A trial to compare the pharmacokinetics and pharmacodynamics of insulin lispro administered s.c. into lipohypertrophic or normal abdominal adipose tissue in subjects with diabetes mellitus type 1

• Conditions: Diabetes mellitus; MedDRA version: 17.0Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2014-003144-12-DE
• Lead Sponsor: Profil Institut für Stoffwechselforschung GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-18
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 < 1.2 U/kg/day.
8.Diabetes duration of at least 3 years.
9.Stable insulin regimen (either multiple daily injection or insulin infusion pump) for at least 2 months prior to inclusion into the study, as judged by the investigator.
10.Presence of lipohypertrophic and non-lipohypertrophic adipose tissue at comparable sites, as confirmed by two independent investigators via physical examination and sonography.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified