Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353587
Status:
COMPLETED
Last Update Posted:
2015-05-01
First Post:
2006-07-14
Brief Title:
Safety and Efficacy Study of Metaglidasen in Type 2 Diabetes in Patients Suboptimally Controlled on Insulin
Sponsor:
CymaBay Therapeutics Inc
Organization:
CymaBay Therapeutics Inc
Study Overview
Official Title:
Phase 23 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
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:
This is a multicenter randomized double-blind placebo- and active comparator-controlled phase 23 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- andor long-acting insulin or pre-mixed eg 7030 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 agents must be willing and able to discontinue and washout of the hypoglycemic agents for the entire duration of the study in toto approximately 28 weeks Patients who are taking fixed doses of a short-acting insulin eg 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 eg 7030 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 23 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- andor long-acting insulin or pre-mixed eg 7030 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 agents must be willing and able to discontinue and washout of the hypoglycemic agents for the entire duration of the study in toto approximately 28 weeks Patients who are taking fixed doses of a short-acting insulin eg 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 eg 7030 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 eg other than pre-mixed short- or ultrashort-acting insulin andor 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
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 eg other than pre-mixed short- or ultrashort-acting insulin andor 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 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