Type 2 diabetes
Conditions
Interventions
Gliclazide
starting with 20 mg/day or half of equivalent dose of which sulfonylurea a subject took previously (using the preset table showing equivalence among different sulfonylureas), being stepped up to 40-&g
60->
80->
120 mg/day when HbA1c(JDS) is >
=6.5% and does not improve more than 0.3% every 4 weeks until it achieves <
6.5% twice or it remains >
=6.5% twice in spite of using 120 mg/day of gliclazide
among subjects not achieving HbA1c(JDS)<
6.5%, after assessment of the primary outcomes, gliclazide 120 mg/day is switched to glimepiride 4 mg/day and secondary outcomes (B) are assessed 8 weeks later.
Glimepiride
starting with 0.5 mg/day or half of equivalent dose of which sulfonylurea a subject took previously (using the preset table showing equivalence among different sulfonylureas), being stepped up to 1-&g
2->
3->
4 mg/day when HbA1c(JDS) is >
=6.5% twice in spite of using 4 mg/day of glimepiride
6.5%, after assessment of the primary outcomes, glimepiride 4 mg/day is switched to gliclazide 120 mg/day and secondary outcomes (B) are assessed 8 weeks later.
Sponsors
Hokuriku Incretin-based Therapy Study Group (HINT Study Group)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Outpatients of type 2 diabetes satisfying the following criteria A) or B); A) Participants of the clinical study "Switching from sulfonylurea to sitagliptin among type 2 diabetic patients in combination with metformin or pioglitazone" (UMIN000003584), not achieving HbA1c(JDS)<6.5% after 12 weeks of the sitagliptin therapy, whose written informed consent is obtainable. B) New subjects satisfying all the following criteria; 1) receiving sitagliptin monotherapy (50 or 100 mg/day) or combination therapies of sitagliptin + metoformin (500 &#8211; 1,000 mg/day) or sitagliptin + pioglitazone (15 &#8211; 45 mg/day) for more than 12 weeks 2) with the baseline HbA1c(JDS)>=6.5% and <=9.0%, and without improvement more than 0.3% of HbA1c for 4 weeks immediately before the starting 3) having preproliferative or less advanced retinopathy, and early stage of overt proteinuria (< 1.0 g/day) or less advanced nephropathy 4) whose written informed consent is obtainable
Exclusion criteria
Exclusion criteria: Patients satisfying any of the following criteria; 1) receiving or having received any combination therapies of sitagliptin + sulfonylureas 2) having more than moderate renal dysfunction (sCr > 1.5 mg/dl in men, > 1.3 mg/dl in women) 3) having severe liver dysfunction 4) having malignancy 5) being pregnant, or breast-feeding 6) having any of contraindications for gliclazide and glimepiride 7) having any of contraindications for sitagliptin 8) suspected as pheochromocytoma, or having allergic history against glucagon
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratios of subjects achieving HbA1c(JDS)<6.5% at the "primary outcome assessment point", and numbers of hypoglycemic episodes (major and minor) from the starting point to the "primary outcome assessment point". | — |
Secondary
| Measure | Time frame |
|---|---|
| (A) Changes from the starting point to the "primary outcome assessment point" of the following items; fasting plasma glucose, body weight, fasting insulin, glucagon test CPR (0 and 6 min), fasting GLP-1, fasting GIP, and power spectrum obtained with Fourier analysis of RR-intervals of ECG. (B) Among subjects not achieving HbA1c(JDS)<6.5%, the following items 8 weeks after switching sulfonylureas; changes of HbA1c, numbers of hypoglycemic episodes (major and minor) during the 8-weeks, fasting plasma glucose, body weight, fasting insulin, glucagon test CPR (0 and 6 min), fasting GLP-1, fasting GIP, and power spectrum obtained with Fourier analysis of RR-intervals of ECG. | — |
Countries
Japan
Contacts
Public ContactAtsushi NAKAGAWA
Kanazawa Medical University Hospital Department of Endocrinology and Metabolism
Outcome results
None listed