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Durable effect of imeglimin on the glycemic control in patients with type 2 diabetes mellitus: a multicenter, open-label, randomized, controlled trial (DIGNITY Trial)

Durable effect of imeglimin on the glycemic control in patients with type 2 diabetes mellitus: a multicenter, open-label, randomized, controlled trial (DIGNITY Trial)

Bouuchi Ryoutarou

Research Institute National Center for Global Health and Medicine

1-21-1 Toyama, Shinjuku-ku, Tokyo

rybouchi@hosp.ncgm.go.jp

Bouuchi Ryoutarou

Center Hospital of the National Center for Global Health and Medicine

1-21-1 Toyama, Shinjuku-ku, Tokyo

+81-3-3202-7181

rybouchi@hosp.ncgm.go.jp

Not Recruiting

Feb. 22, 2022

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1) Patients diagnosed with type 2 diabetes mellitus who are 20 years of age or older at the time of obtaining consent
2) Patients being treated with diet and exercise therapy only at the time of eligibility test
However, if the patient is taking one oral hypoglycemic drug at the time of obtaining consent, the patient must be able to wash out the oral hypoglycemic drug for at least 12 weeks before the start of study treatment.
3) Patients whose HbA1c level is between 6.5% and 9.0% as measured at the time of the eligibility test.
4) Patients who have given written consent to participate in this study.

When consent is obtained
1)Patients with type 1 diabetes mellitus
2)Patients who have been given more than 2 oral hypoglycemic drugs within 12 weeks
3)Patients who have received GLP-1 RA (short-term use of insulin for trauma or educational admission) within 1 year or less
4) Patients with proliferative retinopathy (except for patients with stable treated proliferative retinopathy)
5) Patients with severe diabetic neuropathy (patients with severe symptoms and significant support for daily life)
6) Patients with a contraindication to Imeglimin, Metformin, or Vildagliptin
7) Patients with severe obesity (BMI 35 kg/m2 or more)
8) Patients with NYHA (New York Heart Association) cardiac function classification of Grade III or IV within 1 year of evaluation
9) Excessive regular drinkers
10)Patients with a previous history of lactic acidosis
11)Patients with severe cachexia, diabetic coma or precoma
12)Patients with severe infections, surgical patients and those with serious injuries
13)Patients who are pregnant, who are planning to be pregnant, or who are breastfeeding
14)Patients who are undergoing treatment for malignancy or those with a history of treatment for malignancy within 5 years
15)Patients who are participating in a clinical study with other interventions
16) Patients to whom a responsible physician/investigator judged inappropriate for participating in the study
In case of eligibility testing
17) Patients with an estimated glomerular filtration rate(eGFR) of 45 mL/min/1.73 m2 or less including those undergoing dialysis
18) Patients with severe hepatic disorders (Child-Pugh classification Grade C)

Both

Type 2 diabetes mellitus

Study subjects randomly assigned to each of the three groups will receive the study drug for a maximum of 156 weeks and undergo blood sampling and other diabetes mellitus-related tests.

The period from the start of treatment with the study drug to the second consecutive HbA1c level of 7.0% or higher at the clinical examination after 16 weeks of treatment (If the study treatment is discontinued due to lack of efficacy, adverse events or use of prohibited concomitant drugs, the period will be considered as the period up to that time even if it is less than 16 weeks after the start of treatment).

1) The period from the start of treatment with the study drug until the addition of the combination drug for the treatment of type 2 diabetes mellitus after 16 weeks of treatment
2) The period between the achievement of the primary endpoint and the addition of the combination drug for the treatment of type 2 diabetes mellitus.
3) Change in HbA1c and fasting glucose levels (Measured and change from baseline)
4) Maximum change in decrease in HbA1c level
5) Rate of achievement of HbA1c levels below 7.0%.
6) Number of times HbA1c level below 7.0% was achieved
7) Subgroup analysis

+81-3-3202-7181

Dec. 15, 2021

No

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