Efficacy of trelagliptin for glucose fluctuation, oxidative stress and inflammation in patients with type 2 diabetes mellitus.

Efficacy of trelagliptin for glucose fluctuation, oxidative stress and inflammation in patients with type 2 diabetes mellitus. - Efficacy of trelagliptin for glucose fluctuation, oxidative stress and inflammation in patients with type 2 diabetes mellitus.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018334

Enrollment

Registered

2015-07-17

Start date

2015-07-21

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

Patients with type 2 diabetes

Interventions

Oral trelagliptin administration (100 mg) once a week after breakfast

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Outpatients 2) Inadequate glucose control even after dietary and exercise therapies for more than 8 weeks 3) 6.5% more than fasting HbA1c under 10% 4) Fasting blood glucose levels greater than 110mg/dl and under 250mg/dl 5) Patients who themselves can voluntarily provide consent to participate in this study, and can also follow the study protocol

Exclusion criteria

Exclusion criteria: 1) Type 1 diabetes 2) Had ketosis or coma within 6 month 3) Secondary diabetes 4) Patients receiving insulin or GLP-1 analogue therapy 5) Poor-controlled diabetes (HbA1c>10.0 % or fasting blood glucose levels>250mg/dl) 6) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 7) Either level of aspartate aminotransaminase or alanine aminotransferase exceed three-fold of the normal limits 8) Renal insufficiency: serum creatinine>1.5 or Ccr<50ml/min 9) Malignancies or other diseases with poor prognosis 10) Pregnant 11) Subjects whose doctor in charge do not agree to join the trial

Design outcomes

Primary

Measure	Time frame
CGMS measurements (mean 24-h blood glucose level, fasting plasma glucose level, postprandial glucose level at 2 h after a meal, AUC, AOC, SD, MAGE)	—

Secondary

Measure	Time frame
IL-6, IL-18, 8-OHdG, MDA-LDL, Hemoglobin A1C levels, BMI	—

Countries

Japan

Contacts

Public ContactSatoshi Ida

Ise Red Cross Hospital Department of Metabolic Diseases

bboy98762006@yahoo.co.jp0596-28-2171

Outcome results

None listed

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