Gestational diabetes (GD) MedDRA version: 18.0 Level: PT Classification code 10018209 Term: Gestational diabetes System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions
Conditions
Interventions
Trade Name: LEVEMIR
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: INSULIN DETEMIR
CAS Number: 169148-63-4
Concentration unit: IU/ml international unit(s)/millilitr
Sponsors
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 18-45 years old. 2) Diagnosis of GD, with fasting glucose 95 mg / dl in at least 2-3 times or 1 hour postprandial >140 mg / dl on, at least 2-3 times a week. 4) 2nd or 3rd trimesters of pregnancy. 5) Able to give informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Psychopathological situations that do not guarantee proper adhesion to follow up 2) 1st trimester of pregnancy 3) gastrointestinal diseases that may cause poorer tolerance or increased symptoms with metformin. 4) Patients who can not attend the scheduled consultation. 5) Language barrier limiting for understanding treatment settings 6) Twin pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate that treatment with metformin in women with GD (not controlled with diet) can get no lower obstetric and perinatal outcomes to standard treatment with insulin. Demonstrate that glycemic control with metformin in women obtained properly selected can be equivalent to that obtained with insulin.;Secondary Objective: State that the adverse effect profile of treatment is safe and can favor the metformin, at least in a lower risk of hypoglycemia, and that digestive intolerance will not be a limitant factor in most pregnant. Demonstrate that women treated with metformin have a weight gain significant lower than those treated with insulin. State If fructosamine may be a marker of insulinization need in patients treated with metformin. Women treated with metformin will found more satisfied than those treated with insulin Check for differences in parameters of inflammation, endothelial injury and oxidativge stress as well as in lipid profile, between groups and based on metabolic control and perinatal outcomes.;Primary end point(s): Demonstrate that treatment with metformin in women with GD (not controlled with diet) can get no lower obstetric and perinatal outcomes to standard treatment with insulin. Demonstrate that glycemic control with metformin in women obtained properly selected can be equivalent to that obtained with insulin.;Timepoint(s) of evaluation of this end point: Selection visit, subsequent visits (every 1-3 weeks), 36-37 week pregnancy, 8-10 weeks after delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): State that the adverse effect profile of treatment is safe and can favor the metformin, at least in a lower risk of hypoglycemia, and that digestive intolerance will not be a limitant factor in most pregnant. Demonstrate that women treated with metformin have a weight gain significant lower than those treated with insulin. State If fructosamine may be a marker of insulinization need in patients treated with metformin. Women treated with metformin will found more satisfied than those treated with insulin Check for differences in parameters of inflammation, endothelial injury and oxidativge stress as well as in lipid profile, between groups and based on metabolic control and perinatal outcomes.;Timepoint(s) of evaluation of this end point: Selection visit, subsequent visits, 36-37 week pregnancy, 8-10 weeks after delivery | — |
Countries
Spain
Contacts
Public ContactClinical Studies Platform
FIMABIS
Outcome results
None listed