Safety and Tolerability Study of MBX-2044 in Patients With Type 2 Diabetes
April 29, 2015 updated by: CymaBay Therapeutics, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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San Antonio, Texas, United States, 78229-4801
- Diabetes and Glandular Disease Research Associates
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
|
Placebo Intervention
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|
Experimental: MBX-2044 1.5 mg
|
MBX-2044 1.5 mg one capsule daily for 14 days
MBX-2044 4.5 mg three 1.5 mg capsules daily for 14 days
MBX-2044 15 mg one capsule daily for 14 days
MBX-2044 30 mg two 15 mg capsules daily for 14 days
MBX-2044 60 mg one capsule daily for 14 days
MBX-2044 90 mg one 60 mg capsule and two 15 mg capsules daily for 14 days
|
|
Experimental: MBX-2044 4.5 mg
|
MBX-2044 1.5 mg one capsule daily for 14 days
MBX-2044 4.5 mg three 1.5 mg capsules daily for 14 days
MBX-2044 15 mg one capsule daily for 14 days
MBX-2044 30 mg two 15 mg capsules daily for 14 days
MBX-2044 60 mg one capsule daily for 14 days
MBX-2044 90 mg one 60 mg capsule and two 15 mg capsules daily for 14 days
|
|
Experimental: MBX-2044 15 mg
|
MBX-2044 1.5 mg one capsule daily for 14 days
MBX-2044 4.5 mg three 1.5 mg capsules daily for 14 days
MBX-2044 15 mg one capsule daily for 14 days
MBX-2044 30 mg two 15 mg capsules daily for 14 days
MBX-2044 60 mg one capsule daily for 14 days
MBX-2044 90 mg one 60 mg capsule and two 15 mg capsules daily for 14 days
|
|
Experimental: MBX-2044 30 mg
|
MBX-2044 1.5 mg one capsule daily for 14 days
MBX-2044 4.5 mg three 1.5 mg capsules daily for 14 days
MBX-2044 15 mg one capsule daily for 14 days
MBX-2044 30 mg two 15 mg capsules daily for 14 days
MBX-2044 60 mg one capsule daily for 14 days
MBX-2044 90 mg one 60 mg capsule and two 15 mg capsules daily for 14 days
|
|
Experimental: MBX-2044 60 mg
|
MBX-2044 1.5 mg one capsule daily for 14 days
MBX-2044 4.5 mg three 1.5 mg capsules daily for 14 days
MBX-2044 15 mg one capsule daily for 14 days
MBX-2044 30 mg two 15 mg capsules daily for 14 days
MBX-2044 60 mg one capsule daily for 14 days
MBX-2044 90 mg one 60 mg capsule and two 15 mg capsules daily for 14 days
|
|
Experimental: MBX-2044 90 mg
|
MBX-2044 1.5 mg one capsule daily for 14 days
MBX-2044 4.5 mg three 1.5 mg capsules daily for 14 days
MBX-2044 15 mg one capsule daily for 14 days
MBX-2044 30 mg two 15 mg capsules daily for 14 days
MBX-2044 60 mg one capsule daily for 14 days
MBX-2044 90 mg one 60 mg capsule and two 15 mg capsules daily for 14 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sherwyn Schwartz, MD, Diabetes and Glandular Research Associates
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
August 1, 2007
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
January 15, 2007
First Submitted That Met QC Criteria
January 15, 2007
First Posted (Estimate)
January 17, 2007
Study Record Updates
Last Update Posted (Estimate)
May 1, 2015
Last Update Submitted That Met QC Criteria
April 29, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M2044-20610
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