GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1, PHASE2

A Trial to Assess Safety and Efficacy of ADO09 Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus

A Randomized, Single-centre, Double-blind, 2-period Cross-over Trial to Assess Safety and Efficacy of ADO09 Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus

Lead sponsor

Adocia

Asset

Pramlintide

Amylin analog

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 1 diabetes

Key I/E criterion

•HbA1c ≤9%

Primary endpoint

•Postprandial glucose

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03981627

Org study IDCT038-ADO09

Timeline

Milestones

Study start2019-06-06actual

Study first posted2019-06-11actual

Primary completion2020-06-27actual

Study completion2020-06-27actual

Last update posted2020-11-30actual

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Signed and dated informed consent obtained before any trial-related activities.

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

•Treated with insulin ≥ 12 months.

•Using a multiple dosing insulin therapy (MDI) with basal and bolus insulin.

•HbA1c ≤ 9.0%.

•Fasting negative C-peptide (≤ 0.30 nmol/L).

•Total daily prandial dose: ≤ 40U in the Part A and ≥ 40 U in the Part B

Exclusion criteria

•Known or suspected hypersensitivity to products used in the clinical trial

•Type 2 diabetes mellitus

•Previous participation in this trial. Participation is defined as randomized.

•Receipt of any medicinal product in clinical development within 3 months before randomization in this trial.

•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.

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

•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 (5)

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

2 endpoints

Primary/protocol endpoint

ΔAUCPG(0-4h)

Time frame:From 0 to 4 hours

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Plasma glucose control as measured by CGM

Time frame:Over 24 hours

CGM time-in-range

threshold achievement, improvement

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Pharmacokinetics of pramlintide

Time frame:From 0 to 4 hours

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics of insulins

Time frame:From 0 to 4 hours

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Safety and tolerability (Adverse Events recording)

Time frame:Up to 24 days

Treatment-emergent AEs (any)

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

A co-formulation of pramlintide and insulin A21G (ADO09) improves postprandial glucose and short-term control of mean glucose, time in range, and body weight versus insulin aspart in adults with type 1 diabetes.
Diabetes, obesity & metabolism2023 May (month)PMID36633505doi:10.1111/dom.14972via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 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 1, 2026 snapshot.