Afrezza for Diabetes Mellitus, Type 2

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Diabetes Mellitus, Type 2+2 More
Afrezza - Biological
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

2 of 3
This is further along than 85% of similar trials

Other trials for Diabetes Mellitus, Type 2

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

3 of 3
This is further along than 85% of similar trials

Other trials for Diabetes Mellitus, Type 2

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
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT02527265) in the Afrezza Cohort 2 (Ages 8-12) ARM group. Side effects include: Hypoglycemia with 67%, Cough with 33%, Upper respiratory tract infection with 20%, Tonsillar hypertrophy with 7%, Gastroenteritis viral with 7%.

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 preview

Michael Gill - B. Sc.

First Published: October 23rd, 2021

Last Reviewed: October 12th, 2022

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.