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Study to Determine the Efficacy, Safety, Tolerability & Pharmacokinetics of RO 205-2349 in Patients With Type 2 Diabetes Mellitus

NCT00057304

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Diabetes

Interventions: RO 205-2349

Countries: United States, Bulgaria, Estonia, Mexico, Panama, Puerto Rico, Romania, Switzerland

The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to placebo, are efficacious, safe and tolerable in improving glycemic control in patients with type 2 diabetes. Doses of 2 to 5 mg/day will be studied.

Eligibility overview

Sex: ALL

Age: 35 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Age 35 to 75
* Type 2 diabetes for longer than 3 months
* HbA1c (glycosylated hemoglobin A1c) greater than 7.0% at screening
* FPG (fasting plasma glucose) greater than 126 mg/dL at screening
* BMI (body mass index) less than 40 kg/square meter

Exclusion Criteria:

* Type I diabetes
* Type 2 diabetes patients currently treated with insulin
* Type 2 diabetes patients currently or previously treated with Actos, Avandia or Rezulin
* FPG (fasting plasma glucose) greater than 270 mg/dL at baseline
* Impaired liver or kidney function
* Triglycerides greater than 600 mg/dL
* Uncontrolled hypertension
* Pregnant or lactating women
* Women not using adequate contraception

Locations (46)

Hollywood, Florida, United States
Durham, North Carolina, United States
Morrisville, North Carolina, United States
Portland, Oregon, United States
Portland, Oregon, United States
Camp Hill, Pennsylvania, United States
Greer, South Carolina, United States
Memphis, Tennessee, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Midland, Texas, United States
Lebanon, Virginia, United States
Virginia Beach, Virginia, United States
Pleven, Bulgaria
Plovdiv, Bulgaria
Sofia, Bulgaria
Sofia, Bulgaria
Sofia, Bulgaria
Tallinn, Estonia
Tartu, Estonia
Tartu, Estonia
Võru, Estonia
Chihuahua, Chih., Mexico
Guadalajara, Mexico
Guadalajara, JAL., Mexico
Mexico City, Mexico
Mérida, Mexico
Monterrey, Mexico
Monterrey, Mexico
+ 16 more on CT.gov