Diabetes Mellitus, Type 2Phase 4DIABEX-VILDANCT01867502
Effects of Vildagliptin Versus Glibenclamide on Glycemia After Exercise in Patients With Type 2 Diabetes
A Phase 4 study testing MET + Vildagliptin Group and MET + Glibenclamide Group in people with Diabetes Mellitus, Type 2 and Hypoglycemic Agents, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypoglycemic Agents, Diabetic Blood Glucose Monitoring
- What is being tested?
- MET + Vildagliptin Group and MET + Glibenclamide Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2014to Aug 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Lactose intolerance;
- Renal insufficiency (creatinine clearance <60ml/min);
- Blood pressure more than 180/100mmHg at rest (3 consecutive measures).
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Aline Fofonka, MSc, 55-5192339191, alinefofonka@hotmail.com
Beatriz D Schaan, PhD
About this study
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.
Read the detailed description
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.
- Conditions
- Diabetes Mellitus, Type 2, Hypoglycemic Agents, Diabetic Blood Glucose Monitoring, Exercise
- Being tested
- MET + Vildagliptin Group, MET + Glibenclamide Group
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MET + Vildagliptin GroupDrug
Also called Galvus®, Glyburide, Glucophage
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.
MET + Glibenclamide GroupDrug
Also called Daonil®, Glucophage
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.
| Study group | Role | What they receive |
|---|---|---|
| MET + Glibenclamide Group | Other | Usual 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. Receives: Drug: MET + Glibenclamide Group |
| MET + Vildagliptin Group | Other | Usual 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. Receives: Drug: MET + Vildagliptin Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycemic variability
Continuous glucose monitoring system (CGMS) during 48 hours (24h before and 24 after the submaximal exercise test).
Measured: Baseline and 12 weeks
Secondary outcomes (1)
Change in Hemodynamic response to exercise: Cardiac output (Q), Stroke Volume (SV) and blood pressure (BP)
Cardiac output (Q) and the Stroke Volume (SV)and blood pressure (BP) will be measured before the sub-maximal tests, 10% below the second threshold and every 2 minutes of recovery.
Measured: Each 2 minutes during exercise and until 60 min post in baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startApr 2014
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beatriz BS Schaan, PhD, Principal investigator, Federal University of Rio Grande do SulAline AF Fofonka, MSc, Study chair, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867502
- Sponsor's protocol ID
- CLAF237ABR05T
- Other IDs
- 12-0444
- Acronym
- DIABEX-VILDA
- Status last verified
- May 2014
- First submitted
- 17 May 2013
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25366037
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01867502
- Acronym / sponsor ID
- DIABEX-VILDA / CLAF237ABR05T
- Conditions
- Diabetes Mellitus, Type 2, Hypoglycemic Agents, Diabetic Blood Glucose Monitoring, Exercise
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MET + Glibenclamide Group | Other | Drug: MET + Glibenclamide GroupUsual 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 | Other | Drug: MET + Vildagliptin GroupUsual 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MET + Vildagliptin GroupAlso: Galvus®, Glyburide, GlucophageVidagliptin 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. | Drug | MET + Vildagliptin Group |
| MET + Glibenclamide GroupAlso: Daonil®, GlucophageThe 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. | Drug | MET + Glibenclamide Group |
Primary outcome
Change in Glycemic variability
Time frame: Baseline and 12 weeks
Continuous glucose monitoring system (CGMS) during 48 hours (24h before and 24 after the submaximal exercise test).
1 secondary outcome
Change in Hemodynamic response to exercise: Cardiac output (Q), Stroke Volume (SV) and blood pressure (BP)
Time frame: Each 2 minutes during exercise and until 60 min post in baseline and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
- Derived from this study: PubMed 25366037Fofonka 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.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatriz BS Schaan, PhD principal investigator
Federal University of Rio Grande do Sul
Aline AF Fofonka, MSc study chair
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MET + Vildagliptin Group and MET + Glibenclamide Group in people with Diabetes Mellitus, Type 2 and Hypoglycemic Agents, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aline AF Fofonka, MSc (55-5192339191, alinefofonka@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycemic variability (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01867502, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2014.