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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01509001
• Other study ID #: SILVAMER
• Secondary ID: CUNHAMR
• Status: Completed
• Phase: Phase 4
• First received: January 9, 2012
• Last updated: January 13, 2012
• Start date: January 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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

Description:

Measurements were be made at fasting

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Metformin
750 to 2500 mg/day, two times a day during 4 months
• Glimepiride
1 to 8 mg/day , two times a dya, during 4 months.

Locations

Country	Name	City	State
Brazil	Clinical Hospital of São Paulo Medical School	são Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glucose control	measurements of glucose , glycated haemoglobin and insulin levels	every 2 weeks	Yes
Secondary	haemodynamic improvement	flow indexes of carotid and brachial arteries	every 4 months	No