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Effectiveness of V-Go™ for Patients With Diabetes in a Real-world Setting (SIMPLE)

1. juni 2015 oppdatert av: Valeritas, Inc.

Effectiveness of V-Go™ for Patients With Diabetes in a Real-world Setting: A Long-term, Prospective, Observational Registry (SIMPLE)

The aim of the present study is to observe glycemic control, dose requirements, hypoglycemia risk, other possible adverse effects and weight changes, as well as to compare these parameters to prior treatment when patients with type 2 diabetes are initiated and treated using V-Go during circumstances as close to normal clinical practice as possible.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Faktiske)

270

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • California
      • Chula Vista, California, Forente stater, 91911
        • San Diego Coastal Endocrinology Group
      • San Francisco, California, Forente stater, 94110
        • Nancy J. Bohannon Med. Corp
    • Connecticut
      • Danbury, Connecticut, Forente stater, 06810
        • Western Connecticut Health Network, Inc.
    • Florida
      • Port Charlotte, Florida, Forente stater, 33952
        • Medsol Clinical Research Center
    • Georgia
      • Atlanta, Georgia, Forente stater, 30309
        • Atlanta Diabetes Associates
      • Dunwoody, Georgia, Forente stater, 30338
        • Albert Johary M.D., P.C.
      • Roswell, Georgia, Forente stater, 30076
        • Endocrine Research Solutions, Inc.
    • Kansas
      • Wichita, Kansas, Forente stater, 67211
        • MidAmerica Diabetes Associates
    • Maryland
      • Baltimore, Maryland, Forente stater, 21204
        • Model Clinical Research
    • Michigan
      • Bloomfield Hills, Michigan, Forente stater, 48302
        • Grunberger Diabetes Institute
    • New Jersey
      • Denville, New Jersey, Forente stater, 07834
        • North Jersey Endocrine Consultants, LLCAND
      • Parsippany, New Jersey, Forente stater, 07054
        • Parsippany Endocrine, LLC
    • New Mexico
      • Santa Fe, New Mexico, Forente stater, 87505
        • Regional Endocrinology Associates, PC
    • New York
      • New Hyde Park, New York, Forente stater, 11042
        • North Shore Diabetes & Endocrine Assoc.
      • Smithtown, New York, Forente stater, 11787
        • Endocrine Associates of Long Island, PC
      • Smithtown, New York, Forente stater, 11787
        • Middle Country Endocrinology, P.C.
      • Staten Island, New York, Forente stater, 10301
        • University Physicians Group
    • North Carolina
      • Greenville, North Carolina, Forente stater, 27834
        • Physicians East, PA
      • Morehead City, North Carolina, Forente stater, 28557
        • Diabetes & Endocrinology Consultants
      • Morehead City, North Carolina, Forente stater, 28557
        • Down East Medical Associates
      • Winston-Salem, North Carolina, Forente stater, 27103
        • PMG Research of Winston-Salem
    • Pennsylvania
      • Langhorne, Pennsylvania, Forente stater, 19047
        • Alan B. Schorr, DO FACE
    • Tennessee
      • Bristol, Tennessee, Forente stater, 37620
        • Pmg Research of Bristol
      • Chattanooga, Tennessee, Forente stater, 37403
        • University Diabetes & Endocrine Consultants
      • Knoxville, Tennessee, Forente stater, 37919
        • PMG Research of Knoxville

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

21 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Type 2 Diabetes Mellitus

Beskrivelse

Inclusion Criteria:

  1. Diagnosed type 2 diabetes mellitus for at least 12 months.

  2. Must be and have been in stable treatment for at least a month within each of the following diabetes medication regimens:

    • OADs only,
    • OADs in combination with either exenatide, pramlintide, liraglutide (collectively termed "incretin mimetics") without receiving insulin,
    • Once or twice daily injection of an intermediate or long acting insulin (insulin NPH, insulin detemir or insulin glargine) with or without OADs and/or an incretin.
    • One to three daily injections of premix insulin (human insulin 70/30, insulin lispro 75/25 or insulin aspart 70/30) with or without OADs and/or an incretin.
    • Any insulin therapy with three or more insulin injections a day with or without OADs (MDI).
  3. Must be willing to self monitor glucose at least twice a day.
  4. The patient must be willing and able in the opinion of the investigator to try V-Go as therapy.
  5. Age between 21 and 80 years old, inclusive.
  6. A1C greater than or equal to 7.0%.

Exclusion Criteria:

  1. Acute infection with fever.
  2. Serum creatinine > 3.0 mg/dl if not on metformin, or if on metformin for females creatinine > 1.4 mg/dl, for males creatinine > 1.5 mg/dl within the last 6 months.
  3. Pregnancy, intention to become pregnant or failure to agree to use adequate contraceptive measures during the trial for females of current reproductive potential.Medically acceptable contraceptives include: (1) surgical sterilization (such as tubal ligation or hysterectomy), (2) approved hormonal contraceptives (pills, patches, implants, or injections), (3) barrier methods (condom, diaphragm) used with spermicide, or (4) intrauterine device (IUD). Contraceptive measures such as "Plan B™", for emergency use after unprotected sex, are not acceptable methods for routine use. A lifestyle of abstinence from sexual activity is an acceptable means of contraception. If currently abstinent, the subject must agree to use a double-barrier method as described above if they become sexually active during the study period.
  4. Any medical history of malignant melanoma or breast cancer.
  5. Medical history of any other cancers within the last five years except adequately treated basal cell carcinoma or cervical carcinoma in-situ.
  6. History of alcohol or drug abuse within the last year.
  7. Any medical condition that in the opinion of the investigator may preclude safe and successful completion of the trial.
  8. Participation in other clinical trials involving receipt of investigational drug that cannot be disclosed within the last 30 days.
  9. Unwillingness and/or inability to comply with study procedures.
  10. Require regular adjustments or modifications to the basal rate during a 24-hour period, or if the amount of insulin used at meals require adjustments of less-than 2-Unit increments.
  11. History of hypersensitivity or hyperreactivity to adhesives.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
T2DM patients with A1C<7.0%
Enhet: V-Go™
Use of Insulin Delivery Device, V-Go, and the effect on A1C for T2DM patients in five categories of baseline oral antidiabetes drug (OAD) use with or without insulin.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
The primary objective is to compare change of average glycemic control as measured by A1C from baseline to the end of V-Go use for the whole cohort as well as each of the five categories of baseline treatment.
Tidsramme: 12 month
12 month

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Glycemic control is measured by the HbA1C from the beginning of the study to the end.
Tidsramme: 12 month
To describe change of average glycemic control as measured by A1C from baseline to the particular time point of analysis irrespective of treatment, and to describe this change for subjects who are still treated with the V-Go and those who have switched to other therapies.
12 month
To describe the incidence of hypoglycemia in participants as measured by blood glucose of <70 mg/dl.
Tidsramme: 12 month
Occurrence of hypoglycemia confirmed with self monitored plasma referenced glucose measurement <70 mg/dl.
12 month
Number of Participants with adverse events.
Tidsramme: 12 month
12 month
How well the participants follow their doctors prescriptions for diabetes care.
Tidsramme: 12 month
To describe frequency of self monitoring plasma glucose with V-Go therapy
12 month
To describe insulin dose requirements from the beginning to the end of the study , and concomitant drugs to lower blood glucose.
Tidsramme: 12 month
Some of the insulin dose requirement that will described are: starting dose, dose titration, basal rate selection, dose conversion from previous therapy.
12 month
To describe changes in participants' weight from the beginning to the end of the study.
Tidsramme: 12 month
12 month

Samarbeidspartnere og etterforskere

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

Sponsor

Valeritas, Inc.

Samarbeidspartnere

Integrated Medical Development

Etterforskere

  • Hovedetterforsker: Rickey Manning, MD, PMG Research of Knoxville
  • Hovedetterforsker: Nancy J. Bohannon, MD, Nancy J. Bohannon Med. Corp
  • Hovedetterforsker: David Huffman, MD, University Diabetes & Endocrine Consultants
  • Hovedetterforsker: George Grunberger, MD, Grunberger Diabetes Institute
  • Hovedetterforsker: Kenneth Hershon, MD, North Shore Diabetes & Endocrine Assoc.
  • Hovedetterforsker: Chip Reed, MD, Endocrine Research Solutions, Inc.
  • Hovedetterforsker: Cheryl Rosenfeld, DO, North Jersey Endocrine Consultants, LLCAND
  • Hovedetterforsker: Alan B. Schorr, DO, Alan B. Schorr, DO FACE
  • Hovedetterforsker: Mark Warren, MD, Physicians East, PA
  • Hovedetterforsker: Richard A. Guthrie, MD, MidAmerica Diabetes Associates
  • Hovedetterforsker: Lenita Hanson, MD, Medsol Clinical Research Center
  • Hovedetterforsker: Philip A. Levin, MD, Model Clinical Research
  • Hovedetterforsker: Michael Shanik, MD, Endocrine Associates of Long Island, PC
  • Hovedetterforsker: Kathryn Jean Lucas, MD, Diabetes & Endocrinology Consultants
  • Hovedetterforsker: Mary Katherine Lawrence, MD, Down East Medical Associates
  • Hovedetterforsker: Sherry Sussman, MD, Middle Country Endocrinology, P.C.
  • Hovedetterforsker: Robert Bernstein, MD, Regional Endocrinology Associates, PC
  • Hovedetterforsker: Albert Johary, MD, Albert Johary M.D., P.C.
  • Hovedetterforsker: Jeffrey Rothman, MD, University Physicians Group
  • Hovedetterforsker: Robert Savino, DO, Western Connecticut Health Network, Inc.
  • Hovedetterforsker: Sarah Khan, MD, Parsippany Endocrine, LLC
  • Hovedetterforsker: Jonathan Wilson, DO, PMG Research of Winston-Salem
  • Hovedetterforsker: Georges M. Argoud, MD, San Diego Coastal Endocrinology Group

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

Hjelpsomme linker

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. januar 2012

Primær fullføring (Faktiske)

1. mars 2014

Studiet fullført (Faktiske)

1. mai 2014

Datoer for studieregistrering

Først innsendt

3. mars 2011

Først innsendt som oppfylte QC-kriteriene

30. mars 2011

Først lagt ut (Anslag)

31. mars 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

2. juni 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juni 2015

Sist bekreftet

1. juni 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • V4006

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