Clinical trial NCT01169090: A Study Comparing the Safety, Tolerance, and Efficacy of Various Doses of SK-0403 Versus Placebo and Sitagliptin 100 mg in Patients Not Well-Controlled on Metformin Therapy
Official title: A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo Controlled Phase 2 Dose Finding Study Comparing the Safety, Tolerance, and Efficacy of Various Doses of SK-0403 Versus Placebo and Sitagliptin 100 mg in Patients Not Well-Controlled on Metformin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2010-07-23
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 safety and efficacy of a range of doses of SK-0403 in subjects with type 2 diabetes that are not adequately controlled on metformin alone.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects with type 2 diabetes between 18 and 75 years of age, inclusive
* Screening HbA1c between 7.0% to 10.0% for metformin stable subjects, 6.5% to 9.0% for subjects on metformin and 1 other antidiabetic agent (excluding thiazolidinediones, insulin, or incretin therapies \[DPP-4 inhibitors and GLP-1 analogues\]), or 7.5% to 11.0% for subjects on no antidiabetic medication or, if taking metformin, not on a stable dose of 1500 mg/day or maximum tolerated dose.
* No antidiabetic medication other than metformin for 3 months prior to randomization.
* Fasting plasma glucose less than 270 mg/dL (15 mmol/L) at screening.
* Body mass index between 20 kg/m2 and 45 kg/m2 inclusive at screening.

Exclusion Criteria:

* History of type 1 diabetes.
* Received treatment with insulin within 30 days of the screening visit or for more than 1 week within 3 months of the screening visit.
* Use of 3 or more oral antidiabetic medications at the time of the screening visit.

Primary outcomes:
measure: Change in HbA1c from baseline to Week 16.
timeFrame: Baseline, 16 weeks
Secondary outcomes:
measure: Change from baseline in Fasting Plasma Glucose (FPG)
timeFrame: Baseline, 16 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Muscle Shoals
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Encinitas
country: United States
state: California
city: Huntington Park
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Mateo
country: United States
state: California
city: Spring Valley
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Palm Harbour
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Honolulu
country: United States
state: Hawaii
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Paducah
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: St. Paul
country: United States
state: Minnesota
city: Charlotte
country: United States
state: North Carolina
city: Greenville
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: Mount Giliad
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Beaver
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Greensboro
country: United States
state: South Carolina
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: Sandy
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
Study officials:
References: