Study of Metabolic and Haemodynamic Effects of Metformin and Glimepiride in Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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: Hormonal and metabolic determinations: fasting plasma glucose, insulin, catecholamine, lipid profile and HbA1 levels. Haemostatic factors: t-PA antigen and activity, PAI-1 antigen and activity, platelet aggregation, fibrinogen and plasminogen levels. 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
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Measurements were be made at fasting

Official Title
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Study of Metabolic and Haemodynamic Effects of Metformin and Glimepiride in Patients With Type 2 Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Metformin
* Drug: Glimepiride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: metformin<br>Participants will randomized into Metformin (750 to 2500 mg/day) or Glimepiride (1 to 8 mg/day) therapy. After 4 months, the patients will crossed-over with no washout period to the alternative treatment for an additional 4-month period on similar dosage schedule | Drug: Metformin<br>* 750 to 2500 mg/day, two times a day during 4 months<br>* Other names: glifage;|
| Active Comparator: glimepiride<br>Participants will randomized into Metformin (750 to 2500 mg/day) or Glimepiride (1 to 8 mg/day) therapy. After 4 months, the patients will crossed-over with no washout period to the alternative treatment for an additional 4-month period on similar dosage schedule | Drug: Glimepiride<br>* 1 to 8 mg/day , two times a dya, during 4 months.<br>* Other names: Amaryl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose control | measurements of glucose , glycated haemoglobin and insulin levels | every 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| haemodynamic improvement | flow indexes of carotid and brachial arteries | every 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes, metformin, glimepiride, glucose control, vascular reactivity, Adverse Reaction to Other Drugs and Medicines