NCT01509001

Brief Summary

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.

  1. 1.Hormonal and metabolic determinations: fasting plasma glucose, insulin, catecholamine, lipid profile and HbA1 levels.
  2. 2.Haemostatic factors: t-PA antigen and activity, PAI-1 antigen and activity, platelet aggregation, fibrinogen and plasminogen levels.
  3. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4 type-2-diabetes

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2012

Completed
Last Updated

January 16, 2012

Status Verified

January 1, 2012

Enrollment Period

1 year

First QC Date

January 9, 2012

Last Update Submit

January 13, 2012

Conditions

Type 2 Diabetes

Keywords

type 2 diabetesmetforminglimepirideglucose controlvascular reactivityAdverse Reaction to Other Drugs and Medicines

Outcome Measures

Primary Outcomes (1)

  • glucose control

    measurements of glucose , glycated haemoglobin and insulin levels

    every 2 weeks

Secondary Outcomes (1)

  • haemodynamic improvement

    every 4 months

Study Arms (2)

metformin

ACTIVE COMPARATOR

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

glimepiride

ACTIVE COMPARATOR

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

Interventions

MetforminDRUG

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

Also known as: glifage
metformin
GlimepirideDRUG

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

Also known as: Amaryl
glimepiride

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Hospital of São Paulo Medical School

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metforminglimepiride

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Maria Elizabeth R Silva, Md,Phd

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 12, 2012

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 16, 2012

Record last verified: 2012-01

Locations

BR(1)