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A Trial to Compare Post Prandial Blood Glucose Control of BioChaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes

NCT02915250 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-06-29

No results posted yet for this study

Summary

This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over study using a standardised solid meal test in subjects with type 2 diabetes to investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25 and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate dosing visits.

Conditions

Interventions

DRUG

BioChaperone® Combo

Injection of BioChaperone® Combo

DRUG

Humalog® Mix25

Injection of Humalog® Mix25

DRUG

Humalog®

Injection of Humalog®

DRUG

Lantus®

Injection of Lantus®

DRUG

Placebo

Injection of 0.9% NaCl

Sponsors & Collaborators

  • Adocia

    lead INDUSTRY

Principal Investigators

  • Leona Plum-Mörschel, MD · Profil Mainz GmbH & Co KG

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
2016-10-31
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • Germany

Study Locations

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Entities

Drugs
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 NCT02915250 on ClinicalTrials.gov