Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A 12-week Study to Compare the Effects of Vildagliptin Versus Glibenclamide on Glycemic Variability After a Sub Maximal Exercise Test in Patients With Type 2 Diabetes Inadequately Controlled With Metformin.
Exercise is considered a way to benefit the health of unhealthy and healthy individuals.
This is confirmed by different scientific researches, in which people who participated
improve their health. The present study will be conducted to test the hypothesis that
vildagliptin associated with metformin may have more impact in improving glucose variability
after a sub-maximal exercise test, as compared to glibenclamide. Our general aim will be to
evaluate glucose variability after the submaximal exercise test under the treatment with
vildagliptin or glibenclamide. The specific aims of this study are to evaluate the oxidative
stress, endothelial function, metabolic and cardiovascular responses to exercise under the
treatment with vildagliptin or glibenclamide. All these responses are important in patients
with Diabetes Mellitus type II. Allied to the patient's routine treatment (metformin), they
will receive orally a second drug, to take in 12 weeks. The patients will be raffled to take
one of the two drugs that act on glycemia, that are called vildagliptin (50 mg of this drug
twice a day) and glibenclamide (5 mg once a day during the first week and later you will
increase to 5 mg twice a day). The metformin drug will continue be used.
Patients who meet the eligible criteria for the study will first make the test of the
maximum effort, to determination of peak oxygen consumption (VO2peak) and ventilatory
thresholds. Forty eight hours after this test, patients will be allowed to do the pre-drugs
protocol that will be given in three consecutive days as explained below.
- Day 1: Begin a 24-hour urinary collection, perform vascular doppler ultrasound to
evaluate endothelial function and then the glucose sensor will be inserted
subcutaneously (begin continuous glucose monitoring system - CGMS evaluation);
- Day 2: End the 24-hour urinary collection, submit to the submaximal test (blood
collection at baseline, 15 and 30 min of the session, and 60 min after recovery). On
the same day, the patients will begin 24h ambulatory blood pressure monitoring
(24h-ABPM).
- Day 3: Removal of the glucose sensor; end of the 24h ABPM, randomization. This same
protocol, except the randomization will be repeated at the end of the 12 week
treatment.
The main procedures will occur during three consecutive days, before randomization and 3
days before 12 weeks. In the first day, the patients will begin the 24hour urinary
collection; the ultrasonography will be made in fasting state and they will place the
sensors (CGMS and MAPA). In the second day, the blood samples will be collected and the
patients will undergo sub-maximal exercise test; in the third day the sensors will be
removed. The sub-maximal exercise test will occur on day 2 after a standard breakfast (500
kcal; 60% carbohydrate, 30% fat and 10% protein) after 8 hours overnight fast. After the
three days of the first assessments, the selected patients will be divided into two groups,
the group 1 receiving vildagliptin and the group 2 receiving glibenclamide for 12 weeks.
There will be follow up visits on week 4 and 8. The variables in response to exercise
(sub-maximal test) will be compared between the groups after 12 weeks.
The sample estimated will be 20 patients (10% drop out included) with DM2, from outpatient
clinics of Serviço de Endocrinologia do Hospital de Clínicas de Porto Alegre (HCPA) or from
public health. Patients will be randomized to metformin plus vildagliptin (MET + vilda),
which will receive an additional vidagliptin dose of 50 mg twice a day and metformin plus
glibenclamide group (MET + gliben) that will receive an additional glibenclamide dose of 5 -
20 mg once a day. Based on Marfella et al (13) study on the evaluation of the efficacy of
treatment with Vildagliptin or Sitagliptin on blood glucose in patients with DM2
inadequately controlled with Metformin, a sample size with a 90% power and one alpha (α) of
0, 01 was calculated. Vidagliptin had a serious effect (51% reduction in MAGE), since the
average difference was 25mg/dl with a 16 and 7mg/dl SD. After 20 subjects were analyzed, the
calculated sample will be redone for confirming the sample efficacy for evidence of the
expected effect evidence.
Adverse events, including serious adverse events or pregnancies will be collected and
reported in the medical report of the study (Annex IV).
The reports containing serious adverse events or pregnancies will be forwarded to the
respective manufacturer laboratory within 24 hrs after their knowledge, and the health
authority according to the local law.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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