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A Trial to Investigate the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes

NCT03180710 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-01-10

No results posted yet for this study

Summary

This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.

Conditions

Interventions

DRUG

BioChaperone® Combo 75/25 at 0.6 U/kg

Injection of BioChaperone® Combo 75/25 at 0.6 U/kg

DRUG

BioChaperone® Combo 75/25 at 0.8 U/kg

Injection of BioChaperone® Combo 75/25 at 0.8 U/kg

DRUG

BioChaperone® Combo 75/25 at 1.0 U/kg

Injection of BioChaperone® Combo 75/25 at 1.0 U/kg

DRUG

Humalog® Mix25 at 0.8 U/kg

Injection of Humalog® Mix25 at 0.8 U/kg

Sponsors & Collaborators

  • Adocia

    lead INDUSTRY

Principal Investigators

  • Oliver Klein, MD · Profil Institut für Stoffwechselforschung GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-06-06
Primary Completion
2017-08-28
Completion
2017-12-21

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT03180710 on ClinicalTrials.gov