Effects of Vildagliptin Versus Glibenclamide on Glycemia After Exercise in Patients With Type 2 Diabetes
DIABEX-VILDA
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.
2 other identifiers
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 diabetes-mellitus-type-2
Started Apr 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2013
CompletedFirst Posted
Study publicly available on registry
June 4, 2013
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedMay 6, 2014
May 1, 2014
1.3 years
May 17, 2013
May 5, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Glycemic variability
Continuous glucose monitoring system (CGMS) during 48 hours (24h before and 24 after the submaximal exercise test).
Baseline and 12 weeks
Secondary Outcomes (1)
Change in Hemodynamic response to exercise: Cardiac output (Q), Stroke Volume (SV) and blood pressure (BP)
Each 2 minutes during exercise and until 60 min post in baseline and 12 weeks
Other Outcomes (4)
Change in Flow Mediated Dilatation (FMD)
Baseline and 12 weeks
Change in Blood pressure variability
Baseline and 12 weeks
Change in Plasma glucagon concentration on exercise
-1h, 0, 15min, 30 min (end), 60min post exercise in baseline and 12 weeks
- +1 more other outcomes
Study Arms (2)
MET + Glibenclamide Group
OTHERUsual Metformin stipulated: 500 or 850mg 3 times a day, if tolerated by patients. The initial dose of glibenclamide group will be 5mg / day during the first week of study, later it will increase to 10 mg / day (2 x 5mg). When the adjustments will be done, the dose may reaching the maximum dose allowed, which is 20 mg / day.
MET + Vildagliptin Group
OTHERUsual Metformin stipulated: 500 or 850mg 3 times a day, if tolerated by patients. Vidagliptin group will receive 50mg of this drug twice a day during 12 weeks.
Interventions
Vidagliptin group will receive 50mg of this drug twice a day during 12 weeks added to usual metformin. For the glicemic control evaluation will be used the capilar glycemia at home. The adjustments will be done by the researcher coordinator.
The initial dose of glibenclamide group will be 5mg / day during the first week of study, later it will increase to 10 mg / day (2 x 5mg). With the control the dose may be adjusted, reaching the maximum dose allowed, which is 20 mg / day. For the glycemic control evaluation will be used the capillar glycemia at home. The adjustments will be done by the researcher coordinator.
Eligibility Criteria
You may qualify if:
- Type 2 diabetes (fasting glucose ≥ 126 mg/dl or 7.0 mmol/l)(25);
- Recent HbA1C determination (between 7, 5 and 10%);
- Not involved in regular physical exercise;
- Older than 18 years;
- In use of Metformin.
You may not qualify if:
- Smoker and use of analgesic or anti-inflammatory drugs during the week of the study
- BMI \> 40 kg/m²;
- Proliferative retinopathy;
- Ischemic cardiomyopathy;
- Peripheral vascular disease;
- Blood Aspartate transaminase (AST) and Alanine transaminase (ALT) 2.5 times higher the normal concentration before screening visit
- Lactose intolerance;
- Renal insufficiency (creatinine clearance \<60ml/min);
- Blood pressure more than 180/100mmHg at rest (3 consecutive measures).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clínicas de Porto Alegre Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Related Publications (1)
Fofonka A, Ribeiro JP, Casali KR, Schaan BD. Effects of vildagliptin compared with glibenclamide on glucose variability after a submaximal exercise test in patients with type 2 diabetes: study protocol for a randomized controlled trial, DIABEX VILDA. Trials. 2014 Nov 4;15:424. doi: 10.1186/1745-6215-15-424.
PMID: 25366037DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beatriz BS Schaan, PhD
Federal University of Rio Grande do Sul
- STUDY CHAIR
Aline AF Fofonka, MSc
Federal University of Rio Grande do Sul
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2013
First Posted
June 4, 2013
Study Start
April 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
May 6, 2014
Record last verified: 2014-05