Clinical trial NCT03324776: Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients
Official title: Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type2 Diabetes
Keywords: inhaled insulin
Lead sponsor: Model Clinical Research LLC
Sponsor class: OTHER
Collaborators: name: Mannkind Corporation
First posted: 2017-10-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Percentage of HbA1c From Baseline to 3 Months
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Percentage of Patients With HbA1c Under 7% at 3 Months
timeFrame: 3 months
measure: Percent of Time With Blood Glucose (BG) Under 70 mg/dL on CGMS
timeFrame: 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: MODEL Clinical Research
state: Maryland
Study officials:
affiliation: Senior Director of MODEL Clinical Research
name: Philip Levin, MD
role: PRINCIPAL_INVESTIGATOR
References: