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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 10, 2020

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.

Interventions

  • Drug: Afrezza Inhalant Product
    • Mealtime Ultra-Rapid Acting Insulin

Arms, Groups and Cohorts

  • Other: 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

Clinical Trial Outcome Measures

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

Secondary 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 7.5 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Model Clinical Research LLC
  • Collaborator
    • Mannkind Corporation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Philip Levin, Senior Director of Clinical Research – Model Clinical Research LLC
  • Overall Official(s)
    • Philip Levin, MD, Principal Investigator, Senior Director of MODEL Clinical Research

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