Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

1. juni 2015 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

270

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
T2DM patients with A1C<7.0%
Enhed: 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.

Hvad måler undersøgelsen?

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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Valeritas, Inc.

Samarbejdspartnere

Integrated Medical Development

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2012

Primær færdiggørelse (Faktiske)

1. marts 2014

Studieafslutning (Faktiske)

1. maj 2014

Datoer for studieregistrering

Først indsendt

3. marts 2011

Først indsendt, der opfyldte QC-kriterier

30. marts 2011

Først opslået (Skøn)

31. marts 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. juni 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2015

Sidst verificeret

1. juni 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • V4006

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Type 2 diabetes mellitus

Kliniske forsøg med V-Go™

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Algeria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner