Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535789
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Inhaled Insulin vs Rapid-acting Injections for Post-meal Glucose Control in Women With Gestational Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Safety and Efficacy of Rapid Acting Inhaled Technosphere Insulin Afrezza Compared With Subcutaneous Insulin to Achieve Pregnancy-Specific Postprandial Targets Among Patients With Gestational Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INHALE-GDM
Brief Summary:
Pregnant women aged 18-49 with gestational diabetes GDM will take part in this study We want to see how two different insulin treatments affect their blood sugar after they eat These women usually use a rapid-acting insulin analog RAA thats injected to control their blood sugar before and after meals They will come to the clinic for two meal sessions For the first meal we will randomly decide if they will use the usual RAA insulin or a newer inhaled insulin called technosphere insulin TI They will use the other type of insulin for their second meal After each meal we will compare their blood sugar levels
Detailed Description:
Gestational diabetes mellitus GDM affects up to 25 of births globally and its rates continue to rise each year Pregnancy is a dynamic time marked by rapid changes in physiology anatomy and metabolism that support the growth and development of the fetus This period can also be vulnerable as expectant mothers may experience shifts in body perception food preferences and physical fitness which can lead to decreased self-esteem depression and anxiety A diagnosis of GDM often catches women by surprise and may bring feelings of guilt and anxiety about the potential effects on their babys health For pregnant individuals unable to meet specific glucose targets through diet and exercise alone insulin is recommended as the primary treatment However transitioning to insulin injections can provoke fear stress and discomfort-both emotionally and physically-for many patients Consequently some pregnant women opt for oral anti-diabetic medications like metformin or glyburide due to their apprehension about using insulin injections Both of these drugs pass through the placenta and raise safety concerns making them secondary choices according to the American Diabetes Association ADA and the American College of Obstetricians and Gynecologists ACOG
While GDM is typically managed with injectable insulin inhalable insulin offers a potential alternative Technosphere Insulin inhalation powder TI is an ultra-rapid-acting insulin administered via oral inhalation using a breath-powered inhaler It provides an alternative to injectable insulin for prandial glucose control It consists of recombinant human insulin adsorbed onto fumaryl diketopiperazine FDKP a proprietary excipient that at acidic pH self-assembles into particles and polysorbate 80 TI particles have a median diameter of approximately 2 to 25 μm a size appropriate for inhalation into the lung Following inhalation Afrezza particles dissolve immediately at the physiologic pH of the lung and insulin and FDKP are absorbed systemically After administration of TI in adults the maximum serum insulin concentration occurs in approximately 12 to 15 minutes versus 45 to 60 minutes for RAA via subcutaneous route and returns to near baseline levels in approximately 180 minutes versus about 5 hours for RAA
The United States Food and Drug Administration FDA approved TI Inhalation Powder and the Gen2 Inhaler a dry powder device as Afrezza to improve blood sugar control in adults aged 18 years and older with diabetes on June 27 2014 Inhaled TI has proven safe and effective in reducing postprandial after-meal hyperglycemia in individuals with Type 1 and Type 2 diabetes Its important to note that TI units are not equivalent to injectable insulin units TIs bioequivalent dose has been found to be about twice that of injectable rapid-acting insulin when prescribed for diabetes management
All insulins including TI have a similar label wording with respect to use in pregnancy indicating that studies have not shown an association of insulin and birth defects and that there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy Insulin whether subcutaneously administered or inhaled has not been demonstrated to cross the placenta secondary to its large molecular weight TIs inert excipient FDKP is not metabolized and is fully excreted from the body with the majority in urine and some in the feces ie for the amount swallowed Animal studies using subcutaneous administration of carrier particles at 21 times human dosing demonstrated no adverse fertility teratogenicity or other developmental outcomes described in Afrezza label
TIs optimal dosing efficacy and risk for hypoglycemia in pregnancy is unknown Outside of pregnancy TI has been shown to cause less hypoglycemia than RAA insulin The dose conversions of TI from RAA therapy have not been characterized in pregnancy to effectively administer across gestation with the dynamic metabolic changes although insulin resistance is high in the 3rd trimester and dosing is expected to be at least as high as in patients with T2D 2X SQ insulin dosing
The goal of this investigator-initiated randomized crossover trial is to assess the efficacy of TI in lowering PP glycemia and the frequency of hypoglycemia compared with subcutaneous RAA insulin among pregnant individuals with GDM
While GDM is typically managed with injectable insulin inhalable insulin offers a potential alternative Technosphere Insulin inhalation powder TI is an ultra-rapid-acting insulin administered via oral inhalation using a breath-powered inhaler It provides an alternative to injectable insulin for prandial glucose control It consists of recombinant human insulin adsorbed onto fumaryl diketopiperazine FDKP a proprietary excipient that at acidic pH self-assembles into particles and polysorbate 80 TI particles have a median diameter of approximately 2 to 25 μm a size appropriate for inhalation into the lung Following inhalation Afrezza particles dissolve immediately at the physiologic pH of the lung and insulin and FDKP are absorbed systemically After administration of TI in adults the maximum serum insulin concentration occurs in approximately 12 to 15 minutes versus 45 to 60 minutes for RAA via subcutaneous route and returns to near baseline levels in approximately 180 minutes versus about 5 hours for RAA
The United States Food and Drug Administration FDA approved TI Inhalation Powder and the Gen2 Inhaler a dry powder device as Afrezza to improve blood sugar control in adults aged 18 years and older with diabetes on June 27 2014 Inhaled TI has proven safe and effective in reducing postprandial after-meal hyperglycemia in individuals with Type 1 and Type 2 diabetes Its important to note that TI units are not equivalent to injectable insulin units TIs bioequivalent dose has been found to be about twice that of injectable rapid-acting insulin when prescribed for diabetes management
All insulins including TI have a similar label wording with respect to use in pregnancy indicating that studies have not shown an association of insulin and birth defects and that there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy Insulin whether subcutaneously administered or inhaled has not been demonstrated to cross the placenta secondary to its large molecular weight TIs inert excipient FDKP is not metabolized and is fully excreted from the body with the majority in urine and some in the feces ie for the amount swallowed Animal studies using subcutaneous administration of carrier particles at 21 times human dosing demonstrated no adverse fertility teratogenicity or other developmental outcomes described in Afrezza label
TIs optimal dosing efficacy and risk for hypoglycemia in pregnancy is unknown Outside of pregnancy TI has been shown to cause less hypoglycemia than RAA insulin The dose conversions of TI from RAA therapy have not been characterized in pregnancy to effectively administer across gestation with the dynamic metabolic changes although insulin resistance is high in the 3rd trimester and dosing is expected to be at least as high as in patients with T2D 2X SQ insulin dosing
The goal of this investigator-initiated randomized crossover trial is to assess the efficacy of TI in lowering PP glycemia and the frequency of hypoglycemia compared with subcutaneous RAA insulin among pregnant individuals with GDM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None