Metformin Plus Insulin on Non-obese Autoimmune Diabetes | NCT03513874

Studies
Metformin Plus Insulin on Non-obese Autoimmune Diabetes

NCT03513874

Sponsor

Second Xiangya Hospital of Central South University

Status

Unknown status

Last Update Posted

Mar 18, 2020Actual

Enrollment

15Estimated

Phase

Phase 4

Conditions

Type 1 Diabetes Mellitus
Autoimmune Diabetes

Interventions

Metformin
Insulin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2017Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Apr 1, 2021Estimated

First Submitted Date

Apr 12, 2018

First Submission Date that Met QC Criteria

Apr 19, 2018

First Posted Date

May 2, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2020

Last Update Posted Date

Mar 18, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Second Xiangya Hospital of Central South UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metformin + Insulin	Experimental		Drug: Metformin Drug: Insulin
Insulin alone	Active Comparator		Drug: Insulin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metformin	Drug	Patients will be subscribed with 850mg metformin orally twice daily. Insulin will be continued as routine therapy.	Metformin + Insulin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change in HbA1c		6 months
Change in daily insulin dose		6 months
Change in body mass index (BMI)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhiguang Zhou, M.D./Ph.D	Contact	86-0731-85292154		zhouzg@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University	Recruiting	Changsha	Hunan	410011	China

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008687	Metformin
D007328	Insulin

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals
D011384

Browse Leaves

Not provided

Browse Branches

Not provided