Comparing the effects of Insulin and Glibenclamide in treating gestational diabetes mellitus

The comparative study of therapeutic effects of insulin and Glibenclamide in the gestational diabetes mellitus

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201010203797N2

Enrollment

Registered

2010-12-01

Start date

2010-04-09

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Diabetes in pregnancy. Diabetes mellitus in pregnancy, unspecified

Interventions

Intervention 1: Insulin (100units/ vial, Eksir co, Iran) 0.5 unit/kg subcutaneous twice a day: 2/3 in the morning and 1/3 in the evening. Insulin dose is increased weekly if it is necessary. Intervent

Treatment - Drugs

Insulin (100units/ vial, Eksir co, Iran) 0.5 unit/kg subcutaneous twice a day: 2/3 in the morning and 1/3 in the evening. Insulin dose is increased weekly if it is necessary.

Glibenclamid (tablet 5mg, Kimia Daroo, Iran), 2.5 mg oral then its dose is increased 5mg per week up to getting the maximum dose of 20mg per day

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Inclusion criteria: single pregnancy with gestational age between 11-33 weeks Exclusion criteria: patient's disagreement, multi pregnancy, history of pre-pregnancy diabetes, infectious disease, cardiovascular diseases, agglutination disorders

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Blood glucose level. Timepoint: 4 times a day (being fast, 2h after breakfast, 2h after lunch, 2h after dinner. Method of measurement: daily recording by patient, weekly measuring in ever visit.	—

Secondary

Measure	Time frame
Fetal disorders such as macrosomia,. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.;Oligohydroaminus. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.;Determination of polyhydroaminous. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.;Determination of intrauterine fetal death. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.;Determination of intrauterine retardation frequency. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.;Determination of fetal abnormalities. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.;Determination of apgar at birth. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.;Hypoglycemia. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.;Hypoglylcemia. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.;Infants bedridden in NICU. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.;Cesarean section frequency. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.;Pre-eclampcia frequency. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.	—

Measure

Time frame

Fetal disorders such as macrosomia,. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.;Oligohydroaminus. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.;Determination of polyhydroaminous. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.;Determination of intrauterine fetal death. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.;Determination of intrauterine retardation frequency. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.;Determination of fetal abnormalities. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.;Determination of apgar at birth. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.;Hypoglycemia. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.;Hypoglylcemia. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.;Infants bedridden in NICU. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.;Cesarean section frequency. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.;Pre-eclampcia frequency. Timepoint: during and after birth. Method of measurement: laboratory works and usual tests for newborns.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Maryam Zangeneh

Kermanshah University of Medical Sciences

mzangene@kums.ac.ir+98 83 1433 4157

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026