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Completed

NCT Number: NCT02765347

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Third Affliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1 diabetes mellitus;
  • Age≥12 yr;
  • Tanner sexual maturation rating 2-5;
  • HbA1c levels: 7.5%-10%;
  • MDI or CSII ≥6 months;
  • Insulin dose ≥ 0.8U/kg before the enrollment，and the dosage is stable at least >1 month（dosage change<10%）.

Exclusion criteria

  • Serious acute and chronic complications associated with diabetes;
  • Repeated and serious hypoglycemia episodes repeatedly;
  • Hepatic function damage (ALT≥2.5 times higher than the upper limit of the normal accepted range);
  • Moderate to advanced renal impairment (calculated according to MDRD equation: eGFR<60ml/min/1.73m2);
  • Clinically significant heart attacks: myocardial infarction, arrhythmia，II-III°AVB，unstable angina，decompensated HF（NYHA III~IV;
  • Female patients who have a sex life and are not willing to use contraceptive methods;
  • Pregnancy.

Treatment and study plan

metformin

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.

Other names: Glucophage

Insulin

Drug

For arm 2, just accept insulin for 24 weeks

Other names: CSII or MDI

Primary outcomes

  1. HbA1c

    Time frame: half one year

Sponsors and collaborators

Lead sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 6, 2016
Registry last updated
Apr 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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