Metformin Plus Insulin on Non-obese Autoimmune Diabetes

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03513874

Enrollment

Registered

2018-05-02

Start date

2017-08-01

Completion date

2021-04-01

Last updated

2020-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Diabetes, Type 1 Diabetes Mellitus

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.

Interventions

DRUGMetformin

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

DRUGInsulin

Patients will continue insulin therapy following physicians' instructions.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

China

Contacts

Primary ContactZhiguang Zhou, M.D./Ph.D

zhouzg@hotmail.com86-0731-85292154

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026