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

21 april 2017 uppdaterad av: University of North Carolina, Chapel Hill

Pilot Study of Metformin vs. Insulin in Pregnant Overt Diabetics (MIPOD)

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 neutral protamine Hagedorn (NPH) insulin or Metformin. Our hypothesis is that Metformin will provide glycemic control that is equivalent to insulin in these women.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

31

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • North Carolina
      • Chapel Hill, North Carolina, Förenta staterna, 27599
        • University of North Carolina Hospitals Obstetric Clinics

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: 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 naïve, 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.
Andra namn:
  • Glucophage
Aktiv komparator: 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.
Läkemedel: 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.
Andra namn:
  • Novolin R
  • Vanligt insulin
  • Humulin R
  • Humulin N
  • Novolin N
  • NPH Insulin

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Blood Glucose Measurements
Tidsram: Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery
Patients self monitored glucose measures throughout pregnancy to aid glycemic control. Fasting morning measures and postprandial measures were taken at 1 hour after breakfast, lunch, and dinner.
Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Patients With Obstetric Complications
Tidsram: Throughout pregnancy until hospital discharge following delivery.
Maternal complications were stillbirths, major malformations, shoulder dystocia, or postpartum hemorrhage requiring transfusion.
Throughout pregnancy until hospital discharge following delivery.
Maternal Weight Gain
Tidsram: Baseline throughout pregnancy until last prenatal visit.
Baseline throughout pregnancy until last prenatal visit.
Number of Babies With Neonatal Hypoglycemia
Tidsram: Time of delivery through hospital discharge
Initial neonatal glucose < 40 mg/dL
Time of delivery through hospital discharge
Glycosylated Hemoglobin (HbA1c) by Pregnancy Trimester
Tidsram: 1st, 2nd, and 3rd trimester
1st, 2nd, and 3rd trimester
Percent of Glucose Values at or Below Fasting Goal (<95 mg/dL)
Tidsram: Baseline throughout pregnancy until time of delivery
NUMBER OF ASSESSMENTS OF FASTING GLUCOSE VALUES <95
Baseline throughout pregnancy until time of delivery
Percent of Glucose Values at or Below Postprandial Goal (<130 mg/dL)
Tidsram: Baseline throughout pregnancy until time of delivery
NUMBER OF ASSESSMENTS OF POSTPRANDIAL GLUCOSE VALUES <130
Baseline throughout pregnancy until time of delivery
Number of Episodes Maternal Hypoglycemia
Tidsram: Baseline throughout pregnancy until time of delivery
Maternal glucose < 60 mg/dL
Baseline throughout pregnancy until time of delivery
Number of Babies With Adverse Neonatal Outcomes
Tidsram: Delivery until hospital discharge
Resuscitation in the delivery room, preterm birth < 37 weeks, neonatal intensive care unit care, birth injury or diagnosis of neonatal complication, glucose infusion, antibiotics, or phototherapy.
Delivery until hospital discharge

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of North Carolina, Chapel Hill

Samarbetspartners

WakeMed Health and Hospitals

Utredare

  • Huvudutredare: Ashley Hickman, MD, University of North Carolina, Chapel Hill

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2008

Primärt slutförande (Faktisk)

1 februari 2010

Avslutad studie (Faktisk)

1 april 2010

Studieregistreringsdatum

Först inskickad

2 februari 2009

Först inskickad som uppfyllde QC-kriterierna

2 februari 2009

Första postat (Uppskatta)

4 februari 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 april 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 april 2017

Senast verifierad

1 april 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • UNC08-0898

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