Dose Response of Dance 501 in Subjects With Type 2 Diabetes Mellitus (T2DM)

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)

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Inhaled Human Insulin; Drug: Insulin Lispro (Humalog U-100)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Malakoff-Passage
    • Mainz, Malakoff-Passage, Germany
      • Profil Mainz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dance 501; Dance 501(Human Insulin Inhalation Solution and Inhaler) will be administered using the Dance 501 Inhaler.	Drug: Inhaled Human Insulin; Dance 501 administered using the Dance 501 Inhaler; Other Names: Dance 501
ACTIVE_COMPARATOR: Insulin Lispro; Insulin Lispro (Humalog®) will be administered by subcutaneous injection.	Drug: Insulin Lispro (Humalog U-100); Lispro; Other Names: Insulin Lispro (Humalog U-100) will be administered by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Pharmacokinetic Endpoint - PK 1	Area under the human insulin and insulin lispro concentrations time curves	0 - 10 hours
Primary Pharmacokinetic Endpoint - PK 2	Maximum observed concentration of human insulin and insulin lispro	0 - 10 hours
Primary Pharmacodynamic Endpoint - PD 1	Area under the glucose infusion rate time curve	0 - 10 hours
Primary Pharmacodynamic Endpoint - PD 2	Maximum observed glucose infusion rate	0 - 10 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dance Biopharm Inc.
• Collaborators: Profil Institut für Stoffwechselforschung GmbH
• Investigators: Principal Investigator: Oliver Klein, Profil Institut für Stoffwechselforschung GmbH

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 23, 2018
• Primary Completion (ACTUAL): August 11, 2018
• Study Completion (ACTUAL): August 1, 2019

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: September 20, 2019
• First Posted (ACTUAL): September 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 20, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Inhaled Insulin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Lispro
• Other Study ID Numbers: Samba-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No