Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2016-10-26
2020-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Metformin
850-2550 mg every 24h.
Metformin
850-2550 mg every 24h.
Insulin Detemir
Insulin detemir associated or not with rapid insulin analogue (aspart) according to individual glycemic controls.
Insulin Detemir
Individual doses according to glycemic controls.
Metformin
850-2550 mg every 24h.
Insulin Detemir
Insulin detemir associated or not with rapid insulin analogue (aspart) according to individual glycemic controls.
Interventions
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Metformin
850-2550 mg every 24h.
Insulin Detemir
Insulin detemir associated or not with rapid insulin analogue (aspart) according to individual glycemic controls.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of GD, with fasting glucose \<120 mg / dL.
3. not controlled by diet: fasting capillary blood 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.
Exclusion Criteria
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.
18 Years
45 Years
FEMALE
No
Sponsors
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Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
OTHER
Responsible Party
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Other Identifiers
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FIM-MET-2015-01
Identifier Type: -
Identifier Source: org_study_id
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