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Incidence of diabetes remission after a short-term intensive intervention with insulin, dapagliflozin, and metformin in patients with type 2 diabetes mellitus

Incidence of diabetes remission after a short-term intensive intervention with insulin, dapagliflozin, and metformin in patients with type 2 diabetes mellitus

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063310
Enrollment
Unknown
Registered
2022-09-04
Start date
2022-10-10
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Type 2 diabetes mellitus

Interventions

control group:Short-term intensive insulin therapy
trial group:Short-term intensive intervention with insulin, metformin, and dapagliflozin

Sponsors

The first People's Hospital of Xuzhou
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria are as follows: 1. consecutive diabetic patients who visited our hospital; 2. men and women aged 20 to 70 years; 3. patients with type 2 diabetes mellitus; 4. patients with a duration of type 2 diabetes mellitus of 5?years or less; 5. hemoglobin A1c = 1.1 µg/L; 7. body mass index >= 25 kg/m2; 8. women who had to be non-child bearing or willing to use birth control; 9. participant willing to perform regular capillary blood glucose monitoring; 10. able and willing to inject insulin; 11. able and willing to provide informed consent.

Exclusion criteria

Exclusion criteria: The exclusion criteria are as follows: 1. current use of insulin; 2. history of hypoglycemia unawareness; history of severe hypoglycemia requiring assistance within the last 5 years; 3. renal dysfunction as evidenced by estimation of the glomerular filtration rate = 2.5 times upper limit of normal at the time of enrollment; 6. history of pancreatitis; 7. cardiovascular disease including any of: systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 110 mmHg; peripheral vascular disease; left bundle branch block or second or third degree AV block; tachyarrhythmias or bradyarrhythmias with uncontrolled ventricular rate; stenotic valvular heart disease; cardiomyopathy; history of heart failure; h) history of aortic dissection; documented history of angina or coronary artery disease; history of stroke or transient ischemic attack; 8. history of any disease requiring continuous systemic glucocorticoid treatment; 9. history of any major illness with a life expectancy of 14 alcoholic drinks per week in men and > 7 alcoholic drinks per week in women); and (12) known hypersensitivity to insulin, metformin, or dapagliflozin.

Design outcomes

Primary

MeasureTime frame
Fasting C-peptide;Fasting Plasma Glucose;Glycosylated Hemoglobin;Hepatorenal Function;Blood Fat;Height;Weight;Incidence of diabetes remission;

Countries

China

Contacts

Public ContactHao Hu

The first People's Hospital of Xuzhou

18361811955@163.com+86 13685135953

Outcome results

None listed

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