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A Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With T1DM

NCT02739906 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-08-18

No results posted yet for this study

Summary

This is a 2 centres, randomised, double blind, three-treatment, three-period cross-over trial in subjects with type 1 diabetes mellitus.

Each subject will be administered individualised single subcutaneous doses of BioChaperone Human Insulin (HinsBet®), insulin lispro (Humalog®) and regular human insulin (Huminsulin® Normal) immediately before ingesting a standardised mixed meal.

Following trial drug administration, PK and PD assessments will be carried until 6 hours after start of the standardized test meal.

The total trial duration for an individual subject will be up to 11 weeks.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

BioChaperone Human Insulin (HinsBet®)

BioChaperone Human Insulin (HinsBet®) individualised single subcutaneous injection followed by test meal intake

DRUG

Insulin Lispro (Humalog®)

Insulin Lispro (Humalog®) individualised single subcutaneous injection followed by test meal intake

DRUG

Regular human insulin (Huminsulin® Normal)

Regular human insulin (Huminsulin® Normal) individualised single subcutaneous injection followed by test meal intake

Sponsors & Collaborators

  • Adocia

    lead INDUSTRY

Principal Investigators

  • Oliver Klein, MD · Profil 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
2016-04-30
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Germany

Study Locations

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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 NCT02739906 on ClinicalTrials.gov