Safety and Efficacy Study of JTT-851 in Patients With Type 2 Diabetes Mellitus
Recruiting in Palo Alto (17 mi)
+78 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Akros Pharma Inc.
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The purpose of this study is to evaluate the effect of JTT-851 on diabetes as well as to assess the safety, tolerability, and pharmacokinetics of JTT-851 in type 2 diabetic patients either treated with metformin or treatment-naïve.
Research Team
HK
Hisashi Kodama, Ph.D.
Principal Investigator
Akros Pharma Inc.
Eligibility Criteria
Inclusion Criteria
Males and females with type 2 diabetes, 18-70 years of age at Visit 1
Managing diabetes with diet and exercise only or currently being treated with a stable dose of metformin (at least 1500 mg/day)
Glycosylated hemoglobin at Visit 1 between 7.5% and 10.0%, if on metformin and between 7.5% and 10.9%, if without treatment
See 1 more
Treatment Details
Interventions
- Glimepiride (Sulfonylureas)
- JTT-851 (Other)
- Placebo for Active (Drug)
- Placebo for comparator (Drug)
Participant Groups
5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: JTT-851 Dose 3Experimental Treatment2 Interventions
JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
Group II: JTT-851 Dose 2Experimental Treatment2 Interventions
JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
Group III: JTT-851 Dose 1Experimental Treatment2 Interventions
JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
Group IV: Glimepiride Dose 1Active Control2 Interventions
Active Comparator Capsule and Placebo Tablets, administered once daily for 12 weeks
Group V: Placebo active & Placebo comparatorPlacebo Group2 Interventions
Placebo Tablets for study drug and Placebo Capsule for active comparator, administered once daily for 12 weeks
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NCT01699737Sacramento, CA
NCT01699737Ft. Lauderdale, FL
NCT01699737Kissimee, FL
NCT01699737Miramar, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Akros Pharma Inc.
Lead Sponsor
Trials
24
Patients Recruited
2,800+