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

NCT01154348 | Completed Phase 1 DMC

• 1 other identifier: 1011N0913
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes Mellitus

Keywords

Metformin

Outcome Measures

Primary Outcomes (2)

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

  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

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

  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

  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

Secondary Outcomes (2)

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

  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

  On Day 14

Study Arms (4)

Washout period, S-707106 tablet

EXPERIMENTAL

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

Drug: S-707106

Washout, placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Maintenance, S-707106 tablet plus metformin

EXPERIMENTAL

14-day maintenance of metformin, followed by S-707106 once daily plus open-label metformin twice daily for 14 days under fed conditions

Drug: Metformin, S-707106 plus metformin

Maintenance, placebo plus metformin

PLACEBO COMPARATOR

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

Interventions

S-707106 DRUG

Tablet, taken once daily with morning meal

Washout period, S-707106 tablet

Placebo DRUG

Placebo tablet, taken once daily with morning meal

Washout, placebo

Metformin, S-707106 plus metformin DRUG

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

Maintenance, S-707106 tablet plus metformin

Metformin, placebo plus metformin DRUG

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

Maintenance, placebo plus metformin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Shionogi: lead

Study Sites (1)

Dennis Ruff, MD

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

S-707106; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: June 30, 2010
• Study Start: June 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 27, 2018

Record last verified: 2018-04

Locations

US (1)