Metformin Plus Insulin on Non-obese Autoimmune Diabetes

March 17, 2020 updated by: Zhiguang Zhou, Second Xiangya Hospital of Central South University

The Effect of Metformin as add-on to Insulin in Non-obese Patients With Autoimmune Diabetes

The objective of this study is to evaluate the therapeutic effect of metformin as additional treatment with insulin on non-obese autoimmune diabetes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 diabetes according to ADA criterias <5 years.
  • Age≥ 18 years and less than 70 years.
  • Non-obese: defined as BMI less than 28 kg/m2
  • Positive for at least one of the anti-islet autoantibodies: GADA, IA2A, ZnT8A
  • Fasting or postprandial plasma C-peptide more than 100 pmol/L
  • Written informed consent from the patient or family representative.

Exclusion Criteria:

  • History of any malignancy or other severe diseases
  • Female patients who are pregnant or breastfeeding before or during the three-year follow-up
  • Poor compliance or refusal to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin + Insulin
Drug: Metformin
Patients will be subscribed with 850mg metformin orally twice daily. Insulin will be continued as routine therapy.
Drug: Insulin
Patients will continue insulin therapy following physicians' instructions.
Active Comparator: Insulin alone
Drug: Insulin
Patients will continue insulin therapy following physicians' instructions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean amplitude of glycemic excursions (MAGE)
Time Frame: 6 months
MAGE is measured by applying continuous glucose monitoring system (CGMS) on subjects in each follow-up of this 6-month study.
6 months
Change in C-peptide
Time Frame: 6 months
C-peptide are measured before and 2-hour after a mixed meal tolerance test at each follow-up of this study.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: 6 months
6 months
Change in daily insulin dose
Time Frame: 6 months
6 months
Change in body mass index (BMI)
Time Frame: 6 months
6 months
Change in lipid profiles
Time Frame: 6 months
Including triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol
6 months
Adverse effects
Time Frame: 6 months
Adverse effects are recorded at each time-point of the follow-up
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

April 12, 2018

First Submitted That Met QC Criteria

April 19, 2018

First Posted (Actual)

May 2, 2018

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MET201801

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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