Status:
COMPLETED
Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients
Lead Sponsor:
Model Clinical Research LLC
Collaborating Sponsors:
Mannkind Corporation
Conditions:
Type2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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, ba...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03324776
Start Date
October 16 2017
End Date
June 10 2020
Last Update
June 26 2024
Active Locations (1)
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1
MODEL Clinical Research
Baltimore, Maryland, United States, 21204