Study to Assess Safety and Pharmacokinetics of Double-Blind S-707106 Alone and in Combination With Open-Label Metformin in Patients With Type 2 Diabetes Mellitus

Completed · Phase 1 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

The purpose of this study is to determine the safety and pharmacokinetics of double-blind S-707106 alone and in combination with open-label metformin in patients with type 2 diabetes mellitus

Key facts

Study ID

NCT01154348

Run by

Shionogi

People needed

34

Starts

2010-06-01

Expected to finish

2010-12-01

Last updated by the study team

2018-04-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Body mass index range (25.0-38 kg/m2) with type 2 diabetes mellitus receiving stable dose of metformin BID for the previous 60 days for glucose control
• Patients sterile or agree to use approved method of contraception
• No clinically significant abnormal tests
• Hemoglobin A1c level ≤10.5%

You may not qualify if…

• History of clinical manifestations of significant metabolic, hepatic, renal, and hematological pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders other than type 2 diabetes mellitus
• Uncontrolled diabetes
• Exclusionary labs - fasting blood sugar, low hemoglobin, elevated liver function tests, positive result for human immunodeficiency virus, hepatitis B surface antigen, and anti-hepatitis C virus
• Low creatinine clearance
• History of myocardial infarction within past 90 days or other cardiovascular conditions
• Prior exposure to S-707106
• Treatment with investigational study drug within 30 days of study admission day

Where it is running

• Dennis Ruff, MD — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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