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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maria Elizabeth Rossi da Silva, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01509001
First received: January 9, 2012
Last updated: January 13, 2012
Last verified: January 2012
  Purpose

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

Condition Intervention Phase
Type 2 Diabetes
Drug: Metformin
Drug: Glimepiride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Metabolic and Haemodynamic Effects of Metformin and Glimepiride in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • glucose control [ Time Frame: every 2 weeks ] [ Designated as safety issue: Yes ]
    measurements of glucose , glycated haemoglobin and insulin levels


Secondary Outcome Measures:
  • haemodynamic improvement [ Time Frame: every 4 months ] [ Designated as safety issue: No ]
    flow indexes of carotid and brachial arteries


Enrollment: 20
Study Start Date: January 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: metformin
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
750 to 2500 mg/day, two times a day during 4 months
Other Name: glifage
Active Comparator: glimepiride
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
1 to 8 mg/day , two times a dya, during 4 months.
Other Name: Amaryl

Detailed Description:

Measurements were be made at fasting

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509001

Locations
Brazil
Clinical Hospital of São Paulo Medical School
são Paulo, SP, Brazil
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Maria Elizabeth R Silva, Md,Phd University of Sao Paulo
  More Information

No publications provided

Responsible Party: Maria Elizabeth Rossi da Silva, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01509001     History of Changes
Other Study ID Numbers: SILVAMER, CUNHAMR
Study First Received: January 9, 2012
Last Updated: January 13, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
type 2 diabetes
metformin
glimepiride
glucose control
vascular reactivity
Adverse Reaction to Other Drugs and Medicines

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 20, 2014