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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01509001
First Posted: January 12, 2012
Last Update Posted: January 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maria Elizabeth Rossi da Silva, University of Sao Paulo
  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
Intervention Model: Crossover Assignment
Masking: None (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 Maria Elizabeth Rossi da Silva, University of Sao Paulo:

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


Secondary Outcome Measures:
  • haemodynamic improvement [ Time Frame: every 4 months ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: University of Sao Paulo )
First Submitted: January 9, 2012
First Posted: January 12, 2012
Last Update Posted: January 16, 2012
Last Verified: January 2012

Keywords provided by Maria Elizabeth Rossi da Silva, 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
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors