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The Effect of Metformin Accompanied by Insulin on Type I Diabetes in Adolescents

Metformin Accompanied by Insulin on Type I Diabetes

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200701001
Enrollment
Unknown
Registered
2020-07-01
Start date
2019-06-30
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Diabetes type I Diabetes&#44

Interventions

Daily 500 mg for 7 days and then gradually increased by 2000 mg based on the weight of the adolescent. When the fasting blood sugar was less than 70 mg/dl&#44
routine dose of insulin decreased just 1 unit and when it was more than 130 mg/dl&#44
2 units of insulin dose was increased. Actually the routine treatment was inslunin in which in this group metformin was added. ,Taking routine insulin for the treatment of diabetes type I.
Experimental Drug,Experimental Drug
Metformin+insulin,Insulin

Sponsors

Shahid BeheshtiUniversity of Medical Sciences
Lead Sponsor
Shahid BeheshtiUniversity of Medical Sciences
Collaborator

Eligibility

Sex/Gender
All
Age
10 Years to 20 Years

Inclusion criteria

Inclusion criteria: The factors including age 10 to 20 years, diabetes infliction for more than a year, manifestation of diabetic ketoacidosis, the lack of history of diabetes in the family, treatment with multiple daily insulin injections from at least one year ago, receiving of instruction on how to control diabetes at the Children's Endocrine Clinic at least a year ago, the dose of insulin more than one unit per kilogram of body weight, and hemoglobin A1C levels more than 8% over the past six months were considered as inappropriate control criteria for entry into the study.

Exclusion criteria

Exclusion criteria: The excluding criteria were nephropathy (excretion of more than 200 g of albumin per minute), incidence of diabetic ketoacidosis more than twice a year, proliferative retinopathy, current insulin therapy by conventional method, times of incidence per year, severe and recurrent hypoglycemia, along with decreased level of consciousness, having more than two seizures over the past year (liver or kidney dysfunction, concomitant serious illness, and eating disorders).

Design outcomes

Primary

MeasureTime frame
HBA1C 4 points: Before and after intervention every 3 months Blood sampling

Secondary

MeasureTime frame
Insulin 4 points: Before and after intervention every 3 months Sampling

Countries

Iran

Contacts

Public ContactZahra Eydian

Shahid Beheshti University of Medical Sciences

zahraeyd1982@gmail.com00982122432040

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026