2 Diabetes
A Phase 2 study testing MBX-2044 in people with Type 2 Diabetes Mellitus, run by Gilead Sciences at 1 site in United States.
Trial summary
The purpose of this study is to collect important information regarding the glucose-lowering efficacy of MBX-2044 and the safety of MBX-2044 (especially weight gain and edema) in diabetics. 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-2044
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Sep 2007
- 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
- Type 2 diabetes previously controlled with up to one or two non-TZD hypoglycemic agents including sulfonylureas (e.g., glyburide, glipizide, glimeprimide), meglitinides (e.g., Prandin®, Starlix®), metformin (e.g., Glucophage®), α-glucosidase inhibitors (e.g.,acarbose, miglitol) or Byetta®
- All female patients must be either surgically sterile or post-menopausal.
- Male patients with female partners of childbearing potential must agree to use condoms, or their partner must use a medically acceptable form of contraception.
- BMI 24-44 kg/m2.
- Patients must have a FPG ≤ 200 mg/dL at screening.
- Patients must have Hemoglobin A1c ≥ 6.5%, ≤ 10.0% at screening.
- Electrocardiogram (ECG) and chest x-ray 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
- History of Type 1 diabetes or diabetes secondary to pancreatitis or pancreatectomy.
- History of TZD use (Actos or Avandia) within 6 months of Screening Visit.
- History of TZD discontinuation due to lack of efficacy.
- History of congestive heart failure within last 5 years.
- History of significant pulmonary disease, myocardial infarction, cerebrovascular accident, or nephrotic syndrome within last 1 year.
- Malignancy within the last 5 years (except resected basal cell carcinoma).
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- Ongoing active infection.
- Change in treatment with lipid-lowering agent within 7 days of screening visit.
- Current or expected requirement for anticoagulant therapy [except for low-dose aspirin ≤ 325 mg/d or Plavix® ≤ 75 mg/d].
- Current or expected treatment with phenytoin for the duration of the study.
- Known hypersensitivity to NSAIDs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Diabetes and Glandular Disease Research Associates
San Antonio, Texas, 78229-4801
About this study
Official title: Phase 2a, Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study of MBX-2044 to Evaluate the Multiple-dose Pharmacokinetics, Safety and Tolerability When Administered Orally in Patients With Type 2 Diabetes
The purpose of this study is to collect important information regarding the glucose-lowering efficacy of MBX-2044 and the safety of MBX-2044 (especially weight gain and edema) in diabetics. It will also provide important information about the appropriate doses to be used in subsequent longer-term studies to evaluate the safety and efficacy of MBX-2044 alone and in combination with other anti-diabetic agents.
Read the detailed description
The current study is designed to test the short-term effectiveness and tolerability of MBX-2044 in patients with type 2 diabetes who are currently being controlled with up to one or two non-TZD hypoglycemic agent(s) including sulfonylureas, meglitinides, metformin, α-glucosidase inhibitors or Byetta®. Eligible patients will be enrolled into one of the following treatment cohorts receiving either placebo or MBX-2044 at 1.5, 4.5, 15, 30, or 60 mg/day in a double-blinded study for a 14-day treatment period. Patients will be evaluated for adverse events and vital signs daily. All efficacy and laboratory safety measures will be assessed after 2 weeks. This study will provide important information regarding the glucose-lowering efficacy of MBX-2044 and the safety of MBX-2044 (especially weight gain and edema) in diabetics. It will also provide important information about the appropriate doses to be used in subsequent longer-term studies to evaluate the safety and efficacy of MBX-2044 alone and in combination with other anti-diabetic agents.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- MBX-2044, Placebo for MBX-2044
- Keywords
- Type 2 Diabetes Mellitus
- 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-2044Drug
MBX-2044 1.5 mg one capsule daily for 14 days
MBX-2044Drug
MBX-2044 4.5 mg three 1.5 mg capsules daily for 14 days
MBX-2044Drug
MBX-2044 15 mg one capsule daily for 14 days
MBX-2044Drug
MBX-2044 30 mg two 15 mg capsules daily for 14 days
MBX-2044Drug
MBX-2044 60 mg one capsule daily for 14 days
MBX-2044Drug
MBX-2044 90 mg one 60 mg capsule and two 15 mg capsules daily for 14 days
Placebo for MBX-2044Drug
Placebo Intervention
| Study group | Role | What they receive |
|---|---|---|
| MBX-2044 1.5 mg | Experimental | Not described Receives: Drug: MBX-2044 |
| MBX-2044 4.5 mg | Experimental | Not described Receives: Drug: MBX-2044 |
| MBX-2044 15 mg | Experimental | Not described Receives: Drug: MBX-2044 |
| MBX-2044 30 mg | Experimental | Not described Receives: Drug: MBX-2044 |
| MBX-2044 60 mg | Experimental | Not described Receives: Drug: MBX-2044 |
| MBX-2044 90 mg | Experimental | Not described Receives: Drug: MBX-2044 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo for MBX-2044 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the multiple-dose pharmacokinetics of MBX-2044 administered as monotherapy at the protocol-specified daily dose orally for 14 days
Evaluate the clinical safety and tolerability of MBX-2044 after 14 days administration, including the parameters of weight gain and edema
Determine the maximum tolerated dose (MTD) of MBX-2044, after 14 days administration
Determine the effect of MBX-2044 after 14 days administration, on efficacy parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2007 (estimated)
- Study startOct 2006
- Primary completionAug 2007
- Study completionSep 2007
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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sherwyn Schwartz, MD, Principal investigator, Diabetes and Glandular Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422487
- Sponsor's protocol ID
- M2044-20610
- Status last verified
- Apr 2015
- First submitted
- 15 Jan 2007
- Last updated
- 1 May 2015
- Results posted
- 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 2a, Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study of MBX-2044 to Evaluate the Multiple-dose Pharmacokinetics, Safety and Tolerability When Administered Orally in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00422487
- Acronym / sponsor ID
- M2044-20610
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 17 Jan 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 collect important information regarding the glucose-lowering efficacy of MBX-2044 and the safety of MBX-2044 (especially weight gain and edema) in diabetics. It will also provide important information about the appropriate doses to be used in subsequent longer-term studies to evaluate the safety and efficacy of MBX-2044 alone and in combination with other anti-diabetic agents.
Detailed description
The current study is designed to test the short-term effectiveness and tolerability of MBX-2044 in patients with type 2 diabetes who are currently being controlled with up to one or two non-TZD hypoglycemic agent(s) including sulfonylureas, meglitinides, metformin, α-glucosidase inhibitors or Byetta®. Eligible patients will be enrolled into one of the following treatment cohorts receiving either placebo or MBX-2044 at 1.5, 4.5, 15, 30, or 60 mg/day in a double-blinded study for a 14-day treatment period. Patients will be evaluated for adverse events and vital signs daily. All efficacy and laboratory safety measures will be assessed after 2 weeks. This study will provide important information regarding the glucose-lowering efficacy of MBX-2044 and the safety of MBX-2044 (especially weight gain and edema) in diabetics. It will also provide important information about the appropriate doses to be used in subsequent longer-term studies to evaluate the safety and efficacy of MBX-2044 alone and in combination with other anti-diabetic agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| MBX-2044 1.5 mg | Experimental | Drug: MBX-2044 |
| MBX-2044 4.5 mg | Experimental | Drug: MBX-2044 |
| MBX-2044 15 mg | Experimental | Drug: MBX-2044 |
| MBX-2044 30 mg | Experimental | Drug: MBX-2044 |
| MBX-2044 60 mg | Experimental | Drug: MBX-2044 |
| MBX-2044 90 mg | Experimental | Drug: MBX-2044 |
| Placebo | Placebo comparator | Drug: Placebo for MBX-2044 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 2 diabetes previously controlled with up to one or two non-TZD hypoglycemic agents including sulfonylureas (e.g., glyburide, glipizide, glimeprimide), meglitinides (e.g., Prandin®, Starlix®), metformin (e.g., Glucophage®), α-glucosidase inhibitors (e.g.,acarbose, miglitol) or Byetta®
- All female patients must be either surgically sterile or post-menopausal.
- Male patients with female partners of childbearing potential must agree to use condoms, or their partner must use a medically acceptable form of contraception.
- BMI 24-44 kg/m2.
- Patients must have a FPG ≤ 200 mg/dL at screening.
Key exclusion criteria (11 listed)
- History of Type 1 diabetes or diabetes secondary to pancreatitis or pancreatectomy.
- History of TZD use (Actos or Avandia) within 6 months of Screening Visit.
- History of TZD discontinuation due to lack of efficacy.
- History of congestive heart failure within last 5 years.
- History of significant pulmonary disease, myocardial infarction, cerebrovascular accident, or nephrotic syndrome within last 1 year.
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-2044MBX-2044 1.5 mg one capsule daily for 14 days | Drug | MBX-2044 1.5 mg |
| MBX-2044MBX-2044 4.5 mg three 1.5 mg capsules daily for 14 days | Drug | MBX-2044 4.5 mg |
| MBX-2044MBX-2044 15 mg one capsule daily for 14 days | Drug | MBX-2044 15 mg |
| MBX-2044MBX-2044 30 mg two 15 mg capsules daily for 14 days | Drug | MBX-2044 30 mg |
| MBX-2044MBX-2044 60 mg one capsule daily for 14 days | Drug | MBX-2044 60 mg |
| MBX-2044MBX-2044 90 mg one 60 mg capsule and two 15 mg capsules daily for 14 days | Drug | MBX-2044 90 mg |
| Placebo for MBX-2044Placebo Intervention | Drug | Placebo |
Primary outcome
Evaluate the multiple-dose pharmacokinetics of MBX-2044 administered as monotherapy at the protocol-specified daily dose orally for 14 days
Evaluate the clinical safety and tolerability of MBX-2044 after 14 days administration, including the parameters of weight gain and edema
Determine the maximum tolerated dose (MTD) of MBX-2044, after 14 days administration
Determine the effect of MBX-2044 after 14 days administration, on efficacy parameters
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.
Sherwyn Schwartz, MD principal investigator
Diabetes and Glandular Research Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MBX-2044 in people with Type 2 Diabetes Mellitus, run by Gilead Sciences at 1 site 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 8 inclusion and 11 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 1 site 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 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 multiple-dose pharmacokinetics of MBX-2044 administered as monotherapy at the protocol-specified daily dose orally for 14 days. The study lists 4 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.