Phase 3
N=20
Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients
Type2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03324776 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Change in Percentage of HbA1c From Baseline to 3 Months — 1.6 change in percentage of HbA1c
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Afrezza Inhalant Product (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Model Clinical Research LLC
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percentage of HbA1c From Baseline to 3 Months |
1.6 | — |
| SECONDARY Percentage of Patients With HbA1c Under 7% at 3 Months |
4 | — |
| SECONDARY Percent of Time With Blood Glucose (BG) Under 70 mg/dL on CGMS |
2.6 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03324776). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.