type 1 diabetes
Conditions
Interventions
Group A:insulin+metformin
Group B:insulin+placebo
Sponsors
Department of Endocrinology & Metabolism, The Third Affiliated Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
10 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1) type 1 diabetes diagnosed by an endocrinologist; 2) be treated with multiple insulin injections (except for premix insulin) or insulin pump for at least 3 months, with stable dose for at least 1 month; 3) HbA1c=7.5%; 4)total daily insulin dose =0.6U/kg/day; 5) Aged 10 to 18 years old; 6) without using antidiabetic agents other than insulin in the past three months.
Exclusion criteria
Exclusion criteria: 1. once or more than 1 times diabetic ketoacidosis happened in the past three months; 2. once or more than 1 times severe hypoglycemic events happened in the past three months; 3. liver function damage (aspertate aminotransferase 2.5 times higher than normal upper limit); 4. moderate to severe renal insufficiency (eGFR < 45 ml/min / 1.73 m2 calculated by MDRD); 5. in the clinical significance of cardiovascular disease, including myocardial infarction, arrhythmia, the ECG chart heart block (Type I second-degree AV block and above), unstable angina or decompensated heart failure (NYHA Graded III ~ IV); 6. women with sexual life and don't want to use contraception;during pregnancy and lactation; 7. using hypoglycemic drugs except insulin within 6 months or planned to use for 6 months thereafter; 8. used or using diet pills within 6 months of the previous 6 months; 9. Using or planning to use drugs that affect weight or blood sugar, such as stimulants, psychotropic substances, oral or inhaled corticosteroids; 10. according to the researcher's judgement, the subjects have any condition or disease that may affect the subjects to complete the whole Research or participate in all aspects of the trial; 11. have taken any other research drugs or participated in other clinical studies in the past 3 months; 12. Anemia or vitamin B12 deficiency in the past two years; 13. Uncontrolled celiac disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Countries
China
Contacts
Public ContactBin Yao
Department of Endocrinology & Metabolism The Third Affiliated Hospital, Sun Yat-Sen University
Outcome results
None listed