Metformin in Women With Type 2 Diabetes in Pregnancy Trial
Overview[ - collapse ][ - ]
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. |
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Condition | Type 2 Diabetes |
Intervention | Drug: Metformin Drug: Placebo Comparator |
Phase | Phase 4 |
Sponsor | Mount Sinai Hospital, Canada |
Responsible Party | Mount Sinai Hospital, Canada |
ClinicalTrials.gov Identifier | NCT01353391 |
First Received | May 2, 2011 |
Last Updated | March 20, 2014 |
Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | May 2, 2011 |
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Last Updated Date | March 20, 2014 |
Start Date | May 2011 |
Estimated Primary Completion Date | December 2016 |
Current Primary Outcome Measures | A composite of: pregnancy loss, preterm birth, birth injury, respiratory distress, neonatal hypoglycemia, and NICU admission > 48 hours. [Time Frame: conception to 28 days after birth] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Metformin in Women With Type 2 Diabetes in Pregnancy Trial |
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Official Title | Metformin in Women With Type 2 Diabetes in Pregnancy Trial |
Brief Summary | 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. |
Detailed Description | 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. |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Type 2 Diabetes |
Intervention | Drug: Metformin 500 mg daily OD from randomisation for 2 weeks, then 1000mg BID throughout the duration of pregnancy Drug: Placebo Comparator Sugar Pill |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 500 |
Estimated Completion Date | December 2016 |
Estimated Primary Completion Date | December 2016 |
Eligibility Criteria | Inclusion Criteria: - Women who are between of 18-45 years of age - Women diagnosed with type 2 diabetes prior to pregnancy OR women with undiagnosed type 2 diabetes diagnosed prior to 20 weeks gestation [defined as women presenting with gestational diabetes before 20 weeks gestation with an elevated HbA1c which is 8% or more above the upper normal range (i.e. HbA1c of 6.5% if upper normal is 6.0%, or HbA1c 7% if upper normal is 6.5%) or fasting glucose >= 7.0 mmol/L] - Pregnancy gestation between 12 weeks 0 days - 22 weeks 6 days - Live singleton fetus. Exclusion Criteria: - Women who are not on insulin. Women who are on oral hypoglycemic agents should be switched to insulin prior to randomization - Diabetes diagnosed after 20 weeks gestation - Type 1 diabetes - Known intolerance to metformin - Contraindications to metformin use which include: a) Renal insufficiency (defined as serum creatinine of greater than 130 umol/L or creatinine clearance < 60 ml/min b) Moderate to severe liver dysfunction (defined as liver enzymes (aspartate aminotransferase (AST) and alanine aminotransferase (ALT)) greater than 3 times the upper limit of normal) c) Shock or sepsis d) Previous hypersensitivity to metformin - Women with significant gastrointestinal problems such as severe vomiting requiring intravenous fluids or hospitalization, or active Crohn's or colitis - - Previous participation in the trial - Patients who have a fetus with a known potentially lethal anomaly will be excluded. Information regarding congenital anomalies diagnosed after randomization will be recorded. - Known higher order pregnancies (twins, triplets, etc). These women will be excluded as they have a higher rate of adverse outcomes and we want to avoid any inequalities if they are unequally distributed between the groups - Presence of acute or chronic metabolic acidosis, including diabetic ketoacidosis - History of diabetic ketoacidosis or history of lactic acidosis - Presence of excessive alcohol intake, acute or chronic - Presence of congestive heart failure or history of congestive heart failure |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Asma Qureshi, MPH 416-480-5631 mity@sunnybrook.ca |
Location Countries | Canada |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01353391 |
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Other Study ID Numbers | MOP-106678 |
Has Data Monitoring Committee | Yes |
Information Provided By | Mount Sinai Hospital, Canada |
Study Sponsor | Mount Sinai Hospital, Canada |
Collaborators | University Health Network, Toronto Sunnybrook Research Institute Canadian Institutes of Health Research (CIHR) |
Investigators | Principal Investigator: Denice Feig, MD Mount Sinai Hospital, New York |
Verification Date | March 2014 |
Locations[ + expand ][ + ]
The Centre for Mother, Infant, and Child Research, Sunnybrook Research Institute | Toronto, Ontario, Canada, M4N 3M5 Contact: Asma Qureshi, MPH | 416-480-5631 | mity@sunnybrook.caSub-Investigator: Shital Gandhi, MD Recruiting |
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