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NCT Number: NCT01509001

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

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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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Hospital of São Paulo Medical School

São Paulo, Brazil

About this study

Measurements were be made at fasting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

metformin

Drug

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

Other names: glifage

Glimepiride

Drug

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

Other names: Amaryl

Primary outcomes

  1. glucose control

    Time frame: every 2 weeks

    measurements of glucose , glycated haemoglobin and insulin levels

Secondary outcomes

  1. haemodynamic improvement

    Time frame: every 4 months

    flow indexes of carotid and brachial arteries

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 12, 2012
Registry last updated
Jan 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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