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HyperglycemiaPhase 3Covid19DPP4iNCT04542213

Dipeptidyl Peptidase-4 Inhibitor (DPP4i) for the Control of Hyperglycemia in Patients With COVID-19

A Phase 3 study testing Linagliptin tablet and Insulin in people with Hyperglycemia and Covid19, run by Hospital Regional de Alta Especialidad del Bajio at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been a world health issue during the last months, affecting mostly countries with a high metabolic risk, like Mexico. Patients with type 2 diabetes (T2D) have an increased risk of any kind of infection as well as an increased mortality risk. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hyperglycemia, Covid19
What is being tested?
Linagliptin tablet and Insulin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteMexico
Study dates
1 Aug 2020to 28 Feb 2021
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Hospitalized patients with confirmed infection by SARS-CoV-2
  • Hyperglycemia higher than 140 mg/dl
  • Patients accepting oral medications
  • Both sex
  • Older than 18 years of age
  • Patients who accept to participate in the study and sign the consent form

Who cannot join

  • Type 1 diabetes
  • Pregnancy
  • Hyperosmolar hyperglycemic state or diabetic ketoacidosis

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Hospital Regional de Alta Especialidad del Bajìo

    Leòn, Guanajuato, 37660

Other trials in Mexico

About this study

Official title: Effect of the Combination of Dipeptidyl Peptidase-4 Inhibitor (DPP4i) and Insulin in Comparison to Insulin on Metabolic Control and Prognosis in Hospitalized Patients With COVID-19

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been a world health issue during the last months, affecting mostly countries with a high metabolic risk, like Mexico. Patients with type 2 diabetes (T2D) have an increased risk of any kind of infection as well as an increased mortality risk. Hyperglycemia has been established as an important predictor of mortality in patients with T2D and SARS-CoV-2. The standard treatment of hyperglycemia in hospitalized patients has been basen on insulin schemes, but recently evidence suggest the utility of some other drugs, reducing the risk of hypoglucemia and increasing the probability of a proper metabolic control. The goal of this study is to compare the utility of dipeptidyl peptidase-4 inhibitor (DPP4i) as a combination with insulin on metabolic control and prognosis in hospitalized patients with SARS-CoV-2 and hyperglycemia.

Read the detailed description

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been a world health issue during the last months, affecting mostly countries with a high metabolic risk, like Mexico. Patients with type 2 diabetes (T2D) have an increased risk of any kind of infection as well as an increased mortality risk. Hyperglycemia has been established as an important predictor of mortality in patients with T2D and SARS-CoV-2. The standard treatment of hyperglycemia in hospitalized patients has been basen on insulin schemes, but recently evidence suggest the utility of some other drugs, reducing the risk of hypoglucemia and increasing the probability of a proper metabolic control. DPP4 enzyme has an ubiquitous distribution and has been considered as a pro-inflammatory enzyme, considering that DPP4 inhibitors could have and anti-inflammatory effect, as it has been shown in different works. The goal os this study is to compare the utility of DPP4 inhibitor as a combination with insulin on metabolic control and prognosis in hospitalized patients with SARS-CoV-2 and hyperglycemia. For this purpose we will randomize patients with SARS-CoV-2 and hyperglycemia to receive either the combination of DPP4i + insulin or insulin alone and will follow al algorithm treatment to define metabolic control as well as prognosis.

Being tested
Linagliptin tablet, Insulin
Medical subject headings
Hyperglycemia, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Linagliptin tabletDrug

    Also called Linagliptin

    Linagliptin 5mg once daily plus a basal-bolus insulin scheme

  • InsulinDrug

    Also called Insulin group

    Basal-bolus insulin scheme

Study groups in NCT04542213
Study groupRoleWhat they receive
DPP4 inhibitor + insulinExperimentalPatients assigned to this group of treatment will receive Linagliptin 5mg orally once daily plus a basal-bolo insulin scheme
Receives: Drug: Linagliptin tablet
Insulin scheme aloneActive comparatorPatients assigned to this group will receive only a basal-bolus insulin scheme
Receives: Drug: Insulin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glucose levels

    Glucose levels during hospitalization

    Measured: 5-10 days

  2. Number of patients who achieve metabolic control

    Patients who achieve fasting glucose levels below 140 mg/dl and posprandial levels below 180 mg/dl

    Measured: 5-10 days

Secondary outcomes (2)

  1. Number of patients who die or need mechanical ventilation

    If the patient requires mechanical ventilation or dies

    Measured: 5-10 days

  2. C reactive protein levels

    C reactive protein measured at basal and at 5-10 days in mg/dl

    Measured: 5-10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2020
  2. Study start1 Aug 2020
  3. Primary completion28 Feb 2021
  4. Study completion28 Feb 2021

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study will include two parallel groups of intervention
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04542213
Sponsor's protocol ID
CEI-22-2020
Acronym
Covid19DPP4i
Status last verified
Mar 2021
First submitted
3 Sep 2020
Last updated
23 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Sharing of the data can be done, depending on the requested purposes

Publications

  • DeFronzo RA. Pathogenesis of type 2 diabetes mellitus. Med Clin North Am. 2004 Jul;88(4):787-835, ix. doi: 10.1016/j.mcna.2004.04.013.

    PubMed 15308380

  • Levetan CS, Passaro M, Jablonski K, Kass M, Ratner RE. Unrecognized diabetes among hospitalized patients. Diabetes Care. 1998 Feb;21(2):246-9. doi: 10.2337/diacare.21.2.246.

    PubMed 9539990

  • Umpierrez GE, Isaacs SD, Bazargan N, You X, Thaler LM, Kitabchi AE. Hyperglycemia: an independent marker of in-hospital mortality in patients with undiagnosed diabetes. J Clin Endocrinol Metab. 2002 Mar;87(3):978-82. doi: 10.1210/jcem.87.3.8341.

    PubMed 11889147

  • McAlister FA, Majumdar SR, Blitz S, Rowe BH, Romney J, Marrie TJ. The relation between hyperglycemia and outcomes in 2,471 patients admitted to the hospital with community-acquired pneumonia. Diabetes Care. 2005 Apr;28(4):810-5. doi: 10.2337/diacare.28.4.810.

    PubMed 15793178

  • Kes VB, Solter VV, Supanc V, Demarin V. Impact of hyperglycemia on ischemic stroke mortality in diabetic and non-diabetic patients. Ann Saudi Med. 2007 Sep-Oct;27(5):352-5. doi: 10.5144/0256-4947.2007.352.

    PubMed 17921684

  • Angeli F, Verdecchia P, Karthikeyan G, Mazzotta G, Del Pinto M, Repaci S, Gatteschi C, Gentile G, Cavallini C, Reboldi G. New-onset hyperglycemia and acute coronary syndrome: a systematic overview and meta-analysis. Curr Diabetes Rev. 2010 Mar;6(2):102-10. doi: 10.2174/157339910790909413.

    PubMed 20034367

  • Noordzij PG, Boersma E, Schreiner F, Kertai MD, Feringa HH, Dunkelgrun M, Bax JJ, Klein J, Poldermans D. Increased preoperative glucose levels are associated with perioperative mortality in patients undergoing noncardiac, nonvascular surgery. Eur J Endocrinol. 2007 Jan;156(1):137-42. doi: 10.1530/eje.1.02321.

    PubMed 17218737

  • Pomposelli JJ, Baxter JK 3rd, Babineau TJ, Pomfret EA, Driscoll DF, Forse RA, Bistrian BR. Early postoperative glucose control predicts nosocomial infection rate in diabetic patients. JPEN J Parenter Enteral Nutr. 1998 Mar-Apr;22(2):77-81. doi: 10.1177/014860719802200277.

    PubMed 9527963

  • McDonnell ME, Umpierrez GE. Insulin therapy for the management of hyperglycemia in hospitalized patients. Endocrinol Metab Clin North Am. 2012 Mar;41(1):175-201. doi: 10.1016/j.ecl.2012.01.001. Epub 2012 Feb 17.

    PubMed 22575413

  • Stentz FB, Umpierrez GE, Cuervo R, Kitabchi AE. Proinflammatory cytokines, markers of cardiovascular risks, oxidative stress, and lipid peroxidation in patients with hyperglycemic crises. Diabetes. 2004 Aug;53(8):2079-86. doi: 10.2337/diabetes.53.8.2079.

    PubMed 15277389

  • Corathers SD, Falciglia M. The role of hyperglycemia in acute illness: supporting evidence and its limitations. Nutrition. 2011 Mar;27(3):276-81. doi: 10.1016/j.nut.2010.07.013. Epub 2010 Sep 24.

    PubMed 20869205

  • Feng W, Zong W, Wang F, Ju S. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): a review. Mol Cancer. 2020 Jun 2;19(1):100. doi: 10.1186/s12943-020-01218-1.

    PubMed 32487159

  • Hamming I, Timens W, Bulthuis ML, Lely AT, Navis G, van Goor H. Tissue distribution of ACE2 protein, the functional receptor for SARS coronavirus. A first step in understanding SARS pathogenesis. J Pathol. 2004 Jun;203(2):631-7. doi: 10.1002/path.1570.

    PubMed 15141377

  • Mossel EC, Wang J, Jeffers S, Edeen KE, Wang S, Cosgrove GP, Funk CJ, Manzer R, Miura TA, Pearson LD, Holmes KV, Mason RJ. SARS-CoV replicates in primary human alveolar type II cell cultures but not in type I-like cells. Virology. 2008 Mar 1;372(1):127-35. doi: 10.1016/j.virol.2007.09.045. Epub 2007 Nov 26.

    PubMed 18022664

  • Gheblawi M, Wang K, Viveiros A, Nguyen Q, Zhong JC, Turner AJ, Raizada MK, Grant MB, Oudit GY. Angiotensin-Converting Enzyme 2: SARS-CoV-2 Receptor and Regulator of the Renin-Angiotensin System: Celebrating the 20th Anniversary of the Discovery of ACE2. Circ Res. 2020 May 8;126(10):1456-1474. doi: 10.1161/CIRCRESAHA.120.317015. Epub 2020 Apr 8.

    PubMed 32264791

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Linagliptin tablet and Insulin in people with Hyperglycemia and Covid19, run by Hospital Regional de Alta Especialidad del Bajio 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 6 inclusion and 3 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 23 Mar 2021. 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?

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 (time frame: 5-10 days). 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 NCT04542213, which also lists 64 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 23 Mar 2021.

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