Metformin Plus Insulin on Non-obese Autoimmune Diabetes

NCT ID: NCT03513874

Last Updated: 2020-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2021-04-01

Brief Summary

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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

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Conditions

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Type 1 Diabetes Mellitus Autoimmune Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin + Insulin

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Patients will be subscribed with 850mg metformin orally twice daily. Insulin will be continued as routine therapy.

Insulin

Intervention Type DRUG

Patients will continue insulin therapy following physicians' instructions.

Insulin alone

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

Patients will continue insulin therapy following physicians' instructions.

Interventions

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Metformin

Patients will be subscribed with 850mg metformin orally twice daily. Insulin will be continued as routine therapy.

Intervention Type DRUG

Insulin

Patients will continue insulin therapy following physicians' instructions.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Zhiguang Zhou

Director, Department of Endocrinology, Institute of Metabolism and Endocrinology, National Clinical Research Center for Metabolic Diseases, Second Xiangya Hospital, Central South University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhiguang Zhou, M.D./Ph.D

Role: CONTACT

86-0731-85292154

Facility Contacts

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Zhiguang Zhou, MD/PhD

Role: primary

86-731-85292154

Other Identifiers

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MET201801

Identifier Type: -

Identifier Source: org_study_id

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