Prediabetic StatePhase 34TNCT04131582
Effect of Empagliflozin + Linagliptin + Metformin + Lifestyle in Patients With Prediabetes
A Phase 3 study testing Linagliptin + metformin and Empagliflozin + metformin and Metformin in people with Prediabetic State and Insulin Resistance, run by Universidad de Guanajuato at 1 site in Mexico.
Trial summary
Type 2 diabetes is a worldwide epidemic disease, and preventive strategies are needed to face this health problem. The goal of this trial is to evaluate the effect of empagliflozin + linagliptin + metformin + lifestyle on physiopathological parameters, sush as glucose metabolism, insulin resistance, pancreatic beta… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Prediabetic State, Insulin Resistance
- What is being tested?
- Linagliptin + metformin and Empagliflozin + metformin and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteMexico
- Study dates
- 1 Sep 2019to 30 Dec 2020
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with prediabetes, defined for the existence impaired glucose tolerance (glucose between 140 and 199 mg/dL at the 2 hours of the Oral Tolerance Glucose Test (OGTT) with impaired fasting glucose (fasting glucose between 100 and 125 mg/dL)
- Patients who accept to participate in the study and sign the informed consent letter.
Who cannot join
- Patients with diagnosed Type 2 Diabetes previously or detected during the OGTT
- Patients in actual treatment or during the last 3 months with metformin, pioglitazone or another antidiabetic drug, including insulin
- Serum creatinine > 1.6 mg/dL
- Hypertriglyceridemia very high (>500 mg/dL)
- Pregnant women
- Altered arterial hypertension (Systolic >180 mmHg or Diastolic >105 mmHg)
- Excessive alcohol intake, acute or chronic
- Medications or medical conditions that affect glucose homeostasis (thiazides, beta blockers, glucocorticoids for systemic use, weight-reducing drugs or anorexigenics, Cushing´s syndrome, thyrotoxicosis
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Universidad de Guanajuato
León, Guanajuato, 37670
Rodolgo Guardado, MDPhD, 4772674900 ext. 3683, guardamen@gmail.com
Jessica González, MIC, 4772674900 ext. 3683
About this study
Official title: Effect of a Quadruple Therapy on Pancreatic Islet Function, Insulin Resistance and Cardiovascular Function in Patients With Mixed Prediabetes and Obesity: Randomized Clinical Trial
Type 2 diabetes is a worldwide epidemic disease, and preventive strategies are needed to face this health problem. The goal of this trial is to evaluate the effect of empagliflozin + linagliptin + metformin + lifestyle on physiopathological parameters, sush as glucose metabolism, insulin resistance, pancreatic beta cell function and cardiovascular function in patients with impaired fasting glucose plus impaired glucose tolerance, during 12 months
Read the detailed description
The main goal of this clinical trial is to compare the effect of two different treatments during 12 months:
- Lifestyle modification program + metformin 850 mg twice daily
- Lifestyle modification program empagliflozin (12.5 mg) + metformin (850 mg) once daily plus linagliptin (2.5 mg) + metformin (850 mg) once daily On the following parameters, after 12 months of treatment
- Glucose metabolism, evaluated by oral glucose tolerance test 2) Insulin resistance evaluated by the oral glucose tolerance 3) Insulin secretion, evaluated by the oral glucose tolerance 4) Pancreatic beta cell function, evaluated by the oral glucose tolerance test 5) Cardiovascular function, evaluated by standard echocardiography by left ventricular ejection fraction
All the patients will have a basal evaluation with an oral glucose tolerance test, lipid profile and body composition measurement by dual energy X-ray absorptiometry (DEXA). After the basal evaluation, if the patients results with impaired fasting glucose and impaired glucose tolerance, they will be invited to the intervention phase where they will be randomized to one of the two treatment groups.
Patients will have a follow-up visit every month to review the adherence to the lifestyle modification program and to the medication, and every 6 months an OGTT. After 12 months , patients will repeat the same evaluation performed at basal.
- Conditions
- Prediabetic State, Insulin Resistance
- Being tested
- Linagliptin + metformin and Empagliflozin + metformin, Metformin
- Keywords
- prediabetes
- Medical subject headings
- Prediabetic State, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linagliptin + metformin and Empagliflozin + metforminCombination product
Also called Trayenta Duo + Jardianz Duo
Linagliptin-Metformin 2.5/850mg once daily, Empagliflozin-Metformin 12.5/850mg one daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling
MetforminDrug
Metformin 850mg twice daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin + linagliptin + metformin plus lifestyle | Experimental | Patients are randomized to receive for 12 months Linagliptin 2.5 mg + metformin 850 mg every 12 hours and empagliflozin 12.5 mg + metformin 850 mg every 12 hours. The start of the dose in this group will be gradual so that at the month of treatment the patient can be with the full doses. Together with this, patients will receive a lifestyle modification program seeking to reduce 5-7% of body weigh and increase physical activity to 90/150 min/week Receives: Combination Product: Linagliptin + metformin and Empagliflozin + metformin |
| Metformin plus lifestyle | Active comparator | Patients are randomized to receive for 12 months Metformin 850 mg every 12 hours. The start of the dose in this group will be gradual so that at the month of treatment the patient can be with the complete dose. Together with this, patients will receive a lifestyle modification program seeking to reduce 5-7% of body weigh and increase physical activity to 90/150 min/week Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from basal fasting and post2h OGTT glucose levels at 6 and 12 months
Fasting and post-2h OGTT glucose values (mg/dl)
Measured: 6 and 12 months
Secondary outcomes (3)
Change from basal pancreatic beta cell function at 6 and 12 months
Evaluated with the measurements of glucose and insulin during the oral glucose tolerance
Measured: 6 and 12 months
Change from basal insulin sensitivity at 6 and 12 months
Insulin sensitivity evaluated during the oral glucose tolerance test by Matsuda index
Measured: 6 and 12 months
Change from basal Weight at 6 and 12 months
Weight measurement during the study, in kg
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start1 Sep 2019
- Primary completion15 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Prediabetic StateStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Guanajuato
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Regional de Alta Especialidad del Bajio
- Responsible party
- Principal investigator, Rodolfo Guardado Mendoza, Universidad de Guanajuato
- Investigators
- Rodolfo Guardado-Mendoza, MDPhD, Principal investigator, Universidad de Guanajuato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131582
- Sponsor's protocol ID
- CI/HRAEB/2017/049
- Acronym
- 4T
- Status last verified
- Oct 2019
- First submitted
- 16 Oct 2019
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data collection could be shared by the principal investigator on a particular request
Publications
Juarez-Rojop IE, Fortuny-Falconi CM, Gonzalez-Castro TB, Tovilla-Zarate CA, Villar-Soto M, Sanchez ER, Hernandez-Diaz Y, Lopez-Narvaez ML, Ble-Castillo JL, Perez-Hernandez N, Rodriguez-Perez JM. Association between reduced quality of life and depression in patients with type 2 diabetes mellitus: a cohort study in a Mexican population. Neuropsychiatr Dis Treat. 2018 Oct 4;14:2511-2518. doi: 10.2147/NDT.S167622. eCollection 2018.
PubMed 30323600van Dieren S, Beulens JW, van der Schouw YT, Grobbee DE, Neal B. The global burden of diabetes and its complications: an emerging pandemic. Eur J Cardiovasc Prev Rehabil. 2010 May;17 Suppl 1:S3-8. doi: 10.1097/01.hjr.0000368191.86614.5a.
PubMed 20489418Lupi R, Del Prato S. Beta-cell apoptosis in type 2 diabetes: quantitative and functional consequences. Diabetes Metab. 2008 Feb;34 Suppl 2:S56-64. doi: 10.1016/S1262-3636(08)73396-2.
PubMed 18640587Huang Y, Cai X, Chen P, Mai W, Tang H, Huang Y, Hu Y. Associations of prediabetes with all-cause and cardiovascular mortality: a meta-analysis. Ann Med. 2014 Dec;46(8):684-92. doi: 10.3109/07853890.2014.955051. Epub 2014 Sep 18.
PubMed 25230915Sun ZJ, Yang YC, Wu JS, Wang MC, Chang CJ, Lu FH. Increased risk of glomerular hyperfiltration in subjects with impaired glucose tolerance and newly diagnosed diabetes. Nephrol Dial Transplant. 2016 Aug;31(8):1295-301. doi: 10.1093/ndt/gfv385. Epub 2015 Nov 25.
PubMed 26610595Butler AE, Janson J, Bonner-Weir S, Ritzel R, Rizza RA, Butler PC. Beta-cell deficit and increased beta-cell apoptosis in humans with type 2 diabetes. Diabetes. 2003 Jan;52(1):102-10. doi: 10.2337/diabetes.52.1.102.
PubMed 12502499Martin BC, Warram JH, Krolewski AS, Bergman RN, Soeldner JS, Kahn CR. Role of glucose and insulin resistance in development of type 2 diabetes mellitus: results of a 25-year follow-up study. Lancet. 1992 Oct 17;340(8825):925-9. doi: 10.1016/0140-6736(92)92814-v.
PubMed 1357346Ferrannini E. Insulin resistance versus beta-cell dysfunction in the pathogenesis of type 2 diabetes. Curr Diab Rep. 2009 Jun;9(3):188-9. doi: 10.1007/s11892-009-0031-8. No abstract available.
PubMed 19490819Gastaldelli A, Ferrannini E, Miyazaki Y, Matsuda M, DeFronzo RA; San Antonio metabolism study. Beta-cell dysfunction and glucose intolerance: results from the San Antonio metabolism (SAM) study. Diabetologia. 2004 Jan;47(1):31-9. doi: 10.1007/s00125-003-1263-9. Epub 2003 Dec 10.
PubMed 14666364Dunning BE, Gerich JE. The role of alpha-cell dysregulation in fasting and postprandial hyperglycemia in type 2 diabetes and therapeutic implications. Endocr Rev. 2007 May;28(3):253-83. doi: 10.1210/er.2006-0026. Epub 2007 Apr 4.
PubMed 17409288Nauck MA, El-Ouaghlidi A, Gabrys B, Hucking K, Holst JJ, Deacon CF, Gallwitz B, Schmidt WE, Meier JJ. Secretion of incretin hormones (GIP and GLP-1) and incretin effect after oral glucose in first-degree relatives of patients with type 2 diabetes. Regul Pept. 2004 Nov 15;122(3):209-17. doi: 10.1016/j.regpep.2004.06.020.
PubMed 15491793Enoki S, Mitsukawa T, Takemura J, Nakazato M, Aburaya J, Toshimori H, Matsukara S. Plasma islet amyloid polypeptide levels in obesity, impaired glucose tolerance and non-insulin-dependent diabetes mellitus. Diabetes Res Clin Pract. 1992 Jan;15(1):97-102. doi: 10.1016/0168-8227(92)90074-2.
PubMed 1541241American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S13-S28. doi: 10.2337/dc19-S002.
PubMed 30559228Ascaso JF, Romero P, Real JT, Priego A, Valdecabres C, Carmena R. [Insulin resistance quantification by fasting insulin plasma values and HOMA index in a non-diabetic population]. Med Clin (Barc). 2001 Nov 3;117(14):530-3. doi: 10.1016/s0025-7753(01)72168-9. Spanish.
PubMed 11707218DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol. 1979 Sep;237(3):E214-23. doi: 10.1152/ajpendo.1979.237.3.E214.
PubMed 382871
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Quadruple Therapy on Pancreatic Islet Function, Insulin Resistance and Cardiovascular Function in Patients With Mixed Prediabetes and Obesity: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04131582
- Acronym / sponsor ID
- 4T / CI/HRAEB/2017/049
- Conditions
- Prediabetic State, Insulin Resistance
- Keywords
- prediabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Universidad de GuanajuatoUniversity, hospital or other
- Collaborators
- Hospital Regional de Alta Especialidad del Bajio
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 18 Oct 2019 (actual)
- 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.
Type 2 diabetes is a worldwide epidemic disease, and preventive strategies are needed to face this health problem. The goal of this trial is to evaluate the effect of empagliflozin + linagliptin + metformin + lifestyle on physiopathological parameters, sush as glucose metabolism, insulin resistance, pancreatic beta cell function and cardiovascular function in patients with impaired fasting glucose plus impaired glucose tolerance, during 12 months
Detailed description
The main goal of this clinical trial is to compare the effect of two different treatments during 12 months:
- Lifestyle modification program + metformin 850 mg twice daily
- Lifestyle modification program empagliflozin (12.5 mg) + metformin (850 mg) once daily plus linagliptin (2.5 mg) + metformin (850 mg) once daily On the following parameters, after 12 months of treatment
- Glucose metabolism, evaluated by oral glucose tolerance test 2) Insulin resistance evaluated by the oral glucose tolerance 3) Insulin secretion, evaluated by the oral glucose tolerance 4) Pancreatic beta cell function, evaluated by the oral glucose tolerance test 5) Cardiovascular function, evaluated by standard echocardiography by left ventricular ejection fraction
All the patients will have a basal evaluation with an oral glucose tolerance test, lipid profile and body composition measurement by dual energy X-ray absorptiometry (DEXA). After the basal evaluation, if the patients results with impaired fasting glucose and impaired glucose tolerance, they will be invited to the intervention phase where they will be randomized to one of the two treatment groups.
Patients will have a follow-up visit every month to review the adherence to the lifestyle modification program and to the medication, and every 6 months an OGTT. After 12 months , patients will repeat the same evaluation performed at basal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin + linagliptin + metformin plus lifestyle | Experimental | Combination Product: Linagliptin + metformin and Empagliflozin + metforminPatients are randomized to receive for 12 months Linagliptin 2.5 mg + metformin 850 mg every 12 hours and empagliflozin 12.5 mg + metformin 850 mg every 12 hours. The start of the dose in this group will be gradual so that at the month of treatment the patient can be with the full doses. Together with this, patients will receive a lifestyle modification program seeking to reduce 5-7% of body weigh and increase physical activity to 90/150 min/week |
| Metformin plus lifestyle | Active comparator | Drug: MetforminPatients are randomized to receive for 12 months Metformin 850 mg every 12 hours. The start of the dose in this group will be gradual so that at the month of treatment the patient can be with the complete dose. Together with this, patients will receive a lifestyle modification program seeking to reduce 5-7% of body weigh and increase physical activity to 90/150 min/week |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with prediabetes, defined for the existence impaired glucose tolerance (glucose between 140 and 199 mg/dL at the 2 hours of the Oral Tolerance Glucose Test (OGTT) with impaired fasting glucose (fasting glucose between 100 and 125 mg/dL)
- Patients who accept to participate in the study and sign the informed consent letter.
Key exclusion criteria (8 listed)
- Patients with diagnosed Type 2 Diabetes previously or detected during the OGTT
- Patients in actual treatment or during the last 3 months with metformin, pioglitazone or another antidiabetic drug, including insulin
- Serum creatinine > 1.6 mg/dL
- Hypertriglyceridemia very high (>500 mg/dL)
- Pregnant women
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 |
|---|---|---|
| Linagliptin + metformin and Empagliflozin + metforminAlso: Trayenta Duo + Jardianz DuoLinagliptin-Metformin 2.5/850mg once daily, Empagliflozin-Metformin 12.5/850mg one daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling | Combination product | Empagliflozin + linagliptin + metformin plus lifestyle |
| MetforminMetformin 850mg twice daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling | Drug | Metformin plus lifestyle |
Primary outcome
Change from basal fasting and post2h OGTT glucose levels at 6 and 12 months
Time frame: 6 and 12 months
Fasting and post-2h OGTT glucose values (mg/dl)
3 secondary outcomes
Change from basal pancreatic beta cell function at 6 and 12 months
Time frame: 6 and 12 months
Change from basal insulin sensitivity at 6 and 12 months
Time frame: 6 and 12 months
Change from basal Weight at 6 and 12 months
Time frame: 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Background: PubMed 30323600Juarez-Rojop IE, Fortuny-Falconi CM, Gonzalez-Castro TB, Tovilla-Zarate CA, Villar-Soto M, Sanchez ER, Hernandez-Diaz Y, Lopez-Narvaez ML, Ble-Castillo JL, Perez-Hernandez N, Rodriguez-Perez JM. Association between reduced quality of life and depression in patients with type 2 diabetes mellitus: a cohort study in a Mexican population. Neuropsychiatr Dis Treat. 2018 Oct 4;14:2511-2518. doi: 10.2147/NDT.S167622. eCollection 2018.
- Background: PubMed 20489418van Dieren S, Beulens JW, van der Schouw YT, Grobbee DE, Neal B. The global burden of diabetes and its complications: an emerging pandemic. Eur J Cardiovasc Prev Rehabil. 2010 May;17 Suppl 1:S3-8. doi: 10.1097/01.hjr.0000368191.86614.5a.
- Background: PubMed 18640587Lupi R, Del Prato S. Beta-cell apoptosis in type 2 diabetes: quantitative and functional consequences. Diabetes Metab. 2008 Feb;34 Suppl 2:S56-64. doi: 10.1016/S1262-3636(08)73396-2.
- Background: PubMed 25230915Huang Y, Cai X, Chen P, Mai W, Tang H, Huang Y, Hu Y. Associations of prediabetes with all-cause and cardiovascular mortality: a meta-analysis. Ann Med. 2014 Dec;46(8):684-92. doi: 10.3109/07853890.2014.955051. Epub 2014 Sep 18.
- Background: PubMed 26610595Sun ZJ, Yang YC, Wu JS, Wang MC, Chang CJ, Lu FH. Increased risk of glomerular hyperfiltration in subjects with impaired glucose tolerance and newly diagnosed diabetes. Nephrol Dial Transplant. 2016 Aug;31(8):1295-301. doi: 10.1093/ndt/gfv385. Epub 2015 Nov 25.
- Background: PubMed 12502499Butler AE, Janson J, Bonner-Weir S, Ritzel R, Rizza RA, Butler PC. Beta-cell deficit and increased beta-cell apoptosis in humans with type 2 diabetes. Diabetes. 2003 Jan;52(1):102-10. doi: 10.2337/diabetes.52.1.102.
- Background: PubMed 1357346Martin BC, Warram JH, Krolewski AS, Bergman RN, Soeldner JS, Kahn CR. Role of glucose and insulin resistance in development of type 2 diabetes mellitus: results of a 25-year follow-up study. Lancet. 1992 Oct 17;340(8825):925-9. doi: 10.1016/0140-6736(92)92814-v.
- Background: PubMed 19490819Ferrannini E. Insulin resistance versus beta-cell dysfunction in the pathogenesis of type 2 diabetes. Curr Diab Rep. 2009 Jun;9(3):188-9. doi: 10.1007/s11892-009-0031-8. No abstract available.
- Background: PubMed 14666364Gastaldelli A, Ferrannini E, Miyazaki Y, Matsuda M, DeFronzo RA; San Antonio metabolism study. Beta-cell dysfunction and glucose intolerance: results from the San Antonio metabolism (SAM) study. Diabetologia. 2004 Jan;47(1):31-9. doi: 10.1007/s00125-003-1263-9. Epub 2003 Dec 10.
- Background: PubMed 17409288Dunning BE, Gerich JE. The role of alpha-cell dysregulation in fasting and postprandial hyperglycemia in type 2 diabetes and therapeutic implications. Endocr Rev. 2007 May;28(3):253-83. doi: 10.1210/er.2006-0026. Epub 2007 Apr 4.
- Background: PubMed 15491793Nauck MA, El-Ouaghlidi A, Gabrys B, Hucking K, Holst JJ, Deacon CF, Gallwitz B, Schmidt WE, Meier JJ. Secretion of incretin hormones (GIP and GLP-1) and incretin effect after oral glucose in first-degree relatives of patients with type 2 diabetes. Regul Pept. 2004 Nov 15;122(3):209-17. doi: 10.1016/j.regpep.2004.06.020.
- Background: PubMed 1541241Enoki S, Mitsukawa T, Takemura J, Nakazato M, Aburaya J, Toshimori H, Matsukara S. Plasma islet amyloid polypeptide levels in obesity, impaired glucose tolerance and non-insulin-dependent diabetes mellitus. Diabetes Res Clin Pract. 1992 Jan;15(1):97-102. doi: 10.1016/0168-8227(92)90074-2.
- Individual participant dataSharing planned: No. Data collection could be shared by the principal investigator on a particular request
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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.
Rodolfo Guardado-Mendoza, MDPhD principal investigator
Universidad de Guanajuato
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Linagliptin + metformin and Empagliflozin + metformin and Metformin in people with Prediabetic State and Insulin Resistance, run by Universidad de Guanajuato 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 2 inclusion and 8 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 21 Oct 2019. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Rodolfo Guardado-Mendoza, MDPhD (011524772672000 ext. 1701, guardamen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from basal fasting and post2h OGTT glucose levels at 6 and 12 months (time frame: 6 and 12 months). 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 NCT04131582, which also lists 26 linked publications.
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 21 Oct 2019.