Safety and Efficacy of S-707106 in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control With Metformin Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )
ClinicalTrials.gov Identifier:
NCT01240759
First received: November 11, 2010
Last updated: April 9, 2013
Last verified: April 2013

November 11, 2010
April 9, 2013
October 2010
December 2011   (final data collection date for primary outcome measure)
Change from Baseline to Week 12 in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
Hemoglobin A1c
Change from Baseline at Week 12 in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
Hemoglobin A1c
Complete list of historical versions of study NCT01240759 on ClinicalTrials.gov Archive Site
  • Serial pharmacokinetic (PK) assessments [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Serial pharmacokinetic sampling at Visit 6 prior to dosing, at Visit 7 prior to dosing and at 0.5, 1, 2, 3, 4, 6, 8 and 24 hours after dosing, at Visit 8, at Visit 9, and Early Termination Visit
  • Sparse pharmacokinetic assessments [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Sparse pharmacokinetic sampling at Visit 6 and Visit 7 prior to dosing, at Visit 6 or Visit 7 one additional post-dose sample, at Visit 8, at Visit 9, and Early Termination Visit
  • Percent of subjects with Hemoglobin A1c < 7.0% at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Hemoglobin A1c
  • Change from Baseline at Week 12 in: Fasting plasma glucose, 1,5-Anhydroglucitol, Fructosamine, Glycoalbumin, C-peptide, Beta-cell function and insulin resistance indices using Homeostatic Model Assessment, and Postprandial glucose test [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
    Fasting plasma glucose, 1,5-Anhydroglucitol, Fructosamine, Glycoalbumin, C-peptide, Beta-cell function and insulin resistance indices using Homeostatic Model Assessment, and Postprandial glucose test
  • Safety assessments [ Time Frame: 5-6 months ] [ Designated as safety issue: Yes ]
    Safety will be assessed by monitoring of treatment-emergent adverse events, serious adverse events, treatment-emergent adverse events leading to study drug discontinuation, clinical laboratory evaluations, vital signs, 12-lead electrocardiograms (ECGs), adrenal axis hormones, and treatment-emergent adverse events of hypoglycemia, hyperglycemia, confirmed hypoglycemia or hyperglycemia
  • Percent of subjects with Hemoglobin A1c (HbA1c) < 7.0% at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Hemoglobin A1c
  • Change from Baseline at Week 12 in Fasting plasma glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Fasting plasma glucose
Not Provided
Not Provided
 
Safety and Efficacy of S-707106 in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control With Metformin Therapy
A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of S-707106 in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control With Metformin Therapy

The purpose of this study is to evaluate the safety and efficacy of S-707106 co-administered with metformin in subjects with type 2 diabetes mellitus.

Based on the unmet clinical need for more safe and effective type 2 diabetes mellitus therapies, together with the nonclinical efficacy and safety profile of S-707106, Shionogi USA, Inc. is initiating studies to further assess the efficacy, clinical pharmacology and safety profile of S-707106 in preparation for full clinical development as a novel treatment for type 2 diabetes mellitus. It is anticipated that S-707106 will provide clinicians and patients with a new therapeutic option to treat type 2 diabetes mellitus with potential advantages over existing therapy.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: S-707106 dose 1
    One S-707106 dose 1 tablet and 3 Placebo A tablets matching S-707106 dose 1- and dose 2 tablets and metformin
  • Drug: S-707106 dose 2
    One S-707106 dose 2 tablet and 3 Placebo A tablets matching S-707106 dose 1- and dose 2 tablets and metformin
  • Drug: S-707106 dose 3
    Four S-707106 dose 2 tablets and metformin
  • Drug: Placebo
    Four Placebo A tablets matching S-707106 dose 1- and dose 2 tablets and metformin
  • Experimental: S-707106 dose 1 plus metformin
    S-707106 tablets concurrently with their usual metformin dose for 12 weeks
    Intervention: Drug: S-707106 dose 1
  • Experimental: S-707106 dose 2 plus metformin
    S-707106 tablets concurrently with their usual metformin dose for 12 weeks
    Intervention: Drug: S-707106 dose 2
  • Experimental: S-707106 dose 3 plus metformin
    S-707106 tablets concurrently with their usual metformin dose for 12 weeks
    Intervention: Drug: S-707106 dose 3
  • Placebo Comparator: Placebo plus metformin
    Placebo tablets concurrently with their usual metformin dose for 12 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
218
January 2012
December 2011   (final data collection date for primary outcome measure)

Main Inclusion Criteria:

  • Subjects with type 2 diabetes mellitus receiving a stable dose of metformin for the past 3 months (with no other medication for glycemic control) and who are clinically stable as determined by medical history
  • Body mass index (BMI) ≥25.0 and <45.0 (kg/m2) using http://www.bmicalculator.org/ as the BMI calculator
  • No clinically significant abnormal laboratory tests as determined by the investigator except Hemoglobin A1c level ≥7.5% and ≤11.0% and C peptide level >1.0 ng/mL

Main Exclusion Criteria:

  • Type 1 diabetes mellitus or gestational diabetes mellitus within last 6 months
  • Use of any medication for glycemic control other than metformin during the past 3 months or thiazolidinediones within the past year
  • Congestive heart failure as defined by New York Heart Association class III or IV
  • Fasting glucose >270 mg/dL
  • Creatinine clearance is <60 mL/minute
  • History of myocardial infarction within the past 3 months, history of clinically significant cardiac arrhythmia, clinically significant hypotension or hypertension, or clinically significant abnormal electrocardiogram as determined by the investigator
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01240759
1010N0921
Yes
Shionogi Inc. ( Shionogi )
Shionogi
Not Provided
Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line Shionogi
Shionogi Inc.
April 2013

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