Current partner codePEPTIDESDE

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

Status

Completed

Phase

Phase 1 / Phase 2

Enrollment

44

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

This is a randomized, double-blind, active-controlled, 2 period cross-over clinical trial in subjects with type 1 diabetes mellitus using a Multiple Daily Injection (MDI) regimen.

Full detailed description

After a screening visit, eligible subjects will enter a run-in period. Subjects will receive a Continuous Glucose Monitoring (CGM) system for glucose monitoring and control at the beginning of the run-in and for the whole duration of the study. Each eligible subject will then be randomly allocated to a sequence of the 2 treatments, i.e. multiple daily injections of ADO09 and insulin aspart during 2 dosing periods. At Day 1 a mixed meal test (MMT) will be conducted at breakfast and subjects will remain at the clinical site until day 3. At Day 3 subjects will leave the clinical site and continue the treatment with IMP for the next 3 weeks. On Day 23 subjects will come back for a MMT on Day 24. This study is constituted of 2 parts. In the first part (Part A), only subjects with daily prandial insulin dose ≤ 40 U/day will be enrolled. Following the completion of the part A, an extension part (Part B) will be conducted to particularly assess the safety and tolerability of higher daily doses of ADO09 in patients with insulin requirements ≥ 40 U/day. The clinical conduct and procedures will not change for the Extension Part of the study.

Interventions

Treatment arms and agents.

DRUG

ADO09 formulation

Subcutaneous injection of ADO09 formulation

DRUG

NovoRapid®

Subcutaneous injection of insulin aspart

Timeline

From registration to results.

  1. First posted

    Jun 11, 2019

  2. Study start

    Jun 6, 2019

  3. Primary completion

    Jun 27, 2020

  4. Study completion

    Jun 27, 2020

  5. Results posted

    Not reported

  6. Registry updated

    Nov 30, 2020

Outcomes

What the study measures.

Primary outcomes

ΔAUCPG(0-4h)

Time frame · From 0 to 4 hours

Incremental area under the plasma glucose concentration-time curve from 0-4 hours after start of breakfast, assessed by Super GL at day 24.

Secondary outcomes

Pharmacokinetics of pramlintide

Time frame · From 0 to 4 hours

Area under the pramlintide concentration-time curve

Pharmacokinetics of insulins

Time frame · From 0 to 4 hours

Area under the insulins concentration-time curve

Plasma glucose control as measured by CGM

Time frame · Over 24 hours

Time and percentage of time in Range (TiR) \[70-180\] mg/dL

Safety and tolerability (Adverse Events recording)

Time frame · Up to 24 days

Number of Adverse Events

Eligibility

Who can take part.

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

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.

Study locations

1 registered sites.

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

Profil Institut für Stoffwechselforschung GmbH

Neuss, Germany

Related trials

More studies on Pramlintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.