NCT00997152TerminatedPhase 2
A Phase II, Randomized, Double-Blind, Placebo-controlled, Multi-Center, Parallel Group Study Evaluating the Efficacy, Safety and Pharmacokinetics of JTT-654 Administered for 12 Weeks in Untreated or Metformin-treated Type 2 Diabetic Patients
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Akros Pharma Inc.
- Enrollment
- 152
- Primary Endpoint
- Change in Fasting Plasma Glucose (FPG) levels
Study Overview
Brief Summary
The purpose of this study is to evaluate the effect of JTT-654 on diabetes as well as the safety, tolerability and pharmacokinetics of JTT-654 in type 2 diabetic patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have type 2 diabetes;
- •Body mass index (BMI) of ≤ 45.0 kg/m2;
- •Are either untreated with respect to hypoglycemic agents OR are currently being treated with a stable dose of metformin alone.
Exclusion Criteria
- •Females who are pregnant or breast-feeding;
- •Known medical history or presence of type 1 diabetes or pancreatitis, acute metabolic diabetic complications, presence of unstable or rapidly progressing retinopathy, nephropathy or neuropathy;
- •Acute coronary syndrome or uncontrolled hypertension;
- •Does not meet all diet or previous/concomitant medication restrictions criteria, as described in the protocol.
Arms & Interventions
Dose 1 JTT-654
Experimental
Intervention: JTT-654 (Drug)
Dose 2 JTT-654
Experimental
Intervention: JTT-654 (Drug)
Placebo
Placebo Comparator
Intervention: JTT-654 Placebo (Drug)
Outcomes
Primary Outcomes
Change in Fasting Plasma Glucose (FPG) levels
Time Frame: 3 months
Secondary Outcomes
- Change in glycosylated hemoglobin (HbA1c) levels(3 months)
- Effect on glycated albumin, insulin, C-peptide, glucagon and lipid parameters(3 months)
- Safety (biochemistry, hematology, urinalysis and adrenal-related markers) and tolerability (adverse events)(3 months)
Investigators
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