Prediabetic StatePhase 4RESCATHEMENCT04088461
Effect of Linagliptin + Metformin on Patients Who do Not Achieve Normoglucemia With Metformine
A Phase 4 study testing Linagliptin / Metformin Oral Tablet and Metformin in people with Prediabetic State and Impaired Glucose Tolerance, run by Universidad de Guanajuato at 1 site in Mexico.
Trial summary
The goal of this protocol is to evaluate the effect of addhing linagliptin to patients with prediabetes who do not reverse to normoglycemia after 12 months of treatment with metformin alone. The duration of the study will be 6 months, and it is primarily a efficacy study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Prediabetic State, Impaired Glucose Tolerance, Insulin Resistance
- What is being tested?
- Linagliptin / Metformin Oral Tablet and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2016to Sep 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with impaired glucose tolerance (2 h glucose between 140 - 199 mg / dL) that after 1 year of treatment with metformin at a dose of 1700 mg daily + lifestyle modifications don't achieve normoglycemia.
- Patients who accept to participate in the study and sign informed consent.
Who cannot join
- Patients with type 2 Diabetes diagnosted previuosly or detected during the OGTT
- Serum creatinine > 1.6 mg/dL
- Hypertriglyceridemia very high (>500 mg/dL)
- Pregnancy
- Systolic blood pressure > 180 mmHg or Diastolic blood pressure >105 mmHg (patients could be re-screened after blood pressure control)
- 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 syndrom, Thyrotoxicosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Linagliptin + Metformin on Glucose Metabolism and Pancreatic Beta Cell Function in Patients With Prediabetes Who do Not Achieve Normoglycemia After 12 Months of Treatment With Metformin Alone
The goal of this protocol is to evaluate the effect of addhing linagliptin to patients with prediabetes who do not reverse to normoglycemia after 12 months of treatment with metformin alone. The duration of the study will be 6 months, and it is primarily a efficacy study. Main outcomes will be glucose levels during OGTT, insulin secretion and pancreatic beta cell function measured by the disposition index derived from the OGTT.
Read the detailed description
Randomization and masking. Patients will be randomly assigned in a 1:1 ratio to receive linagliptin/metformin 2.5/850mg every 12 h + lifestyle modification program, or metformin 850mg every 12 h + lifestyle modification program during 6 months. Randomization will be performed using an electronic random numbers table by a Nutritionist not involved in the study. Participants and investigators involved in the patients follow-up and outcome measurements will be masked to treatment allocation during the entire study.
Patients will have a follow-up visit every month. Every appointment is about 30-45 minutes; medications tolerance and side effects will be recorded in every patients´ visit. Nutritional and physical activity assessment according to the patient´s weight will be performed by a Nutritionist every month. Monthly adherence to medications will be evaluated by pill counting; nutritional adherence and energy intake will be evaluated at 6 months by a food frequency questionnaire, and physical activity at 0 and 6 months. At basal and at 6 months patients will have an OGTT. Primary objective is to evaluate at 6 months glucose profile during OGTT, insulin secretion and pancreatic β-cell function by the OGTT DI, and regression to normoglycemia; T2D will be diagnosed and confirmed by at least two consecutive measurements of the same criteria: glycated haemoglobin ≥ 6.5 %, fasting glucose ≥ 126mg/dl, or 2 h glucose ≥ 200 mg/dl.
- Being tested
- Linagliptin / Metformin Oral Tablet, Metformin
- Keywords
- Prediabetes, Insulin resistance, hyperglucemia
- Medical subject headings
- Prediabetic State, Glucose Intolerance, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linagliptin / Metformin Oral TabletDrug
Also called Combined treatment
Linagliptin 2.5 mg + Metformin 850 mg twice daily plus a lifestyle modifications program
MetforminDrug
Also called Metformin alone
Metformin 850 mg twice daily plus lifestyle modifications program
| Study group | Role | What they receive |
|---|---|---|
| Linagliptin + Metformin and lifestyle | Experimental | Patients with impaired glucose tolerance randomly assigned to linagliptin 2.5 mg + metftormin 850 mg every 12 hours during 6 months. Receives: Drug: Linagliptin / Metformin Oral Tablet |
| Metformin | Active comparator | Patients with impaired glucose tolerance randomly assigned to metftormin 850 mg every 12 hours during 6 months. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose levels during OGTT
Glucose levels during OGTT
Measured: 6 months
Pancreatic beta cell function
Pancreatic beta cell function measured with the disposition index during OGTT
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study startSep 2016
- Primary completionSep 2018
- Study completionSep 2018
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 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
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
- NCT04088461
- Sponsor's protocol ID
- CEI-35-16
- Acronym
- RESCATHEME
- Status last verified
- Sep 2019
- First submitted
- 11 Sep 2019
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Alvarez-Canales MFL, Salazar-Lopez SS, Farfan-Vazquez D, Martinez-Lopez YE, Gonzalez-Mena JN, Jimenez-Ceja LM, Vargas-Ortiz K, Evia-Viscarra ML, Montes de Oca-Loyola ML, Folli F, Aguilar-Garcia A, Guardado-Mendoza R. Effect of linagliptin on glucose metabolism and pancreatic beta cell function in patients with persistent prediabetes after metformin and lifestyle. Sci Rep. 2021 Apr 22;11(1):8750. doi: 10.1038/s41598-021-88108-8.
PubMed 33888772
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Linagliptin + Metformin on Glucose Metabolism and Pancreatic Beta Cell Function in Patients With Prediabetes Who do Not Achieve Normoglycemia After 12 Months of Treatment With Metformin Alone
- ClinicalTrials.gov ID
- NCT04088461
- Acronym / sponsor ID
- RESCATHEME / CEI-35-16
- Keywords
- Prediabetes, Insulin resistance, hyperglucemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Universidad de GuanajuatoUniversity, hospital or other
- Collaborators
- Hospital Regional de Alta Especialidad del Bajio
- Study start
- Sep 2016
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 12 Sep 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.
The goal of this protocol is to evaluate the effect of addhing linagliptin to patients with prediabetes who do not reverse to normoglycemia after 12 months of treatment with metformin alone. The duration of the study will be 6 months, and it is primarily a efficacy study. Main outcomes will be glucose levels during OGTT, insulin secretion and pancreatic beta cell function measured by the disposition index derived from the OGTT.
Detailed description
Randomization and masking. Patients will be randomly assigned in a 1:1 ratio to receive linagliptin/metformin 2.5/850mg every 12 h + lifestyle modification program, or metformin 850mg every 12 h + lifestyle modification program during 6 months. Randomization will be performed using an electronic random numbers table by a Nutritionist not involved in the study. Participants and investigators involved in the patients follow-up and outcome measurements will be masked to treatment allocation during the entire study.
Patients will have a follow-up visit every month. Every appointment is about 30-45 minutes; medications tolerance and side effects will be recorded in every patients´ visit. Nutritional and physical activity assessment according to the patient´s weight will be performed by a Nutritionist every month. Monthly adherence to medications will be evaluated by pill counting; nutritional adherence and energy intake will be evaluated at 6 months by a food frequency questionnaire, and physical activity at 0 and 6 months. At basal and at 6 months patients will have an OGTT. Primary objective is to evaluate at 6 months glucose profile during OGTT, insulin secretion and pancreatic β-cell function by the OGTT DI, and regression to normoglycemia; T2D will be diagnosed and confirmed by at least two consecutive measurements of the same criteria: glycated haemoglobin ≥ 6.5 %, fasting glucose ≥ 126mg/dl, or 2 h glucose ≥ 200 mg/dl.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linagliptin + Metformin and lifestyle | Experimental | Drug: Linagliptin / Metformin Oral TabletPatients with impaired glucose tolerance randomly assigned to linagliptin 2.5 mg + metftormin 850 mg every 12 hours during 6 months. |
| Metformin | Active comparator | Drug: MetforminPatients with impaired glucose tolerance randomly assigned to metftormin 850 mg every 12 hours during 6 months. |
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 impaired glucose tolerance (2 h glucose between 140 - 199 mg / dL) that after 1 year of treatment with metformin at a dose of 1700 mg daily + lifestyle modifications don't achieve normoglycemia.
- Patients who accept to participate in the study and sign informed consent.
Key exclusion criteria (7 listed)
- Patients with type 2 Diabetes diagnosted previuosly or detected during the OGTT
- Serum creatinine > 1.6 mg/dL
- Hypertriglyceridemia very high (>500 mg/dL)
- Pregnancy
- Systolic blood pressure > 180 mmHg or Diastolic blood pressure >105 mmHg (patients could be re-screened after blood pressure control)
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 Oral TabletAlso: Combined treatmentLinagliptin 2.5 mg + Metformin 850 mg twice daily plus a lifestyle modifications program | Drug | Linagliptin + Metformin and lifestyle |
| MetforminAlso: Metformin aloneMetformin 850 mg twice daily plus lifestyle modifications program | Drug | Metformin |
Primary outcome
Glucose levels during OGTT
Time frame: 6 months
Glucose levels during OGTT
Pancreatic beta cell function
Time frame: 6 months
Pancreatic beta cell function measured with the disposition index during OGTT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Derived from this study: PubMed 33888772Alvarez-Canales MFL, Salazar-Lopez SS, Farfan-Vazquez D, Martinez-Lopez YE, Gonzalez-Mena JN, Jimenez-Ceja LM, Vargas-Ortiz K, Evia-Viscarra ML, Montes de Oca-Loyola ML, Folli F, Aguilar-Garcia A, Guardado-Mendoza R. Effect of linagliptin on glucose metabolism and pancreatic beta cell function in patients with persistent prediabetes after metformin and lifestyle. Sci Rep. 2021 Apr 22;11(1):8750. doi: 10.1038/s41598-021-88108-8.
- Individual participant dataSharing planned: No
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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 4 study testing Linagliptin / Metformin Oral Tablet and Metformin in people with Prediabetic State and Impaired Glucose Tolerance, 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 7 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 13 Sep 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glucose levels during OGTT (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT04088461, 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 13 Sep 2019.