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NCT Number: NCT04100473

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Profil Mainz

Mainz, Malakoff-Passage, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

inhaled human insulin

Drug

Dance 501 administered using the Dance 501 Inhaler

Other names: Dance 501

Insulin Lispro (Humalog U-100)

Drug

Lispro

Other names: Insulin Lispro (Humalog U-100) will be administered by subcutaneous injection

Primary outcomes

  1. Primary Pharmacokinetic Endpoint - PK 1

    Time frame: 0 - 10 hours

    Area under the human insulin and insulin lispro concentrations time curves

  2. Primary Pharmacokinetic Endpoint - PK 2

    Time frame: 0 - 10 hours

    Maximum observed concentration of human insulin and insulin lispro

  3. Primary Pharmacodynamic Endpoint - PD 1

    Time frame: 0 - 10 hours

    Area under the glucose infusion rate time curve

  4. Primary Pharmacodynamic Endpoint - PD 2

    Time frame: 0 - 10 hours

    Maximum observed glucose infusion rate

Secondary outcomes

  1. Secondary Pharmacokinetic Endpoint - PK 1

    Time frame: 0 - 1 hour, 0 - 2 hours, 0 - 8 hours

    Area under the insulin time curves at different intervals

  2. Secondary Pharmacokinetic Endpoint - PK 2

    Time frame: 0 - 10 hours

    Time to maximum insulin concentrations

  3. Secondary Pharmacokinetic Endpoint - PK 3

    Time frame: 0 - 10 hours

    Relative Efficiency of dose corrected ratio of AUC ins for INH and s.c. lispro

  4. Secondary Pharmacokinetic Endpoint - PK 4

    Time frame: 0 - 10 hours

    Onset of appearance (time from trial product administration until the serum insulin concentrations are > LLOQ.

  5. Secondary Pharmacokinetic Endpoint - PK 5

    Time frame: 0 - 10 hours

    Mean residence time of insulin

  6. Secondary Pharmacodynamic Endpoint - PD 1

    Time frame: 0 - 1 hour, 0 - 2 hours, 0 - 8 hours

    AUC for GIR at different time intervals

  7. Secondary Pharmacodynamic Endpoint - PD2

    Time frame: 0 - 10 hours

    Time to maximum glucose infusion rate

  8. Secondary Pharmacodynamic Endpoint - PD3

    Time frame: 0 - 10 hours

    Relative biopotency of dose corrected ratio of AUC GIR for INH and s.c. lispro

Sponsors and collaborators

Lead sponsor

Dance Biopharm Inc.

Industry

Collaborators

  • Profil Institut für Stoffwechselforschung GmbH

Registry information

Official study 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)

Acronym: T2DM

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Sep 24, 2019
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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