PreDiabetesPhase 4NCT03006471
Effect of Dapagliflozin on Blood Pressure Variability in Prediabetes and Prehypertension
A Phase 4 study testing Dapagliflozin in people with PreDiabetes and Prehypertension, run by University of Guadalajara at 1 site in Mexico.
Trial summary
Prediabetes is defined as an intermediate metabolic state that leads to the development of type 2 diabetes mellitus (DM2) and the prehypertension is a category assigned to identify patients who are at risk of developing hypertension (AH), in both pathologies the abnormalities in the variation of blood pressure (BP)… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- PreDiabetes, Prehypertension
- What is being tested?
- Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 30 Mar 2016to 29 Jun 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent signed
- Patients both sexes, age between 30 and 60 years
- Diagnosis of prediabetes according American Diabetes Association criteria (fasting blood glucose levels between 100-126 mg/dl; postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose between 140-199 mg/dl; or glycosylated hemoglobin between 5.7-6.4%)
- Diagnosis of prehypertension according (JNC8) Eighth Joint National Committee blood pressure between 120-139/ 80-89 mmHg.
Who cannot join
- Women with confirmed or suspected pregnancy
- Women under lactation and/or puerperium
- Hypersensibility to ingredients of intervention
- Physical impossibility for taking pills
- Known uncontrolled renal, hepatic, heart or thyroid diseased
- Diabetes diagnosis
Show all 10Show fewer
- Previous treatment for glucose or blood pressure Triglycerides ≥400 mg/dL
- Total cholesterol ≥240 mg/dL
- History of cardiovascular disease
- Worker per shift / night
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, 44340
About this study
Official title: Effect of Dapagliflozin on Blood Pressure Variability in Patients With Prediabetes and Prehypertension Without Pharmacological Treatment
Prediabetes is defined as an intermediate metabolic state that leads to the development of type 2 diabetes mellitus (DM2) and the prehypertension is a category assigned to identify patients who are at risk of developing hypertension (AH), in both pathologies the abnormalities in the variation of blood pressure (BP) has been related to organ damage, its evaluation is performed by ambulatory blood pressure monitoring (ABPM).
Dapagliflozin is a selective and reversible inhibitor of the sodium-glucose co-transporter type 2 (SGLT-2), which reduces renal reabsorption of glucose and promotes the excretion of glucose through the urine, in the way that glucose blood. Another reported effects is the decrease on BP, so it would be interesting to evaluate this effects in patients with prediabetes and prehypertension, as a potential therapy to treat disorders and to prevent progression to DM2 and Hypertension, respectively.
Read more
The aim of this study is to evaluate the effect of Dapagliflozin on variability of blood pressure in patients with prediabetes and prehypertension without pharmacological treatment.
The investigators hypothesis is that the administration of dapagliflozin decreases variability of blood pressure in patients with prediabetes and prehypertension without pharmacological treatment.
Read the detailed description
A randomized, double-blind, placebo-controlled clinical trial in 30 patients with a diagnosis of prediabetes and prehypertension without treatment.
They will be assigned randomly two groups of 15 patients each to receive 10 mg of Dapagliflozin (Forxiga, Astra Zeneca) or placebo, one per day before breakfast during 12 weeks.
There will be calculated body mass index (BMI) and blood pressure variability. This protocol it's already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.
Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2/ exact fisher test, will be used for differences inter-group Mann-Whitney U Test and coefficient of variation, Wilcoxon Test and index of variability for the within-groups differences. It will be considered statistical significance p ≤0.05.
- Conditions
- PreDiabetes, Prehypertension
- Being tested
- Dapagliflozin, Placebo - Cap
- Keywords
- Prediabetes, Prehypertension, Variability of blood pressure, ABPM, Dapagliflozin, SGLT2
- Medical subject headings
- Prediabetic State, Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called Forxiga
10 mg, one per day before breakfast during 12 weeks.
Placebo - CapDrug
Also called Calcined magnesium
one per day before breakfast during 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Receives: Drug: Dapagliflozin |
| Placebo | Placebo comparator | Placebo capsules, one per day before breakfast during 12 weeks. Receives: Drug: Placebo - Cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hours Systolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Measured: Week 12
24-hours Diastolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Measured: Week 12
Daytime Systolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 am. to 11 p.m. by oscillometric method Microlife WatchBP O3
Measured: Week 12
Daytime Diastolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to p.m. by oscillometric method Microlife WatchBP O3
Measured: Week 12
Nighttime Systolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m to 8 a.m. by oscillometric method Microlife WatchBP O3
Measured: Week 12
Nighttime Diastolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3
Measured: Week 12
Systolic Blood Pressure Weighted Standard Deviation at Week 12
Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Measured: Week 12
Diastolic Blood Pressure Weighted Standard Deviation at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Measured: Week 12
Coefficient of Variation of 24-hours, Systolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Measured: Week 12
Coefficient of Variation of 24-hours, Diastolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Measured: Week 12
Coefficient of Variation Daytime, Systolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m to 11 p.m. by oscillometric method Microlife WatchBP O3
Measured: Week 12
Coefficient of Variation Daytime, Diastolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3
Measured: Week 12
Coefficient of Variation Nighttime, Systolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3
Measured: Week 12
Coefficient of Variation Nighttime, Diastolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3
Measured: Week 12
Average Real Variability of Systolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Measured: Week 12
Average Real Variability of Diastolic Blood Pressure at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Measured: Week 12
Number of Participants With a Nondipper Circadian Blood Pressure Pattern at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Measured: Week 12
Number of Participants With a Dipper Circadian Blood Pressure Pattern at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Measured: Week 12
Number of Participants With a Dipper Reverse Circadian Blood Pattern at Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Measured: Week 12
Secondary outcomes (14)
Body Weight at Week 12
The body weight was measured with a bioimpedance balance
Measured: Week 12
Body Mass Index at Week 12
Body Mas Index was calculated with the Quetelet index formula
Measured: Week 12
Office Systolic Blood Pressure at Week 12
Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.)
Measured: Week 12
Office of Diastolic Blood Pressure at Week 12
Blood pressure was measured using the Omron 907-E digital sphygmomanometer (Healthcare, Inc.)
Measured: Week 12
Fasting Plasma Glucose Levels at Week 12
The fasting glucose levels was evaluated with enzymatic/colorimetric techniques
Measured: Week 12
2-hours Plasma Glucose After a Oral Glucose Tolerance Test at Week 12
2-hours plasma glucose after a oral glucose tolerance test (75 g of glucose load). Glucose was evaluated with enzymatic/ colorimetric technique
Measured: Week 12
Glycated Hemoglobin A1c (A1C) at Week 12
A1C was evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA)
Measured: Week 12
Daytime Mean Arterial Pressure at Week 12
The mean arterial pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3
Measured: Week 12
Nighttime Mean Arterial Pressure at Week 12
The Mean Arterial Pressure was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3
Measured: Week 12
Daytime Hypertensive Load at Week 12
The hypertensive load was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3
Measured: Week 12
Nocturnal Hypertensive Load at Week 12
The Hypertensive Load was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to a.m. by oscillometric method Microlife WatchBP O3
Measured: Week 12
Number of Participants With Prediabetes at Week 12
Prediabetes was diagnosed with the criteria of the American Diabetes Association.
Measured: Week 12
Number of Participants With Prehypertension at Week 12
Prehypertension was diagnosed with the criteria of the Eighth Joint National Committee.
Measured: Week 12
Number of Participants With Prediabetes Plus Prehypertension at Week 12
Criteria of the American Diabetes Association and Eighth Joint National Committee were used to diagnosed prediabetes and prehypertension.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study start30 Mar 2016
- Primary completion30 Mar 2018
- Study completion29 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel González Ortiz, University of Guadalajara
- Investigators
- MANUEL GONZALEZ, PhD, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006471
- Sponsor's protocol ID
- DAPA-BP variability
- Status last verified
- Oct 2020
- First submitted
- 13 Dec 2016
- Last updated
- 9 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dapagliflozin on Blood Pressure Variability in Patients With Prediabetes and Prehypertension Without Pharmacological Treatment
- ClinicalTrials.gov ID
- NCT03006471
- Acronym / sponsor ID
- DAPA-BP variability
- Conditions
- PreDiabetes, Prehypertension
- Keywords
- Prediabetes, Prehypertension, Variability of blood pressure, ABPM, Dapagliflozin, SGLT2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 30 Mar 2016 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 30 Dec 2016 (estimated)
- Results
- Posted 19 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prediabetes is defined as an intermediate metabolic state that leads to the development of type 2 diabetes mellitus (DM2) and the prehypertension is a category assigned to identify patients who are at risk of developing hypertension (AH), in both pathologies the abnormalities in the variation of blood pressure (BP) has been related to organ damage, its evaluation is performed by ambulatory blood pressure monitoring (ABPM).
Dapagliflozin is a selective and reversible inhibitor of the sodium-glucose co-transporter type 2 (SGLT-2), which reduces renal reabsorption of glucose and promotes the excretion of glucose through the urine, in the way that glucose blood. Another reported effects is the decrease on BP, so it would be interesting to evaluate this effects in patients with prediabetes and prehypertension, as a potential therapy to treat disorders and to prevent progression to DM2 and Hypertension, respectively.
The aim of this study is to evaluate the effect of Dapagliflozin on variability of blood pressure in patients with prediabetes and prehypertension without pharmacological treatment.
The investigators hypothesis is that the administration of dapagliflozin decreases variability of blood pressure in patients with prediabetes and prehypertension without pharmacological treatment.
Detailed description
A randomized, double-blind, placebo-controlled clinical trial in 30 patients with a diagnosis of prediabetes and prehypertension without treatment.
They will be assigned randomly two groups of 15 patients each to receive 10 mg of Dapagliflozin (Forxiga, Astra Zeneca) or placebo, one per day before breakfast during 12 weeks.
There will be calculated body mass index (BMI) and blood pressure variability. This protocol it's already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.
Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2/ exact fisher test, will be used for differences inter-group Mann-Whitney U Test and coefficient of variation, Wilcoxon Test and index of variability for the within-groups differences. It will be considered statistical significance p ≤0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: DapagliflozinDapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. |
| Placebo | Placebo comparator | Drug: Placebo - CapPlacebo capsules, one per day before breakfast during 12 weeks. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Informed consent signed
- Patients both sexes, age between 30 and 60 years
- Diagnosis of prediabetes according American Diabetes Association criteria (fasting blood glucose levels between 100-126 mg/dl; postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose between 140-199 mg/dl; or glycosylated hemoglobin between 5.7-6.4%)
- Diagnosis of prehypertension according (JNC8) Eighth Joint National Committee blood pressure between 120-139/ 80-89 mmHg.
Key exclusion criteria (10 listed)
- Women with confirmed or suspected pregnancy
- Women under lactation and/or puerperium
- Hypersensibility to ingredients of intervention
- Physical impossibility for taking pills
- Known uncontrolled renal, hepatic, heart or thyroid diseased
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 |
|---|---|---|
| DapagliflozinAlso: Forxiga10 mg, one per day before breakfast during 12 weeks. | Drug | Dapagliflozin |
| Placebo - CapAlso: Calcined magnesiumone per day before breakfast during 12 weeks. | Drug | Placebo |
Primary outcome
24-hours Systolic Blood Pressure at Week 12
Time frame: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
24-hours Diastolic Blood Pressure at Week 12
Time frame: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Daytime Systolic Blood Pressure at Week 12
Time frame: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 am. to 11 p.m. by oscillometric method Microlife WatchBP O3
Daytime Diastolic Blood Pressure at Week 12
Time frame: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to p.m. by oscillometric method Microlife WatchBP O3
Nighttime Systolic Blood Pressure at Week 12
Time frame: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m to 8 a.m. by oscillometric method Microlife WatchBP O3
Nighttime Diastolic Blood Pressure at Week 12
Time frame: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3
Systolic Blood Pressure Weighted Standard Deviation at Week 12
Time frame: Week 12
Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Diastolic Blood Pressure Weighted Standard Deviation at Week 12
Time frame: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Coefficient of Variation of 24-hours, Systolic Blood Pressure at Week 12
Time frame: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Coefficient of Variation of 24-hours, Diastolic Blood Pressure at Week 12
Time frame: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Coefficient of Variation Daytime, Systolic Blood Pressure at Week 12
Time frame: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m to 11 p.m. by oscillometric method Microlife WatchBP O3
Coefficient of Variation Daytime, Diastolic Blood Pressure at Week 12
Time frame: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3
Coefficient of Variation Nighttime, Systolic Blood Pressure at Week 12
Time frame: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3
Coefficient of Variation Nighttime, Diastolic Blood Pressure at Week 12
Time frame: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3
Average Real Variability of Systolic Blood Pressure at Week 12
Time frame: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Average Real Variability of Diastolic Blood Pressure at Week 12
Time frame: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Number of Participants With a Nondipper Circadian Blood Pressure Pattern at Week 12
Time frame: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Number of Participants With a Dipper Circadian Blood Pressure Pattern at Week 12
Time frame: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
Number of Participants With a Dipper Reverse Circadian Blood Pattern at Week 12
Time frame: Week 12
Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3
14 secondary outcomes
Body Weight at Week 12
Time frame: Week 12
Body Mass Index at Week 12
Time frame: Week 12
Office Systolic Blood Pressure at Week 12
Time frame: Week 12
Office of Diastolic Blood Pressure at Week 12
Time frame: Week 12
Fasting Plasma Glucose Levels at Week 12
Time frame: Week 12
2-hours Plasma Glucose After a Oral Glucose Tolerance Test at Week 12
Time frame: Week 12
Glycated Hemoglobin A1c (A1C) at Week 12
Time frame: Week 12
Daytime Mean Arterial Pressure at Week 12
Time frame: Week 12
Nighttime Mean Arterial Pressure at Week 12
Time frame: Week 12
Daytime Hypertensive Load at Week 12
Time frame: Week 12
Nocturnal Hypertensive Load at Week 12
Time frame: Week 12
Number of Participants With Prediabetes at Week 12
Time frame: Week 12
Number of Participants With Prehypertension at Week 12
Time frame: Week 12
Number of Participants With Prediabetes Plus Prehypertension at Week 12
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
MANUEL GONZALEZ, PhD principal investigator
University of Guadalajara
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 Dapagliflozin in people with PreDiabetes and Prehypertension, run by University of Guadalajara at 1 site in Mexico.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 9 Nov 2020. 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 Mexico. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hours Systolic Blood Pressure at Week 12 (time frame: Week 12). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2020.