Coronavirus InfectionPhase 4NCT04341935
Effects of DPP4 Inhibition on COVID-19
A Phase 4 study testing Linagliptin and Insulin regimen in people with Coronavirus Infection and Type 2 Diabetes, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research is to see if the DPP4 inhibitor linagliptin, an oral medication commonly used to treat type 2 diabetes,can help with diabetes control and reduce the severity of the COVID-19 infection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infection, Type 2 Diabetes
- What is being tested?
- Linagliptin and Insulin regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2021to 30 Dec 2021
- 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 Mellitus (T2DM) as per American Diabetes Association (ADA) guidelines
- Age ≥ 18
- Confirmed COVID-19
- Mild COVID-19 defined as any of the following: fever, malaise, cough, headache, sore throat, myalgia, nasal congestion, diarrhea
- Moderate COVID-19 is defined as > 2 of the following in non-intubated patients: any symptom of mild disease, radiographic imaging (chest x-ray or lung ultrasound) with bilateral ground glass opacities or bilateral consolidations, SpO2 <90% up to 5L Nasal Cannula (NC)
- No additional signs or symptoms of severe COVID-19.
Who cannot join
- Type 1 Diabetes Mellitus (T1DM) diabetes, as per ADA guidelines
- History of Diabetic Ketoacidosis (DKA)
- History of acute pancreatitis
- Chronic or Acute Renal Failure with Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73 m2
- T1DM diabetes, as per ADA guidelines, History of DKA, History of acute pancreatitis; Chronic or Acute Renal Failure with eGFR < 30 ml/min/1.73 m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of DPP4 Inhibition on COVID-19 Patients With Type 2 Diabetes
The purpose of this research is to see if the DPP4 inhibitor linagliptin, an oral medication commonly used to treat type 2 diabetes,can help with diabetes control and reduce the severity of the COVID-19 infection
- Conditions
- Coronavirus Infection, Type 2 Diabetes
- Being tested
- Linagliptin, Insulin regimen
- Keywords
- COVID-19, SARS-Cov 2, DPP4, Type 2 diabetes
- Medical subject headings
- Coronavirus Infections, Diabetes Mellitus, Type 2, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinagliptinDrug
Also called Tradjenta
5 mg Linagliptin administered by mouth once daily
Insulin regimenDrug
Standard of care insulin regimen as per hospital protocol
| Study group | Role | What they receive |
|---|---|---|
| DPP4 group | Experimental | Participants in the Dipeptidyl Peptidase 4 (DPP4) group will receive Linagliptin in addition to standard of care insulin regimen as per hospital protocol during hospitalization for up to 14 days Receives: Drug: Linagliptin |
| Control group | Active comparator | Participants in the control group will receive only the standard of care insulin regimen as per hospital protocol during hospitalization for up to 14 days Receives: Drug: Insulin regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Glucose Llevels
Change in glucose control will be assessed via glucose levels obtained from blood serum samples
Measured: Baseline, up to 2 weeks
Secondary outcomes (3)
Changes in SpO2 levels
changes in SpO2 will be measured with a Pulseimetry, an indirect, non-invasive method
Measured: Baseline, up to 2 weeks
Changes in Interleukin 6 (IL6)
Changes in IL 6 will be assessed from blood serum samples
Measured: Baseline, up to 2 weeks
Changes in chest structures
Changes in Chest radiography (X-ray)
Measured: Baseline, up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start30 Jun 2021 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Why it stopped: Logistical challenges amid COVID-19 pandemic and lack of financial support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Iacobellis, University of Miami
- Investigators
- Gianluca Iacobellis, MD PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341935
- Sponsor's protocol ID
- 20200384
- Status last verified
- Jun 2021
- First submitted
- 6 Apr 2020
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vankadari N, Wilce JA. Emerging WuHan (COVID-19) coronavirus: glycan shield and structure prediction of spike glycoprotein and its interaction with human CD26. Emerg Microbes Infect. 2020 Mar 17;9(1):601-604. doi: 10.1080/22221751.2020.1739565. eCollection 2020.
PubMed 32178593Iacobellis G. COVID-19 and diabetes: Can DPP4 inhibition play a role? Diabetes Res Clin Pract. 2020 Apr;162:108125. doi: 10.1016/j.diabres.2020.108125. Epub 2020 Mar 26. No abstract available.
PubMed 32224164
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of DPP4 Inhibition on COVID-19 Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04341935
- Acronym / sponsor ID
- 20200384
- Conditions
- Coronavirus Infection, Type 2 Diabetes
- Keywords
- COVID-19, SARS-Cov 2, DPP4, Type 2 diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistical challenges amid COVID-19 pandemic and lack of financial support
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 30 Jun 2021 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 10 Apr 2020 (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 purpose of this research is to see if the DPP4 inhibitor linagliptin, an oral medication commonly used to treat type 2 diabetes,can help with diabetes control and reduce the severity of the COVID-19 infection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DPP4 group | Experimental | Drug: LinagliptinParticipants in the Dipeptidyl Peptidase 4 (DPP4) group will receive Linagliptin in addition to standard of care insulin regimen as per hospital protocol during hospitalization for up to 14 days |
| Control group | Active comparator | Drug: Insulin regimenParticipants in the control group will receive only the standard of care insulin regimen as per hospital protocol during hospitalization for up to 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 Diabetes Mellitus (T2DM) as per American Diabetes Association (ADA) guidelines
- Age ≥ 18
- Confirmed COVID-19
- Mild COVID-19 defined as any of the following: fever, malaise, cough, headache, sore throat, myalgia, nasal congestion, diarrhea
- Moderate COVID-19 is defined as > 2 of the following in non-intubated patients: any symptom of mild disease, radiographic imaging (chest x-ray or lung ultrasound) with bilateral ground glass opacities or bilateral consolidations, SpO2 <90% up to 5L Nasal Cannula (NC)
Key exclusion criteria (5 listed)
- Type 1 Diabetes Mellitus (T1DM) diabetes, as per ADA guidelines
- History of Diabetic Ketoacidosis (DKA)
- History of acute pancreatitis
- Chronic or Acute Renal Failure with Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73 m2
- T1DM diabetes, as per ADA guidelines, History of DKA, History of acute pancreatitis; Chronic or Acute Renal Failure with eGFR < 30 ml/min/1.73 m2
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 |
|---|---|---|
| LinagliptinAlso: Tradjenta5 mg Linagliptin administered by mouth once daily | Drug | DPP4 group |
| Insulin regimenStandard of care insulin regimen as per hospital protocol | Drug | Control group |
Primary outcome
Changes in Glucose Llevels
Time frame: Baseline, up to 2 weeks
Change in glucose control will be assessed via glucose levels obtained from blood serum samples
3 secondary outcomes
Changes in SpO2 levels
Time frame: Baseline, up to 2 weeks
Changes in Interleukin 6 (IL6)
Time frame: Baseline, up to 2 weeks
Changes in chest structures
Time frame: Baseline, up to 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Results publication: PubMed 32178593Vankadari N, Wilce JA. Emerging WuHan (COVID-19) coronavirus: glycan shield and structure prediction of spike glycoprotein and its interaction with human CD26. Emerg Microbes Infect. 2020 Mar 17;9(1):601-604. doi: 10.1080/22221751.2020.1739565. eCollection 2020.
- Results publication: PubMed 32224164Iacobellis G. COVID-19 and diabetes: Can DPP4 inhibition play a role? Diabetes Res Clin Pract. 2020 Apr;162:108125. doi: 10.1016/j.diabres.2020.108125. Epub 2020 Mar 26. No abstract available.
- 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.
Gianluca Iacobellis, MD PhD principal investigator
University of Miami
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 and Insulin regimen in people with Coronavirus Infection and Type 2 Diabetes, run by University of Miami at 1 site in United States.
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 5 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: withdrawn, as of the sponsor's last update on 10 Jun 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Changes in Glucose Llevels (time frame: Baseline, up to 2 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 NCT04341935, which also lists 2 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 10 Jun 2021.