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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01240759
• Other study ID #: 1010N0921
• Status: Completed
• Phase: Phase 2
• Start date: October 2010
• Est. completion date: January 2012

Study information

• Verified date: May 2018
• Source: Shionogi Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• S-707106 Dose A
One S-707106 A tablet
• S-707106 Dose B
One S-707106 B tablet
• S-707106 Dose C
Four S-707106 4 X B tablets
• Placebo A tablet
Up to 4 Placebo A tablets
• Metformin
The standard of care dose of metformin for each patient

Locations

Country	Name	City	State
United States	Juno Research, LLC	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Shionogi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline to Week 12 in Hemoglobin A1c (HbA1c)	Hemoglobin A1c	Baseline and at 12 weeks
Secondary	Serial pharmacokinetic (PK) assessments	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	5 days
Secondary	Sparse pharmacokinetic assessments	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	5 days
Secondary	Percent of subjects with Hemoglobin A1c < 7.0% at Week 12	Hemoglobin A1c	12 weeks
Secondary	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	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	Baseline and at 12 weeks
Secondary	Safety assessments	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	5-6 months