Comparative Efficacy of a Two Daily Mixed Insulin Injection Versus a Basal-bolus Scheme With Human Insulin

PHASE4CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

June 15, 2023

Primary Completion Date

April 15, 2024

Study Completion Date

May 1, 2024

Conditions
Type 1 Diabetes
Interventions
DRUG

premix insulin human isophane suspension and insulin human

Sequence (Premix first, then Humulin N + Humulin R): Subjects randomized to this sequence will receive premix insulin, twice per day for 16 weeks. After the first 16 weeks, subjects will cross over to the Humulin N plus Humulin R sequence for a further treatment of 16 weeks

DRUG

Humulin N plus Humulin R

Sequence (Humulin N + Humulin R first, then Premix): Subjects randomized to this sequence will receive basal bolus insulin scheme with Humulin N (twice daily) and Humulin R (before meals) for 16 weeks. After the first 16 weeks, subjects will cross over to the Premix sequence for a further treatment of 16 weeks

Trial Locations (3)

Unknown

CHU Souro Sanou, Bobo-Dioulasso

CHU de Tengandogo, Ouagadougou

CHU Yalgado Ouedraogo, Ouagadougou

Sponsors
All Listed Sponsors
collaborator

Juvenile Diabetes Research Foundation

OTHER

collaborator

International Society for Pediatric and Adolescent Diabetes

UNKNOWN

collaborator

Société de Médecine Interne du Burkina Faso

UNKNOWN

collaborator

Association pour la Formation, la Recherche et l'Education sur le Diabète, Burkina Faso

UNKNOWN

lead

Université NAZI BONI

OTHER