A global trial found the long-acting analogue reduced severe hypoglycemia and nighttime lows in youth with type 1 diabetes by 12 months, not 6.
A large international trial comparing long-acting insulin glargine with older human insulins in children and young adults with type 1 diabetes (T1D) found no early advantage for the newer formulation, but a longer view of the data suggests meaningful benefits may emerge over time in low-resource care settings. The findings, from the HumAn-1 trial (NCT05614089), were published in The Lancet Diabetes & Endocrinology on July 6, 2026.1,2
The randomized, open-label trial randomized 400 participants aged 7 through 25 across 3 sites in Bangladesh and Tanzania, assigning them 1:1 to glargine (Basaglar; Eli Lilly and Company) or to continued usual care with isophane insulin (neutral protamine hagedorn [NPH]) or premixed 70/30 insulin for basal coverage. At 6 months, using blinded continuous glucose monitoring, investigators found no statistically significant differences between groups in the co-primary outcomes: time spent in a very low glucose range (below 54 mg/dL) or time in target range (70-180 mg/dL). Adjusted mean differences were 0.22% for time in the very low range (97.5% CI, –0.83 to 1.27; P = .63) and 0.55% for time in the target range (97.5% CI, –2.78 to 3.89; P = .71).1,3
Trial Name: Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings (HumAn-1)
ClinicalTrials.gov ID: NCT05614089
Sponsor: The Leona M. and Harry B. Helmsley Charitable Trust
Completion Date: March 19, 2025
Although the 6-month data showed no clear separation between arms, longer follow-up told a different story. At 12 months, participants assigned to glargine spent less time in dangerously low glucose ranges and experienced fewer nocturnal hypoglycemic events compared with those receiving usual care. Researchers reported no meaningful differences at 12 months in overall time in range, HbA1c, diabetic ketoacidosis, or rates of severe or symptomatic hypoglycemia between groups.2
Jing Luo, MD, MPH, associate professor of medicine at the University of Pittsburgh Department of Medicine and study author, said in an exclusive interview that despite overall glycemic control being similar, “patients who switch to glargine may require fewer injections or a slightly lower total daily insulin dose compared with twice-a-day NPH to achieve the same HbA1c.”
The lack of injections with glargine insulin is one of multiple factors that may influence adherence and burden for patients and caregivers, especially in resource-limited health systems.
Serious adverse events were infrequent in both arms at 6 months, with 6 events among 5 of 199 (3%) glargine-treated participants versus 14 events among 13 of 201 (6%) usual-care participants.1
The trial adds data to an ongoing debate over insulin access equity. The World Health Organization added long-acting insulin analogues, including glargine, to its Model List of Essential Medicines in 2021, yet adoption in lower-income countries has lagged due to cost and supply constraints. Of an estimated 9.5 million people living with T1D worldwide, approximately 3.2 million rely exclusively on older human insulins, the majority in low- and middle-income countries.2,4
For pharmacists involved in diabetes management, formulary decisions, or global health initiatives, these results underscore that insulin selection in resource-constrained settings is not a simple matter of "newer is better."
“Pharmacists working in resource-limited settings may want to consider first going to their national treatment guidelines with respect to glargine versus human insulin for people living with T1D,” Luo emphasized. Despite their higher cost, using newer insulin formulations could reap health benefits for patients with T1D, especially children who do not have access to these standard therapies.
However, Luo cautioned that pharmacists “may also need to make decisions based on what is available locally, as any insulin is better than no insulin.”
Investigators noted that additional research is needed to clarify longer-term glycemic outcomes when patients in low-resource settings transition from human to analog insulins.2
“If a national treatment guideline does not provide clear guidance or preference, results from our trial suggest that glargine may be preferable over intermediate-acting human insulins for youth living with T1D or those at higher risk of hypoglycemia (either nighttime or severe events),” Luo concluded.
