Status:
COMPLETED
Safety and Efficacy of S-707106 in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control With Metformin Therapy
Lead Sponsor:
Shionogi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of S-707106 co-administered with metformin in subjects with type 2 diabetes mellitus.
Detailed Description
Based on the unmet clinical need for more safe and effective type 2 diabetes mellitus therapies, together with the nonclinical efficacy and safety profile of S-707106, Shionogi USA, Inc. is initiating...
Eligibility Criteria
Inclusion
- Main
- Subjects with type 2 diabetes mellitus receiving a stable dose of metformin for the past 3 months (with no other medication for glycemic control) and who are clinically stable as determined by medical history
- Body mass index (BMI) ≥25.0 and \<45.0 (kg/m2) using http://www.bmicalculator.org/ as the BMI calculator
- No clinically significant abnormal laboratory tests as determined by the investigator except Hemoglobin A1c level ≥7.5% and ≤11.0% and C peptide level \>1.0 ng/mL
- Main
Exclusion
- Type 1 diabetes mellitus or gestational diabetes mellitus within last 6 months
- Use of any medication for glycemic control other than metformin during the past 3 months or thiazolidinediones within the past year
- Congestive heart failure as defined by New York Heart Association class III or IV
- Fasting glucose \>270 mg/dL
- Creatinine clearance is \<60 mL/minute
- History of myocardial infarction within the past 3 months, history of clinically significant cardiac arrhythmia, clinically significant hypotension or hypertension, or clinically significant abnormal electrocardiogram as determined by the investigator
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT01240759
Start Date
October 1 2010
End Date
January 1 2012
Last Update
May 15 2018
Active Locations (1)
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1
Juno Research, LLC
Houston, Texas, United States, 77074