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

NCT03324776 | Completed Phase 3 Results FDA Drug

• 1 other identifier: AFR-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes

Keywords

inhaled insulin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of Patients With HbA1c Under 7% at 3 Months

  3 months

• Percent of Time With Blood Glucose (BG) Under 70 mg/dL on CGMS

  3 months

Study Arms (1)

Addition of mealtime Afrezza Inhalation Powder

OTHER

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

Interventions

Afrezza Inhalant Product DRUG

Mealtime Ultra-Rapid Acting Insulin

Also known as: Afrezza Inhaled Insulin

Addition of mealtime Afrezza Inhalation Powder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Model Clinical Research LLC: lead
• Mannkind Corporation: collaborator

Study Sites (1)

MODEL Clinical Research

Baltimore, Maryland, 21204, United States

Location

Results Point of Contact

• Title: Philip Levin, MD
• Organization: MODEL Clinical Research LLC

pal3420@yahoo.com

4102413438

Study Officials

• Philip Levin, MD

  Senior Director of MODEL Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Director of Clinical Research

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: October 30, 2017
• Study Start: October 16, 2017
• Primary Completion: June 10, 2020
• Study Completion: June 10, 2020
• Last Updated: June 26, 2024
• Results First Posted: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)