Effect of Adding Metformin to Insulin in Uncontrolled Diabetic Patients During the 3rd Trimester of Pregnancy
Condition: Diabetes Mellitus Pregnancy
MeSH terms: Pregnancy in Diabetics
Study type: Interventional
Phase: Phase 4

Summary: 
      Background Diabetes mellitus (DM) is a significant contributor to adverse obstetric and
      perinatal outcome. There is now clear and unequivocal evidence that adverse pregnancy
      outcomes are strongly linked to maternal hyperglycemia, both in the peri-conception period
      and throughout gestation. Although strict glycemic control does improve outcomes, there is
      still a higher rate of complications in women with DM and poorer perinatal outcomes .

      The incidence of type 2 diabetes is rising worldwide at a remarkable rate IDF When receiving
      large doses of insulin, patients complain of pain at the site of injection leading to
      compliance issues and poor glycemic control. This can be explained as when taking large doses
      of insulin it leads to alter absorption kinetics because very large doses are delivered to
      one site, resulting in a failure to reduce postprandial hyperglycemia, but with later
      hypoglycemia once the insulin is absorbed. This poor glycemic control in mothers with
      diabetes leads to an increased risk of severe respiratory distress syndrome, low Apgar
      scores, neonatal hypoglycemia and neonatal intensive care unit (NICU) admissions .

      Infants of mothers with diabetes have high rates of being born large for gestational age
      (LGA) and macrosomic (>4 or 4.5 kg). Macrosomia is associated with increased rates of
      perinatal asphyxia, meconium aspiration, hypoglycemia, shoulder dystocia, brachial plexus
      injury, skeletal injuries, and fetal death .

      Metformin is among the oldest and most well studied oral anti hyperglycemic agents. Its
      efficacy has been demonstrated both in the primary prevention of disease and secondary
      prevention of diabetes-related morbidity and mortality. Because of metformin's proven
      efficacy, low cost, and minimal side effect profile, it is largely recommended as the first
      line, initial monotherapy and as part of any combination therapy (included with insulin) for
      the treatment and prevention of type II diabetes .

      Metformin produces euglycemia by reducing insulin resistance, improving insulin sensitivity,
      reducing hepatic gluconeogenesis, and increasing peripheral glucose uptake and utilization.
    

Detailed description: 
      Objectives To determine whether the addition of metformin to a standard regimen of insulin is
      more effective in glycemic control , fetal and neonatal outcome than conventional insulin
      alone in uncontrolled diabetic patients during the 3rd trimester of pregnancy.
    

Intervention name(s): Metformin; Insulin
Intervention type(s): Drug; Drug
Intervention description(s): 1gm tablet with the 2 main meals; subcutaneous insulin daily administration
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment