NCT02325622 - 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)

Bando Y, Kanehara H, Toya D, Tanaka N, Kasayama S, Koga M
Association of serum glycated albumin to haemoglobin A1C ratio with hepatic function tests in patients with chronic liver disease. Ann Clin Biochem. 2009 Sep;46(Pt 5):368-72. doi: 10.1258/acb.2009.008231. Epub 2009 Aug 12.
Kilpatrick ES, Rigby AS, Atkin SL
Variability in the relationship between mean plasma glucose and HbA1c: implications for the assessment of glycemic control. Clin Chem. 2007 May;53(5):897-901. Epub 2007 Mar 23.
Koga M, Kasayama S, Kanehara H, Bando Y
CLD (chronic liver diseases)-HbA1C as a suitable indicator for estimation of mean plasma glucose in patients with chronic liver diseases. Diabetes Res Clin Pract. 2008 Aug;81(2):258-62. doi: 10.1016/j.diabres.2008.04.012. Epub 2008 Jun 2.
Lahousen T, Hegenbarth K, Ille R, Lipp RW, Krause R, Little RR, Schnedl WJ
Determination of glycated hemoglobin in patients with advanced liver disease. World J Gastroenterol. 2004 Aug 1;10(15):2284-6.
Rohlfing CL, Wiedmeyer HM, Little RR, England JD, Tennill A, Goldstein DE
Defining the relationship between plasma glucose and HbA(1c): analysis of glucose profiles and HbA(1c) in the Diabetes Control and Complications Trial. Diabetes Care. 2002 Feb;25(2):275-8.

Relationships Between Mean Plasma Glucose and HbA1c in Compensated and Decompensated Cirrhotic Patients With Hepatogenous Diabetes

Clinical trial NCT02325622 - References