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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: S-707106 dose 1
Drug: S-707106 dose 2
Drug: S-707106 dose 3
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Shionogi Inc.:

Primary Outcome Measures:
  • Change from Baseline to Week 12 in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
    Hemoglobin A1c


Secondary Outcome Measures:
  • 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


Enrollment: 218
Study Start Date: October 2010
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S-707106 dose 1 plus metformin
S-707106 tablets concurrently with their usual metformin dose for 12 weeks
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
Experimental: S-707106 dose 2 plus metformin
S-707106 tablets concurrently with their usual metformin dose for 12 weeks
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
Experimental: S-707106 dose 3 plus metformin
S-707106 tablets concurrently with their usual metformin dose for 12 weeks
Drug: S-707106 dose 3
Four S-707106 dose 2 tablets and metformin
Placebo Comparator: Placebo plus metformin
Placebo tablets concurrently with their usual metformin dose for 12 weeks
Drug: Placebo
Four Placebo A tablets matching S-707106 dose 1- and dose 2 tablets and metformin

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01240759

Locations
United States, Texas
Juno Research, LLC
Houston, Texas, United States, 77074
Sponsors and Collaborators
Shionogi
Investigators
Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line Shionogi
  More Information

No publications provided

Responsible Party: Shionogi Inc. ( Shionogi )
ClinicalTrials.gov Identifier: NCT01240759     History of Changes
Other Study ID Numbers: 1010N0921
Study First Received: November 11, 2010
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Shionogi Inc.:
Type 2 Diabetes Mellitus
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014