Skip to content

A randomized controlled trial for intensive treatment with empagliflozin in the efficacy and safety of patients with type 2 diabetes

A randomized controlled trial for intensive treatment with empagliflozin in the efficacy and safety of patients with type 2 diabetes

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022412
Enrollment
Unknown
Registered
2019-04-10
Start date
2019-05-01
Completion date
Unknown
Last updated
2019-04-15

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

Conditions

Type 2 diabetes

Interventions

test group :intensive treatment group+empagliflozin
control group:intensive treatment group

Sponsors

The Second Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Aged 18 to 70 years, gender is not limited; ? 18 kg/m2=BMI=35 kg/m2; ? Patients diagnosed with type 2 diabetes according to WHO criteria (1999); ? At screening, newly diagnosed patients with glycosylated hemoglobin (HbA1c) > 9% or fasting blood glucose (FBG) = 11.1 mmol / L;Or HbA1c >7% after oral administration; ? Patients volunteered to participate in the trial and signed informed consent; ? Patients are able to communicate well with the investigator and comply with the entire trial requirements.

Exclusion criteria

Exclusion criteria: The patient has developed diabetic ketoacidosis, non-ketotic hyperosmolar coma, severe infection (especially urinary tract infection), acute cardiovascular and cerebrovascular accident, severe liver and kidney dysfunction in the past 6 months and other diseases that researchers disagree to enroll.

Design outcomes

Primary

MeasureTime frame
1,5 anhydroglucitol;Glycosylated serum albumin;Venous fasting blood glucose;

Secondary

MeasureTime frame
Maximum blood sugar fluctuation;Average blood sugar;Standard deviation of blood glucose levels;Average blood glucose fluctuation;Average absolute difference in blood glucose during the day;Xieqing huóxìng yang 5/5000 Serum reactive oxygen species;Malondialdehyde;Superoxide dismutase;Hypersensitive C-reactive protein;Tumor necrosis factor-a;IL-6;

Countries

China

Contacts

Public ContactLihui Zhang

The Second Hospital of Hebei Medical University

zhanglihui10510@163.com+86 15803210962

Outcome results

None listed

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