Safety and Efficacy of S-707106 in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control With Metformin Therapy
NCT ID: NCT01240759
Last Updated: 2018-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
218 participants
INTERVENTIONAL
2010-10-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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S-707106 Dose A
One S-707106 A tablet + 3 Placebo A tablets
S-707106 Dose A
One S-707106 A tablet
Placebo A tablet
Up to 4 Placebo A tablets
Metformin
The standard of care dose of metformin for each patient
S-707106 Dose B
One S-707106 B tablet + 3 Placebo A tablets
S-707106 Dose B
One S-707106 B tablet
Placebo A tablet
Up to 4 Placebo A tablets
Metformin
The standard of care dose of metformin for each patient
S-707106 Dose C
S-707106 Dose C = Four S-707106 B tablets
S-707106 Dose C
Four S-707106 4 X B tablets
Metformin
The standard of care dose of metformin for each patient
Metformin
The standard of care dose of metformin for the individual patient + 3 Placebo A tablets
Placebo A tablet
Up to 4 Placebo A tablets
Metformin
The standard of care dose of metformin for each patient
Interventions
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S-707106 Dose A
One S-707106 A tablet
S-707106 Dose B
One S-707106 B tablet
S-707106 Dose C
Four S-707106 4 X B tablets
Placebo A tablet
Up to 4 Placebo A tablets
Metformin
The standard of care dose of metformin for each patient
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Shionogi
INDUSTRY
Responsible Party
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Principal Investigators
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Shionogi Clinical Trials Administrator Clinical Support Help Line
Role: STUDY_DIRECTOR
Shionogi
Locations
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Juno Research, LLC
Houston, Texas, United States
Countries
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Other Identifiers
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1010N0921
Identifier Type: -
Identifier Source: org_study_id
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