Effectiveness of Metformin Compared to Insulin in Pregnant Women With Mild Preexisting or Early Gestational Diabetes | RxWiki

Effectiveness of Metformin Compared to Insulin in Pregnant Women With Mild Preexisting or Early Gestational Diabetes

Overview[ - collapse ][ - ]

Purpose	Many women come into pregnancy with diabetes that is controlled with either Metformin or diet control; however, the current standard of care for the treatment of preexisting diabetes in pregnancy is insulin. Metformin is widely used in the non-pregnant population for glycemic control, and has been used in pregnancy for other indications without adverse maternal or fetal outcomes. What remains unproven is the ability of Metformin to adequately control glucose in women during pregnancy. Our goal is to randomize 100 women who enter pregnancy with diabetes that is controlled by either diet or an oral agent and women who are found to have an abnormal glucose challenge test at less than 20 weeks to either standard treatment with weight based Regular and NPH insulin or Metformin. Our hypothesis is that Metformin will provide glycemic control that is equivalent to insulin in these women.
Condition	Non Insulin Dependent Diabetes Pregnancy
Intervention	Drug: Metformin Drug: Insulin
Phase	Phase 2
Sponsor	University of North Carolina, Chapel Hill
Responsible Party	University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier	NCT00835861
First Received	February 2, 2009
Last Updated	May 22, 2013
Last verified	May 2013

Tracking Information[ + expand ][ + ]

First Received Date	February 2, 2009
Last Updated Date	May 22, 2013
Start Date	August 2008
Estimated Primary Completion Date	April 2010
Current Primary Outcome Measures	Our primary outcome is glucose control. [Time Frame: Each patient will self-monitor fasting and one-hour post prandial glucose measurement throughout pregnancy.] [Designated as safety issue: No]
Current Secondary Outcome Measures	We will also be assessing differences in obstetric complications, maternal weight gain, and any neonatal complications. [Time Frame: Throughout pregnancy until discharge from hospital after delivery.] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Effectiveness of Metformin Compared to Insulin in Pregnant Women With Mild Preexisting or Early Gestational Diabetes
Official Title	Pilot Study of Metformin vs. Insulin in Pregnant Overt Diabetics (MIPOD)
Brief Summary	Many women come into pregnancy with diabetes that is controlled with either Metformin or diet control; however, the current standard of care for the treatment of preexisting diabetes in pregnancy is insulin. Metformin is widely used in the non-pregnant population for glycemic control, and has been used in pregnancy for other indications without adverse maternal or fetal outcomes. What remains unproven is the ability of Metformin to adequately control glucose in women during pregnancy. Our goal is to randomize 100 women who enter pregnancy with diabetes that is controlled by either diet or an oral agent and women who are found to have an abnormal glucose challenge test at less than 20 weeks to either standard treatment with weight based Regular and NPH insulin or Metformin. Our hypothesis is that Metformin will provide glycemic control that is equivalent to insulin in these women.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Non Insulin Dependent Diabetes Pregnancy
Intervention	Drug: Metformin Women randomized to the Experimental arm will receive standard diet and glucose self-monitoring education. They will be initiated on Metformin 500 BID if they were medication naive, or will be continued on their current dosage of Metformin if they were taking it prior to pregnancy. At each clinic visit fasting and one hour post prandial glucose values will be reviewed, and dosage will be titrated to a maximum of 2250mg/day to achieve target glycemic control. If glycemic control can not be achieved with Metformin as a single agent insulin will be added. Other Names: GlucophageDrug: Insulin Women randomized to the Insulin group will receive standard diet and glycemic monitoring education. They will be initiated on weight based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular)administered with dinner. At each clinic visit fasting and one hour post prandial glucose values will be reviewed, and dosage will be titrated to achieve optimal glycemic control with fasting values <90 and one hour post prandial values <130. Other Names: Regular Insulin Novolin R Humulin R NPH Insulin Novolin N Humulin N
Study Arm (s)	Experimental: Metformin Women who enter pregnancy with a diagnosis of non insulin dependent/Type 2 Diabetes that is controlled with diet or an oral hypoglycemic agent, and women who demonstrate abnormal glucose tolerance prior to 20 weeks of gestation by abnormal 3 hour glucose challenge testing will be offered study participation. After informed consent, they will be randomized 1:1 to either the Metformin or Insulin group. Active Comparator: Insulin Women who enter pregnancy with a diagnosis of non insulin dependent/Type 2 Diabetes that is controlled with diet or an oral hypoglycemic agent, and women who demonstrate abnormal glucose tolerance prior to 20 weeks of gestation by abnormal 3 hour glucose challenge testing will be offered study participation. After informed consent, they will be randomized 1:1 to either the Metformin or Insulin group.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	32
Estimated Completion Date	April 2010
Estimated Primary Completion Date	February 2010
Eligibility Criteria	Inclusion Criteria: - Receiving prenatal care at University of North Carolina (UNC), Chapel Hill Obstetric clinics and planning delivery at UNC Women's Hospital - Diagnosis of Diabetes prior to pregnancy with use of an oral hypoglycemic agent or dietary control - Diagnosis of early gestational diabetes prior to 20 weeks gestation via abnormal 3 hour glucose challenge testing using the national diabetes data group (NDDG)criteria - Less than 24 weeks at study enrollment - Singleton or twin pregnancy - English or Spanish speaking - Able to give informed consent Exclusion Criteria: - End organ complications of diabetes (retinopathy, renal insufficiency, etc.) - Prior need for insulin for glycemic control - History of diabetic ketoacidosis (DKA) or hyperosmolar state - Prior adverse reaction (ie. lactic acidosis) or allergy to Metformin - Kidney or liver disease - Significant medical co-morbidities (lupus, cystic fibrosis, etc.) Hypertension controlled on one medication, well controlled asthma, and well controlled thyroid disease are not excluded.
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00835861
Other Study ID Numbers	UNC08-0898
Has Data Monitoring Committee	No
Information Provided By	University of North Carolina, Chapel Hill
Study Sponsor	University of North Carolina, Chapel Hill
Collaborators	WakeMed Health and Hospitals
Investigators	Principal Investigator: Ashley Hickman, MD University of North Carolina, Chapel Hill
Verification Date	May 2013

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