Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422487
Status:
COMPLETED
Last Update Posted:
2015-05-01
First Post:
2007-01-15
Brief Title:
Safety and Tolerability Study of MBX-2044 in Patients With Type 2 Diabetes
Sponsor:
CymaBay Therapeutics Inc
Organization:
CymaBay Therapeutics Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 agents 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 15 45 15 30 or 60 mgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None