Preserved supervised synthesis

Pramlintide synthesis · version 1

This URL preserves the exact reviewed public wording and source set for synthesis version 1.

Supervised synthesis

What do selected human studies report about Pramlintide?

Manually reviewed September 15, 2026 · version 1

Browse all Human Evidence Reviews · Open preserved synthesis version 1 →

Three selected reports examine pramlintide alongside insulin in diabetes. Two are year-long adjunctive-treatment trials; the third evaluates an experimental automated insulin-and-pramlintide system and is not interchangeable with routine labeled treatment.123

Bottom line from this bounded source set

Year-long trials reported modest HbA1c and weight changes compared with placebo added to insulin. Nausea was common. The automated-delivery study met its glucose-control noninferiority objective but did not improve its emotional-burden endpoint.123

Reviewed study record

Type 1 diabetes: year-long adjunctive trial

Design

Randomized, double-blind, placebo-controlled trial over 52 weeks alongside insulin.1

Population

651 people with type 1 diabetes participated.1

Outcomes reported

The reported active groups had HbA1c reductions of 0.29–0.34 percentage points versus 0.04 with placebo. Weight declined by 0.4 kg versus a 0.8 kg increase. Transient nausea was the most common adverse event.1

Limitations

HbA1c and body weight are distinct from long-term complication outcomes. The abstract does not replace the full hypoglycemia analysis or label warnings.1

Reviewed study record

Type 2 diabetes: year-long adjunctive trial

Design

Randomized, double-blind, placebo-controlled trial over 52 weeks in insulin-treated patients.2

Population

656 people with type 2 diabetes participated.2

Outcomes reported

One active group had a 0.62 percentage-point HbA1c reduction at week 52 and weight change of −1.4 kg versus +0.7 kg with placebo. The authors reported no overall increase in severe-hypoglycemia rate; nausea was common.2

Limitations

A trial-wide hypoglycemia result does not negate regimen-specific risk or current boxed warnings. The report concerns selected insulin-treated patients.2

Reviewed study record

Experimental automated delivery

Design

Randomized crossover comparison of three automated-delivery approaches, each studied for 14 days.3

Population

32 participants enrolled; 30 completing all interventions were analyzed, including 15 adults and 15 adolescents.3

Outcomes reported

The insulin-and-pramlintide system with simple meal announcements met the prespecified glucose-control noninferiority comparison but did not improve emotional burden. Gastrointestinal symptoms occurred more often with pramlintide; no serious adverse events occurred.3

Limitations

The small, short crossover trial excluded noncompleters from the primary analysis. It evaluates a combined device-and-drug approach and cannot establish longer-term safety or a broader approved indication.3

Reviewed source set

  1. PubMed · 15498087Amylin replacement with pramlintide as an adjunct to insulin therapy improves long-term glycaemic and weight control in Type 1 diabetes mellitus: a 1-year, randomized controlled trial. ↗PubMed PMID 15498087 · EFetch XML reviewed 2026-09-15 · payload SHA-256 c0f7cc8a6cbcc81776a4ab5b35e375bce4952288aed03e499b891ad93ccdb2e7
    No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1111/j.1464-5491.2004.01319.x. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
  2. PubMed · 12610038Pramlintide as an adjunct to insulin therapy improves long-term glycemic and weight control in patients with type 2 diabetes: a 1-year randomized controlled trial. ↗PubMed PMID 12610038 · EFetch XML reviewed 2026-09-15 · payload SHA-256 a89b90837191319cce0d50ea4f2bda1b830e012141308b8b84e4893223694d13
    No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.2337/diacare.26.3.784. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
  3. PubMed · 38906614Simple meal announcements and pramlintide delivery versus carbohydrate counting in type 1 diabetes with automated fast-acting insulin aspart delivery: a randomised crossover trial in Montreal, Canada. ↗PubMed PMID 38906614 · EFetch XML reviewed 2026-09-15 · payload SHA-256 41d8294d068021181ac91c0e24653b6ad9cd594c0d216c1ab732b5e6f7334c8a
    No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1016/s2589-7500(24)00092-x. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗