A phase IIa, double-blinded, randomized trial comparing the efficacy and safety of BioChaperone® rhInsulin to fast-acting insulin analog in patients with Type 1 Diabetes mellitus

• Conditions: Diabetes mellitus; MedDRA version: 13.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 13.1Level: LLTClassification code 10012608Term: Diabetes mellitus insulin-dependentSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2011-001291-19-DE
• Lead Sponsor: Adocia SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-30
• Last Update Posted: 11 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Male and female subjects.
2.Age: 18 –50 years.
3.Diabetes mellitus type 1 (with intensified insulin therapy or pump therapy) (C-Peptide < 1 ng/mL)
4.BMI 18-29 kg/m2
5. HbA1c < 8.5 %
6.Informed consent must be obtained for all volunteers in writing
7.Subject consents that his family physician will be informed of trial participation

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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Diabetes mellitus 2
2. Poor glycemic control or recent changes (within 3 months) in baseline diabetes treatment
3.History of hypersensitivity to the study drugs or to drugs with similar chemical structures
4.History of severe or multiple allergies
5.Evidence of severe secondary complications of diabetes (neuropathy, nephropathy or proliferative retinopathy, macro and micro-angiopathies) as judged by investigator
6.Any systemic treatment with drugs known to interfere with glucose metabolism , and diabetes progression such as systemic or local corticoids, non-selective beta-blockers, and monoamine oxidase (MAO) inhibitors within 3 months prior to randomization
7.Blood donation within the last 3 months.
8.Excessive physical activities in the last 24 hrs before the dosing visits.
9.History of drug or alcohol abuse within the last five years prior to screening.
10.Treatment with any other investigational drug within 3 months prior to screening.
11.Progressive fatal disease.
12.History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine >1.5 mg/dl in men and > 1.1 mg/dl in female), uncontrolled cholesterol (LDL>1g/L) neurological, psychiatric and/or hematological disease as judged by the investigator.
13.Uncontrolled hypertension (HTA>140/80mm Hg)
14.HIV1, HIV2, Hepatitis B, Hepatitis C positive.
15.Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner.
16.Pregnancy or breast feeding
17.Lack of compliance or other similar reason that according to investigator precludes satisfactory participation in the study
18. History or evidence of use of any tobacco – or nicotine-containing product within 6
months of screening
19. Clinical or surgical scares in the intended abdominal region
20. Daily insulin requirement (> 60 IU)
21. Patients with increased thrombosis risk

Study & Design

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