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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: Metformin; Drug: Insulin

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • The Third Affliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	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.; Other Names: Glucophage
Other: Insulin; Accept insulin for 24 weeks	Drug: Insulin; For arm 2, just accept insulin for 24 weeks; Other Names: CSII or MDI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HbA1c	half one year

Collaborators and Investigators

• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Investigators: Principal Investigator: Wen Xu, Associated Professor

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: February 14, 2016
• First Submitted That Met QC Criteria: May 4, 2016
• First Posted (Estimate): May 6, 2016

Study Record Updates

• Last Update Posted (Actual): April 12, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperinsulinism; Diabetes Mellitus, Type 1; Insulin Resistance; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: 2016-T1DM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED