- Design
- Phase 2, randomised, double-blind, placebo-controlled, multicentre, 16 weeks
- Population
- 111 adults with type 1 diabetes, HbA1c 7–10%, BMI ≥27
- Primary outcome
- Change in HbA1c at week 16
- Effect
- Placebo-adjusted HbA1c −0.3% (90% CI −0.6 to −0.1) at 4.1 mg; weight −3.3% to −6.7% vs +0.3%
This was a 16-week phase 2 trial in 111 adults with type 1 diabetes, HbA1c 7–10% and BMI of at least 27. They were randomised equally to once-daily subcutaneous acmopatide at 1.8, 4.1 or 6.6 mg, or placebo. Baseline HbA1c averaged 7.5% and BMI 34.3.
Glycaemic gains were small. HbA1c fell 0.4–0.6% on acmopatide against 0.3% on placebo; the only nominally significant difference was at 4.1 mg, −0.3% (90% CI −0.6 to −0.1). Weight moved more: −3.3% to −6.7% against +0.3% on placebo. Insulin doses fell 3.4–14.9% more than with placebo at the two higher doses. Side effects were mainly gastrointestinal, and there was no ketoacidosis and no severe hypoglycaemia.
The interest is the population. Obesity is now common in type 1 diabetes, and incretin drugs are being used off-label to address it with little trial evidence. This adds a small amount of controlled data. It does not establish safety: 16 weeks and about 80 treated people cannot rule out ketoacidosis, which is the concern whenever insulin doses are cut in type 1 disease.
In clinic, nothing changes yet. Acmopatide is investigational and not available in India.
- Acmopatide is investigational; it is not approved by the FDA, EMA or CDSCO.
- In type 1 diabetes, any incretin-driven insulin reduction needs ketone education and a sick-day plan.
- Record weight and BMI at type 1 reviews; obesity is now a common comorbidity in adults with type 1 diabetes.
- Off-label incretin use in type 1 diabetes still rests on small, short trials.
Why it matters
Obesity in type 1 diabetes has few tested options, and the safety question is ketoacidosis, which this trial was too small to answer.
Don't overread it
Phase 2, 16 weeks and 111 people: absence of ketoacidosis here does not show the drug is safe in type 1 diabetes.
The statistics, in plain English
The HbA1c result is described as nominally significant: it met the threshold for one dose without correction for testing three doses, and the 90% confidence interval is narrower than the usual 95% interval would be. The weight result is larger and consistent across doses, so it is the firmer signal.
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