NCT04148183 - 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)

Davidson MB
Is treatment of insulin resistance beneficial independent of glycemia? Diabetes Care. 2003 Nov;26(11):3184-6. Review.
Derosa G, D'Angelo A, Ragonesi PD, Ciccarelli L, Piccinni MN, Pricolo F, Salvadeo SA, Montagna L, Gravina A, Ferrari I, Paniga S, Cicero AF
Metabolic effects of pioglitazone and rosiglitazone in patients with diabetes and metabolic syndrome treated with metformin. Intern Med J. 2007 Feb;37(2):79-86.
Gulias-Herrero A, Aguilar-Salinas CA, Gómez-Pérez FJ, Rull JA
The combination metformin/glyburide exerts its hypoglycemic effect mainly by increasing insulin secretion: a controlled, randomized, double-blind, crossover study. Diabetes Nutr Metab. 2003 Oct-Dec;16(5-6):268-76.
Lehtovirta M, Forsén B, Gullström M, Häggblom M, Eriksson JG, Taskinen MR, Groop L
Metabolic effects of metformin in patients with impaired glucose tolerance. Diabet Med. 2001 Jul;18(7):578-83.
Mohiyiddeen L, Watson AJ, Apostolopoulos NV, Berry R, Alexandraki KI, Jude EB
Effects of low-dose metformin and rosiglitazone on biochemical, clinical, metabolic and biophysical outcomes in polycystic ovary syndrome. J Obstet Gynaecol. 2013 Feb;33(2):165-70. doi: 10.3109/01443615.2012.745839.
Seufert J, Lübben G, Dietrich K, Bates PC
A comparison of the effects of thiazolidinediones and metformin on metabolic control in patients with type 2 diabetes mellitus. Clin Ther. 2004 Jun;26(6):805-18. Review.

Randomized Clinical Trial, Effect of Metformin and Rosiglitazone Over Glucose Homeoastasis in no Diabetic With Metabolic Syndrome Patients.

Clinical trial NCT04148183 - References