insulin, regular, human
insulin, regular, human: sourced relationships with 1 company · 7 clinical trials tracked · 1 FDA decision.
insulin, regular, human evidence translation
What we can confirm
1 FDA record · 7 tracked trials
What it means
What to watch
Prepared research question
How could insulin, regular, human → MNKD affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence4 indications · 1 study sponsors
Related indications
Study sponsors
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| MANNKIND CORP (MNKD) Diabetes Mellitus, Type 1; Type 1 Diabetes | Phase 4 |
Clinical Trial Registry Records (7)
Sleep Loss and Circadian Misalignment - Mechanisms of Insulin Resistance
Primary endpoint: Insulin resistance-Minimal Model (Si)
A Randomized, Double-blind, Placebo-controlled, Multi-center Phase 2b Study With a Blinded Extension and an Optional Open-label Extension-Assessing the Safety and Efficacy of Frexalimab, a CD40L-antagonist Monoclonal Antibody, for the Preservation of Pancreatic β-cell Function in Adults, Adolescents and Children With Newly Diagnosed Type 1 Diabetes on Insulin Therapy
Primary endpoint: Change in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from AUC from baseline to W52 for Part B (12-21 y.o.)
ABC [Afrezza With Basal Combination]: A Phase 4 Study of Mealtime Control With Afrezza in Adult Subjects With Type 1 Diabetes Mellitus in Combination With an Automated Insulin Pump or Insulin Degludec
Primary endpoint: Change in HbA1c
INHALE-1: A 26-week Primary Treatment Phase, With 26-week Extension, Open-label, Randomized Clinical Trial Evaluating the Efficacy and Safety of Afrezza® Versus Rapid-acting Insulin Analog Injections, Both in Combination With a Basal Insulin, in Pediatric Subjects With Type 1 or Type 2 Diabetes Mellitus
Primary endpoint: Change in HbA1c
A Single-Site, Investigator-Initiated Study to Evaluate Time in Range in Subjects With Type 2 Diabetes Mellitus Using Mealtime Inhaled Insulin (Afrezza®) Plus Basal Insulin Compared to Multiple Daily Injections
Primary endpoint: Time In Range
Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients
Primary endpoint: Change in Percentage of HbA1c From Baseline to 3 Months
A Prospective, Multicenter, Randomized, Open-label Study of 12 Week Duration to Evaluate the Effect of VILDagliptin Added to Insulin on Glycaemic Control in haemoDIALyzed Patients With Type 2 Diabetes: Probe Analysis of CGM
Primary endpoint: Mean glucose value of CGM [M] to be averaged from day 2 and day 3 of CGM
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with insulin, regular, human?
insulin, regular, human has dated SEC/FDA relationship records for MANNKIND CORP.
How many clinical trials involve insulin, regular, human?
BioSniper tracks 7 clinical trials involving insulin, regular, human.
What is insulin, regular, human's latest FDA decision?
The most recent tracked FDA decision for insulin, regular, human is Approval for 1 INDICATIONS AND USAGE AFREZZA ® is indicated to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus. AFREZZA ® is a rapid acting inhaled human insulin indicated to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus. ( 1 ) Limitations of Use : Not recommended for the treatment of diabetic ketoacidosis (DKA) ( 1 ) Not recommended in patients who smoke or who have recently stopped smoking ( 1 ) Limitations of Use: AFREZZA is not recommended for the treatment of diabetic ketoacidosis (DKA) [see Warnings and Precautions ( 5.6 )] . The safety and effectiveness of AFREZZA in patients who smoke have not been established. The use of AFREZZA is not recommended in patients who smoke or who have recently stopped smoking [see Warnings and Precautions ( 5.5 )]., dated June 27, 2014.