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
MKC-TI-192 is a Phase 4, 90-day, randomized, three-arm, multicenter clinical trial evaluating the treatment paradigm and efficacy of Afrezza in controlling postprandial glucose in adult subjects (≥18 years of age) with Type 1 Diabetes Mellitus (T1DM). Subjects will be randomized to one of three treatment groups (two Afrezza groups and one control group): * Afrezza + AID: Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a continuous subcutaneous insulin infusion (CSII) pump with an automatic insulin delivery (AID) algorithm using rapid acting analogs (RAA) for their basal and correction insulin coverage. * Afrezza + Insulin Degludec: Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. * AID Control: Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group). The study is composed of up to 5 clinic visits (screening, 3 treatment visits, and an end-of-treatment visit) and 9 telephone visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Pharmaceutical form: powder Route of administration: inhalation
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Acceptable AID systems in this study are Medtronic 670G/770G and Tandem Control IQ
Diabetes Treatment Center, Loma Linda University
Loma Linda, California, United States
Texas Diabetes and Endocrinology
Austin, Texas, United States
Change in HbA1c
Change in glycated hemoglobin (HbA1c) from baseline to end of study
Time frame: 90 days
Events of Level 1 Hypoglycemia (SMBG < 70mg/dL)
Events of hypoglycemia (SMBG \<70 mg/dL for SMBG values more than 30 minutes apart)
Time frame: 90 days
Events of Level 2 Hypoglycemia (SMBG < 54 mg/dL)
Events of hypoglycemia (SMBG \<54 mg/dL for SMBG values more than 30 minutes apart)
Time frame: 90 days
Events of Severe Hypoglycemia
Events of severe hypoglycemia requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions
Time frame: 90 days
Change in Time in Range (Glucose of 70 - 180 mg/dL)
Change from baseline to end of study in Time in Range (TIR), defined as the percentage of time spent with glucose in the range of 70 to 180 mg/dL, based on continuous glucose monitoring derived glucose values
Time frame: baseline and 90 days
Change in Time Below Range (Glucose <70 mg/dL)
Change from baseline to end of study in Time Below Range (TBR), defined as the percentage of time spent with glucose \<70 mg/dL, based on continuous glucose monitoring derived glucose values
Time frame: baseline and 90 days
Change in Percentage of Time With Glucose <54 mg/dL
Change from baseline to end of study in percentage of time spent with glucose \<54 mg/dL, based on continuous glucose monitoring derived glucose values
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Time frame: baseline and 90 days
Change in Time Above Range (Glucose >180 mg/dL)
Change from baseline to end of study in Time Above Range (TAR), defined as the percentage of time spent with glucose \>180 mg/dL, based on continuous glucose monitoring derived glucose values
Time frame: baseline and 90 days
Change in Percentage of Time With Glucose >250 mg/dL
Change from baseline to end of study in percentage of time spent with glucose \>250 mg/dL, based on continuous glucose monitoring derived glucose values
Time frame: baseline and 90 days
Change in Coefficient of Variation (CV)
Change from baseline to end of study in glycemic variability as measured by coefficient of variation (CV), based on continuous glucose monitoring derived glucose values
Time frame: baseline and 90 days