drugset / Trial / NCT05614089
Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings
Phase 4
Completed
400 enrolled
Jing Luo
The Leona M. and Harry B. Helmsley Charitable Trust · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-03-15
- Primary completion
- 2024-08-13
- Completion
- 2025-03-19
Outcome
Missed primary endpoint
paper The adjusted mean difference was 0·22% (97·5% CI -0·83 to 1·27, p=0·63). PMID 42409045 ↗
paper The adjusted mean difference was 0·55% (97·5% CI -2·78 to 3·89, p=0·71). PMID 42409045 ↗
Publications
- Luo J, Kehlenbrink S, Chang CH, Lalama CM, Kirsch J, Ansbro E, Prust ML, Garvin A, Zabeen B, Majaliwa E, Ramaiya K, Kayange N, Foulds A, Flabe AH, Nyarubamba RF, Rollman BL, Ogle GD. Human versus analogue insulin for children and young adults with type 1 diabetes in low-resource settings (HumAn-1): a multicentre, open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2026 Jul 6:S2213-8587(26)00097-5. doi: 10.1016/S2213-8587(26)00097-5. Online ahead of print.
- Foulds A, Josey C, Kehlenbrink S, Rollman BL, Chang CH, Lalama C, Ansbro E, Prust ML, Zabeen B, Ramaiya K, Ogle G, Chae SR, Luo J. Human versus Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings (HumAn-1): protocol for a randomised controlled trial. BMJ Open. 2025 Jan 30;15(1):e092432. doi: 10.1136/bmjopen-2024-092432.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | NPH | Protein / enzyme biologic | — | — |
| Subject | insulin glargine | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | premixed 70/30 insulin | Unknown | — | — |