Metformin Plus Insulin on Non-obese Autoimmune Diabetes

Central South University

Status and phase: Unknown; Phase 4

Conditions: Type 1 Diabetes Mellitus; Autoimmune Diabetes

Treatments: Drug: Metformin; Drug: Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT03513874

MET201801

Details and patient eligibility

About

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

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Metformin + Insulin

Experimental group

Treatment:

Drug: Insulin

Drug: Metformin

Insulin alone

Active Comparator group

Treatment:

Drug: Insulin