Phase 4
N=28
Afrezza With Basal Combination (ABC): Afrezza® Combined With AID Pump or Insulin Degludec in Adults With Type 1 Diabetes
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT05243628 ↗Enrolled (actual)
28
Serious AEs
10.7%
Results posted
Oct 2024
Primary outcome: Primary: Change in HbA1c — 0.32; 0.35; 0.52 percent of glycated hemoglobin
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Afrezza (insulin human) Inhalation Powder (Biological); insulin degludec (Biological); Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mannkind Corporation
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c |
0.32; 0.35; 0.52 | — |
| SECONDARY Events of Level 1 Hypoglycemia (SMBG < 70mg/dL) |
12; 20; 14 | — |
| SECONDARY Events of Level 2 Hypoglycemia (SMBG < 54 mg/dL) |
3; 5; 4 | — |
| SECONDARY Events of Severe Hypoglycemia |
0; 0; 0 | — |
| SECONDARY Change in Time in Range (Glucose of 70 - 180 mg/dL) |
4.69; -3.89; 1.99 | — |
| SECONDARY Change in Time Below Range (Glucose <70 mg/dL) |
-0.06; 1.92; -0.18 | — |
| SECONDARY Change in Percentage of Time With Glucose <54 mg/dL |
0.03; 0.88; -0.1 | — |
| SECONDARY Change in Time Above Range (Glucose >180 mg/dL) |
-4.63; 1.97; -1.81 | — |
| SECONDARY Change in Percentage of Time With Glucose >250 mg/dL |
-1.04; 0.84; -4.47 | — |
| SECONDARY Change in Coefficient of Variation (CV) |
1; 4; -5 | — |
Summary
A phase 4 study evaluating the efficacy of mealtime control with Afrezza in combination with an automated insulin pump or insulin degludec in adult subjects with type 1 diabetes
Eligibility Criteria
Inclusion Criteria
- Subjects ≥18 years of age at the time of signing the informed consent form
- Clinical diagnosis of Type 1 Diabetes
- HbA1c ≥7.0% and 1.5 × in the last 6 months, according to the local laboratory reference range
- Hyperthyroidism not controlled, as defined by TSH below the normal reference range, according to the local laboratory
- Use of antiadrenergic drugs (e.g., beta blockers and clonidine)
- Any concurrent illness (other than diabetes mellitus) not controlled by a stable therapeutic regimen
- History of a significant eating disorder (e.g., anorexia or bulimia nervosa)
- Current drug or alcohol abuse or a history of drug or alcohol abuse that, in the opinion of the Investigator or the Sponsor, would make the subject an unsuitable candidate for participation in the study
- History of smoking (includes cigarettes, cigars, pipes, vaping devices, and marijuana) in the 6 months before screening
- Female subject who is pregnant, breast-feeding, intends to become pregnant, or is of child-bearing potential and not using adequate contraceptive methods as required by local regulation or practice (may include sexual abstinence)
- An event of severe hypoglycemia, as reported by the patient, within the last 180 days before screening
- An episode of diabetic ketoacidosis (DKA), as determined by the Investigator, requiring hospitalization within the last 180 days before screening
- Exposure to Afrezza in the 30 days before screening
- Abnormal TSH or creatinine levels above 2.0 mg/dL
Data sourced from ClinicalTrials.gov (NCT05243628). 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.