A Randomised, Double-blind, Active-controlled, Single Dose, Five-way Crossover Trial Design, Investigating the Pharmacokinetics, Pharmacodynamics and Safety of Inhaled Insulin with Three Different Inhalation Regimens in Subjects with Type 1 Diabetes

Conditions: Type 1 diabetes mellitus
MedDRA version: 15.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2012-002071-34-DE

Lead Sponsor: Dance Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

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 are carried out as part of the trial, including activities to determine suitability for the trial.
2.Male or female subjects aged 18–64 years (both inclusive).
3.Type 1 diabetes mellitus (as diagnosed clinically) = 12 months.
4.Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) = 12 months.
5.Current total daily insulin treatment < 1.2 (I)U/kg/day.
6.Body mass index 18.0–28.0 kg/m2 (both inclusive).
7.Glycated haemoglobin (HbA1c) = 9.0 % by local laboratory analysis.
8.Forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) = 75 % of predicted normal values for race, age, gender and height.
9.Fasting C-peptide < 0.3 nmol/L

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 18
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.Subjects with any condition possibly affecting drug absorption from the lung.
4.Subject has any active or chronic pulmonary disease as documented by history, physical examination or pulmonary function tests at screening.
5.Receipt of any investigational medicinal product within 30 days before randomisation in this trial.
6.Haemoglobin < 8.0 mmol/L (male) or < 6.4 mmol/L (female), total leukocyte count < 3.0 x 109/L, thrombocytes <100 x 109/L, serum creatinine levels = 126 µmol/L (male) or = 111 µmol/L (female), bilirubin > 3 x the upper limit of normal (ULN), and alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and gamma-glutamyl transferase (?-GT) > 2 x ULN.
7. Smoker
8. Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods