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

NCT ID: NCT03324776

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-16
• Study Completion Date: 2020-06-10

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.

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.

Conditions

Type2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Afrezza Inhalant Product

Intervention Type: DRUG

Mealtime Ultra-Rapid Acting Insulin

Interventions

Afrezza Inhalant Product

Mealtime Ultra-Rapid Acting Insulin

Intervention Type: DRUG

Other Intervention Names

Afrezza Inhaled Insulin

Eligibility 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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mannkind Corporation

INDUSTRY

Sponsor Role: collaborator

Model Clinical Research LLC

OTHER

Sponsor Role: lead

Responsible Party

Philip Levin

Senior Director of Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip Levin, MD

Role: PRINCIPAL_INVESTIGATOR

Senior Director of MODEL Clinical Research

Locations

MODEL Clinical Research

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

AFR-001

Identifier Type: -

Identifier Source: org_study_id