Profil Institut für Stoffwechselforschung GmbH
Neuss, 41460, Germany
NCT Number: NCT02514954
Each subject will be randomly allocated to a sequence of two treatments applied at two separate dosing visits. At each dosing visit subjects will be injected with individualised doses of either BioChaperone® Combo or Humalog® Mix 25 immediately before ingesting a standardised mixed meal [(t=0 min) start of the meal]. Insulin doses will be identical at both dosing visits of one individual and will be administered subcutaneously in the abdominal region. Subjects will be asked to consume a standardised meal (e.g. pizza) for dinner at home in the evening before each dosing visit. Subjects will attend the clinical site in a fasted state in the morning of each dosing day and stay at the clinical trial centre until 10-hour after dosing (standardised test-meal procedure has been terminated after 6h). The two dosing visits will be separated by a wash-out period of 5-15 days.
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Notify Me18 year–64 year
All sexes
Interventional
Phase 1
Neuss, 41460, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subcutaneous injection of an individualized dose
Subcutaneous injection of an individualized dose
Time frame: 2 hours
Incremental area under the blood glucose concentration-time curve from 0-2 hours after a standardised meal
Time frame: 6 hours
Incremental area under the blood glucose concentration-time curve from 0-6 hours after a standardised meal
Time frame: 6 hours
Maximum blood glucose concentration after a standardised meal (0-6 hours)
Time frame: 6 hours
Time to maximum blood glucose concentration after a standardised meal (0-6 hours)
Time frame: 6 hours
Area under the plasma insulin lispro concentration-time curve from 0-6 hours
Time frame: 6 hours
Area under the plasma insulin glargine concentration-time curve from 0-6 hours
Time frame: 6 hours
Maximum observed plasma insulin lispro concentration
Time frame: 6 hours
Maximum observed plasma insulin glargine concentration
Time frame: Up to 7 weeks
Number of adverse events
Time frame: Up to 7 weeks
Number and intensity of injection site reactions
Adocia
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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