CompletedPhase 1

A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin in Patients With Type 1 Diabetes Mellitus

Lead sponsor

Adocia

Asset

Pramlintide

Amylin analog

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 1 diabetes

Eligibility highlights

Primary endpoints

•CmaxPram•AUCPram_0-8h

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03512236

Org study IDCT031-ADO09

Timeline

Milestones

Study start2018-04-25actual

Study first posted2018-04-30actual

Primary completion2019-02-14actual

Study completion2019-02-14actual

Last update posted2019-02-21actual

Assets

Investigational agents

Pramlintide

Who this study enrolls

Type 1 diabetes

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female subjects aged 18-64 years (both inclusive)

•Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months

•Treated with multiple daily insulin injections ≥ 12 months

•Treated with an evening dose of once-daily insulin glargine U100 at screening

•Fasting C-peptide ≤ 0.30 nmol/L

Exclusion criteria

•Known or suspected hypersensitivity to IMPs, paracetamol (acetaminophen) or related products

•Type 2 diabetes mellitus

•Clinically significant abnormal haematology, biochemistry, or urinalysis screening tests, as judged by the Investigator considering the underlying disease

•Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the Investigator

•Known slowing of gastric emptying, including gastroparesis, and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption

•Intake of medication known to affect gastrointestinal motility, including but not limited to erythromycin, metoclopramide, cisapride, cholestyramine or colestipol within 4 weeks before screening

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Glucose pharmacodynamics

Time frame:From 0 to 8 hours

concentration, descriptive

Safety / tolerability / PK

5 endpoints

Primary/protocol endpoint

CmaxPram

Time frame:From 0 to 8 hours

Cmax

concentration, descriptive

Primary/protocol endpoint

AUCPram_0-8h

Time frame:From 0 to 8 hours

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics of pramlintide

Time frame:From 0 to 8 hours

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics of insulins

Time frame:From 0 to 8 hours

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Safety and tolerability (Adverse Events recording)

Time frame:From 0 to 8 hours

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.