Type 2 diabetes
Conditions
Interventions
1) To take 250 to 2250 mg/day (twice or three times a day) of metformin hydrochloride for 52 weeks. Up to the same dose of glimepiride or gliclazide as in the screening period can be used additionall
Sponsors
Department of Diabetes and Metabolic Medicine, National Center for Global Health and Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus by the criteria of Japan Diabetes Society. 2. If female, not currently pregnant or not planning pregnancy during the study period. 3. Body mass index less than 30 kg/m2. 4. Diabetes is treated with any of the following therapies with three month prior to study enrollment: (1) medical nutrition therapy alone; (2) monotherapy with the same dose of glimepiride (=< 4mg per day); (3) monotherapy with the same dose of gliclazide (=< 80mg per day). 5. 7% =< HbA1c < 9%. 6. Stable HbA1c (difference between the HbA1c of the latest visit (21 days to three months before the screening visit) and that of the screening visit is less than or equal to 1.0% points). 7. Stable HbA1c (difference between the HbA1c of all the visits (within 20 days before the screening visit, if any) and that of the screening visit are less than or equal to 1.0% points) 8. Subject has given full written informed consent prior to the study.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation. 2. Previous adverse effects on either metformin or DPP-4 inhibitors. 3. a)GADA positivity, history of lactic acidosis, or severe complication derived from diabetes or other diseases, b)history of diabetic ketoacidosis, hyperglycemic hyperosmolar syndrome, or massive ketonuria within 6 months prior to screening visit. 4. Episode of severe infection, massive hemorrhage or donation of blood within 4 weeks prior to screening visit. 5. Administeration glucocorticoids or immunosuppressive medications. 6. Renal insufficiency (value of serum creatinine equal to or above 1.3mg/dL in man or equal to or above 1.2mg/dL in women or eGFR less than 40). 7. Abnormal liver function (value of AST and/or ALT more than the double of the normal upper limit) or liver cirrosis. 8.Presence of edema. 9.Heart failure. 10.Respiratory failure. 11.Alcohol abuse. 12.Hematological diseases including anemia (Hb value less than 11g/dL in men and less than 10g/dL in women). 13.Likely to be non-compliant, in the investigator's opinion, with respect to the protocol and related scheduled visits. 14.Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) The proportion of participants with HbA1c levels less than 7.0 % at the 52nd week with the Stage One treatment. 2) The proportion of participants with HbA1c levels less than 7.0 % at the 78th,104th,130th, and 156th week with the Stage One treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The proportion of participants with HbA1c levels less than 6.2 % at the 52nd week with the Stage One treatment. 2) The tolerance rate for preselected "therapeutic" dose of the drug for intervention. 3) Percent point change in the HbA1c levels form baseline to post-intervention (at the 4th, 8th, 12th, 24th, 36th, and 52nd week). 4) Values of and change in fasting plasma glucose, body weight, blood pressure, and serum cholesterol , HDL cholesterol, and triglyceride at the 0, 4th, 8th, 12th, 24th, 36th, and 52nd week. 5) Values of and change in serum 1,5-anhydroglucitol at the 0, 4th, 8th, 12th, 24th, and 52nd week. 6) Values of and change in serum glycoalbumin at the 0, 4th, 8th, 12th, 24th week. 7) The proinsulin:insulin ratio, HOMA2-IR, and HOMA2-B before and after 52 weeks after the beginning of the treatment. 8) Values of and change in urine albumin:creatinine ratio at 0, 12th, 24th, 36th, and 52nd week. 9)The proportion of participants who fullfilled the criteria of Stage One treatment, Stage Two treatment, and dropout. 10) The difference between the baseline characteristics and labolatory data of the participants whose HbA1c levels are and are not less than 7% at the 52nd week with the drug of intervention. 11)The proportion of participants with HbA1c levels less than 6.2 % at the 78th,104th,130th, and 156th week with the Stage One treatment. 12) Percent point change in the HbA1c levels from baseline to the 78th, 104th, 130th, and 156th week. 13) Values of and change in fasting plasma glucose level and body weight at the 0, 65th, 78th, 91st, 104th, 117th, 130th, and 156th week. 14)HOMA2-IR, and HOMA2-B at the 104th and 156th week. 15) The adherence of the drug of intervention. 16) The proportion of participants who deviated from the protocol. 17) Safety and adverse events. | — |
Countries
Japan
Contacts
Public ContactRitsuko Yamamoto-Honda
National Center for Global Health and Medicine Department of Diabetes and Metabolic Medicine
Outcome results
None listed