- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03651531
Comparison of Insulin Alone to Insulin With Metformin to Treat Gestational Diabetes Mellitus
22. juli 2020 oppdatert av: Women and Infants Hospital of Rhode Island
This study is a prospective, unmasked randomized clinical trial comparing the use of insulin vs combination insulin and metformin for treatment in women diagnosed with gestational diabetes mellitus (GDM).
The investigator's hypothesis is that the combination of metformin and insulin will be superior to insulin alone to achieve tight glucose control during pregnancy.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The objective of this study is to compare the effectiveness of insulin alone vs the combination of insulin and metformin in treating patients with gestational diabetes (GDM).
Currently, outside of pregnancy, the treatment of type 2 diabetes mellitus (T2DM) with both metformin and insulin is superior to using insulin alone.
In pregnancy, insulin alone has traditionally been used, though some advocate the use of metformin alone as primary therapy.
There have been no trials published to date specifically comparing combination therapy to insulin alone.
Our hypothesis is that the combination of metformin and insulin will improve overall control of blood glucose, the improvement of which has been demonstrated to improve maternal and neonatal outcomes.
Control of blood glucose will be determined by hemoglobin A1c at the time of delivery.
Studietype
Intervensjonell
Registrering (Faktiske)
1
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Rhode Island
-
Providence, Rhode Island, Forente stater, 02905
- Women & Infants Hospital
-
-
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:
- Able to read and write English and/or Spanish and give written consent
- Diagnosis of GDM, defined as an abnormal glucose tolerance test performed after 12 weeks gestation using 1 of the 2 criteria below:
- 50 gram 1 hour oral diabetes screening testing yielding a result of > 200 mg/dL
- A 100 gram 3 hour oral glucose tolerance testing yielding >2 abnormal values (normal values defined as fasting blood glucose < 95, 1 hour < 180, 2 hour < 155 and 3 hour < 140)
- Singleton gestation
- Gestational age between 12 and 34 weeks and 6 days determined by last menstrual period (LMP) confirmed by ultrasound using criteria set forth by the ACOG (Committee on Obstetric Practice). If LMP is unknown then gestational age must be set by ultrasound prior to 20 weeks gestation.
Exclusion Criteria:
- Pre-existing DM either by diagnosis preceding pregnancy or hemoglobin A1c >6.5 collected during the current pregnancy
- Uncontrolled chronic hypertension, as this may alter maternal and perinatal outcomes measured.
- Multiple gestations
- Major fetal anomalies anticipated to require NICU admission
- Contraindication to metformin (allergy, history of lactic acidosis, pre-existing renal disease (Cr >1.5 mg/dL), active liver disease, current alcohol abuse).
- Vitamin B12 deficiency, as metformin reduces intestinal absorption of vitamin B12
- Medications known to effect glucose metabolism other than insulin and metformin as this may mask any effect between the two treatments.
- Known inability to tolerate metformin.
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 |
---|---|
Aktiv komparator: insulin
|
Weight based insulin will be calculated using 0.7 units/kg/day in the first trimester, 0.8 units/kg/day in the second trimester and 1 units/kg/day in the third trimester.
This total insulin will then be divided into short acting insulin and intermediate acting insulin per provider discretion.
|
Aktiv komparator: insulin and metformin
|
Weight based insulin will be calculated using 0.7 units/kg/day in the first trimester, 0.8 units/kg/day in the second trimester and 1 units/kg/day in the third trimester.
This total insulin will then be divided into short acting insulin and intermediate acting insulin per provider discretion.
Will be initiated at dose of 500 mg twice daily.
If glycemic control is suboptimal, the dose of metformin will be increased to 1000 mg twice a day.
Metformin will be titrated prior to increases in insulin.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Hgb A1c
Tidsramme: collected at the time of delivery
|
Hgb A1c test
|
collected at the time of delivery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Total daily dose of insulin
Tidsramme: Will be recorded on hospital admission for delivery
|
Total daily dose of insulin at the end of pregnancy
|
Will be recorded on hospital admission for delivery
|
Glucose control
Tidsramme: patients will collect glucose values fasting and 2 hrs postprandial every day from enrollment until delivery.
|
Average of fasting and 2 hour postprandial glucose values
|
patients will collect glucose values fasting and 2 hrs postprandial every day from enrollment until delivery.
|
Incidence of maternal hypoglycemia
Tidsramme: patients will be screened weekly for episodes of hypoglycemia until delivery
|
episodes of maternal hypoglycemia defined as glucose ≤70 mg/dL
|
patients will be screened weekly for episodes of hypoglycemia until delivery
|
Change in hemoglobin A1c over the course of the pregnancy
Tidsramme: hemoglobin A1c will be collected at delivery (per above) and comparison performed after collection
|
If baseline hemoglobin A1c was collected as part of routine care prior to enrollment, this value will be compared to the hemoglobin A1c collected at delivery
|
hemoglobin A1c will be collected at delivery (per above) and comparison performed after collection
|
Incidence of maternal side effects
Tidsramme: Will be assessed weekly until delivery
|
maternal reported medication side effects (i.e.
nausea, vomiting, diarrhea)
|
Will be assessed weekly until delivery
|
Treatment acceptability
Tidsramme: Will be collected postpartum after delivery
|
determined using Diabetes Treatment Satisfaction Questionnaire.
Survey includes 8 questions that are answered on a scale of 0-6; 0 indicating the least and 6 the highest level of satisfaction.
The individual questions will be compared.
Total satisfaction will also be compared by summing the responses to all 8 questions on a composite scale of 0-48
|
Will be collected postpartum after delivery
|
Maternal weight gain
Tidsramme: This will be calculated as the difference from the weight measured at the inital prenatal visit (the specific timing of which is patient dependant) and at the time of admission for delivery
|
weight gain through pregnancy
|
This will be calculated as the difference from the weight measured at the inital prenatal visit (the specific timing of which is patient dependant) and at the time of admission for delivery
|
Incidence of hypertensive disorder of pregnancy
Tidsramme: from enrollment through study completion (30 days after delivery)
|
gestational HTN, superimposed pre-eclampsia, pre-eclampsia-eclampsia
|
from enrollment through study completion (30 days after delivery)
|
Incidence of composite of adverse maternal outcomes
Tidsramme: from enrollment through study completion (30 days after delivery)
|
death, ICU admission, postpartum hemorrhage, blood transfusion, organ failure, chorioamnionitis/endometritis
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from enrollment through study completion (30 days after delivery)
|
Breast feeding status
Tidsramme: Will be recorded at the time of hospital discharge after delivery (typically 2-4 days after delivery)
|
Whether patient is breast feeding or bottle feeding upon discharge from the hospital after delivery
|
Will be recorded at the time of hospital discharge after delivery (typically 2-4 days after delivery)
|
Mode of delivery
Tidsramme: recorded at time of delivery
|
Mode of delivery
|
recorded at time of delivery
|
Gestational age at delivery
Tidsramme: recorded at time of delivery
|
Gestational age at delivery
|
recorded at time of delivery
|
Infant birthweight (using age/sex matched percentiles)
Tidsramme: measured at time of birth
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Infant birthweight (using age/sex matched percentiles)
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measured at time of birth
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Incidence of composite neonatal morbidity
Tidsramme: from delivery through study completion (30 days after delivery)
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Presence of any of the following: NICU admission, hypoglycemia, hyperbilirubinemia, birth trauma, stillbirth, respiratory distress syndrome, sepsis, neonatal death prior to discharge, 5 minute Apgar score < 7, umbilical artery cord pH <7.10
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from delivery through study completion (30 days after delivery)
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Incidence neonatal hypoglycemia
Tidsramme: from delivery through study completion (30 days after delivery)
|
hypoglycemia requiring intravenous treatment
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from delivery through study completion (30 days after delivery)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Christopher Nau, MD, Women & Infants Hospital
- Hovedetterforsker: Erika Werner, Women & Infants Hospital
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.
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 (Faktiske)
3. januar 2018
Primær fullføring (Faktiske)
30. juli 2019
Studiet fullført (Faktiske)
30. juli 2019
Datoer for studieregistrering
Først innsendt
12. juni 2018
Først innsendt som oppfylte QC-kriteriene
27. august 2018
Først lagt ut (Faktiske)
29. august 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. juli 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. juli 2020
Sist bekreftet
1. juli 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1099865-3
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
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Nei
produkt produsert i og eksportert fra USA
Ja
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