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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:
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glimepiride
Metformin
Anti-Arrhythmia Agents
Cardiovascular Agents
Hypoglycemic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014