Metformin Plus Insulin on Non-obese Autoimmune Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03513874
• Other study ID #: MET201801
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2017
• Est. completion date: April 1, 2021

Study information

• Verified date: March 2020
• Source: Second Xiangya Hospital of Central South University
• Contact: Zhiguang Zhou, M.D./Ph.D
• Phone: 86-0731-85292154
• Email: zhouzg[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: April 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autoimmune Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Metformin
Patients will be subscribed with 850mg metformin orally twice daily. Insulin will be continued as routine therapy.
• Insulin
Patients will continue insulin therapy following physicians' instructions.

Locations

Country	Name	City	State
China	Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

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