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

2015年6月1日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

观察性的

注册 (实际的)

270

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Type 2 Diabetes Mellitus

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
T2DM patients with A1C<7.0%
设备：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.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
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.
大体时间：12 month
12 month

次要结果测量

结果测量
措施说明
大体时间
Glycemic control is measured by the HbA1C from the beginning of the study to the end.
大体时间：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.
大体时间：12 month
Occurrence of hypoglycemia confirmed with self monitored plasma referenced glucose measurement <70 mg/dl.
12 month
Number of Participants with adverse events.
大体时间：12 month
12 month
How well the participants follow their doctors prescriptions for diabetes care.
大体时间：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.
大体时间：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.
大体时间：12 month
12 month

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Valeritas, Inc.

合作者

Integrated Medical Development

调查人员

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

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年1月1日

初级完成 (实际的)

2014年3月1日

研究完成 (实际的)

2014年5月1日

研究注册日期

首次提交

2011年3月3日

首先提交符合 QC 标准的

2011年3月30日

首次发布 (估计)

2011年3月31日

研究记录更新

最后更新发布 (估计)

2015年6月2日

上次提交的符合 QC 标准的更新

2015年6月1日

最后验证

2015年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • V4006

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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