A Study to Investigate Dance 501 (Human Insulin Inhalation Solution and Inhaler) in Subjects with Type 1 Diabetes Mellitus (T1DM)

Phase 1

• Conditions: Type 1 Diabetes Mellitus; MedDRA version: 20.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-003737-95-DE
• Lead Sponsor: Dance Biopharm Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-25
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

• Male and female subjects 18 to 55 years of age (both inclusive) with T1DM
• HbA1c = 9.0% inclusive
• Subjects with T1DM taking 2 or more injections of insulin daily or continuous s.c. insulin infusion for at least 6 months prior to screening
• Current total daily insulin treatment < 1.2 (I)U/kg/day
• BMI = 18.5 and = 30 kg/m2
• Non-smoker for = 5 years prior to screening, confirmed by a negative screening urine cotinine test
• Forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) = 75 % of predicted normal values for race, age, gender and height
• Fasting C-peptide = 0.30 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 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Any condition possibly affecting drug absorption from the lung, in particular subjects with decreased lung
function, any active pulmonary disease or taking bronchodilators
• Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer
• Any history or presence of clinically relevant comorbidity (with the exception of conditions associated with
diabetes mellitus), or signs of acute illness, as judged by the Investigator
• Recurrent severe hypoglycemia
• Proliferative retinopathy or maculopathy or severe autonomic neuropathy
• Current treatment with medications that may interfere with glucose metabolism
• Clinical significant abnormal findings during physical examination, laboratory and ECG results at screening

Study & Design

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