Study of OmarigliptiN, Weekly DPP-4 inhibitor, to evaluate the effect on psychological Attitudes and Responses compared with Daily DPP-4 inhibitors in patients with type 2 diabetes mellitus

JRCT ID: jRCTs031200437

Registered date:23/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes mellitus
• Date of first enrollment: 02/04/2021
• Target sample size: 216
• Study type: Interventional

Intervention(s)

After obtaining their written consent, the study subjects are randomely assigned to the following two groups;
Group A:
Group B:

Outcome(s)

• Primary Outcome: Change of DTBQ score from baseline to week 12

Secondary Outcome

1.Change in the following items from baseline to week 12
- DTSQ score
- DTR-QOL score
- HbA1c
- general blood tests (lipid biomarkers (HDL-chol, T-chol, LDL-chol*, TG), hepatic biomarkers (T-Bil, AST, ALT, gamma-GTP), blood count (red blood cell count, hemoglobin, hematcrit, white blood cell count, platelet count),
uric acid, serum creatinine, eGRF*)
*calculated by formula
- blood pressure
- body weight
- medication adherence
2.Medication preference
3.Correlation between each item and each score of QOL questionnaire
4.Frequency of adverse event or the disease or the like

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following criteria are included in this study:
1.Patients with type 2 diabetes mellitus who use once daily or twice daily DPP-4 inhibitor.
2.Patients who do not change the anti-diabetic agents (dose, usage, or type) within 8 weeks before giving their consent.
3.Male or female aged 20 years or older at giving their consent.
4.Patients who provide their consent in a written form by themselves.

Exclude criteria

Patients who fall into any of the following criteria are excluded from participating in the study:
1.Patients who use any combination tablets with DPP-4 inhibitor.
2.Patients who have history of use of omarigliptin or trelagliptin.
3.Patients who use 10 or more pharmaceutical agents.
4.Patients whose HbA1c is 10% or higher at giving their consent.
5.Patients who have history of severe hypoglycemia within a year before giving their consent.
6.Patients with type 1 diabetes mellitus or secondary diabetes.
7.Patients who routinely use any infusions such as insulin or GLP-1 receptor agonist.
8.Patients with cognitive dysfunction or psychiatric disease.
9.Patients with alcoholism or drug addiction
10.Patients in the perioperative period, or with serious infection or injury.
11.Patients with atrial fibrillation or frequent premature ventricular contraction.
12.Patients with moderate-to-severe heart failure (class 3 or worse based on the New York Heart Association (NYHA) Functional Classification).
13.Patients with moderate-to-severe renal function (male: serum creatinine > 1.4 mg/dL, female: serum creatinine > 1.2 mg/dL).
14.Patients with ascitic fluid or severe hepatic function (AST >= 100 IU/L).
15.Patients with history of poorly-controlled hypertension or dyslipidemia within 12 weeks before giving their consent.
16.Patients with contraindicated condition to use the study agents.
17.Patients who are pregnant, breastfeeding, possibly pregnant, or planning to be pregnant.
18.Patients who need legal representative for giving consent.
19.Patients with other conditions that the responsible investigator or subinvestigators think inappropriate to participate in the study

Related Information

• Primary Sponsor: Akai Hiroaki
• Secondary Sponsor: Ishii Hitoshi,Japan Society for Patient Reported Outcome