COVID-19

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Cliniques Universitaires de Kinshasa

COVID-19 Lessons Learned: the Outcome of TOMEKA® Project is to Teach

TOMEKA® Project Was Sponsored by the University of Kinshasa: it's an Observational Study by Its Reviewed Documentation

Guyguy K Tshima, MD

Principal Investigator

University of Kinshasa

University Ghent

Université de Montréal

Daily Injection
Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards.

Placebo

Daily Injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.

Liraglutide 1.8mg

Daily injections
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.

Liraglutide 1.2mg

Daily injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.

Liraglutide 0.6 mg

Total

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

Age of Type 1 Diabetes Diagnosis

The primary endpoint of the study is to detect a difference from baseline in mean weekly blood glucose concentrations before and after 12 weeks of treatment in each of the Liraglutide groups.

Change in Mean Weekly Glucose Concentrations From Baseline at 12 Weeks

Change in HbA1c From Baseline at 12 Weeks

Change in Body Weight From Baseline at Week 12

Total insulin dose = Basal insulin dose plus bolus insulin dose.

Change in Total Insulin Dose From Baseline at 12 Weeks

Percent Time Spent in Hyperglycemia and Hypoglycemia

Reduction in the Area Under Curve(AUC) of Glucose Following the Meal

Serum Acetaminophen Concentrations Following Meal Challenge

Carbohydrate Intake

Insulin, C-peptide, Glucagon, GLP-1(Glucagon Like Peptide-1) and GIP(Gastric Inhibitory Polypeptide) Concentrations Following Meal Challenge.

Overall Study

Nitesh D Kuhadiya,MD,MPH ;Co-Investigator;Assistant Professor of Medicine, Section of Endocrinology

Type 1 Diabetes

Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.

Liraglutide

Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards.

rhinitis/carbohydrate

COVID-19 Lessons Learned: the Outcome of TOMEKA® Project is to Teach

Liraglutide in the Treatment of Type 1 Diabetes Mellitus

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