Clinical trial NCT01699737: Safety and Efficacy Study of JTT-851 in Patients With Type 2 Diabetes Mellitus
Official title: A Phase 2, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of JTT-851 in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes
Lead sponsor: Akros Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-04
Enrollment: 325
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-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.

Detailed description: This is a randomized, double-blind, double-dummy, placebo and active-controlled (glimepiride), multi-center, parallel-group study to investigate the effect of JTT-851 on HbA1c and other ancillary efficacy parameters and to assess the safety, tolerability, and pharmacokinetics of JTT-851 in inadequately-controlled treatment-naïve or metformin-treated type 2 diabetic patients.

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
* Body mass index (BMI) ≥ 23.0 kg/m\^2 and ≤ 45.0 kg/m\^2 at Visit 1

Exclusion Criteria:

* Females who are pregnant or breast-feeding
* Known medical history or presence of type 1 diabetes or acute metabolic diabetic complications, unstable or rapidly progressing retinopathy, nephropathy or neuropathy
* Acute coronary syndrome or uncontrolled hypertension
* Does not meet all diet or previous/concomitant medication restriction criteria

Primary outcomes:
measure: Change in glycosylated hemoglobin (HbA1c) after administration of JTT-851
timeFrame: 12 weeks
Secondary outcomes:
measure: Safety and tolerability of JTT-851 in patients with type 2 diabetes compared to glimepiride and placebo
timeFrame: 12 weeks
measure: Effect on ancillary efficacy measures
timeFrame: 12 weeks
measure: Pharmacokinetics of JTT-851 and its metabolites
timeFrame: 12 weeks
Other outcomes:
measure: Relationship between dose and response of JTT-851
timeFrame: 12 weeks
Locations:
city: Birmingham
country: United States
state: Alabama
city: Dothan
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Muscle Shoals
country: United States
state: Alabama
city: Glendale
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Artesia
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Buena Park
country: United States
state: California
city: Chino
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Lincoln
country: United States
state: California
city: Lomita
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: North Hollywood
country: United States
state: California
city: Paramount
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Spring Valley
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Cooper City
country: United States
state: Florida
city: Ft. Lauderdale
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Kissimee
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miramar
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Port Orange
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Columbus
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Nampa
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Evanston
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Lake Charles
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Oxon Hill
country: United States
state: Maryland
city: Olive Branch
country: United States
state: Mississippi
city: Las Vegas
country: United States
state: Nevada
city: Berlin
country: United States
state: New Jersey
city: Mine Hill
country: United States
state: New Jersey
city: Glen Falls
country: United States
state: New York
city: Greensboro
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Kettering
country: United States
state: Ohio
city: Marion
country: United States
state: Ohio
city: Munroe Falls
country: United States
state: Ohio
city: Wadsworth
country: United States
state: Ohio
city: Norman
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Lansdale
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
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: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Sugarland
country: United States
state: Texas
city: Tomball
country: United States
state: Texas
city: Murray
country: United States
state: Utah
city: Orem
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Burke
country: United States
state: Virginia
city: Manassas
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Suffolk
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Akros Pharma Inc.
name: Hisashi Kodama, Ph.D.
role: STUDY_CHAIR
References: