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Insulin Comparison for Type 2 Diabetes (In-FI Trial)
In-FI Trial Summary
This trial will compare the effects of two different types of insulin on blood sugar levels in patients with type 2 diabetes.
- Type 2 Diabetes
In-FI Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.In-FI Trial Design
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Who is running the clinical trial?
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- You are taking aspirin or vitamin C while in the hospital.You have been diagnosed with gastroparesis or cirrhosis before.You have been diagnosed with type 2 diabetes for at least 6 months before the screening.Men and women who are admitted to a medical or surgical floor at Boston Medical Center.Your weight in relation to your height is within a certain range.Your blood sugar level is higher than 140 mg/dL during your hospital stay.You have been admitted to the hospital for diabetic ketoacidosis, hyperosmolar hyperglycemic state, solid organ transplantation, or coronary artery bypass surgery.You are between 21 and 80 years old.You are expected to not eat or drink anything for more than 24 hours.You are using tube feeding or IV nutrition.You are taking more than 1 unit of insulin per kilogram per day before the study.You have used an insulin pump in the 2 weeks before or during the study.You are currently using a continuous glucose monitoring system.You have had an allergic reaction to any type of insulin or the other ingredients in the insulin used in the study.You must take insulin glargine only at bedtime for the entire study. Taking it in the morning or afternoon will disqualify you.You have been diagnosed with type 1 diabetes or late-onset autoimmune diabetes (LADA).You are currently taking or planning to take glucocorticoid medications during your hospital stay.You have severe kidney disease with high levels of a substance called creatinine in your blood.You often feel very sick to your stomach or throw up, or you can't eat meals with enough carbohydrates.Before joining the study, you must be using insulin, at least two oral or injectable medications, or one oral or injectable medication with a high hemoglobin A1c level in the past three months.You will need to stay in the hospital for at least 48 hours after the CGM sensor is put in place.
- Group 1: Group 2 insulin glargine and Fiasp
- Group 2: Group 1 insulin glargine and Novolog
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are octogenarians welcome in this particular clinical trial?
"This particular clinical trial requires that all participants are between the ages of 21 and 80."
What is the government's stance on Insulin Fiasp?
"Insulin Fiasp is currently in Phase 3 trials, which means that while there is supporting data for its efficacy, multiple rounds of testing have confirmed its safety."
For what sort of ailment is Insulin Fiasp most commonly prescribed?
"Insulin Fiasp is commonly used to manage hyperglycemia, but can also be helpful in treating conditions like type 2 diabetes mellitus, gestational diabetes mellitus (GDM), and exercise-induced hypoglycemia."
Who meets the requirements to take part in this medical study?
"Eligible patients for this clinical study must be between the ages of 21 and 80, have type 2 diabetes mellitus, and meet other specified criteria. At present, the trial is looking to recruit 160 individuals."
How large is the sample group for this research?
"Indeed, the listing on clinicaltrials.gov appears to show that this study is still actively looking for participants. According to the information provided, recruitment started on December 7th 2020 and the most recent update was made on May 3rd 2022. They are hoping to have 160 patients total at 1 location."
Are there any other Insulin Fiasp clinical trials that have completed?
"Presently, 95 clinical trials are underway to study Insulin Fiasp. Out of those, 17 have reached Phase 3. Most investigations into this treatment are based in Sao Luis, MA; however, there are a total of 672 locations running these sorts of studies."
Are patients being actively recruited for this study?
"That is correct. The clinical trial, which was first posted on December 7th 2020, is still recruiting patients according to the information available on clinicaltrials.gov. They are looking for 160 more patients from 1 site."
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