Metformin Plus Insulin on Non-obese Autoimmune Diabetes

Phase 4

• Conditions: Type 1 Diabetes Mellitus; Autoimmune Diabetes
• Interventions: Drug: Metformin; Drug: Insulin

• Registration Number: NCT03513874
• Lead Sponsor: Second Xiangya Hospital of Central South University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-04-19
• Study First Posted: 2018-05-02
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-18
• Primary Completion: 2020-12-31
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin + Insulin	Insulin	-
Insulin alone	Insulin	-
Metformin + Insulin	Metformin	-

Primary Outcome Measures

Name	Time	Method
Mean amplitude of glycemic excursions (MAGE)	6 months	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	6 months	C-peptide are measured before and 2-hour after a mixed meal tolerance test at each follow-up of this study.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University; 🇨🇳 Changsha, Hunan, China