Clinical trial NCT01240759: Safety and Efficacy of S-707106 in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control With Metformin Therapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Metformin
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-15
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Change from Baseline to Week 12 in Hemoglobin A1c (HbA1c)
timeFrame: Baseline and at 12 weeks
Secondary outcomes:
measure: Serial pharmacokinetic (PK) assessments
timeFrame: 5 days
measure: Sparse pharmacokinetic assessments
timeFrame: 5 days
measure: Percent of subjects with Hemoglobin A1c < 7.0% at Week 12
timeFrame: 12 weeks
measure: 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
timeFrame: Baseline and at 12 weeks
measure: Safety assessments
timeFrame: 5-6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Juno Research, LLC
state: Texas
Study officials:
affiliation: Shionogi
name: Shionogi Clinical Trials Administrator Clinical Support Help Line
role: STUDY_DIRECTOR
References: