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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Inhaled Human Insulin; Drug: Insulin Lispro (Humalog U-100)

• Registration Number: NCT04100473
• Lead Sponsor: Dance Biopharm Inc.

Brief 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)

Detailed Description

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

Study Timeline

• Study Start: 2018-04-23
• Primary Completion: 2018-08-11
• Study First Submitted: 2019-02-25
• Study Completion: 2019-08-01
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-20
• Last Update Submitted: 2019-09-20
• Study First Posted: 2019-09-24
• Last Update Posted: 2019-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dance 501	Inhaled Human Insulin	Dance 501(Human Insulin Inhalation Solution and Inhaler) will be administered using the Dance 501 Inhaler.
Insulin Lispro	Insulin Lispro (Humalog U-100)	Insulin Lispro (Humalog®) will be administered by subcutaneous injection.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Profil Mainz; 🇩🇪 Mainz, Malakoff-Passage, Germany