Phase 4
N=400
Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings
Diabetes Mellitus, Type 1 · Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT05614089 ↗Enrolled (actual)
400
Serious AEs
4.5%
Results posted
Sep 2025
Primary outcome: Primary: Time-in-serious Hypoglycemia — 3.6; 3.4; 2.4; 3.8 percentage of time — p=0.43
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Insulin Glargine (Drug); NPH or premixed 70/30 (human insulin) (Drug)
- Age
- Pediatric, Adult · 7+ yrs
- Sex
- All
- Sponsor
- Jing Luo
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-in-serious Hypoglycemia |
3.6; 3.4; 2.4; 3.8 | 0.43 |
| PRIMARY Time-in-range (TIR) |
40.5; 38.1; 38.5; 37.7 | 0.71 |
| SECONDARY Time-in-hypoglycemia |
10.8; 10.2; 9.4; 11.2 | 0.54 |
| SECONDARY Time-above-range |
48.7; 51.8; 52.1; 51.1 | 0.58 |
| SECONDARY Nocturnal Hypoglycemic Events |
3.5; 3.6; 3.2; 4.2 | 0.70 |
| SECONDARY Glycemic Control (HbA1c) |
9.7; 9.9; 9.3; 9.4; 9.4; 9.5 | 0.81 |
| SECONDARY Rate of Severe Hypoglycemic Events |
0; 3.11; 1.33; 1.41 | 0.98 |
| SECONDARY Rate of Diabetic Ketoacidosis (DKA) |
0; 0; 0; 0 | 0.83 |
| SECONDARY Pediatric Quality of Life Inventory 3.2 Diabetes Module (PedsQL 3.2 DM) Diabetes Symptoms Score |
68.1; 69.3; 74.6; 75.2; 75.9; 76.9 | 0.95 |
| SECONDARY Pediatric Quality of Life Inventory 3.2 Diabetes Module (PedsQL 3.2 DM) Diabetes Management Score |
80.0; 81.5; 85.8; 85.7; 88.0; 88.8 | 0.81 |
| SECONDARY Insulin Treatment Satisfaction Questionnaire (ITSQ) Scores |
75.0; 75.6; 84.1; 82.1; 87.1; 85.9 | 0.04 sig |
Summary
The primary objective of this trial is to determine whether insulin glargine reduces the risk of serious hypoglycemia or improves Time in Range at 6 months when compared against standard of care human insulin (e.g. NPH or premixed 70/30) among youth living with type 1 diabetes (T1D) in low resource settings.
Eligibility Criteria
Inclusion Criteria
- Children and young adults (age 7-25)
- Have a clinical diagnosis of type 1 diabetes (T1D)
Exclusion Criteria
- Prior use of any insulin analogue
- Patients (or parents for children <18 years old) who refuse to or cannot provide informed consent
- Who are currently pregnant or plan to become pregnant over the next year
- Who have previously used a continuous glucose monitor (CGM) for glucose monitoring
- Who were first diagnosed with T1D less than 12 months ago
- Who is diagnosed with severe malnutrition
Data sourced from ClinicalTrials.gov (NCT05614089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.