Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes Mellitus, Metformin
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.
Interventions
DRUGS-707106 Dose C
Four S-707106 4 X B tablets
DRUGS-707106 Dose A
One S-707106 A tablet
DRUGS-707106 Dose B
One S-707106 B tablet
DRUGPlacebo A tablet
Up to 4 Placebo A tablets
DRUGMetformin
The standard of care dose of metformin for each patient
Sponsors
Shionogi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline to Week 12 in Hemoglobin A1c (HbA1c) | Baseline and at 12 weeks | Hemoglobin A1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serial pharmacokinetic (PK) assessments | 5 days | 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 | 5 days | 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 | 12 weeks | 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 | Baseline and at 12 weeks | 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 | 5-6 months | 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 |
Countries
United States
Outcome results
None listed