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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01154348
First Posted: June 30, 2010
Last Update Posted: September 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shionogi Inc.
  Purpose
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

Condition Intervention Phase
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
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Shionogi Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 34
Study Start Date: June 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Washout period, S-707106 tablet
14-day washout of metformin, followed by S-707106 once daily for 14 days under fed conditions
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
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
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Texas
Dennis Ruff, MD
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Shionogi
Investigators
Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line Shionogi
  More Information

Responsible Party: Shionogi Clinical Trials Administrator, Shionogi
ClinicalTrials.gov Identifier: NCT01154348     History of Changes
Other Study ID Numbers: 1011N0913
First Submitted: June 25, 2010
First Posted: June 30, 2010
Last Update Posted: September 14, 2011
Last Verified: September 2011

Keywords provided by Shionogi Inc.:
Metformin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs