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

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 Overview

• Status: Completed
• Conditions: Type2 Diabetes
• Intervention / Treatment: Drug: Afrezza Inhalant Product

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 hemoglobin A1c (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 HbA1c's. 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Model Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Glucagon-like peptide-1 (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, chronic obstructive pulmonary disease (COPD) or smoking within 6 months
• Forced Expiratory Volume in one second (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 investigator, would interfere with ability to understand or respond to the administration of inhaled insulin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Addition of mealtime Afrezza Inhalation Powder; 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 Names: Afrezza Inhaled Insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Percentage of HbA1c From Baseline to 3 Months	Change in percentage of HbA1c from baseline to 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 7.5 or higher and 11.5% or lower	Baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With HbA1c Under 7% at 3 Months	Percentage of patients with uncontrolled type 2 diabetes with HbA1c that is under 7% at 3 months	3 months
Percent of Time With Blood Glucose (BG) Under 70 mg/dL on CGMS	Percent of time with BG under 70 mg/dL on CGMS at 3 months in participants with uncontrolled type 2 diabetes.	3 months

Collaborators and Investigators

• Sponsor: Model Clinical Research LLC
• Collaborators: Mannkind Corporation
• Investigators: Principal Investigator: Philip Levin, MD, Senior Director of MODEL Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Actual): June 10, 2020
• Study Completion (Actual): June 10, 2020

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: October 25, 2017
• First Posted (Actual): October 30, 2017

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: inhaled insulin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: AFR-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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