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 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.

• Study Type: Interventional
• Enrollment (Actual): 28
• 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
• Genders Eligible for Study: All

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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
Percentage change from baseline HbA1c	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients having HbA1c under 7%	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.	3 months
Percent of time that Blood glucose (BG) is under 70 mg/dL on CGMS	Demonstrate that the addition of mealtime Afrezza can lower blood glucose in uncontrolled type 2 diabetes patients.	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): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

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