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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01509001

Enrollment

Registered

2012-01-12

Start date

2011-01-31

Completion date

2012-01-31

Last updated

2012-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes, metformin, glimepiride, glucose control, vascular reactivity, Adverse Reaction to Other Drugs and Medicines

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

Interventions

DRUGMetformin

750 to 2500 mg/day, two times a day during 4 months

DRUGGlimepiride

1 to 8 mg/day , two times a dya, during 4 months.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
glucose control	every 2 weeks	measurements of glucose , glycated haemoglobin and insulin levels

Secondary

Measure	Time frame	Description
haemodynamic improvement	every 4 months	flow indexes of carotid and brachial arteries

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026