Phase 4 Completed N=48 Randomized Treatment

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

Source: ClinicalTrials.gov NCT02312063 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcomePrimary: Correlation of Plasma Levels of EPA and DHA With HbA1c Reduction — -0.414; 0.067; -0.319; 0.093 pearson's correlation coefficient

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Correlation of Plasma Levels of EPA and DHA With HbA1c Reduction	-0.414; 0.067; -0.319; 0.093	—
SECONDARY Correlation of Estimated Seafood Intake With HbA1c Reduction	-0.042; 0.215	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02312063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.