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| Sponsor: | Sunnybrook Health Sciences Centre |
|---|---|
| Collaborators: |
Canadian Institutes of Health Research (CIHR) Mount Sinai Hospital, Canada |
| Information provided by: | Sunnybrook Health Sciences Centre |
| ClinicalTrials.gov Identifier: | NCT01353391 |
Purpose
Insulin is the standard treatment for the management of type 2 diabetes in pregnancy, however despite treatment with insulin, these women continue to face increased rates of adverse maternal and fetal outcomes. The investigators hypothesize that metformin use, in addition to treatment with insulin, will help with blood sugar control, lower the dose of insulin needed, lower weight gain, and improve baby outcomes.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Drug: Metformin Drug: Placebo Comparator |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Metformin in Women With Type 2 Diabetes in Pregnancy Trial |
Gestational hypertension: New onset of hyperstension (diastolic of 90 mm Hg or higher) in pregnancy after 20 weeks gestation in a woman with previously normal blood pressure (124, 125).
Pre-eclampsia: new-onset proteinuria, Eclampsia (Seizures in pregnancy), Elevated liver function tests, Decreased platelet count < 100 x 109/L, Elevated serum creatinine (> 80 mmol/L) or small for gestational age infant (birth weight less than 10%).
| Estimated Enrollment: | 500 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Metformin |
Drug: Metformin
500 mg daily OD from randomisation for 2 weeks, then 1000mg BID throughout the duration of pregnancy
|
| Placebo Comparator: Sugar pill |
Drug: Placebo Comparator
Sugar Pill
|
Type 2 diabetes in pregnancy is increasing in prevalence and these women continue to face increased rates of adverse maternal and fetal outcomes. The investigators hypothesize that metformin use, as an adjunct to insulin, will decrease these adverse outcomes by reducing maternal hyperglycemia, high maternal insulin doses, excessive maternal weight gain and gestational hypertension/pre-eclampsia, all of which should reduce perinatal and neonatal mortality and morbidity. In addition, since metformin crosses the placenta, metformin treatment of the fetus may have a direct beneficial effect on neonatal outcomes. This study is an randomized controlled trial (RCT) that adds metformin to insulin, and is a double-blind, placebo-controlled RCT. The investigators believe that neither metformin alone nor insulin alone will effectively treat this population, and therefore our design, which includes the addition of metformin to insulin, will be the most relevant to our patients.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Asma Qureshi, MPH | 416-480-5631 | mity@sunnybrook.ca |
| Contact: Johanna Sanchez, MIPH | 416-480-5628 | johanna.sanchez@sunnybrook.ca |
| Canada, Ontario | |
| The Centre for Mother, Infant, and Child Research, Sunnybrook Research Institute | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Contact: Asma Qureshi, MPH 416-480-5631 mity@sunnybrook.ca | |
| Contact: Dalah Mason, MPH 416-480-5639 dalah.mason@sunnybrook.ca | |
| Sub-Investigator: Shital Gandhi, MD | |
| Principal Investigator: | Denice Feig, MD | Mount Sinai Hospital, New York |
More Information
| Responsible Party: | Dr Denice Feig, Mount Sinai Hospital, Toronto |
| ClinicalTrials.gov Identifier: | NCT01353391 History of Changes |
| Other Study ID Numbers: | MOP-106678 |
| Study First Received: | May 2, 2011 |
| Last Updated: | June 21, 2011 |
| Health Authority: | Canada: Canadian Institute for Health Research |
|
Diabetes MiTy Metformin in Women Type 2 Diabetes Pregnancy |
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Pregnancy in Diabetics Diabetes, Gestational Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Pregnancy Complications Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |