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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

Information source: Shionogi Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: S-707106 (Drug); Placebo (Drug); Metformin, S-707106 plus metformin (Drug); Metformin, placebo plus metformin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Shionogi

Official(s) and/or principal investigator(s):
Shionogi Clinical Trials Administrator Clinical Support Help Line, Study Director, Affiliation: Shionogi

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Safety and pharmacokinetics of multiple-dose oral administration of S-707106 in fed state in patients with type 2 diabetes mellitus

Safety and pharmacokinetics of multiple-dose oral co-administration of S-707106 and metformin in fed state in patients with type 2 diabetes mellitus

Secondary outcome:

The effect of multiple doses of S-707106 on pharmacokinetics of metformin

The effect of multiple doses of metformin on pharmacokinetics of S-707106

Detailed description: 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. Specific study withdrawal criteria during washout periods of metformin have been established for loss of glycemic control, i. e., glucose monitoring. Pharmacokinetic assessments of monotherapy cohort versus add-on therapy will be performed

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Dennis Ruff, MD, San Antonio, Texas 78209, United States
Additional Information

Starting date: June 2010
Last updated: September 13, 2011

Page last updated: August 23, 2015

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