A Study to Investigate the Dose Response of Dance 501 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: EUCTR2015-003672-76-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: 24

Inclusion Criteria

• Male and female subjects 18 to 55 years of age, inclusive
• Diagnosed with T1DM
• Body mass index (BMI) = 18.5 and = 30 kg/m2
• HbA1c = 9.0 % inclusive
• Fasting C-peptide = 0.30 nmol/L
• Treated with 2 or more daily injections of insulin or continuous s.c. insulin infusion for at least 6 months prior to screening
• Current total daily insulin treatment < 1.2 U/kg/day
• Non-smoker for = 5 years prior to screening. Negative screening urine cotinine test

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 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Any condition possibly affecting pulmonary drug absorption, in particular significant abnormalities in lung function testing, any active pulmonary disease, or treatment with 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
• Clinically significant abnormal values for hematology, biochemistry, coagulation, or urinalysis
• Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy
• Recurrent severe hypoglycemia
• Current treatment with drugs which may interfere with glucose metabolism

Study & Design

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