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

NCT01240759 | Completed Phase 2 DMC

• 1 other identifier: 1010N0921
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus; Metformin

Outcome Measures

Primary Outcomes (1)

• Change from Baseline to Week 12 in Hemoglobin A1c (HbA1c)

  Hemoglobin A1c

  Baseline and at 12 weeks

Secondary Outcomes (5)

• Serial pharmacokinetic (PK) assessments

  5 days

• Sparse pharmacokinetic assessments

  5 days

• Percent of subjects with Hemoglobin A1c < 7.0% at Week 12

  12 weeks

• 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

• Safety assessments

  5-6 months

Study Arms (4)

S-707106 Dose A

EXPERIMENTAL

One S-707106 A tablet + 3 Placebo A tablets

Drug: S-707106 Dose A; Drug: Placebo A tablet; Drug: Metformin

S-707106 Dose B

EXPERIMENTAL

One S-707106 B tablet + 3 Placebo A tablets

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

S-707106 Dose C

EXPERIMENTAL

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

Drug: S-707106 Dose C; Drug: Metformin

Metformin

ACTIVE COMPARATOR

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

Drug: Placebo A tablet; Drug: Metformin

Interventions

S-707106 Dose A DRUG

One S-707106 A tablet

S-707106 Dose A

S-707106 Dose B DRUG

One S-707106 B tablet

S-707106 Dose B

S-707106 Dose C DRUG

Four S-707106 4 X B tablets

S-707106 Dose C

Placebo A tablet DRUG

Up to 4 Placebo A tablets

Metformin; S-707106 Dose A; S-707106 Dose B

Metformin DRUG

The standard of care dose of metformin for each patient

Metformin; S-707106 Dose A; S-707106 Dose B; S-707106 Dose C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shionogi: lead

Study Sites (1)

Juno Research, LLC

Houston, Texas, 77074, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Shionogi Clinical Trials Administrator Clinical Support Help Line

  Shionogi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2010
• First Posted: November 15, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: May 15, 2018

Record last verified: 2018-05

Locations

US (1)