Type 2 Diabetes
Conditions
Interventions
Intervention:dapagliflozin plus intensive lifestyle intervention
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Men or women aged 20-70 years old who had a BMI =25 kg/m2. 2 Subjects had been diagnosed with type 2 diabetes within 6 years. 3 HbA1C =6.5% and =10.0% at screening without antidiabetic agents, or HbA1C <6.5% at screening on metformin treatment alone; 4 Able and willing to provide written informed consent and to comply with the study.
Exclusion criteria
Exclusion criteria: 1. Any of the following CV/Vascular Diseases within 3 months prior to signing the consent at enrolment, as assessed by the investigator: Myocardial infarction, Cardiac surgery or revascularization (CABG/PTCA), Unstable angina, Unstable heart failure (HF), HF New York Heart Association (NYHA) Class IV, Transient ischemic attack (TIA) or significant cerebrovascular disease, Unstable or previously undiagnosed arrhythmia. 2. Current use of any anti-diabetic treatment other than metformin. 3. Weight loss of more than 5kg within the past 6 months. 4. Women who are pregnant confirmed with positive pregnancy test, intending to become pregnant during the study period, currently lactating females, or women of child-bearing potential not using highly effective, medically approved birth control methods or precedures. 5. Diagnosis or history of acute metabolic diabetic complications such as ketoacidosis or hyperglycemic hyperosmolar state, or diabetes insipidus within 30 days. 6. Alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake. 7. Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial or participating in another trial (involving an investigational drug and /or follow-up). 8. Patients with clinically apparent hepatobiliary disease, including but not limited to chronic active hepatitis and/or severe hepatic insufficiency. ALT or AST > 3x upper limit of normal (ULN), or serum total bilirubin (TB) >34.2 µmol/L (>2 mg/dL). 9. Patients with severe renal impairment or end-stage renal disease (eGFR< 45 mL/min/1.73 m2). 10. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption. 11. Malignancy within 5 years of the enrollment visit or history of bladder cancer. 12. Known immunocompromised status, including but not limited to, individuals who had undergone organ transplantation or acquired immunodeficiency syndrome (AIDS). 13. History of bone fracture secondary to diagnosed severe osteoporosis. 14. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM. 15. Administration of sibutramine, phentermine, orlistat, rimonabant, benzphetamine, diethylpropion, methamphetamine, or phendimetrazine within 30 days of enrollment visit. 16. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia). 17. Administration of any other investigational drug within 30 days of planned enrollment to this study, or within 5 half-life periods of other investigational drugs. 18. Subject is, in the judgment of the Investigator, unlikely to comply with the protocol or has any severe concurrent medical or psychological condition that may affect the interpretation of efficacy or safety data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of remission of diabetes; | — |
Countries
China
Contacts
Public ContactXiaoying Li
Zhongshan Hospital, Fudan University
Outcome results
None listed