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
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ClinicalTrials.gov Identifier: NCT01154348 |
Recruitment Status :
Completed
First Posted : June 30, 2010
Last Update Posted : April 27, 2018
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Condition or disease | Intervention/treatment | Phase |
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Type 2 Diabetes Mellitus | Drug: S-707106 Drug: Placebo Drug: Metformin, S-707106 plus metformin Drug: Metformin, placebo plus metformin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1b, Randomized, Placebo-Controlled Study to Assess the Safety and Pharmacokinetics of Double-Blind S-707106 Alone and in Combination With Open-Label Metformin in Patients With Type 2 Diabetes Mellitus |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | November 2010 |
Actual Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Washout period, S-707106 tablet
14-day washout of metformin, followed by S-707106 once daily for 14 days under fed conditions
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Drug: S-707106
Tablet, taken once daily with morning meal |
Placebo Comparator: Washout, placebo
14-day washout of metformin followed by placebo for S-707106 once daily for 14 days under fed conditions
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Drug: Placebo
Placebo tablet, taken once daily with morning meal |
Experimental: Maintenance, S-707106 tablet plus metformin
14-day maintenance of metformin, followed by S-707106 once daily plus open-label metformin twice daily for 14 days under fed conditions
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Drug: Metformin, S-707106 plus metformin
Metformin twice daily maintenance, S-707106 tablet taken once daily with morning meal with metformin dosed twice daily |
Placebo Comparator: Maintenance, placebo plus metformin
14-day maintenance of metformin, followed by placebo for S-707106 once daily plus open-label metformin twice daily for 14 days under fed conditions
|
Drug: Metformin, placebo plus metformin
Metformin twice daily maintenance, placebo tablet taken once daily with morning meal with metformin twice daily |
- Safety and pharmacokinetics of multiple-dose oral administration of S-707106 in fed state in patients with type 2 diabetes mellitus [ Time Frame: Adverse events will be monitored from the time of informed consent through 28 days after the last dose of study treatment. Samples for S-707106 will be collected on Days 1, 7, 10, 12, 13, and 14 ]Safety will be evaluated by monitoring of treatment-emergent adverse events, clinical laboratory evaluations, vital signs, 12-lead electrocardiograms, 24-hour telemetry monitoring and physical exams. Pharmacokinetic evaluation of monotherapy cohort versus add-on therapy will be done
- Safety and pharmacokinetics of multiple-dose oral co-administration of S-707106 and metformin in fed state in patients with type 2 diabetes mellitus [ Time Frame: Adverse events will be monitored from the time of informed consent through 28 days after the last dose of study treatment. Samples for S-707106 collected on Days 7, 10, 12, 13, and 14. Samples for metformin collected on Days -1, 7, 10, 12, 13, and 14 ]Safety will be evaluated by monitoring of treatment-emergent adverse events, clinical laboratory evaluations, vital signs, 12-lead electrocardiograms, 24-hour telemetry monitoring and physical exams. Pharmacokinetic evalaution of monotherapy cohort versus add-on therapy will be done
- The effect of multiple doses of S-707106 on pharmacokinetics of metformin [ Time Frame: On Day 14 and on day prior to initiation of dosing of S-707106 ]
- The effect of multiple doses of metformin on pharmacokinetics of S-707106 [ Time Frame: On Day 14 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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%
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154348
United States, Texas | |
Dennis Ruff, MD | |
San Antonio, Texas, United States, 78209 |
Responsible Party: | Shionogi |
ClinicalTrials.gov Identifier: | NCT01154348 |
Other Study ID Numbers: |
1011N0913 |
First Posted: | June 30, 2010 Key Record Dates |
Last Update Posted: | April 27, 2018 |
Last Verified: | April 2018 |
Metformin |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Metformin Hypoglycemic Agents Physiological Effects of Drugs |