The Effects of Metformin on Glycemic Control and Insulin Sensitivity in Adolescents With T1DM

NCT ID: NCT02765347

Last Updated: 2018-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-01-31

Brief Summary

The investigators intends to carry out a randomized, cross-over, prospective study which will last 48 weeks in youth with T1DM followed up by the center. The purpose is to observe the effects of metformin on glycemic control and insulin sensitivity in adolescents with T1DM based on insulin therapy by using 72h CGMS and hyperinsulinemic euglycemic clamps.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metformin and Insulin

MDI or CSII plus metformin (initially starting dosage with 0.5g qd, then gradually increasing to 0.5g bid or tid) for 24 weeks

Group Type: OTHER

Metformin

Intervention Type: DRUG

For arm 1, accept MDI or CSII plus metformin (initially starting dosage with 0.5g qd, then gradually increasing to 0.5g tid) for 24 weeks.

Insulin

Accept insulin for 24 weeks

Group Type: OTHER

Insulin

Intervention Type: DRUG

For arm 2, just accept insulin for 24 weeks

Interventions

Metformin

For arm 1, accept MDI or CSII plus metformin (initially starting dosage with 0.5g qd, then gradually increasing to 0.5g tid) for 24 weeks.

Intervention Type: DRUG

Insulin

For arm 2, just accept insulin for 24 weeks

Intervention Type: DRUG

Other Intervention Names

Glucophage; CSII or MDI

Eligibility Criteria

Inclusion Criteria

1. Type 1 diabetes mellitus;

2. Age≥12 yr;

3. Tanner sexual maturation rating 2-5;

4. HbA1c levels: 7.5%-10%;

5. MDI or CSII ≥6 months;

6. Insulin dose ≥ 0.8U/kg before the enrollment，and the dosage is stable at least >1 month（dosage change<10%）.

Exclusion Criteria

1. Serious acute and chronic complications associated with diabetes;

2. Repeated and serious hypoglycemia episodes repeatedly;

3. Hepatic function damage (ALT≥2.5 times higher than the upper limit of the normal accepted range);

4. Moderate to advanced renal impairment (calculated according to MDRD equation: eGFR<60ml/min/1.73m2);

5. Clinically significant heart attacks: myocardial infarction, arrhythmia，II-III°AVB，unstable angina，decompensated HF（NYHA III~IV;

6. Female patients who have a sex life and are not willing to use contraceptive methods;

7. Pregnancy.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Wen Xu

Associated Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wen Xu

Role: PRINCIPAL_INVESTIGATOR

Associated professor

Locations

The Third Affliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2016-T1DM

Identifier Type: -

Identifier Source: org_study_id