Effect of Metformin as add-on Therapy on Glycemic Control and Other Outcomes in Type 1 Diabetes

Effect of Metformin as add-on Therapy on Glycemic Control and Other Diabetes-Related Outcomes in Type 1 Diabetic Patients:a Open-label,Self-control Study

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03590262

Enrollment

Registered

2018-07-18

Start date

2018-01-01

Completion date

2019-09-30

Last updated

2018-07-20

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

Conditions

Metformin, Type 1 Diabetes Mellitus

Brief summary

Aim Evidence of a possible connection between gut microbiota and several physiological processes linked to type 1 diabetes is increasing. However, the effect of multistrain probiotics in people with type 1 diabetes remains unclear. This study investigated the effect of metformin as add-on therapy on glycemic control and other diabetes-related outcomes in people with type 1 diabetes.

Detailed description

Design An open-label, add-on, self-control clinical trial. Setting Diabetes clinic of a teaching hospital in Shenzhen China Participants A total of 20 participants with type 1 diabetes, aged 18-60 years, will be recruited and treated with metformin as add-on therapy with insulin for 12 weeks. Outcomes Primary outcomes were glycemic control related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity C-reactive protein. The gut microbiota profile will be analyzed before and after intervention .

Interventions

DRUGMetformin

take the metformin 500mg twice or three times a day

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

type 1 diabetes patients age 18-60years old 18 Kg/m2≤BMI≤30Kg/m2 ketonuria (-)；

Exclusion criteria

pregnancy lactation having other severe chronic illnesses taking other anti-diabetic drugs

Design outcomes

Primary

Measure	Time frame	Description
Change of hemoglobin A1c in percentage	3 months	analyze the change of hemoglobin A1c before and after the treatment

Secondary

Measure	Time frame	Description
Change of weight in kilograms	3 months	analyze the change of weight in kilograms before and after the treatment

Countries

China

Contacts

Primary ContactXiuzhen Zhang

876538754@qq.com86-13714902238

Backup ContactPing Xu

86-13692156916

Outcome results

None listed

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