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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 28, 2002 | ||||
| Last Updated Date | June 18, 2008 | ||||
| Start Date ICMJE | May 2001 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Change in HbA1C from baseline to Week 26. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00044447 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Incidence of hypoglycemia. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluate the Role of Adding Amaryl to Non-Insulin Dependent Diabetes Mellitus Patients Unresponsive to Maximum Dose Metformin & Thiazolidinedione | ||||
| Official Title ICMJE | A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study to Evaluate the Role of the Addition of Amaryl to NIDDM Patients Not Responding to Maximum Dose Metformin and Thiazolidinedione Therapy | ||||
| Brief Summary | The purpose of this study is to assess the efficacy and safety of Amaryl when added to Metformin and Thiazolidinedione (TZD) in non-insulin dependent diabetes mellitus (NIDDM) patients. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Diabetes Mellitus, Non-Insulin-Dependent | ||||
| Intervention ICMJE | Drug: Glimepiride | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 170 | ||||
| Completion Date | September 2002 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00044447 | ||||
| Responsible Party | ICD Study Director, sanofi-aventis | ||||
| Study ID Numbers ICMJE | HOE490/4033 | ||||
| Study Sponsor ICMJE | Sanofi-Aventis | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Sanofi-Aventis | ||||
| Verification Date | June 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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