Dose Response of Dance 501 in Subjects With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

— T2DM  

Official title:

A Randomized, Open-Label, 6-Period Cross-Over Study to Investigate the Dose Response of Dance 501 (Human Insulin Inhalation Solution and Inhaler) in Subjects With Type 2 Diabetes Mellitus (T2DM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04100473
• Other study ID #: Samba-04
• Status: Completed
• Phase: Phase 2
• Start date: April 23, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: September 2019
• Source: Dance Biopharm Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be a randomized, open-label, active-controlled, 6-period crossover study. Target population will be subjects with Type 2 Diabetes Mellitus (T2DM)

Description:

To assess the dose-response and dose-exposure of Dance 501 (Human Insulin Inhalation Solution) administered with the Dance 501 Inhaler.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 1, 2019
• Est. primary completion date: August 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subjects diagnosed with T2DM.

• BMI between 25.0 and 40.0 kg/m2.

• Treated with metformin and/or at least 1 daily injection of insulin for at least 6 months.

• Non-smoker for at least 5 years.

• Forced vital capacity and forced expiratory volume in one second is at least 75% normal.

Exclusion Criteria:

• Any condition affecting pulmonary drug absorption.

• History or presence of cancer except basal cell skin cancer or squamous cell skin cancer.

• Serious systemic infectious disease during four weeks prior to dosing.

• Clinically significant abnormal lab values.

• Proliferative retinopathy and/or severe neuropathy.

• Recurrent severe hypoglycemia.

• Current treatment with oral anti-diabetic drugs except metformin, glucagon-like peptide receptor agonists.

• Current treatment with MAO inhibitors.

• Unstable Thyroid hormones for at least 3 months.

• Insufficient glycemic control with significant fluctuations of blood glucose.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Inhaled Human Insulin
Dance 501 administered using the Dance 501 Inhaler
• Insulin Lispro (Humalog U-100)
Lispro

Locations

Country	Name	City	State
Germany	Profil Mainz	Mainz	Malakoff-Passage

Sponsors (2)

Lead Sponsor	Collaborator
Dance Biopharm Inc.	Profil Institut für Stoffwechselforschung GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Pharmacokinetic Endpoint - PK 1	Area under the human insulin and insulin lispro concentrations time curves	0 - 10 hours
Primary	Primary Pharmacokinetic Endpoint - PK 2	Maximum observed concentration of human insulin and insulin lispro	0 - 10 hours
Primary	Primary Pharmacodynamic Endpoint - PD 1	Area under the glucose infusion rate time curve	0 - 10 hours
Primary	Primary Pharmacodynamic Endpoint - PD 2	Maximum observed glucose infusion rate	0 - 10 hours
Secondary	Secondary Pharmacokinetic Endpoint - PK 1	Area under the insulin time curves at different intervals	0 - 1 hour, 0 - 2 hours, 0 - 8 hours
Secondary	Secondary Pharmacokinetic Endpoint - PK 2	Time to maximum insulin concentrations	0 - 10 hours
Secondary	Secondary Pharmacokinetic Endpoint - PK 3	Relative Efficiency of dose corrected ratio of AUC ins for INH and s.c. lispro	0 - 10 hours
Secondary	Secondary Pharmacokinetic Endpoint - PK 4	Onset of appearance (time from trial product administration until the serum insulin concentrations are > LLOQ.	0 - 10 hours
Secondary	Secondary Pharmacokinetic Endpoint - PK 5	Mean residence time of insulin	0 - 10 hours
Secondary	Secondary Pharmacodynamic Endpoint - PD 1	AUC for GIR at different time intervals	0 - 1 hour, 0 - 2 hours, 0 - 8 hours
Secondary	Secondary Pharmacodynamic Endpoint - PD2	Time to maximum glucose infusion rate	0 - 10 hours
Secondary	Secondary Pharmacodynamic Endpoint - PD3	Relative biopotency of dose corrected ratio of AUC GIR for INH and s.c. lispro	0 - 10 hours