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

NCT03916640 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-04-16

No results posted yet for this study

Summary

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

Conditions

  • Type 1 Diabetes Mellitus

Interventions

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

Sponsors & Collaborators

  • Adocia

    lead INDUSTRY

Principal Investigators

  • Grit Andersen, MD · Profil Institut für Stoffwechselforschung GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-04
Primary Completion
2019-03-01
Completion
2019-03-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03916640 on ClinicalTrials.gov