Patients with type 2 diabetes mellitus who meet the following selection criteria, but not violate any of the exclusion criterion at Week 0 However, in case where an examination result about a test level of e-GFR of exclusion criteria 7) is unavailable on the prescribed day at Week 0, the most current examination result from 0 weeks to within the past 12 weeks can be adopted. In addition, in case where examination results on the prescribed day at Week 0 are obtained at a later day, and the resul
Conditions
Interventions
SGLT2 inhibitor (dapagliflozin) and high protein formula diet
SGLT2 inhibitor (dapagliflozin) and high fat formula diet
Sponsors
Nonprofit Organization Hokkaido Health-Science Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients whose age is <=0 years but >75 years old at the time obtaining consent 2) Patients whose HbA1c is <=7.0% but >=8.5% 3) Patients whose BMI is <=22 kg/m2 4) Patients whose eGFR is <=45 mL/min/1.73 m2 or higher 5) Patients from whom informed consent in writing is obtained voluntarily after enough understanding after having received sufficient explanation on participating of this study
Exclusion criteria
Exclusion criteria: 1) Type 1 diabetic patients 2) Patients who use SGTL2 inhibitor in the past 3) Patients with hypersensitivity to the ingredient(s) of said drug 4) Patients suffering from severe ketosis, diabetic coma, or precoma 5) Patients treated with insulin 6) Patients who are judged to be inadequate to participate in this study by a doctor in charge 7) Patients with eGFR <45 ml/min/1.73 m2 8) Patients having a plan of pregnancy 9) Pregnant women, patients who might be pregnant, and lactating women 10) Patients with severe infections, patients before or after operations or having serious external injuries 11) Patients with allergy to said food ingredients (soy bean, egg, yeast,milk)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The variation of HbA1c from starting time of the therapy to 24 weeks after starting the therapy in between two groups Summary statistics of the change of HbA1c is calculated, and the variation from starting time of the therapy to 24 weeks after starting the therapy are compared between the two groups by the two sample t-test. | — |
Secondary
| Measure | Time frame |
|---|---|
| The variation/variation rates of the following items from starting time of the therapy to 4, 8, 12, and 24 weeks after starting the therapy in between two groups (*:at the starting time of the therapy, 12 and 24 weeks after starting the therapy,:**at 24 weeks after starting the therapy) Summary statistics of the following items are calculated at each measurement time point, and the variation and variation rates from starting time of the therapy to 4, 8, 12, and 24 weeks after starting the therapy are compared between the two groups by the two sample t-test. In addition, an intra-group comparison is performed for the variation from starting time of the therapy to 24 weeks after starting by the one sample t-test. The relation between variation of HbA1c and variation of other measurement contents from starting time of the therapy to 24 weeks after starting the therapy is to be evaluated by using Pearsons product moment correlation coefficient or Spearmans rank correlation coefficient. (1) Body weight, BMI (2) Blood pressure, heart rate (3) Abdominal circumference (4) Fasting blood sugar, HOMA-beta**, HOMA-R**(measurement of insulin to calculate HOMA-beta** and HOMA-R) (5) Serum lipid level(total cholesterol, HDL-cholesterol, triglyceride, LDL-cholesterol) (6) ketone body fraction(venous blood)** (7) Items related to lipid:pre-heparin LPL protein**, lipoprotein fraction precision measurement**, remnant-like lipoprotein cholesterol**, apoproteins (Apo A1, A2, B, C2, C3, E)** (8) High sensitivity CRP** (9) Urinary albumin quantitation** (10) ABI test/CAVI test(Only centers which can conduct these tests will measure these items.)* (11) InBody (Only centers which can conduct this test will measure these items.)* | — |
Countries
Japan
Contacts
Public ContactNaohide Noumi
IBEC Co.,Ltd. CEO office
Outcome results
None listed