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

21. april 2017 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

31

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27599
        • University of North Carolina Hospitals Obstetric Clinics

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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.
Andre navn:
  • 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.
Legemiddel: 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.
Andre navn:
  • Novolin R
  • Vanlig insulin
  • Humulin R
  • Humulin N
  • Novolin N
  • NPH Insulin

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Blood Glucose Measurements
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Patients With Obstetric Complications
Tidsramme: 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
Tidsramme: Baseline throughout pregnancy until last prenatal visit.
Baseline throughout pregnancy until last prenatal visit.
Number of Babies With Neonatal Hypoglycemia
Tidsramme: Time of delivery through hospital discharge
Initial neonatal glucose < 40 mg/dL
Time of delivery through hospital discharge
Glycosylated Hemoglobin (HbA1c) by Pregnancy Trimester
Tidsramme: 1st, 2nd, and 3rd trimester
1st, 2nd, and 3rd trimester
Percent of Glucose Values at or Below Fasting Goal (<95 mg/dL)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of North Carolina, Chapel Hill

Samarbeidspartnere

WakeMed Health and Hospitals

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2008

Primær fullføring (Faktiske)

1. februar 2010

Studiet fullført (Faktiske)

1. april 2010

Datoer for studieregistrering

Først innsendt

2. februar 2009

Først innsendt som oppfylte QC-kriteriene

2. februar 2009

Først lagt ut (Anslag)

4. februar 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. april 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. april 2017

Sist bekreftet

1. april 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • UNC08-0898

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