NCT02312063 - 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)

Iwasaki M, Hoshian F, Tsuji T, Hirose N, Matsumoto T, Kitatani N, Sugawara K, Usui R, Kuwata H, Sugizaki K, Kitamoto Y, Fujiwara S, Watanabe K, Hyo T, Kurose T, Seino Y, Yabe D
Predicting efficacy of dipeptidyl peptidase-4 inhibitors in patients with type 2 diabetes: Association of glycated hemoglobin reduction with serum eicosapentaenoic acid and docosahexaenoic acid levels. J Diabetes Investig. 2012 Oct 18;3(5):464-7. doi: 10.1111/j.2040-1124.2012.00214.x.
Kim YG, Hahn S, Oh TJ, Kwak SH, Park KS, Cho YM
Differences in the glucose-lowering efficacy of dipeptidyl peptidase-4 inhibitors between Asians and non-Asians: a systematic review and meta-analysis. Diabetologia. 2013 Apr;56(4):696-708. doi: 10.1007/s00125-012-2827-3. Epub 2013 Jan 24. Review.
Park H, Park C, Kim Y, Rascati KL
Efficacy and safety of dipeptidyl peptidase-4 inhibitors in type 2 diabetes: meta-analysis. Ann Pharmacother. 2012 Nov;46(11):1453-69. doi: 10.1345/aph.1R041. Epub 2012 Nov 7.
Senmaru T, Fukui M, Kobayashi K, Iwase H, Inada S, Okada H, Asano M, Yamazaki M, Hasegawa G, Nakamura N, Iwasaki M, Yabe D, Kurose T, Seino Y
Dipeptidyl-peptidase IV inhibitor is effective in patients with type 2 diabetes with high serum eicosapentaenoic acid concentrations. J Diabetes Investig. 2012 Dec 20;3(6):498-502. doi: 10.1111/j.2040-1124.2012.00220.x.

Dietary Impacts on Glucose-lowering Effects of Sitagliptin in Type 2 Diabetes: a Multicenter, Randomized, Prospective, Open-label, Clinical Trial

Clinical trial NCT02312063 - References