Dipeptidyl Peptidase-4 Inhibitor (DPP4i) for the Control of Hyperglycemia in Patients With COVID-19
Condition: Hyperglycemia; Covid19
MeSH terms: COVID-19; Hyperglycemia
Study type: Interventional
Phase: Phase 3

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. 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.
    

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.
    

Intervention name(s): Linagliptin tablet; Insulin
Intervention type(s): Drug; Drug
Intervention description(s): Linagliptin 5mg once daily plus a basal-bolus insulin scheme; Basal-bolus insulin scheme
Other intervention name(s): Linagliptin; Insulin group
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study will include two parallel groups of intervention
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment