Diabetes mellitus MedDRA version: 17.0 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Humalog®
Product Name: Humalog®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN LISPRO
CAS Number: 133107-64-9
Concentration unit: U unit(s)
Concentration type: eq
Sponsors
Profil Institut für Stoffwechselforschung GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedures that would not have been performed during normal management of the subject). 2.Male or female subject with diabetes mellitus type 1. 3.Age between 18 and 64 years, both inclusive. 4.Body Mass Index (BMI) between 18.5 and 30 kg/m2, both inclusive. 5.HbA1c = 10%. 6.Negative C-peptide (= 0.30 nmol/L). 7.Total insulin dose of =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1.Known or suspected hypersensitivity to trial product(s) or related products. 2.Previous participation in this trial. Participation is defined as randomised. 3.Receipt of any investigational medicinal product within 30 days before randomisation in this trial. 4.History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction. 5.Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the investigator. 6.Any history or presence of clinically relevant cardiovascular, pulmonary, respiratory, gastrointestinal, hepatic, renal, metabolic, endocrinological (with the exception of conditions associated with diabetes mellitus), haematological, dermatological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the investigator. 7.Any serious systemic infectious disease during four weeks prior to first dosing of the study drug, as judged by the investigator. 8.Clinically significant abnormal lab results for haematology, clinical chemistry, or urinalysis as judged by the investigator. 9.Abnormalities in renal function (e.g. serum creatinine > 120 µmol/L for male, >100 µmol/L for female subjects) as judged by the investigator that would pose a problem of clearance of injected insulin. 10.Supine blood pressure at screening (after resting for at least 5 min in supine position) outside the ranges for systolic 95-140 mmHg blood pressure and for diastolic greater than 90 mmHg or symptoms and a heart rate at rest outside of 50-90 beats per minute (excluding white-coat hypertension; therefore, if a repeated measurement shows values within the range, the subject can be included in the trial). This exclusion criterion also pertains to subjects being on anti-hypertensives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the pharmacokinetic and pharmacodynamic effects of insulin lispro during the first 4 hours after s.c. administration into either lipohypertrophic or normal adipose tissue during a euglycaemic clamp examination.;Secondary Objective: • to compare the pharmacokinetic and pharmacodynamic effects of insulin lispro during the first 4 hours after s.c. administration into either lipohypertrophic or normal adipose tissue during an MMTT • to compare the intra-subject variability of the pharmacokinetic and pharmacodynamic efficacy of insulin lispro administration into either lipohypertrophic or normal adipose tissue • to further compare the pharmacokinetic and pharmacodynamic effects of insulin lispro administration into either lipohypertrophic or normal adipose tissue during a euglycaemic clamp examination and MMTT ;Primary end point(s): PK endpoint: •AUCINS.0-4h, area under the serum insulin concentration curve from 0 to 4 hours in each dosing interval during treatment period 1 PD endpoint: •AUCGIR.0-4h, area under the glucose infusion rate curve from 0 to 4 hours in each dosing interval during treatment period 1 ;Timepoint(s) of evaluation of this end point: Data Base release | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •AUCINS.0-4h area under the serum insulin concentration curve from 0 to 4 hours during treatment period 2 •AUCBG.0-4h, area under the blood glucose excursion curve in the indicated time-intervals during treatment period 2 •Intra-subject variability of AUCINS.0-4h and AUCGIR.0-4h during treatment period 1 ;Timepoint(s) of evaluation of this end point: Data Base release | — |
Countries
Germany
Contacts
Public ContactRegulatory Affairs Manager
Profil Institut für Stoffwechselforschung GmbH
Outcome results
None listed