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

Shionogi

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: S-707106 Dose A; Drug: S-707106 Dose B; Drug: Placebo A tablet; Drug: S-707106 Dose C; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01240759

1010N0921

Details and patient eligibility

About

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.

Full 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.

Enrollment: 218 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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218 participants in 4 patient groups

S-707106 Dose A

Experimental group

Description:

One S-707106 A tablet + 3 Placebo A tablets

Treatment:

Drug: Placebo A tablet

Drug: S-707106 Dose A

Drug: Metformin

S-707106 Dose B

Experimental group

Description:

One S-707106 B tablet + 3 Placebo A tablets

Treatment:

Drug: Placebo A tablet

Drug: S-707106 Dose B

Drug: Metformin

S-707106 Dose C

Experimental group

Description:

S-707106 Dose C = Four S-707106 B tablets

Treatment:

Drug: S-707106 Dose C

Drug: Metformin

Metformin

Active Comparator group

Description:

The standard of care dose of metformin for the individual patient + 3 Placebo A tablets

Treatment:

Drug: Placebo A tablet

Drug: Metformin