Metabolic Effects of Treatment in Patients With Recently Diagnosed Type 2 Diabetes
Overview[ - collapse ][ - ]
| Purpose | The aim of the present study is to investigate the influence of several anti-diabetic regimens (metformin,glitazone,sulfonylurea,glinidine) and diet on metabolic parameters in patients with recently diagnosed type 2 diabetes. |
|---|---|
| Condition | Type 2 Diabetes Mellitus |
| Intervention | Drug: rosiglitazone Drug: metformin Drug: Anti-diabetic medications |
| Phase | Phase 4 |
| Sponsor | Aristotle University Of Thessaloniki |
| Responsible Party | Aristotle University Of Thessaloniki |
| ClinicalTrials.gov Identifier | NCT00373178 |
| First Received | September 6, 2006 |
| Last Updated | November 1, 2012 |
| Last verified | November 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 6, 2006 |
|---|---|
| Last Updated Date | November 1, 2012 |
| Start Date | January 2005 |
| Estimated Primary Completion Date | June 2008 |
| Current Primary Outcome Measures | Novel cardiovascular risk factors modification [Time Frame: 2 years] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Lipid and glucose regulation [Time Frame: 2 years] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Metabolic Effects of Treatment in Patients With Recently Diagnosed Type 2 Diabetes |
|---|---|
| Official Title | Metabolic Effects of Treatment in Patients With Recently Diagnosed Type 2 Diabetes |
| Brief Summary | The aim of the present study is to investigate the influence of several anti-diabetic regimens (metformin,glitazone,sulfonylurea,glinidine) and diet on metabolic parameters in patients with recently diagnosed type 2 diabetes. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Type 2 Diabetes Mellitus |
| Intervention | Drug: rosiglitazone Drug: metformin Drug: Anti-diabetic medications |
| Study Arm (s) | Active Comparator: Metformin,lifestyle counselling |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 100 |
| Estimated Completion Date | June 2008 |
| Estimated Primary Completion Date | January 2007 |
| Eligibility Criteria | Inclusion Criteria: - Recently diagnosed type 2 diabetes - No previous anti-diabetic medications Exclusion Criteria: - Heart failure - Renal disease - Liver disease - Life-threatening diseases |
| Gender | Both |
| Ages | 40 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Greece |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00373178 |
|---|---|
| Other Study ID Numbers | 020401975 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Aristotle University Of Thessaloniki |
| Study Sponsor | Aristotle University Of Thessaloniki |
| Collaborators | University of Athens |
| Investigators | Study Chair: Miltiadis Alevizos, PhD University Hospital AHEPA,Thessaloniki,Greece |
| Verification Date | November 2012 |
Locations[ + expand ][ + ]
| AHEPA University Hospital of Thessaloniki | Thessaloniki, Greece |
|---|---|
| Aristotle University of Thessaloniki | Thessaloniki, Greece |