MNKD Studies.

[peppy]

Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal Volunteers

clinicaltrials.gov/ct2/show/NCT03464864

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Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study—STAT Study (STAT)
clinicaltrials.gov/ct2/show/NCT03143816
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Afrezza Safety and Pharmacokinetics Study in Pediatric Patients
clinicaltrials.gov/ct2/show/NCT02527265

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The dose optimization study is the Afrezza dynamic dosing study, which we're calling [AED-1] study. This protocol is very close to finalization and we're aiming for a July/August start with the possible Q4 completion, date available soon after.

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Technosphere® Insulin Inhalation Powder (TI) Displays Earlier Onset and Shorter Duration
www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdf

[lakers]

Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients

Locations
United States, Maryland
MODEL Clinical Research Recruiting
Baltimore, Maryland, United States, 21204
Contact: Karen Klein 443-524-1789 [e-mail]
Contact: Lee Bromberger 410-279-0036 [e-mail]
Sponsors and Collaborators
Model Clinical Research LLC
Mannkind Corporation
Investigators
Principal Investigator: Philip Levin, MD Senior Director of MODEL Clinical Research

clinicaltrials.gov/ct2/show/NCT03324776?term=Inhaled+Afrezza&cond=Diabetes&rank=5

[lakers]

Improving Post-Prandial Blood Glucose Control With Afrezza During Closed-Loop Therapy

clinicaltrials.gov/ct2/show/NCT03234491?term=Inhaled+Afrezza&cond=Diabetes&draw=10&rank=98

Contacts
Contact: Sonali Saxena, MD 203-737-3595 [e-mail]
Contact: Alfonso Galderisi, MD 203-737-3595 [e-mail]

Locations
United States, Connecticut
Yale Diabetes Research Clinic Recruiting
New Haven, Connecticut, United States, 06511
Contact: Lori Carria 203-737-3595 [e-mail]
Contact: Kristen Kraemer [e-mail]
Sponsors and Collaborators
Yale University

Brief Summary:
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.

Detailed Description:
There are 2 primary study aims that this research will address. The first study aim will be to determine whether use of Afrezza inhaled insulin with ultra-fast kinetics will improve the performance of a closed-loop (CL) system, both with respect to immediate post-prandial hyperglycemia and the subsequent late post-prandial hypoglycemia as compared to hybrid CL (HCL) with subcutaneous (SC) rapid-acting insulin (RAI) pre-meal bolus.
The second study aim will be to examine the efficiency and feasibility of Afrezza inhaled insulin as a pre-meal bolus and a missed meal correction bolus on mitigating post-prandial blood glucose control during outpatient CL therapy.

This study will test the hypothesis that Afrezza inhaled insulin given before a meal to mimic physiologic first phase insulin release will limit the magnitude and rate of rise of glucose levels following a meal and will achieve greater percent time spent within target blood glucose range as compared to conventional hybrid CL therapy without inhaled insulin both in the in-clinic research and outpatient real-life setting.

[golfeveryday]

Aug 4, 2018 15:43:30 GMT -5 lakers said:

Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients

Locations
United States, Maryland
MODEL Clinical Research Recruiting
Baltimore, Maryland, United States, 21204
Contact: Karen Klein 443-524-1789 [e-mail]
Contact: Lee Bromberger 410-279-0036 [e-mail]
Sponsors and Collaborators
Model Clinical Research LLC
Mannkind Corporation
Investigators
Principal Investigator: Philip Levin, MD Senior Director of MODEL Clinical Research

clinicaltrials.gov/ct2/show/NCT03324776?term=Inhaled+Afrezza&cond=Diabetes&rank=5

very interested to see this one. Just a few weeks until completed. 👍🏻

[peppy]

Mar 14, 2018 14:44:30 GMT -5 peppy said:

Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal Volunteers

clinicaltrials.gov/ct2/show/NCT03464864

====================================================================================

Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study—STAT Study (STAT)
clinicaltrials.gov/ct2/show/NCT03143816
====================================================================================

Afrezza Safety and Pharmacokinetics Study in Pediatric Patients
clinicaltrials.gov/ct2/show/NCT02527265

---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

The dose optimization study is the Afrezza dynamic dosing study, which we're calling [AED-1] study. This protocol is very close to finalization and we're aiming for a July/August start with the possible Q4 completion, date available soon after.

--------------------------------------------------------------------------------------------------------------------------------------

Technosphere® Insulin Inhalation Powder (TI) Displays Earlier Onset and Shorter Duration
www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdf

Afrezza® INHALE-1 Study in Pediatrics (INHALE-1)
clinicaltrials.gov/ct2/show/NCT04974528?term=pediatric+Afrezza&recrs=ab&cond=Diabetes&draw=2&rank=2