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. 2020 Jun 5;2020(6):CD012906. doi: 10.1002/14651858.CD012906.pub2

ChiCTR1800018825.

Methods Type of trial: safety and efficacy trial
Allocation: randomised
Intervention model: parallel assignment
Masking: —
Primary purpose: treatment
Participants Condition: T2DM
Enrollment: estimated 80 participants
Inclusion criteria: T2DM, drug‐naive, aged between 18 to 70 years old, HbA1c between 6.5% to 13%, with one of atherosclerotic cardiovascular disease (SBP ≥140 bmmHg or DBP ≥ 90 mmHg; older than 50 years old in male or 60 years old in female; LDL‐C≥ 2.6 mmol/L or TG ≥ 2.3 mmol/L or HDL‐C ≤ 0.88 mmol/L; BMI ≥ 28 kg/m2; urine microalbumin/creatinine > 30; ankle brachial pressure index (ABI) ≤0.9 in either side), there is a fixed residence for at least 5 years, in good ability of memory and activity, be in good mental health and self‐reliant, with an informed consent form.
Exclusion criteria: with positive diabetes antibody (insulin autoantibody, islet cell antibodies, or glutamic acid decarboxylase), or diagnosed type 1 diabetes, with severe diabetes complications, e.g. leg ulcers, severe liver and kidney damage, severe neurological diseases and severe retinopathy, blood pressure≥180/110 mmHg or total cholesterol ≥ 6.2 mmol/L, antibiotics used in the past 3 months for 3 days or more, pregnancy or planning to become pregnant, intemperance (drinking more than 5 times in one week and drinking more than 100 g spirit, 250 g rice wine or 5 bottles of beer), patients diagnosed with severe mental disease in 6 months, received drug therapy aim at the following diseases, e.g. cholecystitis, peptic ulcer, urinary tract infection, acute pyelonephritis, urocystitis or hyperthyreosis, had gastrointestinal surgery, except for appendicitis and hernia surgery, patients with severe liver diseases such as chronic, persistent hepatitis or cirrhosis, or HBsAg positive, or liver dysfunction (serum alanine transaminase and oxaloacetic transaminase 2.5 times than normal), patients with IBD or Cushing syndrome; patients with abnormal pituitary function; patients with severe diseases like cancer, cardiovascular disease, AMI, or stroke etc patients with infectious diseases such as tuberculosis and acquired immune deficiency syndrome etc, physical disability, or other causes of life can not be self‐care, can not be clearly recalled, answer the question of the person, anaemia: HbA1c less than 10 g/dL, physical disability or self‐care disability or disability of recalling clearly and answering questions caused by any other reasons, without enough time taking part in this project, participating in other research program
Interventions Intervention(s): metformin
Comparator(s): empagliflozin
Outcomes Primary outcome(s): HbA1c
Secondary outcome(s): weight, blood pressure, carotid ultrasound, cardiac ultrasound
Other outcome(s):
Study details Trial identifier:ChiCTR1800018825
Publication details Language of protocol: Chinese / English
Funding: non‐commercial (hospital)
Publication status: unclear if published
Stated aim of study Quote: "to estimate: (1) Clinical efficacy and safety of Empagliflozin in the treatment of patients with new‐onset type 2 diabetes and risk factor for atherosclerotic cardiovascular disease; (2) Mechanism of Empagliflozin in the treatment of patients with new‐onset type 2 diabetes and risk factor for atherosclerotic cardiovascular disease; (3) Provide a new treatment for patients with new‐onset type 2 diabetes and risk factor for atherosclerotic cardiovascular disease;(4) Provide new target and new perspective for individualized treatment of type 2 diabetes mellitus. "
Notes Only the protocol is available. Marked as a study awaiting classification due to a lack of data to assess inclusion. Trial authors have been contacted.