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| Sponsor: | AtheroGenics |
|---|---|
| Information provided by: | AtheroGenics |
| ClinicalTrials.gov Identifier: | NCT00525577 |
Purpose
This double-blind, placebo-controlled, dose-finding study is designed to identify the lowest AGI-1067 dose that improves glycemic control as measured by HbA1c and fasting glucose in subjects with Type 2 diabetes mellitus. Glycemic control will be measured during a 6-month treatment period in subjects who are on 1 or no antidiabetic drugs
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes |
Drug: Placebo Drug: AGI-1067 |
Phase II Phase III |
| 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: | AGI-1067 as a Novel Antidiabetic Agent Evaluation Study |
| Estimated Enrollment: | 1012 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | September 2008 |
| Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1:A
Placebo
|
Drug: Placebo
Placebo tablet, once daily
|
|
Experimental: 2:B
AGI-1067 75 mg
|
Drug: AGI-1067
75 mg AGI-1067 tablet, once daily
Other Name: AGI-1067 (succinobucol)
|
|
Experimental: 3:C
AGI-1067 150 mg
|
Drug: AGI-1067
150 mg AGI-1067 Tablet, once daily
Other Name: AGI-1067 (succinobucol)
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 90 Study Locations| Study Chair: | Walker Long, MD | AtheroGenics, Inc |
More Information
| Responsible Party: | Walker Long, MD, AtheroGenics, Inc |
| ClinicalTrials.gov Identifier: | NCT00525577 History of Changes |
| Other Study ID Numbers: | AGI-1067-052 |
| Study First Received: | September 4, 2007 |
| Last Updated: | February 4, 2008 |
| Health Authority: | United States: Food and Drug Administration; South Africa: Medicines Control Council; India: Ministry of Health; Georgia: Ministry of Health; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Ukraine: Ministry of Health; Macedonia: Ethics Committee; Russia: Pharmacological Committee, Ministry of Health |
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Type 2 diabetes, glycemic control |
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |