Dietary impacts on glucose-lowering effects of sitagliptin in type 2 diabetes; a randomized, prospective, open-label clinical study

Dietary impacts on glucose-lowering effects of sitagliptin in type 2 diabetes; a randomized, prospective, open-label clinical study - Dietary impacts on glucose-lowering effects of sitagliptin in type 2 diabetes (DIET)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000034866

Enrollment

Registered

2019-01-04

Start date

2015-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin: Januvia 50 mg a day for 16 weeks Glimepiride: Amaryl 0.5 mg a day for 16 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Japanese T2DM patient 2.OAD naive or receive 4-week wash out of one OAD (glinides, alpha-GI, metformin) before randomization 3. HbA1c 6.0-8.0 % 4. BMI 18 - 30 kg/m2 5. Age 20 - 75 years 8. CrCl 60mL/min or above

Exclusion criteria

Exclusion criteria: 1.Patients on DPP-4 inhibitors or glimepiride 2.Patients treated with pioglitazone within the last 8 weeks 3.Patients with moderate/severe renal impairments (CrCl < 60mL/min) 4. Patients with insulin or GLP-1 receptor agonists 5. Patients with a history ofcerebrovascular disorder or cardiovascular disturbance Patients with heart failure (NYHA I-IV) 6. Patients with severe hepatic dysfunction 7. Patients with a history of pancreatitis 8. Patients with diabetic retinopathy 9. Patients with a history of gastrointestinal surgery 10. Patients with a history of malignancy within the last 5 yrs 11. Patients with severe infection, severe injury or before/after operation 12. Patients with excessive drinking habit 13. Male Hb < 13.0 g/dl, Female Hb < 12.5 g/dl 14. Patients with a difficulty to follow instructions by investigators 15. Patients participating in any other clinical study 16. Pregnancy 17. Patients judged ineligible by investigators

Design outcomes

Primary

Measure	Time frame
Correlation of plasma levels of EPA and DHA with changes in HbA1c levels from baseline to week 16 in each treatment group with sitagliptin and glimepiride	—

Secondary

Measure	Time frame
Correlation of estimated fish intake with changes in HbA1c levels from baseline to week 16 in each treatment group with sitagliptin and glimepiride. Identification of blood metabolite correlating with changes in HbA1c levels from baseline to week 16 in each treatment group with sitagliptin and glimepiride.	—

Countries

Japan

Contacts

Public ContactDaisuke Yabe

Kansai Electric Power Hospital Center for Diabetes, Endocrinology and Metabolism

ydaisuke-kyoto@umin.ac.jp06-6458-5821

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026