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

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Sun Yat-sen University

Status and phase

Completed
Phase 4

Conditions

Diabetes Mellitus, Type 1

Treatments

Drug: Insulin
Drug: Metformin

Study type

Interventional

Funder types

Other

Identifiers

NCT02765347
2016-T1DM

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Metformin and Insulin
Other group
Description:
MDI or CSII plus metformin (initially starting dosage with 0.5g qd, then gradually increasing to 0.5g bid or tid) for 24 weeks
Treatment:
Drug: Metformin
Insulin
Other group
Description:
Accept insulin for 24 weeks
Treatment:
Drug: Insulin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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