Type2 Diabetes
Conditions
Keywords
inhaled insulin
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.
Interventions
Mealtime Ultra-Rapid Acting Insulin
Sponsors
Mannkind Corporation
Model Clinical Research LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percentage of HbA1c From Baseline to 3 Months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With HbA1c Under 7% at 3 Months | 3 months | Percentage of patients with uncontrolled type 2 diabetes with HbA1c that is under 7% at 3 months |
| Percent of Time With Blood Glucose (BG) Under 70 mg/dL on CGMS | 3 months | Percent of time with BG under 70 mg/dL on CGMS at 3 months in participants with uncontrolled type 2 diabetes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Addition of Mealtime Afrezza Inhalation Powder Adults with Type 2 diabetes on a variety of glucose-lowering regimens instructed to add mealtime Afrezza for 3 months and to follow a weekly treat-to-target BG testing regimen, making Afrezza dose changes according to an Afrezza Titration Algorithm | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Addition of Mealtime Afrezza Inhalation Powder |
|---|---|
| Age, Continuous | 61.4 years STANDARD_DEVIATION 10.1 |
| Hemoglobin A1c (HbA1c) | 9.0 percentage of HbA1c STANDARD_DEVIATION 0.94 |
| Percent of Time Blood glucose (BG) under 70 mg/dL on Continuous Glucose Monitoring System (CGMS) | 1.1 percentage of time with glucose <70mg/dL STANDARD_DEVIATION 2.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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
Time frame: Baseline to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Addition of Mealtime Afrezza Inhalation Powder | Change in Percentage of HbA1c From Baseline to 3 Months | 1.6 change in percentage of HbA1c | Standard Error 0.247 |
Secondary
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
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Addition of Mealtime Afrezza Inhalation Powder | Percentage of Patients With HbA1c Under 7% at 3 Months | 4 Participants |
Secondary
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Addition of Mealtime Afrezza Inhalation Powder | Percent of Time With Blood Glucose (BG) Under 70 mg/dL on CGMS | 2.6 percent of time with glucose <70mg/dL | Standard Deviation 2.5 |