Effect of insulin combined with acarbose or metformin on glycemic control in patients with type 1 diabetes: a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800019426

Enrollment

Unknown

Registered

2018-11-10

Start date

2018-11-20

Completion date

Unknown

Last updated

2018-11-19

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

Conditions

type 1 diabetes

Interventions

Group A:insulin+acarbose

Group B:insulin+metformin

Group C:insulin

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

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 =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

yaobin1910@126.com+86 13808885203

Outcome results

None listed

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