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Clinical assessment of dapagliflozin on cardiovascular risk factors in patients with type 2 diabetes mellitus: study protocol for a single-center, randomized, double-blind control trial

Clinical assessment of dapagliflozin on cardiovascular risk factors in patients with type 2 diabetes mellitus: study protocol for a single-center, randomized, double-blind control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058761
Enrollment
Unknown
Registered
2022-04-16
Start date
2022-04-29
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes

Interventions

Control group:conventional therapy

Sponsors

Taizhou First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures; 2. Type 2 diabetes mellitus; 3. Cardiovascular disease; 4. Uninterrupted anti-diabetic treatment for at least 8 weeks before enrolment.

Exclusion criteria

Exclusion criteria: 1. Patients with type 1 diabetes or diabetes insipidus; 2. Patients with 3 or more oral anti-hyperglycaemic drugs with or without insulin and/or poorly controlled diabetes; 3. Subjects who have history of unstable or rapidly progressing renal disease; 4. Subjects who have severe hepatic insufficiency and/or significant abnormal liver function; 5. Significant cardiovascular history.

Design outcomes

Primary

MeasureTime frame
Glycosylated Hemoglobin, Type A1C, HbA1c;Fasting blood glucose;Incidence of hypoglycemia;

Secondary

MeasureTime frame
Body weight;Low density lipoprotein cholesterol;High density lipoprotein cholesterol;Triglyceride;

Countries

China

Contacts

Public ContactZhu Shuang

Taizhou First People's Hospital

361299381@qq.com+86 15257616516

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026