search
Back to results

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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Metformin
Insulin
Sponsored by
Third Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The Third Affliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Metformin and Insulin

Insulin

Arm 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

Accept insulin for 24 weeks

Outcomes

Primary Outcome Measures

HbA1c

Secondary Outcome Measures

Full Information

First Posted
February 14, 2016
Last Updated
April 10, 2018
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
search

1. Study Identification

Unique Protocol Identification Number
NCT02765347
Brief Title
The Effects of Metformin on Glycemic Control and Insulin Sensitivity in Adolescents With T1DM
Official Title
The Effects of Metformin on Glycemic Control and Insulin Sensitivity in Adolescents With T1DM: A Randomized, Cross-over, Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metformin and Insulin
Arm Type
Other
Arm 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
Arm Title
Insulin
Arm Type
Other
Arm Description
Accept insulin for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Glucophage
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Insulin
Other Intervention Name(s)
CSII or MDI
Intervention Description
For arm 2, just accept insulin for 24 weeks
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
half one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Xu
Organizational Affiliation
Associated professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Third Affliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs