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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

The Effects of Metformin on Glycemic Control and Insulin Sensitivity in Adolescents With T1DM: A Randomized, Cross-over, Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02765347
• Other study ID #: 2016-T1DM
• Status: Completed
• Phase: Phase 4
• First received: February 14, 2016
• Last updated: April 10, 2018
• Start date: June 2016
• Est. completion date: January 2018

Study information

• Verified date: October 2017
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Insulin Resistance

Intervention

Drug:
• 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.
• Insulin
For arm 2, just accept insulin for 24 weeks

Locations

Country	Name	City	State
China	The Third Affliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		half one year