A Phase 3 interventional study of Metformin and Insulin Detemir in Diabetes, Gestational, Perinatal Disorder and Puerperal Disorder, sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud. Status unknown. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-05-15.
Sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Phase 3, Interventional, and Treatment
Women with gestational diabete (GD) who do not meet glycemic control objectives with diet will be assigned to two treatment groups randomly. One: metformin at a dose of 850-2550mg every 24h; two: insulin detemir associated or not with rapid insulin analogue (aspart) according to your glycemic controls. The Metformin group may additionally receive insulin in a second time in case the glycemic control is not appropriate with monotherapy.
Women with gestational diabete (GD) who do not meet glycemic control objectives with diet will be assigned to two treatment groups randomly. One: metformin at a dose of 850-2550mg every 24h; two: insulin detemir associated or not with rapid insulin analogue (aspart) according to your glycemic controls. The Metformin group may additionally receive insulin in a second time in case the glycemic control is not appropriate with monotherapy.
The objectives are: Demonstrate that treatment with metformin in women with GD (not controlled with diet) can get no lower obstetric and perinatal outcomes than those with standard treatment with insulin.
Demonstrate that glycemic control with metformin in properly selected women, can be equivalent to that obtained with insulin.
877 studies on the registry are indexed under Diabetes, Gestational; 203 are open to participants now.
This study's enrollment of 200 is above the median of 110 across 564 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud is the lead sponsor of 71 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
850-2550 mg every 24h.
Drug: Metformin · Drug: Insulin Detemir
Individual doses according to glycemic controls.
Drug: Metformin · Drug: Insulin Detemir
850-2550 mg every 24h.
Insulin detemir associated or not with rapid insulin analogue (aspart) according to individual glycemic controls.
Metformin benefits
Change of Weigth
Time frame: 50 weeks
Good glycemic control
Change of glycemic levels
Time frame: 50 weeks
Baby wellness
Weight
Time frame: Delivery
Adverse event profile
Number of adverse events
Time frame: 50 weeks
Fructosamine as a marker of insulinization
Concentration of fructosamine
Time frame: 50 weeks
Satisfaction with the treatment
Questionnaire of satisfaction with the treatment. Range: 5 (worst)-16 (best)
Time frame: 50 weeks
IL-6 profile
IL-6 levels
Time frame: 50 weeks
IL-10 profile and oxidativge stress as well as in lipid profile
IL-10 (ultrasensitive PCR) levels
Time frame: 50 weeks
Leptin profile
Leptin levels
Time frame: 50 weeks
Ladiponectin and oxidativge stress as well as in lipid profile
Ladiponectin levels
Time frame: 50 weeks
LPS profile
LPS levels
Time frame: 50 weeks
LBP profile and oxidativge stress as well as in lipid profile
LBP levels
Time frame: 50 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Metformin
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud