A Phase 2 interventional study of MBX-2044 and MBX-2044 in Type 2 Diabetes Mellitus, sponsored by Gilead Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-05-01.
Sponsored by Gilead Sciences · Phase 2, Interventional, and Treatment
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 60 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: MBX-2044
Drug: MBX-2044
Drug: MBX-2044
Drug: MBX-2044
Drug: MBX-2044
Drug: MBX-2044
Drug: Placebo for MBX-2044
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
Placebo Intervention
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
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Gilead Sciences