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

NCT ID: NCT01154348

Last Updated: 2018-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2010-12-31

Brief 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

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

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Washout period, S-707106 tablet

14-day washout of metformin, followed by S-707106 once daily for 14 days under fed conditions

Group Type: EXPERIMENTAL

S-707106

Intervention Type: DRUG

Tablet, taken once daily with morning meal

Washout, placebo

14-day washout of metformin followed by placebo for S-707106 once daily for 14 days under fed conditions

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet, taken once daily with morning meal

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

Group Type: EXPERIMENTAL

Metformin, S-707106 plus metformin

Intervention Type: DRUG

Metformin twice daily maintenance, S-707106 tablet taken once daily with morning meal with metformin dosed twice daily

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

Group Type: PLACEBO_COMPARATOR

Metformin, placebo plus metformin

Intervention Type: DRUG

Metformin twice daily maintenance, placebo tablet taken once daily with morning meal with metformin twice daily

Interventions

S-707106

Tablet, taken once daily with morning meal

Intervention Type: DRUG

Placebo

Placebo tablet, taken once daily with morning meal

Intervention Type: DRUG

Metformin, S-707106 plus metformin

Metformin twice daily maintenance, S-707106 tablet taken once daily with morning meal with metformin dosed twice daily

Intervention Type: DRUG

Metformin, placebo plus metformin

Metformin twice daily maintenance, placebo tablet taken once daily with morning meal with metformin twice daily

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shionogi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dennis Ruff, MD

San Antonio, Texas, United States

Countries

United States

Other Identifiers

1011N0913

Identifier Type: -

Identifier Source: org_study_id