I004 vs NovoLog for Fast-Acting Insulin Comparison
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two fast-acting insulin treatments, I004 and NovoLog, to determine if they function similarly in the body. It aims to understand how these treatments move through and affect individuals without diabetes. The trial seeks participants who are non-smokers, have normal blood sugar levels, and no history of diabetes or major health issues. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Earlier studies have shown that NovoLog is safe and well-tolerated, as it is already approved for use in the United States. This approval indicates it has undergone thorough testing to ensure safety.
I004, however, is currently being tested to determine if it functions and behaves in the body like NovoLog. Some early safety data for I004 suggests it might cause minor breathing irritation, such as coughing or sneezing. More research is necessary to fully understand its safety profile.
This trial includes Phase 2 and 3 stages, indicating that I004 has already passed some initial safety tests. Researchers continue to study it carefully to ensure it is safe for a broader population.12345Why are researchers excited about this trial's treatments?
Researchers are excited about I004 because it offers a potentially faster-acting option for insulin therapy in managing diabetes. Unlike current standard treatments like NovoLog, I004 is being explored for its unique formulation, which might provide more rapid absorption and onset of action. This could mean more precise blood sugar control for patients, which is crucial in preventing complications associated with diabetes. If successful, I004 could offer a new, more effective tool for patients needing fast and reliable insulin management.
What evidence suggests that this trial's treatments could be effective for fast-acting insulin comparison?
This trial will compare I004 with NovoLog for fast-acting insulin. Research has shown that fast-acting insulin aspart, such as I004, can reduce the risk of low blood sugar in people with Type 1 diabetes. One study found that patients who switched to faster aspart experienced a noticeable decrease in low blood sugar episodes, with strong evidence supporting its effectiveness. NovoLog, another quick-acting insulin tested in this trial, is also known for managing blood sugar levels after meals. Both treatments act quickly to control blood sugar, aiding people with diabetes in maintaining better overall glucose levels.678910
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single-dose subcutaneous administration of either the biosimilar I004 or NovoLog in a crossover design
Follow-up
Participants are monitored for pharmacokinetic and pharmacodynamic responses through blood sampling and euglycemic clamp procedure
Post-study follow-up
Participants may be contacted for additional safety monitoring or data collection
What Are the Treatments Tested in This Trial?
Interventions
- I004
- NovoLog
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants who were dosed with I004
Participants who were dosed with NovoLog
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amphastar Pharmaceuticals, Inc.
Lead Sponsor
Citations
Comparison of the effectiveness of fast-acting insulin aspart ...
Patients with T1D who switched to faster aspart experienced a significant reduction in rate of hypoglycaemia (p=0.0021). Treatment persistency ...
Comparative Effectiveness of Rapid-Acting Insulins in ...
CONCLUSIONS: This study provides a comprehensive assessment of outcomes and costs between 2 commonly used rapid-acting insulin products. Overall, there was ...
Outcomes of “Real-World” Insulin Strategies in the ... - PMC
Initial therapy with BB was associated with more hypoglycemic (2.40; CI, 2.04 to 2.82) (P < .001) and fewer euglycemic days (0.90; CI, 0.85 to 0.97) (P = .003) ...
Efficacy and safety comparison of rapid-acting insulin aspart ...
This well-conducted review found that rapid-acting insulin aspart resulted in moderately better metabolic control and treatment satisfaction than regular ( ...
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diatribe.org
diatribe.org/diabetes-medications/future-rapid-acting-insulin-treatments-diabetes-careThe Future of Rapid-Acting Insulin Treatments in Diabetes ...
This early phase 1 trial with 76 participants demonstrates that AT-278 may improve post-meal glucose management significantly. “Despite the ...
NCT05539872 | Comparison of the Pharmacokinetics (PK) ...
The purpose of this study is to establish pharmacokinetic (PK) and pharmacodynamics (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.
022472Orig1s000 - accessdata.fda.gov
FDKP undergoes acid-induced intermolecular self-assembly in aqueous solution resulting in adsorption of insulin onto the Technosphere particles to form ...
Efficacy and safety of ipragliflozin as add‐on therapy to insulin ...
To examine the efficacy and safety of add‐on ipragliflozin in Japanese patients with type 2 diabetes in the early stage of insulin therapy.
MATERIAL SAFETY DATA SHEET
Additional Hazard Information: Short Term: Antidiabetic drug: has blood-sugar lowering properties. May cause respiratory tract irritation.
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accessdata.fda.gov
accessdata.fda.gov/drugsatfda_docs/nda/2021/761201Orig1s000MultidisciplineR.pdf761201Orig1s000 - accessdata.fda.gov
The studies collected a limited amount of safety data during their conduct, but the safety data collected were not necessary to the ...
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