Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 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 HbA1cs. 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Afrezza Inhalant Product Patients will be instructed to follow a Weekly Treat-to-Target BG Testing Regimen and make Afrezza dose changes according to an Afrezza Titration Algorithm |
Drug: Afrezza Inhalant Product
Mealtime Ultra-Rapid Acting Insulin
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage change from baseline HbA1c [3 months]
Demonstrate that the addition of mealtime Afrezza can significantly lower HbA1c within 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 7.5 or higher, despite at least 6 months of prior therapy with diabetes medications.
Secondary Outcome Measures
- Percentage of patients having HbA1c under 7% [3 months]
Demonstrate that the addition of mealtime Afrezza can significantly lower HbA1c within 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 7.5 or higher, despite at least 6 months of prior therapy with diabetes medications.
- Percent of time that Blood glucose (BG) is under 70 mg/dL on CGMS [3 months]
Demonstrate that the addition of mealtime Afrezza can lower blood glucose in uncontrolled type 2 diabetes patients.
Eligibility Criteria
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 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, COPD or smoking within 6 months
-
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
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Prior use of Afrezza in the last 3 months
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Unwilling to test blood glucose before or after each meal
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Exposure to systemic glucocorticoids within 6 weeks of screening
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Severe hypoglycemia in last 6 months or hypoglycemia unawareness
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Any medical condition which, in the opinion of the PI, would interfere with ability to understand or respond to the administration of inhaled insulin
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MODEL Clinical Research | Baltimore | Maryland | United States | 21204 |
Sponsors and Collaborators
- Model Clinical Research LLC
- Mannkind Corporation
Investigators
- Principal Investigator: Philip Levin, MD, Senior Director of MODEL Clinical Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AFR-001