Clinical trial NCT00929539: Safety and Efficacy Study of JTT-130 in Obese Type 2 Diabetic Patients
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy, Safety and Tolerability of JTT-130 in Treatment-naïve, Metformin Only or Metformin Plus Sulfonylurea-treated Obese Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type II Diabetes Mellitus
Keywords: Diabetes
Lead sponsor: Akros Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-29
Enrollment: 496
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-130 on diabetes as well as the safety and tolerability of JTT-130 in obese Type 2 diabetic patients.


Eligibility criteria: Inclusion Criteria:

1. Have type 2 diabetes;
2. Body mass index (BMI) of \> 27.0 kg/m2 and ≤ 45.0 kg/m2;
3. Are either drug naïve with respect to hypoglycemic agents OR are currently being treated with metformin alone or in combination with a sulfonylurea. Metformin and sulfonylurea dosing must be stable.

Exclusion Criteria:

1. Females who are pregnant or breast-feeding
2. Known medical history or presence of type 1 diabetes, pancreatitis, unstable or rapidly progressing retinopathy, nephropathy or neuropathy;
3. Acute coronary syndrome or uncontrolled hypertension;
4. Does not meet medication restriction criteria, as described in the protocol.

Primary outcomes:
measure: Change in glycosylated hemoglobin (HbA1c) levels
timeFrame: End of Study
Secondary outcomes:
measure: Safety and tolerability data
timeFrame: End of Study
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Muscle Shoals
country: United States
state: Alabama
city: Scottsboro
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Encino
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Spring Valley
country: United States
state: California
city: Valley Village
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Waterbury
country: United States
state: Connecticut
city: Delray Beach
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Sandy Springs
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Erlanger
country: United States
state: Kentucky
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Madisonville
country: United States
state: Kentucky
city: Paducah
country: United States
state: Kentucky
city: New Hyde Park
country: United States
state: New York
city: Greensboro
country: United States
state: North Carolina
city: Morehead City
country: United States
state: North Carolina
city: Statesville
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Marion
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Charleston
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: North Charleston
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Austin
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: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Manassas
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Olympia
country: United States
state: Washington
city: Oregon
country: United States
state: Wisconsin
city: Beroun
country: Czech Republic
city: Brno
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Pardubice
country: Czech Republic
city: Prague
country: Czech Republic
city: Velke Hostice
country: Czech Republic
city: Satoraljaujhely
country: Hungary
city: Szikszo
country: Hungary
city: Eindhoven
country: Netherlands
city: Groningen
country: Netherlands
city: Arkhangelsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhniy Novgorod
country: Russian Federation
city: St. Petersburg
country: Russian Federation
Study officials:
References: