Study of Efficacy, Weight Control, and Safety in Newly-diagnosed Type 2 Diabetes With Different Antidiabetic Therapy

• Status: Unknown status
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Zhujiang Hospital
• Collaborators: Dongguan Kanghua Hospital; First People's Hospital, Shunde China; Peking University Shenzhen Hospital; Shenzhen Sixth People's Hospital; The Fifth Affiliated Hospital of Zunyi Medical College; the Fifth Affiliated Hospital of Zunyi Medical University; The First Affiliated Hospital of Guangdong Pharmaceutical University; The Sixth Affiliated Hospital of Guangzhou Medical University; Third Affiliated Hospital, Sun Yat-Sen University
• Treatments: Dapagliflozin; Hypoglycemic Agents; Insulin; Insulin Aspart; Insulin, Globin Zinc; Metformin; Saxagliptin

Criteria

Inclusion Criteria:

1. The newly-diagnosed type 2 diabetes mellitus according to the 1999 WHO guideline on diagnosing type 2 diabetes mellitus; 9%≤HbA1c≤12%;

2. Age: 18-65 years old, Men or women;

3. Voluntarily taking the triple combination therapy using metformin, saxagliptin plus dapagliflozin or premixed insulin therapy, without taking any other hypoglycemic therapy before;

4. 18.5kg/m2≦BMI≦32 kg/m2;

5. 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:

1. Type 1 diabetes mellitus, or islet dysfunction (fasting C-peptide <0.1nmol/L (0.3ng/ml), peak value <0.17nmol/L (0.5ng/ml))

2. Patients with acute complication：ketoacidosis / hyperglycemic hyperosmolar status / lactic acidosis.

3. Patients with proliferative diabetic retinopathy.

4. Patients with severe infection or urinary tract infection.

5. 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).

6. Patients with the following nephrotic history or kidney disease-related characteristics：

1. history of unstable or acute kidney disease;

2. Patients with moderate / severe renal injury or end-stage renal disease (eGFR <60 mL / min / 1.73 m2)

3. urinary albumin: creatinine ratio> 1800 mg / g;

4. the serum (Cr) ≥133 μmol / L (≥1.50 mg / dL) in male subjects; the serum Cr≥124μmol / L (> 1.40 mg / dL) in female subjects;

5. congenital renal glucosuria;

7. Poor control of Severe hypertension, SBP ≥ 160 mmHg and / or DBP ≥ 100 mmHg; SBP <96 mmHg;

8. Patients with myocardial infarction / unstable angina / severe arrhythmia / heart failure in the past 3 months;

9. Hb≤110g/L in female subjects and Hb≤120g/L in male subjects;

10. Pregnant women or women who are planning to be pregnant during the study, women who are currently in lactation, or who having not adopted highly effective, medical-approved birth control methods.

11. Gastrointestinal diseases or surgical history, including Roemheld syndrome, severe hernia, intestinal obstruction, intestinal ulcers, gastrointestinal anastomosis, bowel resection, weight loss surgery or banding surgery;

12. Taking any drugs that affect blood sugar or body weight, history of alcohol or drug abuse over the past 6 months;

13. Patients who have received organ transplants or who have been definitely diagnosed as immunodeficiency syndrome with immune disfunction;

14. With a history of hypersensitivity or contraindication to metformin, saxagliptin, dapagliflozin or other drugs to be used in the researched.

15. Patients that might not follow this program, or with severe physical/mental illness that may affect the effectiveness or safety, based on the judgement of investigator.