Study of Metabolic and Haemodynamic Effects of Metformin and Glimepiride in Patients With Type 2 Diabetes Mellitus
Overview[ - collapse ][ - ]
| Purpose | Aim: The purpose of this study is to compare the effects of glimepiride(G) and metformin(M) on vascular reactivity, haemostatic factors and glucose and lipid profile in patients with type 2 diabetes. Methods: A prospective study will be performed in 20 uncontrolled patients previously treated with dietary intervention. Participants will randomized into M (750 to 2500 mg/day) or G (1 to 8 mg/day) therapy. After 4 months, the patients will be crossed-over with no washout period to the alternative treatment for an additional 4-month period on similar dosage schedule. - The following variables were assessed before (basal values) and after 4 months of each treatment period: 1. Hormonal and metabolic determinations: fasting plasma glucose, insulin, catecholamine, lipid profile and HbA1 levels. 2. Haemostatic factors: t-PA antigen and activity, PAI-1 antigen and activity, platelet aggregation, fibrinogen and plasminogen levels. 3. Cardiovascular evaluation: flow indexes of carotid and brachial arteries. Also, at the end of each treatment period, a 12-hour metabolic profile including measurements of glucose, insulin, glucagon, proinsulin and triglycerides levels at fasting and every 2 hours (7:00 am to 7:00 pm)will be done |
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| Condition | Type 2 Diabetes |
| Intervention | Drug: Metformin Drug: Glimepiride |
| Phase | Phase 4 |
| Sponsor | University of Sao Paulo |
| Responsible Party | University of Sao Paulo |
| ClinicalTrials.gov Identifier | NCT01509001 |
| First Received | January 9, 2012 |
| Last Updated | January 13, 2012 |
| Last verified | January 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 9, 2012 |
|---|---|
| Last Updated Date | January 13, 2012 |
| Start Date | January 2011 |
| Estimated Primary Completion Date | January 2012 |
| Current Primary Outcome Measures | glucose control [Time Frame: every 2 weeks] [Designated as safety issue: Yes]measurements of glucose , glycated haemoglobin and insulin levels |
| Current Secondary Outcome Measures | haemodynamic improvement [Time Frame: every 4 months] [Designated as safety issue: No]flow indexes of carotid and brachial arteries |
Descriptive Information[ + expand ][ + ]
| Brief Title | Study of Metabolic and Haemodynamic Effects of Metformin and Glimepiride in Patients With Type 2 Diabetes Mellitus |
|---|---|
| Official Title | Study of Metabolic and Haemodynamic Effects of Metformin and Glimepiride in Patients With Type 2 Diabetes |
| Brief Summary | Aim: The purpose of this study is to compare the effects of glimepiride(G) and metformin(M) on vascular reactivity, haemostatic factors and glucose and lipid profile in patients with type 2 diabetes. Methods: A prospective study will be performed in 20 uncontrolled patients previously treated with dietary intervention. Participants will randomized into M (750 to 2500 mg/day) or G (1 to 8 mg/day) therapy. After 4 months, the patients will be crossed-over with no washout period to the alternative treatment for an additional 4-month period on similar dosage schedule. - The following variables were assessed before (basal values) and after 4 months of each treatment period: 1. Hormonal and metabolic determinations: fasting plasma glucose, insulin, catecholamine, lipid profile and HbA1 levels. 2. Haemostatic factors: t-PA antigen and activity, PAI-1 antigen and activity, platelet aggregation, fibrinogen and plasminogen levels. 3. Cardiovascular evaluation: flow indexes of carotid and brachial arteries. Also, at the end of each treatment period, a 12-hour metabolic profile including measurements of glucose, insulin, glucagon, proinsulin and triglycerides levels at fasting and every 2 hours (7:00 am to 7:00 pm)will be done |
| Detailed Description | Measurements were be made at fasting |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Type 2 Diabetes |
| Intervention | Drug: Metformin 750 to 2500 mg/day, two times a day during 4 months Other Names: glifageDrug: Glimepiride 1 to 8 mg/day , two times a dya, during 4 months. Other Names: Amaryl |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 20 |
| Estimated Completion Date | January 2012 |
| Estimated Primary Completion Date | January 2012 |
| Eligibility Criteria | Inclusion Criteria: - type 2 diabetes patients with fasting glucose values >7.78 mmol/L and/or glycated hemoglobin exceeding 1.0% or more the normal range (4-8.5%) after 2 or more months of a diet therapy Exclusion Criteria: - any severe concomitant illness - nephropathy (serum creatinine >1.6 mg/dL and microalbuminuria) - uncontrolled hypertension (BP >190x120 mmHg) - stroke - peripheral vascular disease - marked dyslipidemia (total cholesterol>6.5mM/L and triglycerides levels >2.8mM/L) - coagulopathy - proliferative retinopathy and use of hypolipemic and anticoagulant medications or autonomic neuropathy - assessed by blood pressure response to standing - beat-to -beat heart rate variation - Valsalva maneuver and handgrip test. |
| Gender | Both |
| Ages | 40 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Brazil |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01509001 |
|---|---|
| Other Study ID Numbers | SILVAMER |
| Has Data Monitoring Committee | No |
| Information Provided By | University of Sao Paulo |
| Study Sponsor | University of Sao Paulo |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Maria Elizabeth R Silva, Md,Phd University of Sao Paulo |
| Verification Date | January 2012 |
Locations[ + expand ][ + ]
| Clinical Hospital of São Paulo Medical School | são Paulo, SP, Brazil |
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