New Clinical Trial Posted 10/30

[itellthefuture777]

clinicaltrials.gov/ct2/show/NCT03324776?lupd_s=09%2F30%2F2017&lupd_d=30

[itellthefuture777]

Oct 31, 2017 0:55:12 GMT -5 itellthefuture777 said:

clinicaltrials.gov/ct2/show/NCT03324776?lupd_s=09%2F30%2F2017&lupd_d=30

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

This study is currently recruiting participants.

See  Contacts and Locations

Verified October 2017 by Philip Levin, Model Clinical Research LLC

Sponsor:

Model Clinical Research LLC

ClinicalTrials.gov Identifier:

NCT03324776

First Posted: October 30, 2017

Last Update Posted: October 30, 2017

 The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read ourdisclaimer for details.

Collaborator:

Mannkind Corporation

Information provided by (Responsible Party):

Philip Levin, Model Clinical Research LLC

Full Text ViewTabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record

  Purpose

To examine the effects of adding prandial Afrezza inhaled insulin to patients with type 2 diabetes who are not controlled after at least 6 months of other diabetes treatments including oral agents, basal insulin, or GLP-1 use.


ConditionInterventionPhaseType2 DiabetesDrug: Afrezza Inhalant ProductPhase 3


Study Type:InterventionalStudy Design:Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: TreatmentOfficial Title:Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients

Resource links provided by NLM:


Drug Information available for: InsulinInsulin human

U.S. FDA Resources 


Further study details as provided by Philip Levin, Model Clinical Research LLC:


Primary Outcome Measures:Percentage change from baseline HbA1c [ Time Frame: 3 months ]

Demonstrate that the addition of mealtime Afrezza can significantly lower HbA1c within 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 8 or higher, despite at least 6 months of prior therapy with diabetes medications.



Secondary Outcome Measures:Percentage of patients having HbA1c under 7% [ Time Frame: 3 months ]

Demonstrate that the addition of mealtime Afrezza can significantly lower HbA1c within 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 8 or higher, despite at least 6 months of prior therapy with diabetes medications.


Percent of time that Blood glucose (BG) is under 70 mg/dL on CGMS [ Time Frame: 3 months ]

Demonstrate that the addition of mealtime Afrezza can lower blood glucose in uncontrolled type 2 diabetes patients.



Estimated Enrollment:40Actual Study Start Date:October 16, 2017Estimated Study Completion Date:April 15, 2018Estimated Primary Completion Date:April 15, 2018 (Final data collection date for primary outcome measure)

ArmsAssigned InterventionsAfrezza Inhalant Product

Patients will be instructed to follow a Weekly Treat-to-Target BG Testing Regimen and make Afrezza dose changes according to an Afrezza Titration Algorithm

Drug: Afrezza Inhalant Product

Mealtime Ultra-Rapid Acting Insulin

Other Name: Afrezza Inhaled Insulin


Detailed Description:

Clinical inertia in intensifying treatment of type 2 diabetes patients occurs in the range of 70% in numerous real world database assessments. We propose treating patients with Afrezza who have an index HbA1c between 8% and 11% despite being treated with diabetes medications for at least 6 months. The response to Afrezza will be assessed with Continuous Glucose Monitoring Systems (CGMS) studies and initial and follow-up HbA1cs. Our goal is to assess how we can rapidly and safely initiate intensification in this patient population, where extensive delays in HbA1c improvement often occur.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:  18 Years and older   (Adult, Senior)Sexes Eligible for Study:  AllAccepts Healthy Volunteers:  No

Criteria

Inclusion Criteria:

Adult type 2 diabetes patients age 18 or older

HbA1c ≥ 8% and ≤ 11% after at least 6 months treatment with diabetes medication. Treatment may include oral agents, basal insulin or GLP-1 in any combination.

Patient and provider agree not to add additional diabetes medications during the 3 months of study (unless rescue treatment is indicated).

Exclusion Criteria:

History of asthma, COPD or smoking within 6 months

FEV1 under 70% predicted

Pregnancy

Active malignancies and/or life expectancy of < 12 months

Major surgery planned during study period

Currently using rapid acting insulins - Novolog, Humalog, Apidra

Prior use of Afrezza in the last 6 months

Unwilling to test blood glucose before or after each meal

Exposure to systemic glucocorticoids within 6 weeks of screening

Severe hypoglycemia in last 6 months or hypoglycemia unawareness

Any medical condition which, in the opinion of the PI, would interfere with ability to understand or respond to the administration of inhaled insulin

  Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324776


Contacts

Contact: Karen [e-mail]: Lee [e-mail]


Locations

United States, MarylandMODEL Clinical ResearchRecruitingBaltimore, Maryland, United States, 21204Contact: 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, MDSenior Director of MODEL Clinical Research

  More Information


Responsible Party:Philip Levin, Senior Director of Clinical Research, Model Clinical Research LLCClinicalTrials.gov Identifier:NCT03324776    History of ChangesOther Study ID Numbers:AFR-001 
First Submitted:October 25, 2017First Posted:October 30, 2017Last Update Posted:October 30, 2017Last Verified:October 2017Individual Participant Data (IPD) Sharing Statement:Plan to Share IPD:No
Studies a U.S. FDA-regulated Drug Product:YesStudies a U.S. FDA-regulated Device Product:NoProduct Manufactured in and Exported from the U.S.:Yes
Keywords provided by Philip Levin, Model Clinical Research LLC:

inhaled insulin


Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin, Short-Acting
Hypoglycemic Agents
Physiological Effects of Drugs

[joeypotsandpans]

BOOM!! This is a very nice one, combined with the STAT, and the One Drop...I will refer to this as the Afrezza hat trick knockout of the current dinosaurs. Keep 'em coming!

[kimi]

www.healthgrades.com/physician/dr-philip-levin-yqjkm

modelclinicalresearch.com/ (not available)

great news !!!

[mnholdem]

"Our goal is to assess how we can rapidly and safely initiate intensification in this patient population, where extensive delays in HbA1c improvement often occur."

Over a year ago I posted studies in the ProBoards-MNKD Resources Section detailing how short-term intensive insulin (STII) therapy has been proven to result in drug-free remission of diabetes mellitus for nearly two years in 48% of the patients who received the therapy. The research team concluded that the intensification of insulin treatment enabled the over stressed beta cells in the pancreas to heal and begin producing more insulin.

This study isn't STII therapy, but it's close. Repair of the pancreas will depend on how early the patient was diagnosed and how much irreparable damage to the pancreas has already occurred while on oral medications.

It's a shame that measurement of indigenous insulin excretion (before and after) isn't one of the secondary outcomes. To be able to achieve remission of the disease would be front page news.

[sayhey24]

Does anyone know anything about Model Clinical Research? Their facebook page does not seem to be updated lately/

[digger]

It makes little sense. It says it's a "phase 3" study. Afrezza has completed its phase 3 studies.

It also says the patients will be using CGMs, but an exclusion criterion is "Unwilling to test blood glucose before or after each meal." Well, if they're wearing a CGM, they shouldn't need to do that.

CGMs are expensive; will MNKD be paying for those?

There's no comparison with lispro; what good will it do to show afrezza improves A1c if they don't show it does it better than lispro?

As far as "Model Clinical Research," their linkedin page says they have only two employees and their website is dead. The doctor Levin appears to be on this page:

www.bayendocrinology.com/physicians.html

[itellthefuture777]

Oct 31, 2017 5:27:23 GMT -5 sayhey24 said:

Does anyone know anything about Model Clinical Research? Their facebook page does not seem to be updated lately/

My first guess is with this clinical Afrezza moves to frontline therapy. Here read Levin's stuff. www.sciencedirect.com/science/article/pii/S0149291815012400

[itellthefuture777]

Oct 31, 2017 8:46:06 GMT -5 itellthefuture777 said:

Oct 31, 2017 5:27:23 GMT -5 sayhey24 said:

Does anyone know anything about Model Clinical Research? Their facebook page does not seem to be updated lately/

My first guess is with this clinical Afrezza moves to frontline therapy. Here read Levin's stuff. www.sciencedirect.com/science/article/pii/S0149291815012400

Basically what this guy is doing is demonstrating the clinical utility as frontline subplanting metformin. By taking the load off the pancrease early on halting progression is my guess

[itellthefuture777]

Oct 31, 2017 5:27:23 GMT -5 sayhey24 said:

Does anyone know anything about Model Clinical Research? Their facebook page does not seem to be updated lately/

In some of his transparency requirments show he is supported by Novo Nordisk and Sanofi (maybe others) when presenting powerpoints

[sophie]

Wonder what Dr Urbansky and other previous CMOs were doing the past several years. Good to see several new trials designed to open up market relevance and acceptance by highlighting Afrezza's strengths relative to others.

Hopeful for favorable results. Still more work to be done but encouraging that they're finally moving in the right direction.

[dreamboatcruise]

Oct 31, 2017 10:52:07 GMT -5 sophie said:

Wonder what Dr Urbansky and other previous CMOs were doing the past several years. Good to see several new trials designed to open up market relevance and acceptance by highlighting Afrezza's strengths relative to others.

Hopeful for favorable results. Still more work to be done but encouraging that they're finally moving in the right direction.

Figuring out the titration protocol... and then wishing they had more money to initiate additional clinical trials.

[peppy]

Oct 31, 2017 8:44:02 GMT -5 digger said:

It makes little sense. It says it's a "phase 3" study. Afrezza has completed its phase 3 studies.

It also says the patients will be using CGMs, but an exclusion criterion is "Unwilling to test blood glucose before or after each meal." Well, if they're wearing a CGM, they shouldn't need to do that.

CGMs are expensive; will MNKD be paying for those?

There's no comparison with lispro; what good will it do to show afrezza improves A1c if they don't show it does it better than lispro?

As far as "Model Clinical Research," their linkedin page says they have only two employees and their website is dead. The doctor Levin appears to be on this page:

www.bayendocrinology.com/physicians.html

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

quote: There's no comparison with lispro; what good will it do to show afrezza improves A1c if they don't show it does it better than lispro?

reply: the medical profession is not that keen about putting type two's on subq meal time insulin.

if medicine/physicians want to put type two's on subq mealtime insulin, they can.

www.screencast.com/t/nOwBa4aaA

[dreamboatcruise]

Oct 31, 2017 13:50:55 GMT -5 peppy said:

Oct 31, 2017 8:44:02 GMT -5 digger said:

It makes little sense. It says it's a "phase 3" study. Afrezza has completed its phase 3 studies.

It also says the patients will be using CGMs, but an exclusion criterion is "Unwilling to test blood glucose before or after each meal." Well, if they're wearing a CGM, they shouldn't need to do that.

CGMs are expensive; will MNKD be paying for those?

There's no comparison with lispro; what good will it do to show afrezza improves A1c if they don't show it does it better than lispro?

As far as "Model Clinical Research," their linkedin page says they have only two employees and their website is dead. The doctor Levin appears to be on this page:

www.bayendocrinology.com/physicians.html

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

quote: There's no comparison with lispro; what good will it do to show afrezza improves A1c if they don't show it does it better than lispro?

reply: the medical profession is not that keen about putting type two's on subq meal time insulin.

if medicine/physicians want to put type two's on subq mealtime insulin, they can.

www.screencast.com/t/nOwBa4aaA

Yes, it looks like it may be that this trial is looking at breaking with ADA guidelines and starting people earlier on prandial insulin.  In that case there is well established reasons why ADA guidelines are slow to utilize insulin.  If this trial can show that Afrezza can be inserted earlier in treatment (six months rather than years) with good results and low risk profile, I don't think it necessary to additionally show what has already been demonstrated regarding RAA vs orals.

[Tinkerbell]

So then to recap, currently there are four Phase 4 trials recruiting and they are each posted below. The Stat study is the first of the four that is expected to be presented in early 2018 to insurance companies who've asked for more data.

*Assuming* the hard evidence confirms superiority of Afrezza over Lispro (and in under 4 weeks), then IMO it will serve as the 'official' launch platform from where a more positive clinical perspective of Afrezza begins to emerge. The remaining three Phase 4 studies therefore would *likely* confirm such positive evidence in both the Pediatrics and Type 2 population.

The reality is that these studies have not yet been published which is why I use the asterisk. IMO, if I were looking to partner with or get married to an up and coming biotech, I'd have to see and analyze the STAT study results myself before I considered getting hitched. Call it a prenup.

For me, that would dispell any concerns I'd have given all that's available now are the studies upon which approval was granted. JMO.

Here are the four P4 studies:

1) clinicaltrials.gov/ct2/show/NCT03324776?id=NCT03143816+OR+NCT03324776+OR+NCT02527265+OR+NCT03313960&rank=1&load=cart

2) clinicaltrials.gov/ct2/show/NCT03313960?id=NCT03143816+OR+NCT03324776+OR+NCT02527265+OR+NCT03313960&rank=2&load=cart

3) clinicaltrials.gov/ct2/show/NCT03143816?id=NCT03143816+OR+NCT03324776+OR+NCT02527265+OR+NCT03313960&rank=3&load=cart

4) clinicaltrials.gov/ct2/show/NCT02527265?id=NCT03143816+OR+NCT03324776+OR+NCT02527265+OR+NCT03313960&rank=4&load=cart