Afrezza for Diabetes Mellitus, Type 2
Phase-Based Progress Estimates
Effectiveness
Safety
Diabetes Mellitus, Type 2+2 More
Afrezza - BiologicalEligibility
< 18
All Sexes
What conditions do you have?
Select
Eligibility
< 18
All Sexes
What conditions do you have?
Select
Study Summary
This trial is testing the efficacy and safety of Afrezza, a inhaled insulin, in children with type 1 or 2 diabetes. The trial has a screening and run-in period of up to 5 weeks, followed by a 26-week randomized treatment period, during which subjects will receive either Afrezza or a rapid-acting insulin injection. All subjects will then enter a 26-week treatment extension, during which they will receive Afrezza. The trial will conclude with a 4-week follow-up period.
Eligible Conditions
- Diabetes Mellitus, Type 2
- Diabetes, Autoimmune
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: During treatment extension at week 26 to week 52
26 weeks
Change in DTSQ score After 26 Weeks of Afrezza
Change in Fasting Plasma Glucose (FPG)
Change in Fasting Plasma Glucose (FPG) After 26 weeks
Change in HbA1c After 26 Weeks
Change in Percent Time with Glucose <54 mg/dL
Change in percent Time Above Range (glucose >180 mg/dL)
Change in percent Time Below Range (glucose <70 mg/dL)
Change in percent Time In Range (glucose 70 - 180 mg/dL)
Change in percent time with glucose <54 mg/dL
Change in scores of DTSQ Status (s)-Parent
Change in scores of DTSQ Status (s)-Teen
Event rate of level 1 hypoglycemia (SMBG <70 mg/dL)
Event rate of pooled level 2 and level 3 hypoglycemia
Percentage of Subjects with HbA1c <7.0% at Week 26
Rate of Hypoglycemic Events After 26 weeks
Time Above Range (glucose >180 mg/dL)
Time Below Range (glucose <70 mg/dL)
Time in Range (70 - 180 mg/dL)
52 weeks
Change in FPG
Change in HbA1c
Change in HbA1c After 52 Weeks - Afrezza arm
Change in percent Time In Range, Time Below Range and Time Above Range
Change in scores of DTSQ(s)-Parent
Change in scores of DTSQ(s)-Teen
Event Rate of Hypoglycemic Events After 52 Weeks
Event rates of hypoglycemic events
Incidence and Severity of Adverse Events
Incidence and severity of Adverse Events of Special Interest (AESIs)
Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Incidence of Hypoglycemic Events After 52 Weeks
Incidence of hypoglycemic events
56 weeks
Change in Percent Predicted Forced Expiratory Volume in 1 Second
Microscopy, Atomic Force
At Week 26
Percentage of subjects with HbA1c <7.0%
Therapeutic procedure
Score of Diabetes Treatment Satisfaction Questionnaire (DTSQ) Change (c)-Teen
At Week 52
Score of DTSQ(c)-Parent at Week 52
Score of DTSQ(c)-Teen at Week 52
Week 52
Change in HbA1c During Extension - RAA arm
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Afrezza Cohort 2 (Ages 8-12)
67%Hypoglycemia
33%Cough
20%Upper respiratory tract infection
7%Tonsillar hypertrophy
7%Gastroenteritis viral
7%Headache
7%Dizziness
7%Asthenia
7%Flank pain
7%Limb injury
7%Vomiting
7%Erythema
7%Hyperglycemia
7%Blood pressure increased
7%Seasonal allergy
7%Tenderness
Trial Design
2 Treatment Groups
RAA Injection + Basal Insulin
1 of 2
Afrezza (Technosphere Insulin) + Basal Insulin
1 of 2
Active Control
Experimental Treatment
264 Total Participants · 2 Treatment Groups
Primary Treatment: Afrezza · No Placebo Group · Phase 3
Afrezza (Technosphere Insulin) + Basal InsulinExperimental Group · 2 Interventions: Afrezza, Basal Insulin · Intervention Types: Biological, Biological
RAA Injection + Basal InsulinActiveComparator Group · 3 Interventions: Basal Insulin, Rapid-acting Insulin Analog, Rapid-Acting Insulin Analog · Intervention Types: Biological, Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin human
FDA approved
Insulin degludec
FDA approved
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: during treatment extension at week 26 to week 52
Who is running the clinical trial?
Mannkind CorporationLead Sponsor
55 Previous Clinical Trials
7,620 Total Patients Enrolled
23 Trials studying Diabetes Mellitus, Type 2
4,912 Patients Enrolled for Diabetes Mellitus, Type 2
Jaeb Center for Health ResearchOTHER
139 Previous Clinical Trials
31,429 Total Patients Enrolled
3 Trials studying Diabetes Mellitus, Type 2
329 Patients Enrolled for Diabetes Mellitus, Type 2
Kevin KaisermanStudy DirectorMannkind Corporation
Karen JaffeStudy DirectorMannkind Corporation
Eligibility Criteria
Age < 18 · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have HbA1c levels of 7.0% or less and 11% or more.
You have an average prandial dose of insulin of at least 2 units per meal.
You have used CGM for ≥70% of the time over a consecutive 14-day period preceding randomization.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Popular Clinical Trials
Top Clinical Trials in Cities
Relevant Clinical Trials
Unbiased Results
We believe in providing patients with all the options.Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.Back to top
Conditions
Cancer Related
Treatments