Dietary Impacts on Glucose-lowering Effects of Sitagliptin in Type 2 Diabetes

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kansai Electric Power Hospital
• Collaborator: Saiseikai Noe Hospital Osaka
• Treatments: Glimepiride; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• Japanese T2DM patients, who are OAD naïve or receive 4-week wash out of one OAD (glinides, alpha-GI, metformin) before randomization.

• HbA1c:6.0-8.0 %

• BMI:18-30 kg/m2

• Age:20-75 years old

• CrCl: > 60mL/min

Exclusion Criteria:

• Patients on DPP-4 inhibitors or glimepiride

• Patients treated with pioglitazone

• Patients with moderate/severe renal impairments

• Patients with insulin or GLP-1 receptor agonists