Patients with a diagnosis of type 2 diabetes mellitus for at least 6 months prior to enrolling the study type 2 diabetes mellitus, metformin, postprandial glucose
Conditions
Interventions
Metformin is taken at an individual stable dose 30-60 minutes before a meal,Metformin is taken at an individual stable dose immediately after a meal
Experimental Drug,Active Comparator Drug
Metformin pre-meal,Metformin post-meal
Sponsors
Faculty of Medicine, Ramathibodi Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Metformin monotherapy with immediate-release metformin (stable dose for at least 3 months prior to enrolling to the study) or drug-naive 2. HbA1c between 6.5 and 8.0% 3. Age more than18 and less or equal than 65 years 4. eGFR more than 60 ml/min/1.73 m2
Exclusion criteria
Exclusion criteria: 1. Uncontrolled hyperglycemia with a glucose level more than 250 mg/dl after an overnight fast during the run-in 2. Metformin monotherapy with a extended-release formula 3. Gastrointestinal adverse effects induced by metformin 4. Pregnancy or planned pregnancy 5. Presumed limited decision-making capacity (e.g., dementia, encephalopathy, active psychiatric disorders) 6. Blood dyscrasias or any disorders causing hemolysis or unstable red blood cell (e.g., thalassemia, hemolytic anemia) 7. Cirrhosis or cholestatic liver disease 8. Serum albumin level less than 3.0 g/dL 9. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years 10. Planned cardiac surgery or angioplasty within 3 months 11. Currently undergoing systemic corticosteroid therapy, a change in the dosage of thyroid hormones within 6 weeks prior to enrolling to the study, or any other uncontrolled endocrine disorder 12. Currently using hydroxyurea 13. Consume vitamin C equal or more than 500 mg/day 14. Alcohol or drug abuse within the 3 months prior to enrolling to the study 15. Bariatric surgery and other gastrointestinal surgeries that induce chronic malabsorption 16. Unable or unwilling to use continuous glucose monitoring
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postprandial glucose responses 4 weeks after end of the each intervention Plasma glucose level (Hexokinase method, Abbott Alinity C) | — |
Secondary
| Measure | Time frame |
|---|---|
| The difference in postprandial insulin responses 4 weeks after end of the each intervention Plasma insulin level,The difference in continuous glucose monitoring profiles After end of the both interventions continuous glucose monitoring profile | — |
Countries
Thailand
Contacts
Public ContactIssaree Rattarasarn
Faculty of Medicine, Ramathibodi Hospital
Outcome results
None listed