NCT03981627

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 7, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2020

Completed
Last Updated

November 30, 2020

Status Verified

November 1, 2020

Enrollment Period

1.1 years

First QC Date

June 7, 2019

Last Update Submit

November 27, 2020

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • ΔAUCPG(0-4h)

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

    From 0 to 4 hours

Secondary Outcomes (4)

  • Pharmacokinetics of pramlintide

    From 0 to 4 hours

  • Pharmacokinetics of insulins

    From 0 to 4 hours

  • Plasma glucose control as measured by CGM

    Over 24 hours

  • Safety and tolerability (Adverse Events recording)

    Up to 24 days

Study Arms (2)

Co-formulation of insulin analog and pramlintide (ADO09)

EXPERIMENTAL

Subcutaneous injection of ADO09 formulation

Drug: ADO09 formulation

NovoRapid®

ACTIVE COMPARATOR

Subcutaneous injection of insulin aspart

Drug: NovoRapid®

Interventions

ADO09 formulationDRUG

Subcutaneous injection of ADO09 formulation

Co-formulation of insulin analog and pramlintide (ADO09)
NovoRapid®DRUG

Subcutaneous injection of insulin aspart

NovoRapid®

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

Related Publications (1)

  • Andersen G, Eloy R, Famulla S, Heise T, Meiffren G, Seroussi C, Gaudier M, Megret C, Chan YP, Soula O, Riddle M. 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 Obes Metab. 2023 May;25(5):1241-1248. doi: 10.1111/dom.14972. Epub 2023 Jan 31.

    PMID: 36633505DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Grit Andersen, MD

    Profil Institut für Stoffwechselforschung GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2019

First Posted

June 11, 2019

Study Start

June 6, 2019

Primary Completion

June 27, 2020

Study Completion

June 27, 2020

Last Updated

November 30, 2020

Record last verified: 2020-11

Locations

DE(1)