NCT02298803 - 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)

Chugh SS, Reinier K, Singh T, Uy-Evanado A, Socoteanu C, Peters D, Mariani R, Gunson K, Jui J
Determinants of prolonged QT interval and their contribution to sudden death risk in coronary artery disease: the Oregon Sudden Unexpected Death Study. Circulation. 2009 Feb 10;119(5):663-70. doi: 10.1161/CIRCULATIONAHA.108.797035. Epub 2009 Jan 26.
Cleveland JC Jr, Meldrum DR, Cain BS, Banerjee A, Harken AH
Oral sulfonylurea hypoglycemic agents prevent ischemic preconditioning in human myocardium. Two paradoxes revisited. Circulation. 1997 Jul 1;96(1):29-32.
Maia FF, Araújo LR
Efficacy of continuous glucose monitoring system (CGMS) to detect postprandial hyperglycemia and unrecognized hypoglycemia in type 1 diabetic patients. Diabetes Res Clin Pract. 2007 Jan;75(1):30-4. Epub 2006 Jun 27.
Piccirillo G, Rossi P, Magrì D
The QT variability index: a multidimensional approach to understanding cardiovascular disease. Cardiology. 2011;118(1):42-4. doi: 10.1159/000324476. Epub 2011 Mar 11.
UK Hypoglycaemia Study Group
Risk of hypoglycaemia in types 1 and 2 diabetes: effects of treatment modalities and their duration. Diabetologia. 2007 Jun;50(6):1140-7. Epub 2007 Apr 6.

QT Interval Abnormalities in Sulfonylurea Treated Type 2 Diabetes: Relationship to Treatment Induced Hypoglycaemia and Glycaemic Variability Determined by Simultaneous Ambulatory Monitoring

Details for clinical trial NCT02298803

Clinical trial NCT02298803 - References