search
Back to results

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

Primary Purpose

Type 1 Diabetes

Status
Recruiting
Phase
Phase 4
Locations
Burkina Faso
Study Type
Interventional
Intervention
premix insulin human isophane suspension and insulin human
Humulin N plus Humulin R
Sponsored by
Université NAZI BONI
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female 5 - 18 years of age Be diagnosed for at least 1 year at the date of inclusion. Have been regular at consultations during the last 12 years preceding inclusion (at least 3 visits) Willing and able to inject insulin human isophane and multi-day dosing of rapid acting human insulin. Willing and able to perform self-monitoring of blood glucose (SMBG) four times a day and continuous glucose monitoring (CGMS) for 48 hours at three time periods during the study Have (patient or guardian) a minimum 4 years primary school level Have (patient or guardian) a connected cellphone that can install the free FreeStyle link application and use connected messaging app Exclusion Criteria: pregnant or lactating females opposition to participating in the study residing outside the towns where the care centers are located Any disease or condition (including abuse of illicit drugs, prescription medicines or alcohol) that in the opinion of the investigator or sponsor may interfere with the study compliance and completion of the study.

Sites / Locations

  • CHU Souro SanouRecruiting
  • CHU de TengandogoRecruiting
  • CHU Yalgado OuedraogoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Humulin N plus Humulin R

Premix human isophane suspension plus insulin human injection

Arm Description

10 subjects will receive insulin human isophane suspension (Humulin N) twice daily plus regular human insulin (Humulin R) before meals

10 subjects will receive premix insulin human isophane suspension and insulin human injection twice daily

Outcomes

Primary Outcome Measures

To compare improvements from baseline in patient HbA1c when aggressively treated with insulin human isophane plus rapid acting human insulin vs treatment with Premix human insulin

Secondary Outcome Measures

frequency of hypo events (throughout the trial)
weekly frequency of hypo events and time below range
Quality of life score (baseline, week 32) (Using the Pediatric Quality of Life Inventory, 3.2 Diabetes module.)
The PedsQL 3.2 Diabetes Module is composed of 33 items comprising 5 dimensions for ages 8- 45 years and 32 items for ages 2-7 years. Items are reversed scored and linearly transformed to a 0-100 scale. Higher scores indicate lower problems
correlation between patient QoL and glucose variability as measured by CGMS (baseline, week 16 and week 32)

Full Information

First Posted
March 1, 2023
Last Updated
July 6, 2023
Sponsor
Université NAZI BONI
Collaborators
Juvenile Diabetes Research Foundation, International Society for Pediatric and Adolescent Diabetes, Société de Médecine Interne du Burkina Faso, Association pour la Formation, la Recherche et l'Education sur le Diabète, Burkina Faso
search

1. Study Identification

Unique Protocol Identification Number
NCT05768191
Brief Title
Comparative Efficacy of a Two Daily Mixed Insulin Injection Versus a Basal-bolus Scheme With Human Insulin
Official Title
Comparative Efficacy of a Two Daily Mixed Insulin Injection Versus a Basal-bolus Scheme With Human Insulin in a Limited Resources Setting: a Multicenter Randomized Controlled Crossover Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
June 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université NAZI BONI
Collaborators
Juvenile Diabetes Research Foundation, International Society for Pediatric and Adolescent Diabetes, Société de Médecine Interne du Burkina Faso, Association pour la Formation, la Recherche et l'Education sur le Diabète, Burkina Faso

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to compare glycemic control and variability between children and adolescents with type 1 diabetes treated by a two daily injection of premixed human insulin (Humulin 30/70) and those who have a basal bolus scheme (Humulin N + Humulin R) in a resources limited setting. The main question it aims to answer is: what is the effectiveness of premixed human insulin on glycemic control? Ten participants will be randomized initially to premix insulin human isophane suspension and insulin human injection (Humulin 30/70) twice daily, and 10 persons to insulin human isophane suspension (Humulin N) twice daily plus regular human insulin (Humulin R) before meals. At the end of the initial 16-wk treatment (period 1), all patients will be crossed over to the alternate treatment arm for an additional 16 wk (period 2). Insulin doses will be adjusted weekly by the clinical site according to a prespecified insulin intensification algorithm to achieve target fasting [<110 mg/dl (6.1 mmol/liter)], bedtime [<130 mg/dl (7.2 mmol/liter)], and premeal [<110 mg/dl (6.1 mmol/liter)] glucose levels until HbA1c was below 7.0%. Subjects will receive training on the FreeStyle Libre CGMS System, electronic hand-held personal digital assistant (e-diary), and self-monitoring of blood glucose (SMBG), including recording glucose, insulin doses, and symptoms of hypo- or hyperglycemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Humulin N plus Humulin R
Arm Type
Active Comparator
Arm Description
10 subjects will receive insulin human isophane suspension (Humulin N) twice daily plus regular human insulin (Humulin R) before meals
Arm Title
Premix human isophane suspension plus insulin human injection
Arm Type
Experimental
Arm Description
10 subjects will receive premix insulin human isophane suspension and insulin human injection twice daily
Intervention Type
Drug
Intervention Name(s)
premix insulin human isophane suspension and insulin human
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Humulin N plus Humulin R
Intervention Description
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
Primary Outcome Measure Information:
Title
To compare improvements from baseline in patient HbA1c when aggressively treated with insulin human isophane plus rapid acting human insulin vs treatment with Premix human insulin
Time Frame
12 months
Secondary Outcome Measure Information:
Title
frequency of hypo events (throughout the trial)
Description
weekly frequency of hypo events and time below range
Time Frame
8 months
Title
Quality of life score (baseline, week 32) (Using the Pediatric Quality of Life Inventory, 3.2 Diabetes module.)
Description
The PedsQL 3.2 Diabetes Module is composed of 33 items comprising 5 dimensions for ages 8- 45 years and 32 items for ages 2-7 years. Items are reversed scored and linearly transformed to a 0-100 scale. Higher scores indicate lower problems
Time Frame
8 months
Title
correlation between patient QoL and glucose variability as measured by CGMS (baseline, week 16 and week 32)
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female 5 - 18 years of age Be diagnosed for at least 1 year at the date of inclusion. Have been regular at consultations during the last 12 years preceding inclusion (at least 3 visits) Willing and able to inject insulin human isophane and multi-day dosing of rapid acting human insulin. Willing and able to perform self-monitoring of blood glucose (SMBG) four times a day and continuous glucose monitoring (CGMS) for 48 hours at three time periods during the study Have (patient or guardian) a minimum 4 years primary school level Have (patient or guardian) a connected cellphone that can install the free FreeStyle link application and use connected messaging app Exclusion Criteria: pregnant or lactating females opposition to participating in the study residing outside the towns where the care centers are located Any disease or condition (including abuse of illicit drugs, prescription medicines or alcohol) that in the opinion of the investigator or sponsor may interfere with the study compliance and completion of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yempabou Sagna
Phone
+22671221937
Email
my_sagna@yahoo.fr
Facility Information:
Facility Name
CHU Souro Sanou
City
Bobo-Dioulasso
State/Province
Houet
Country
Burkina Faso
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abraham Bagbila, MD
Phone
+22671665138
Facility Name
CHU de Tengandogo
City
Ouagadougou
State/Province
Kadiogo
Country
Burkina Faso
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lassina Séré, MD
Phone
+22671483284
Facility Name
CHU Yalgado Ouedraogo
City
Ouagadougou
State/Province
Kadiogo
Country
Burkina Faso
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yempabou Sagna, MD
First Name & Middle Initial & Last Name & Degree
Pouikomba Patrice Savadogo, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

We'll reach out to this number within 24 hrs