Trial record 2 of 2 for:
707106
Safety and Efficacy of S-707106 in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control With Metformin Therapy
This study has been completed.
Sponsor:
Shionogi
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )
ClinicalTrials.gov Identifier:
NCT01240759
First received: November 11, 2010
Last updated: April 9, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: S-707106 dose 1 Drug: S-707106 dose 2 Drug: S-707106 dose 3 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Shionogi Inc.:
Primary Outcome Measures:
- Change from Baseline to Week 12 in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]Hemoglobin A1c
Secondary Outcome Measures:
- Serial pharmacokinetic (PK) assessments [ Time Frame: 5 days ] [ Designated as safety issue: No ]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 [ Time Frame: 5 days ] [ Designated as safety issue: No ]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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 5-6 months ] [ Designated as safety issue: Yes ]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
| Enrollment: | 218 |
| Study Start Date: | October 2010 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: S-707106 dose 1 plus metformin
S-707106 tablets concurrently with their usual metformin dose for 12 weeks
|
Drug: S-707106 dose 1
One S-707106 dose 1 tablet and 3 Placebo A tablets matching S-707106 dose 1- and dose 2 tablets and metformin
|
|
Experimental: S-707106 dose 2 plus metformin
S-707106 tablets concurrently with their usual metformin dose for 12 weeks
|
Drug: S-707106 dose 2
One S-707106 dose 2 tablet and 3 Placebo A tablets matching S-707106 dose 1- and dose 2 tablets and metformin
|
|
Experimental: S-707106 dose 3 plus metformin
S-707106 tablets concurrently with their usual metformin dose for 12 weeks
|
Drug: S-707106 dose 3
Four S-707106 dose 2 tablets and metformin
|
|
Placebo Comparator: Placebo plus metformin
Placebo tablets concurrently with their usual metformin dose for 12 weeks
|
Drug: Placebo
Four Placebo A tablets matching S-707106 dose 1- and dose 2 tablets and metformin
|
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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240759
Locations
| United States, Texas | |
| Juno Research, LLC | |
| Houston, Texas, United States, 77074 | |
Sponsors and Collaborators
Shionogi
Investigators
| Study Director: | Shionogi Clinical Trials Administrator Clinical Support Help Line | Shionogi |
More Information
No publications provided
| Responsible Party: | Shionogi Inc. ( Shionogi ) |
| ClinicalTrials.gov Identifier: | NCT01240759 History of Changes |
| Other Study ID Numbers: | 1010N0921 |
| Study First Received: | November 11, 2010 |
| Last Updated: | April 9, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Shionogi Inc.:
|
Type 2 Diabetes Mellitus Metformin |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013