Clinical trial NCT00997152: Efficacy and Safety Study of JTT-654 in Type 2 Diabetic Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Type II Diabetes Mellitus
Keywords: Diabetes
Lead sponsor: Akros Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-19
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Have type 2 diabetes;
2. Body mass index (BMI) of ≤ 45.0 kg/m2;
3. Are either untreated with respect to hypoglycemic agents OR are currently being treated with a stable dose of metformin alone.

Exclusion Criteria:

1. Females who are pregnant or breast-feeding;
2. 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;
3. Acute coronary syndrome or uncontrolled hypertension;
4. Does not meet all diet or previous/concomitant medication restrictions criteria, as described in the protocol.

Primary outcomes:
measure: Change in Fasting Plasma Glucose (FPG) levels
timeFrame: 3 months
Secondary outcomes:
measure: Change in glycosylated hemoglobin (HbA1c) levels
timeFrame: 3 months
measure: Effect on glycated albumin, insulin, C-peptide, glucagon and lipid parameters
timeFrame: 3 months
measure: Safety (biochemistry, hematology, urinalysis and adrenal-related markers) and tolerability (adverse events)
timeFrame: 3 months
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tempe
country: United States
state: Arizona
city: Chino
country: United States
state: California
city: Greenbrae
country: United States
state: California
city: Huntington Park
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Paramount
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: West Covina
country: United States
state: California
city: Deland
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Port Orange
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Addison
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Oxon Hill
country: United States
state: Maryland
city: New Bedford
country: United States
state: Massachusetts
city: Great Falls
country: United States
state: Montana
city: Charlotte
country: United States
state: North Carolina
city: Morehead City
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Marion
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Lansdale
country: United States
state: Pennsylvania
city: Bristol
country: United States
state: Tennessee
city: Carrollton
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Katy
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
Study officials:
References: