The effect of one-week sequential treatment of dapagliflozin combined with long acting insulin after one-week intensive insulin therapy

The effect of one-week sequential treatment of dapagliflozin combined with long acting insulin after one-week intensive insulin therapy, a perspective one-centre, single arm, open clinical trial

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900021490

Enrollment

Unknown

Registered

2019-02-23

Start date

2019-07-01

Completion date

Unknown

Last updated

2019-02-25

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

Conditions

Type 2 diabetes

Interventions

Case Series:Phase I: Intensive insulin pump therapy

Phase II: Dapagliflozin combined with long acting insulin

Eligibility

Sex/Gender

All

Age

25 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Uncontrolled type 2 diabetes with 2 or more than 2 oral antihyperglycemic agents for 3 months or more; 2. HbA1c more than 9%; 3. BMI 22-35 kg/m2; 4. Aged 25 to 75 years; 5. Agree to use real-time continuous glucose monitoring and insulin pump for diabetes control during current clinical trial; 6. Agree to participate and cooperate with current clinical trial; 7. No fertility requirement and agree with contraception during follow-up.

Exclusion criteria

Exclusion criteria: 1. Newly diagnosed type 2 diabetes; 2. Having acute diabetes complications, including DKA, HHS, lactic acidosis; 3. Having severe microvascular complications, including proliferative diabetic retinopathy, diabetic renopathy eGFR less than 60 ml/min/1.73m2; 4. Uncontrolled painful diabetic neuropathy and significant diabetic autonomic neuropathy; 5. Having recent macrovascular complications within 3 months, including ACS, stroke, PAD with intravascular intervention or amputation; 6. Having diabetic foot; 7. Complicated with other servere infection diseases or urinary infection or perineal soft tissue infections; 8. complicated with abnormal liver function, ALT or AST more than 3 times of upper limit of normal range, or total bilirubin more than 1.5 times of upper limit of normal range; 9. Taking other glucose affected medication within 3 months, like corticosteroids, immunosuppressor, growth hormone, estrogen and progesterone, large dose of diuretics, antipsychotics and so on; 10. Having chemotherapy or radiotherapy or surgery for malignant tumor within 3 months; Having background of pancreatitis or pancreatic cancer; 11. Uncontrolled endocrine gland dysfunction; 12. Mental disorders or communication disorders; 13. Pregnant or breastfeeding women; 14. Subjects are unable to inject insulin due to blurred vision.

Design outcomes

Primary

Measure	Time frame
Fasting blood glucose;Postprandial blood glucose;	—

Secondary

Measure	Time frame
anthropometric measurements;blood pressure;blood glucose fluctuations;	—

Countries

China

Contacts

Public ContactRenyuan Li

The Third Affiliated Hospital of Guangzhou Medical University

hi_ivyli@163.com+86 18926146852

Outcome results

None listed

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