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Comparative evaluation of clinical markers indicating hypoglycaemia treated with ImeglimiN and its eFfect on erythrocytes IN patIents with TYpe 2 diabetes (INFINITY study)

Comparative evaluation of clinical markers indicating hypoglycaemia treated with ImeglimiN and its eFfect on erythrocytes IN patIents with TYpe 2 diabetes (INFINITY study)

Osonoi Takeshi

Naka Kinen Clinic

745-5, Nakadai, Naka, Ibaraki

t-osonoi@kensei-kai.com

Katoh Makoto

Naka Kinen Clinic

745-5, Nakadai, Naka, Ibaraki

+81-29-353-2800

m-katou@kensei-kai.com

Recruiting

Dec. 05, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Patients who meet all of the following criteria are included in this study;
1) patients with type 2 diabetes mellitus who are treated only with diet therapy and exercise therapy, alpha-glucosidase inhibitor combined with diet therapy and exercise therapy, metformin combined with diet therapy and exercise therapy, or both alpha-glucosidase inhibitor and metformin combined with diet therapy and exercise therapy
2) Male who are aged of 20 years or older, or postmenopausal female
3) patients whose HbA1c is more than 6.5% and 8.5% or less at giving their consent
4) patients who did not change the dose or usage of anti-diabetic agents within 4 weeks before giving their consent
5) patients who provide their consent to participate in this study in a written form by themselves after full explanation of this study

Patients who fall into any of the following criteria at the consent date are excluded from participating in the study;
1) patients who use any anti-diabetic agents other than alpha-glucosidase inhibitor and metformin
2) patients with anemia (male < 13 g/dL, female < 12g/dL)
3) patients with hypoalbuminemia (< 30.mg/dL)
4) patients with thyroid dysfunction
5) patients with hepatic cirrhosis
6) patients with nephrotic syndrome or mild or severe renal dysfunction (eGFR < 45mL/min/1.73m2)
7) patients who are treated with antiplatelet agents or antithrombotic agents
8) patients who are diagnosed as malignant tumor
9) patients who need regal representatives
10) patients who have history of hypersensitivity against content of imeglimin
11) patients who are contraindicated to imeglimin
12) patients with other conditions that the investigator thinks inappropriate for the study

Both

Type 2 diabetes mellitus

The study subjects start to intake imeglimin 500mg, 2 tablets per time, twice daily, orally, within 1 week after the tests of baseline, and continue to intake it for 6 months. They are observed till 3 months after the end of imeglimin intake. Also, continuous glucose monitoring is conducted from 2 months before imeglimin administration to 3 months after the end of imeglimin intake.

Type 2 diabetes mellitus

imeglimin

D003924

C575881

Change of hemoglobin concentration from baseline to month 6 of imeglimin administration

The following items 1 to 4 will be compared between baseline (month 0) and each time point in the preobservation, observation, and follow-up periods, and between 6 months after imeglimin administration and each time point in the follow-up period, as well as change from baseline to the preobservation and observation periods.
1. Red blood cell longevity
2. Red blood cell deformability
3. Red blood cell count, white blood cell count, hemoglobin concentration, Ht
4. Red blood cell constant count (MCV, MCHC, MCH)

Items 5 and 6 will be compared between baseline and each time point of the preobservation and observation periods.
5. Measurements, change, and percent change in HbA1c, GA, and 1,5-AG (percent changes will also be compared between each item at each time point)
6. GA/HbA1c ratio and 1,5-AG/HbA1c ratio

Items 7 and 8 will be measured by flush glucose monitoring system, and compared between baseline and each time point during the observation period (up to 3 months after the end of imeglimin administration).
7. Change in mean daily glucose level and percent change in blood glucose (baseline is the day before imeglimin administration)
8. Measurements and present changes in 14-day mean glucose, estimated HbA1c, and glycemic control index (GMI) (baseline is 14 days prior to imeglimin administration).
Estimated HbA1c (%) = (mean glucose [mmol/L] + 2.59) / 1.59
GMI (%) = 3.31 + 0.02392 x (mean glucose [mg/dL])

9. Comparison of measured HbA1c and estimated HbA1c values at each observation point in preobservation and observation periods

+81-49-276-1662

Nov. 21, 2022

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