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

NCT02765347 | Completed Phase 4 DMC

• 1 other identifier: 2016-T1DM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• HbA1c

  half one year

Study Arms (2)

Metformin and Insulin

OTHER

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

Insulin

OTHER

Accept insulin for 24 weeks

Drug: Insulin

Interventions

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.

Also known as: Glucophage

Metformin and Insulin

Insulin DRUG

For arm 2, just accept insulin for 24 weeks

Also known as: CSII or MDI

Insulin

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%）.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The Third Affliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Metformin; Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Wen Xu

  Associated professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: February 14, 2016
• First Posted: May 6, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: April 12, 2018

Record last verified: 2017-10

Locations

CN (1)