NCT03103854 - 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)

Armstrong MJ, Sigal RJ, Arena R, Hauer TL, Austford LD, Aggarwal S, Stone JA, Martin BJ
Cardiac rehabilitation completion is associated with reduced mortality in patients with diabetes and coronary artery disease. Diabetologia. 2015 Apr;58(4):691-8. doi: 10.1007/s00125-015-3491-1. Epub 2015 Jan 26.
Francois ME, Little JP
Effectiveness and safety of high-intensity interval training in patients with type 2 diabetes. Diabetes Spectr. 2015 Jan;28(1):39-44. doi: 10.2337/diaspect.28.1.39.
Gaede P, Lund-Andersen H, Parving HH, Pedersen O
Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med. 2008 Feb 7;358(6):580-91. doi: 10.1056/NEJMoa0706245.
Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group
Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403.
Thakkar J, Kurup R, Laba TL, Santo K, Thiagalingam A, Rodgers A, Woodward M, Redfern J, Chow CK
Mobile Telephone Text Messaging for Medication Adherence in Chronic Disease: A Meta-analysis. JAMA Intern Med. 2016 Mar;176(3):340-9. doi: 10.1001/jamainternmed.2015.7667. Review.

The Impact of Novel Strategies to Improve Cardiometabolic Status and Adherence to Exercise Regimens in Patients at High Risk for Cardiovascular Disease

Details for clinical trial NCT03103854

Clinical trial NCT03103854 - References