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The effect of short term intensive treatment with continuous subcutaneous Benaglutide injection combined continuous subcutaneous insulin injection on newly diagnosed type 2 diabetes mellitus

The effect of Benaglutide pump combined insulin pump short term intensive treatment on newly diagnosed type 2 diabetes mellitus

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015914
Enrollment
Unknown
Registered
2018-04-28
Start date
2018-05-03
Completion date
Unknown
Last updated
2018-04-30

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

Conditions

Type 2 Diabetes

Interventions

Sponsors

Nanjing First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Volunteer to participate and sign the subject's informed consent; 2) Aged 18 to 60 years; 3) Patients with type 2 diabetes,according to the WHO 1999 diagnostic criteria; 4) BMI 18 to 40 kg/m2; 5) Fasting blood glucose = 16.0 mmolL, postprandial(or random) blood glucose = 22.2 mmol/L, HbA1c = 8.5 %; 6) There are no acute complications of diabetes such as diabetic ketoacidosis, diabetic hypertonic syndrome, etc.; 7) Subjects are able and willing to perform continuous glucose monitoring, insulin intensive treatment, and dietary exercise patterns.

Exclusion criteria

Exclusion criteria: 1) Type 1 diabetes, adult late autoimmune diabetes(LADA), secondary diabetes, gestational diabetes, stress hyperglycemia; 2) has received other research drugs three months prior to taking part in this study; 3) The liver and renal function are damaged, and the ALT is 2.5 times greater than the upper limit of the normal value; Serum creatinine is 1.3 times greater than the upper limit of normal values; 4) History of drug abuse and alcohol dependence in the past five years; 5) The main hypoglycemic events that occur repeatedly, as determined by the researchers; 6) History of hormone therapy for three consecutive days or more during the first three months of the group and current use of systemic hormone therapy; 7) Heart disease: decompensatory heart failure(NYHA III and VI), unstable angina, heart attack within 12 months; 8) Allergies to experimental drugs or related products are known(insulin allergy, GLP-1), and patients with local hardening are prone to insulin injection sites; 9) Pregnancy, lactation or intentional pregnancy, or judged not to be using sufficient contraceptive measures(sufficient contraceptive measures refer to intrauterine devices, oral contraceptives and obstructive measures); 10) Patients with poor compliance, inability to cooperate with intensive treatment, and irregular dietary movements; 11) Any other obvious condition or combination of diseases determined by the researcher: endocrine, heart, nerves, tumors, autoimmune disorders, other pancreatic diseases, a history of mental illness and patients who can not perform insulin pump.

Design outcomes

Primary

MeasureTime frame
Oral glucose tolerance test;function of islet a cell;

Countries

China

Contacts

Public ContactJianhua Ma

Nanjing First Hospital

majianhua196503@126.com+86 18951670116

Outcome results

None listed

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