NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051220028

Registered date:25/05/2022

Investigation of the mechanism of action of imeglimin using the glucose clamp test

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedType 2 diabetes mellitus
Date of first enrollment25/05/2022
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Oral administration of Imeglimin (1000 mg twice a day) or metformin (250 mg twice a day for the first 4 weeks, increasing to 500 mg twice a day after 4 weeks) for 16 weeks

Outcome(s)

Primary OutcomeArea under the curve of insulin concentration in the hyperglycemic clamp between 0 and 10 minutes after 16 weeks of study drug administration (incremental AUCIRI0-10)
Secondary Outcome<Efficacy endpoints> 1)Change in HbA1c from baseline to 16 weeks after drug administration 2)Changes in various glucose metabolism indices ( Insulinogenic index, HOMA-beta, AUCIRI/AUCPG, HOMA-R, composite index, oral disposition index, and proinsulin/insulin) from baseline to 12 weeks after drug administration 3)Glucose infusion rate (GIR) and insulin sensitivity index (ISI) after 16 weeks of drug administration 4)Disposition index (insulinogenic index at 12 weeks - ISI at 16 weeks) after drug administration 5)Disposition index (iAUCIRI0-10 - ISI) after 16 weeks of drug administration 6)Hepatic insulin sensitivity after 16 weeks of drug administration: hepatic glucose uptake / oral glucose tolerance 7)Insulin sensitivity of the liver after 16 weeks drug administration:glucose uptake in the liver/oral glucose tolerance (iAUCIRI) 8)Absolute values and changes in lipid profiles (TG, HDL-C, LDL-C, FFA) from baseline to 16 weeks after drug administration 9)Absolute value and change in adiponectin from baseline to 16 weeks after drug administration 10)Absolute values and changes in body weight, body fat mass, body fat percentage, and muscle mass from baseline to 16 weeks after drug administration 11)Oxidative/non-oxidative glucose disposal and metabolic flexibility measured by indirect calorimetry after 16 weeks of study drug administration 12)Glucose effectiveness (model analysis using time series data of 75g OGTT and glucose clamp) <Safety evaluation items> 1)Frequency and rate of adverse events <Exploratory endpoints> 1)Changes in the composition and function of the intestinal microbiota from baseline to 12 weeks after drug administration 2)Changes in metabolites in feces and plasma (metabolomic analysis) from baseline to 12 weeks afte r drug administration 3)Change in Bristol stool scale from baseline to 12 weeks after drug administration

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 75age old
GenderBoth
Include criteria(1)Patients between 20 and 75 years old (2)Patients diagnosed with type 2 diabetes mellitus (3)BMI of the patients more than 18.5 kg/m2 (4)Patients who have been taking only diet and ex ercise therapy or only dipeptidyl peptidase 4 (DPP 4) inhibitors without changing the dosage and ad ministration for the treatment of diabetes for at least 8 weeks prior to obtaining consent (5)Patients whose HbA1c is less than 9.5 % at the time of eligibility test (6)Patients who have given their free and written consent to participate in this clinical research
Exclude criteria(1)Patients using insulin, GLP-1RA, or oral hypoglycemic agents other than DPP4 inhibitors (2)Patients with severe hepatic dysfunction (AST/ALT greater than 4 times the upper limit of normal) (3)Patients with renal dysfunction (eGFR less than 45 mL/min/1.73m2) (4)Patients who have undergone gastrectomy (not including endoscopic mucosal resection) (5)Patients with proliferative diabetic retinopathy ( except for patients with obsolete proliferative diabetic retinopathy that does not require treatment) (6)Patients with severe diabetic neuropathy (patients whose symptoms are so severe that they seriously interfere with daily life and require assistance) (7)Patients with a cardiac function classification of grade 3 or 4 according to NYHA at an evaluation within the last year (8)Patients who drink excessively and habitually (9)Patients with a history of lactic acidosis (10)Patients with a history of severe ketosis, diabetic coma, or precoma (11)Patients who have undergone major surgery within one month (12)Patients with severe infection or serious trauma (13)Patients with malignant tumors under treatment or within 5 years of completion of treatment (14)Pregnant women, lactating women, and patients who may be or are planning to become pregnant (15)Patients who have used antibiotics or antiparasitic drugs within one month prior to eligibility confirmation (16)Patients who have taken PPI (proton pump inhibitor), steroids, or immunosuppressive drugs within one month prior to eligibility confirmation (17)Patients with lower gastrointestinal diseases ( Crohn's disease, ulcerative colitis, short bowel syndrome, celiac disease, etc.) (18)Patients who are participating in clinical research involving other interventions (19)Patients who are judged by the principal investigator or sub-investigator to be inappropriate for this clinical research

Related Information

Contact

Public contact
Name Tomoko Yamada
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo. Hyogo Japan 650-0017
Telephone +81-78-382-5861
E-mail yamada@med.kobe-u.ac.jp
Affiliation Kobe University Hospital
Scientific contact
Name Kazuhiko Sakaguchi
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo. Hyogo Japan 650-0017
Telephone +81-78-382-5861
E-mail kzhkskgc@med.kobe-u.ac.jp
Affiliation Kobe University Hospital