A study Comparising three intensification therapies for Type 2 Diabetes Mellitus

A Comparison of Premixed Insulin (three times per day), three pre-meal insulin and Basal-Bolus Insulinand insulin pump Intensification Therapies for Newly Diagnosed Type 2 Diabetes Mellitus and Type 2 Diabetes Mellitus With Inadequate Glycaemic Control treated with Oral Drugs

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-11001218

Enrollment

Unknown

Registered

2011-02-13

Start date

2010-05-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

type 2 daibetes

Interventions

1:insulin pump

2:Third-daily Premixed Insulin

3:three pre-meal insulin and Basal-Bolus Insulin

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Present with type 2 diabetes mellitus; 2. 18 years old=<age=<70 years old; 3. 19kg/m2=<BMI=<35kg/m2; 4. Newly diagnosed diabetes mellitus who have been treated by diet management and athletic therapy for more than 1 months; 5. Uncontrolled blood glycemia (FBS: 7-16mmol/L, PBS<22.2mmol/L) after oral antidiabetes drugs treatment (1 secretagogue agent and another oral antidiabetes drug, with the daily dosage of the secretagogue agent more than 50% of its maximum ); 6. With no acute complications of diabetes, such as ketoacidosis and diabetic hyperosmolar syndrome; 7. Sign the informed consent forms.

Exclusion criteria

Exclusion criteria: 1. Take any other drugs within the last 3 months prior to entry into the study; 2. liver or kidney dysfunction: ALT>=2.5 times of the upper limit and serum creatinine>=the upper limit; 3. History of drug abuse or alcohol dependency within 5 years; 4. Have had more than one episode of severe hypoglycaemia within 24 weeks prior to entry into the study; 5. Being treated with glucocorticoids; 6. Encountered the cardiovascular events such as the angina pectoris, myocardial infarction, severe ventricular arrhythmia, cerebral hemorrhage, cerebral infarction, heart failure ect. within the last 12 months; 7. Allergic history to insulin; 8. Pregnant women or women that intend to become pregnant during the course of the study, or sexually active women of childbearing potential not practicing birth control; 9. With poor compliance, and do not regularly consume three meals per day; 10. Comorbidity with other diseases, such as diseases of endocrine system, cardiovascular system, nerve system and tumor, or with other panreatic disorders and mental disorders; 11. With infection or stree within the last four weeks.

Design outcomes

Primary

Measure	Time frame
MAGE;	—

Secondary

Measure	Time frame
MODD;MBG;SDBG;	—

Countries

China

Contacts

Public ContactJianhua MA

majianhua@china.com+86 18951670116

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 5, 2026