Study of Efficacy, Weight Control, and Safety in Newly-diagnosed Type 2 Diabetes With Different A… (NCT03700801) | Clinical Trial Compass
CompletedPhase 4
Study of Efficacy, Weight Control, and Safety in Newly-diagnosed Type 2 Diabetes With Different Antidiabetic Therapy
China130 participantsStarted 2018-10-01
Plain-language summary
Study Hypothesis：Compared with premixed insulin, triple oral combination therapy has similar hypoglycemic effect, better weight control and lower incidence of hypoglycemia.
Main objective: Comparing whether the hypoglycemic efficacy of the triple oral combination therapy is not inferior than that of the premixed insulin in the treatment of newly-diagnosed type 2 diabetes.
Secondary objective: Comparing the effects on body weight and the risk of inducing hypoglycemia between triple oral combination therapy and premixed insulin, and exploring the effects of these two therapies on weight control and safety.
Primary Study Endpoint: The absolute change in baseline of HAb1c after 12 weeks.
Secondary Study Endpoint: fasting blood glucose, 2-hour postprandial blood glucose, fasting C-peptide, 2-hour postprandial C-peptide, body weight, proportion of patients with hypoglycemia, etc.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. The newly-diagnosed type 2 diabetes mellitus according to the 1999 WHO guideline on diagnosing type 2 diabetes mellitus; 9%≤HbA1c≤12%;
✓. Age: 18-65 years old, Men or women;
✓. Voluntarily taking the triple combination therapy using metformin, saxagliptin plus dapagliflozin or premixed insulin therapy, without taking any other hypoglycemic therapy before;
✓. 18.5kg/m2≦BMI≦32 kg/m2;
✓. Voluntarily participating in our study and insisting on monitoring blood glucose at least one day a week, finishing re-examination after three month with the informed consent signed.
Exclusion criteria
✕. Type 1 diabetes mellitus, or islet dysfunction (fasting C-peptide \<0.1nmol/L (0.3ng/ml), peak value \<0.17nmol/L (0.5ng/ml))
✕. Patients with acute complication：ketoacidosis / hyperglycemic hyperosmolar status / lactic acidosis.
✕. Patients with proliferative diabetic retinopathy.
. Patients with severe infection or urinary tract infection.
✕. Patients with clinically significant hepatobiliary disorders, including but not limited to chronic active hepatitis and / or severe liver dysfunction. ALT or AST\> 3 times the normal upper limit (ULN) or serum total bilirubin (TB)\> 34.2 μmol / L (\> 2 mg / dL).
✕. Patients with the following nephrotic history or kidney disease-related characteristics：
✕. history of unstable or acute kidney disease;
✕. Patients with moderate / severe renal injury or end-stage renal disease (eGFR \<60 mL / min / 1.73 m2)