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

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ClinicalTrials.gov Identifier: NCT03324776
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Mannkind Corporation
Information provided by (Responsible Party):
Philip Levin, Model Clinical Research LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Drug: Afrezza Inhalant Product Phase 3

Detailed Description:
Clinical inertia in intensifying treatment of type 2 diabetes patients occurs in the range of 70% in numerous real world database assessments. The investigator proposes treating patients with Afrezza who have an index HbA1c between 7.5% and 11.5% 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. The goal is to assess how the investigator can rapidly and safely initiate intensification in this patient population, where extensive delays in HbA1c improvement often occur.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients
Actual Study Start Date : October 16, 2017
Estimated Primary Completion Date : September 15, 2020
Estimated Study Completion Date : September 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Afrezza 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




Primary Outcome Measures :
  1. 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 7.5 or higher, despite at least 6 months of prior therapy with diabetes medications.


Secondary Outcome Measures :
  1. 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 7.5 or higher, despite at least 6 months of prior therapy with diabetes medications.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult type 2 diabetes patients age 18 or older
  • HbA1c ≥ 7.5% and ≤ 11.5% 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 14 weeks of the 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 3 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

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
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Contact: Karen Klein 443-524-1789 karenklein99@hotmail.com
Contact: Lee Bromberger 443-279-0036 lee-model@hotmail.com

Locations
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United States, Maryland
MODEL Clinical Research Recruiting
Baltimore, Maryland, United States, 21204
Contact: Karen Klein    443-524-1789    karenklein99@hotmail.com   
Contact: Lee Bromberger    443-279-0036    lee-model@hotmail.com   
Sponsors and Collaborators
Model Clinical Research LLC
Mannkind Corporation
Investigators
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Principal Investigator: Philip Levin, MD Senior Director of MODEL Clinical Research

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Responsible Party: Philip Levin, Senior Director of Clinical Research, Model Clinical Research LLC
ClinicalTrials.gov Identifier: NCT03324776     History of Changes
Other Study ID Numbers: AFR-001
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Philip Levin, Model Clinical Research LLC:
inhaled insulin

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