Current partner codePEPTIDESDE
NCT03916640·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

24

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This trial is a monocentric, randomised, double-blind, active comparator, controlled, 3-period cross-over trial.

Full detailed description

In this monocentric, randomised, double-blind, active comparator, controlled, cross-over trial, each patient will be randomly allocated to a sequence of three treatments: one single dose of the co-formulation of insulin analog and pramlintide (also called ADO09), simultaneous separate injections of pramlintide and human insulin and one single dose of insulin lispro. To keep the blinding in this trial, a placebo injection will be given in addition to the ADO09 formulation and insulin lispro dose for a total of 2 injections per dosing visit. During each visit, meal test procedures will be performed and subjects will stay at the clinical centre until post-dose follow-up period has been terminated. IMP administration will be done subcutaneously immediately prior to test meal intake.

Interventions

Treatment arms and agents.

DRUG

ADO09 formulation

Subcutaneous injection of ADO09 formulation

DRUG

Placebo

Subcutaneous injection of 0.9% NaCl

DRUG

Symlin®

Subcutaneous injection of pramlintide

DRUG

Humulin®

Subcutaneous injection of human insulin

DRUG

Humalog®

Subcutaneous injection of insulin lispro

Timeline

From registration to results.

  1. First posted

    Apr 16, 2019

  2. Study start

    Jan 4, 2019

  3. Primary completion

    Mar 1, 2019

  4. Study completion

    Mar 1, 2019

  5. Results posted

    Not reported

  6. Registry updated

    Apr 16, 2019

Outcomes

What the study measures.

Primary outcomes

CmaxPram

Time frame · From 0 to 8 hours

Maximum pramlintide concentration

AUCPram 0-8h

Time frame · From 0 to 8 hours

Area under the pramlintide concentration-time curve from 0-8 hours after IMP administration

CmaxIns

Time frame · From 0 to 8 hours

Maximum insulin analog concentration

AUCIns 0-8h

Time frame · From 0 to 8 hours

Area under the insulin analog concentration-time curve from 0-8 hours after IMP administration

Secondary outcomes

Pharmacokinetics of pramlintide

Time frame · From 0 to 8 hours

Area under the pramlintide concentration-time curve

Pharmacokinetics of insulins

Time frame · From 0 to 8 hours

Area under the insulins concentration-time curve

Glucose pharmacodynamics

Time frame · From 0 to 8 hours

Area under the blood glucose concentration-time curve

Safety and tolerability (Adverse Events recording)

Time frame · From 0 to 8 hours

Number of Adverse Events

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
64 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

Germany. Showing up to 24 locations stored in the fast local snapshot.

Profil Institut für Stoffwechselforschung GmbH

Neuss, Germany

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Pramlintide.

Related PeptideStat pages

Put the record in context.

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