Type 2 diabetes
Conditions
Interventions
administration of imeglimin or metformin
Sponsors
Sugimoto Ken
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At the time of obtaining informed consent, patients who meet all of the following criteria will be included. 1)Patients who meet either a. or b. of the following criteria a. Grip strength: less than 34 kg for men and less than 20 kg for women b.Chair stand test: 12 seconds or more for 5 attempts 2)Patients with type 2 diabetes aged 65 years or older and HbA1c levels below 10% 3)Patients being treated for type 2 diabetes with any of the following 1. Patients on diet/exercise therapy only 2. Patients receiving DPP4 inhibitors, metformin (limited to a daily dose of 1000 mg or less for patients with eGFRcreat less than 45 (mL/min/1.73 m2) or 500 mg or less for patients with eGFRcreat less than 30 (mL/min/1.73 m2)), basal insulin as a treatment for type 2 diabetes (limited to 500 mg or less for 30 to 45 of eGFRcreat (mL/min/1.73 m2)), basal insulin, or two or three of these drugs as treatment for type 2 diabetes. However, DPP4 inhibitors and metformin must be administered at a fixed dosage for at least 8 weeks prior to obtaining consent. 4)Patients receiving basal insulin with HbA1c value of 7.0% or higher 5)Patients who have given written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from this study. 1)Have been diagnosed with dementia 2)Those with renal dysfunction (eGFRcreat less than 30 mL/min/1.73 m2) within the last 6 months or those undergoing dialysis (including peritoneal dialysis) 3)Severe liver dysfunction (3 times upper limit of normal of AST or ALT level at the medical institution) 4)Physically disabled 5)Currently receiving treatment for knee or hip joint problems or have had joint replacement surgery 6)Have had a cerebral infarction or myocardial infarction within the past 6 months 7)Have a pacemaker 8)Patients undergoing steroid treatment (excluding those undergoing treatment with inhaled steroids) 9)Contraindications for imeglimin and metformin apply 10)Using supplements that affect the NAD+ pathway 11)Other cases where the principal investigator or co-investigator is deemed inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the 5-step chair-stand test 24 weeks after starting oral administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Body composition (including SMI, body fat, and phase angle) Grip strength Five-times chair rise test (at 12 weeks) HbA1c Body weight BMI (Body Mass Index) Lower leg circumference Waist circumference SARC-F DASC-8 Walking speed (only at facilities where it can be measured) Visceral fat area (measured by abdominal CT scan, only at facilities where this is possible) Skeletal muscle ultrasound (only at facilities where it can be measured) Blood NAD+ concentration | — |
Contacts
Public ContactKen Sugimoto
KAWASAKI GERIATRIC MEDICAL CENTER
Outcome results
None listed