CompletedPhase 1

A Trial to Assess a Co-formulation of an Insulin Analog and Pramlintide in Subjects With Type 1 Diabetes Mellitus

A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Co-formulation of an Insulin Analog and Pramlintide in Subjects 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

•BMI 18.5-28

Primary endpoints

•CmaxPram•AUCPram 0-8h•CmaxIns

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 IDNCT03916640

Org study IDCT034-ADO09

Timeline

Milestones

Study start2019-01-04actual

Primary completion2019-03-01actual

Study completion2019-03-01actual

Study first posted2019-04-16actual

Last update posted2019-04-16actual

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

•Type 1 Diabetes Mellitus (as diagnosed clinically) ≥ 12 months

•Treated with multiple daily injection ≥ 12 months

•Treated with insulin glargine U100 or U300 or insulin detemir at screening

•Fasting C-peptide ≤ 0.30 nmol/L

•BMI: 18.5-28.0 kg/m² (both inclusive)

Exclusion criteria

•Known or suspected hypersensitivity to IMPs, paracetamol or related products

•Type 2 Diabetes Mellitus

•Clinically significant abnormal haematology, biochemistry or urinalysis screening test, 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 (8)

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

7 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

Primary/protocol endpoint

CmaxIns

Time frame:From 0 to 8 hours

Cmax

concentration, descriptive

Primary/protocol endpoint

AUCIns 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.