drugset / Trial / NCT02312063
Dietary Impacts on Glucose-lowering Effects of Sitagliptin in Type 2 Diabetes
RandomizedParallel-groupOpen-labelTreatment
Summary
In a prospective, randomized case-controlled study, the investigators hope to demonstrate a positive correlation of plasma levels of EPA and DHA as well as fish intake with the HbA1c-lowering effect of sitagliptin but not with the active comparator glimepiride.
Timeline
- Start
- 2015-02
- Primary completion
- 2016-05
- Completion
- 2016-05
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Glimepiride | Small molecule | 0.5 mg | Oral |
| Subject | Sitagliptin | Small molecule | 50 mg | Oral |