Dose Response of Dance 501 in Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT04100473
Last Updated: 2019-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2018-04-23
2019-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Dance 501
Dance 501(Human Insulin Inhalation Solution and Inhaler) will be administered using the Dance 501 Inhaler.
Inhaled Human Insulin
Dance 501 administered using the Dance 501 Inhaler
Insulin Lispro
Insulin Lispro (Humalog®) will be administered by subcutaneous injection.
Insulin Lispro (Humalog U-100)
Lispro
Interventions
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Inhaled Human Insulin
Dance 501 administered using the Dance 501 Inhaler
Insulin Lispro (Humalog U-100)
Lispro
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Profil Institut für Stoffwechselforschung GmbH
INDUSTRY
Dance Biopharm Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Oliver Klein
Role: PRINCIPAL_INVESTIGATOR
Profil Institut fur Stoffwechselforschung GmbH
Locations
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Profil Mainz
Mainz, Malakoff-Passage, Germany
Countries
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Other Identifiers
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Samba-04
Identifier Type: -
Identifier Source: org_study_id
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