Metformin Plus Insulin on Non-obese Autoimmune Diabetes

NCT03513874 | Unknown Phase 4 DMC

• 1 other identifier: MET201801
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus; Autoimmune Diabetes

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• 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

• Adverse effects

  6 months

Study Arms (2)

Metformin + Insulin

EXPERIMENTAL

Drug: Metformin; Drug: Insulin

Insulin alone

ACTIVE COMPARATOR

Drug: Insulin

Interventions

Metformin DRUG

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

Metformin + Insulin

Insulin DRUG

Patients will continue insulin therapy following physicians' instructions.

Insulin alone; Metformin + Insulin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

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

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Metformin; Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Zhiguang Zhou, M.D./Ph.D

CONTACT

86-0731-85292154; zhouzg@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Endocrinology, Institute of Metabolism and Endocrinology, National Clinical Research Center for Metabolic Diseases, Second Xiangya Hospital, Central South University

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: May 2, 2018
• Study Start: August 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: April 1, 2021
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

CN (1)