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

University of Sao Paulo

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Glimepiride; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT01509001

SILVAMER

CUNHAMR (Other Identifier)

Details and patient eligibility

About

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

Full description

Measurements were be made at fasting

Enrollment: 20 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

metformin

Active Comparator group

Description:

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

Treatment:

Drug: Metformin

glimepiride

Active Comparator group

Description:

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

Treatment:

Drug: Glimepiride