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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR AFREZZA

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Clinical Trials for Afrezza

Trial ID Title Status Sponsor Phase Summary
NCT00642616 Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary Disease Terminated Mannkind Corporation Phase 3 Examine the effects of TI in combination with an anti-diabetic regimen including inhaled insulin versus anti-diabetic treatment without inhaled insulin on lung function & pulmonary safety
NCT00642616 Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary Disease Terminated Sanofi Phase 3 Examine the effects of TI in combination with an anti-diabetic regimen including inhaled insulin versus anti-diabetic treatment without inhaled insulin on lung function & pulmonary safety
NCT02470637 Single Dose Clamp Study to Evaluate Concentration-time Profile and Metabolic Activity of 3 Dose Levels of Afrezza and 3 Dose Levels of Insulin Lispro in Patients With Type 1 Diabetes Mellitus Completed Sanofi Phase 1 Primary Objective: To assess the dose-response pattern of the glucose consumption (GIR-AUC0-end) of 3 different single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of subcutaneous (SC) insulin lispro in a euglycemic clamp setting. Secondary Objectives: To assess the dose proportionality of insulin exposure (INS-AUClast) of 3 different single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a euglycemic clamp setting. To assess the pharmacodynamic (PD) characteristics of 3 different single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a euglycemic clamp setting. To assess the pharmacokinetic (PK) characteristics of 3 different single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a euglycemic clamp setting. To assess the safety and tolerability of 3 different single doses of Afrezza inhaled Technosphere insulin.
NCT02485327 PK and PD Within-Subject Variability of a Single Dose of Afrezza Inhaled Technosphere Insulin in Patients With Diabetes Mellitus Type 1 (T1DM) Completed Sanofi Phase 1 Primary Objective: To characterize the within-subject variability in systemic exposure pharmacokinetic (PK) to insulin of a replicate single dose of Afrezza inhaled Technosphere Insulin (TI) in T1DM patients in a euglycemic clamp setting. To characterize the within-subject variability in the metabolic activity (pharmacodynamic [PD]) of a replicate single dose of Afrezza inhaled TI in T1DM patients in a euglycemic clamp setting. Secondary Objectives: To assess the PK characteristics of a replicate single dose of Afrezza inhaled TI in a euglycemic clamp setting. To assess the PD characteristics of a replicate single dose of Afrezza inhaled TI in a euglycemic clamp setting. To assess the safety and tolerability of a replicate single dose of Afrezza inhaled TI in a euglycemic clamp setting.
NCT02527265 Afrezza Safety and Pharmacokinetics Study in Pediatric Patients Suspended Sanofi Phase 1 Primary Objective: -To assess the safety and tolerability of Afrezza in children ages 4 to 17 years with type 1 diabetes mellitus (T1DM). Secondary Objectives: - To assess the ability to titrate the prandial and supplemental doses of Afrezza at each meal. - To assess pharmacokinetics (PK) following a prandial dose of Afrezza in children ages 4 to 17 years with T1DM.
NCT03234491 Improving Post-Prandial Blood Glucose Control With Afrezza During Closed-Loop Therapy Not yet recruiting Yale University Phase 1 The study will be conducted in two phases; an in-patient meal study phase (Phase I) and an outpatient home study (Phase II). The two phase study design is chosen to enhance safety by testing the Afrezza Closed-Loop (CL) system in controlled in-clinic setting under study staff supervision before it could be investigated at the outpatient home setting. Phase II will not begin without the establishment of safety in Phase I.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Afrezza

Condition Name

Condition Name for Afrezza
Intervention Trials
Type 1 Diabetes Mellitus 4
Type 2 Diabetes Mellitus 1
Post-Prandial Hypoglycemia 1
Post-Prandial Hyperglycemia 1
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Condition MeSH

Condition MeSH for Afrezza
Intervention Trials
Diabetes Mellitus 6
Diabetes Mellitus, Type 1 4
Diabetes Mellitus, Type 2 3
Hypoglycemia 1
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Clinical Trial Locations for Afrezza

Trials by Country

Trials by Country for Afrezza
Location Trials
United States 14
Russian Federation 2
Germany 2
Ukraine 1
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Trials by US State

Trials by US State for Afrezza
Location Trials
New York 2
Maryland 1
Pennsylvania 1
Connecticut 1
Colorado 1
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Clinical Trial Progress for Afrezza

Clinical Trial Phase

Clinical Trial Phase for Afrezza
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 1 4
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Clinical Trial Status

Clinical Trial Status for Afrezza
Clinical Trial Phase Trials
Recruiting 2
Completed 2
Not yet recruiting 1
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Clinical Trial Sponsors for Afrezza

Sponsor Name

Sponsor Name for Afrezza
Sponsor Trials
Sanofi 4
Mannkind Corporation 3
Informed Data Systems, Inc. 1
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Sponsor Type

Sponsor Type for Afrezza
Sponsor Trials
Industry 8
Other 2
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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
US Department of Justice
Fuji
Argus Health
Covington
Cipla
UBS
Farmers Insurance
Dow

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