NCT03489031 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Heinemann L, Heise T, Wahl LC, Trautmann ME, Ampudia J, Starke AA, Berger M
Prandial glycaemia after a carbohydrate-rich meal in type I diabetic patients: using the rapid acting insulin analogue [Lys(B28), Pro(B29)] human insulin. Diabet Med. 1996 Jul;13
Laubner K, Molz K, Kerner W, Karges W, Lang W, Dapp A, Schütt M, Best F, Seufert J, Holl RW
Daily insulin doses and injection frequencies of neutral protamine hagedorn (NPH) insulin, insulin detemir and insulin glargine in type 1 and type 2 diabetes: a m
Nosek L, Roggen K, Heinemann L, Gottschalk C, Kaiser M, Arnolds S, Heise T
Insulin aspart has a shorter duration of action than human insulin over a wide dose-range. Diabetes Obes Metab. 2013 Jan;15(1):77-83. doi: 10.1111/j.1463-1326.2012.01677.x. Epub 2

Basal Study - Observational Multicentric Clinical Study: Basal Insulin And Compensation Glycemic In Diabetic Patients In Basal Bolus Outpatient.

Clinical trial NCT03489031 - References