Back to resultsMetformin Plus Insulin on Non-obese Autoimmune Diabetes
Primary Purpose
Type 1 Diabetes Mellitus, Autoimmune Diabetes
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Metformin
Insulin
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
Eligibility Criteria
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.
Sites / Locations
- Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Metformin + Insulin
Insulin alone
Arm Description
Outcomes
Primary Outcome Measures
Mean amplitude of glycemic excursions (MAGE)
MAGE is measured by applying continuous glucose monitoring system (CGMS) on subjects in each follow-up of this 6-month study.
Change in C-peptide
C-peptide are measured before and 2-hour after a mixed meal tolerance test at each follow-up of this study.
Secondary Outcome Measures
Change in HbA1c
Change in daily insulin dose
Change in body mass index (BMI)
Change in lipid profiles
Including triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol
Adverse effects
Adverse effects are recorded at each time-point of the follow-up
Full Information
NCT ID
NCT03513874
First Posted
April 12, 2018
Last Updated
March 17, 2020
Sponsor
Second Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT03513874
Brief Title
Metformin Plus Insulin on Non-obese Autoimmune Diabetes
Official Title
The Effect of Metformin as add-on to Insulin in Non-obese Patients With Autoimmune Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
April 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Xiangya Hospital of Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to evaluate the therapeutic effect of metformin as additional treatment with insulin on non-obese autoimmune diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, Autoimmune Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metformin + Insulin
Arm Type
Experimental
Arm Title
Insulin alone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Patients will be subscribed with 850mg metformin orally twice daily. Insulin will be continued as routine therapy.
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Patients will continue insulin therapy following physicians' instructions.
Primary Outcome Measure Information:
Title
Mean amplitude of glycemic excursions (MAGE)
Description
MAGE is measured by applying continuous glucose monitoring system (CGMS) on subjects in each follow-up of this 6-month study.
Time Frame
6 months
Title
Change in C-peptide
Description
C-peptide are measured before and 2-hour after a mixed meal tolerance test at each follow-up of this study.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in HbA1c
Time Frame
6 months
Title
Change in daily insulin dose
Time Frame
6 months
Title
Change in body mass index (BMI)
Time Frame
6 months
Title
Change in lipid profiles
Description
Including triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol
Time Frame
6 months
Title
Adverse effects
Description
Adverse effects are recorded at each time-point of the follow-up
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiguang Zhou, M.D./Ph.D
Phone
86-0731-85292154
Email
zhouzg@hotmail.com
Facility Information:
Facility Name
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiguang Zhou, MD/PhD
Phone
86-731-85292154
Email
zhouzg@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Metformin Plus Insulin on Non-obese Autoimmune Diabetes
We'll reach out to this number within 24 hrs