Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT01154348
Recruitment Status : Completed
First Posted : June 30, 2010
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )

Tracking Information
First Submitted Date  ICMJE June 25, 2010
First Posted Date  ICMJE June 30, 2010
Last Update Posted Date April 27, 2018
Study Start Date  ICMJE June 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2011)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 29, 2010)
  • Safety & PK of multiple-dose oral administration of S-707106 in fed state in patients with type 2 diabetes mellitus [ Time Frame: 14-day wash-out/ maintenance , 14-day dosing period, 3-day transition to standard of care ]
    Safety will be evaluated by monitoring of treatment-emergent adverse events (TEAEs), clinical laboratory evaluations, vital signd, 12-lead ECGs, 24-hour telemetry monitoring and physical exams. PK evaluation of monotherapy cohort versus add-on therapy.
  • Safety and PK of multiple-dose oral co-administration of S-707106 & metformin in fed state in patients with type 2 diabetes mellitus [ Time Frame: 14-day wash-out / maintenance, 14-day dosing period, 3-day transition to standard of care ]
    Safety will be evaluated by monitoring of treatment-emergent adverse events (TEAEs), clinical laboratory evaluations, vital signs, 12-lead ECGs, 24-hour telmetry monitoring and physical exams. PK evalaution of monotherapy cohort versus add-on therapy.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2010)
  • The effect of multiple doses of S-707106 on PK of metformin [ Time Frame: 14-day wash-out/ maintenance, 14-day dosing period, 3-day transition to standard of care ]
  • The effect of multiple doses of metformin on PK of S-707106 [ Time Frame: 14-day wash-out/ maintenance, 14-day dosing period, 3-day transition to standard of care ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: S-707106
    Tablet, taken once daily with morning meal
  • Drug: Placebo
    Placebo tablet, taken once daily with morning meal
  • Drug: Metformin, S-707106 plus metformin
    Metformin twice daily maintenance, S-707106 tablet taken once daily with morning meal with metformin dosed twice daily
  • Drug: Metformin, placebo plus metformin
    Metformin twice daily maintenance, placebo tablet taken once daily with morning meal with metformin twice daily
Study Arms  ICMJE
  • Experimental: Washout period, S-707106 tablet
    14-day washout of metformin, followed by S-707106 once daily for 14 days under fed conditions
    Intervention: Drug: S-707106
  • Placebo Comparator: Washout, placebo
    14-day washout of metformin followed by placebo for S-707106 once daily for 14 days under fed conditions
    Intervention: Drug: Placebo
  • 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
    Intervention: Drug: Metformin, S-707106 plus metformin
  • 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
    Intervention: Drug: Metformin, placebo plus metformin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2010)
34
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01154348
Other Study ID Numbers  ICMJE 1011N0913
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shionogi Inc. ( Shionogi )
Study Sponsor  ICMJE Shionogi
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shionogi Inc.
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP