Effectiveness of V-Go™ for Patients With Diabetes in a Real-world Setting
NCT ID: NCT01326598
Last Updated: 2015-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
270 participants
OBSERVATIONAL
2012-01-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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T2DM patients with A1C<7.0%
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
21 Years
80 Years
ALL
No
Sponsors
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Integrated Medical Development
INDUSTRY
Valeritas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nancy J. Bohannon, MD
Role: PRINCIPAL_INVESTIGATOR
Nancy J. Bohannon Med. Corp
David Huffman, MD
Role: PRINCIPAL_INVESTIGATOR
University Diabetes & Endocrine Consultants
George Grunberger, MD
Role: PRINCIPAL_INVESTIGATOR
Grunberger Diabetes Institute
Kenneth Hershon, MD
Role: PRINCIPAL_INVESTIGATOR
North Shore Diabetes & Endocrine Assoc.
Chip Reed, MD
Role: PRINCIPAL_INVESTIGATOR
Endocrine Research Solutions, Inc.
Cheryl Rosenfeld, DO
Role: PRINCIPAL_INVESTIGATOR
North Jersey Endocrine Consultants, LLCAND
Alan B. Schorr, DO
Role: PRINCIPAL_INVESTIGATOR
Alan B. Schorr, DO FACE
Mark Warren, MD
Role: PRINCIPAL_INVESTIGATOR
Physicians East, PA
Richard A. Guthrie, MD
Role: PRINCIPAL_INVESTIGATOR
MidAmerica Diabetes Associates
Lenita Hanson, MD
Role: PRINCIPAL_INVESTIGATOR
MEDSOL Clinical Research Center
Philip A. Levin, MD
Role: PRINCIPAL_INVESTIGATOR
MODEL Clinical Research
Michael Shanik, MD
Role: PRINCIPAL_INVESTIGATOR
Endocrine Associates of Long Island, PC
Kathryn Jean Lucas, MD
Role: PRINCIPAL_INVESTIGATOR
Diabetes & Endocrinology Consultants
Mary Katherine Lawrence, MD
Role: PRINCIPAL_INVESTIGATOR
Down East Medical Associates
Sherry Sussman, MD
Role: PRINCIPAL_INVESTIGATOR
Middle Country Endocrinology, P.C.
Robert Bernstein, MD
Role: PRINCIPAL_INVESTIGATOR
Regional Endocrinology Associates, PC
Albert Johary, MD
Role: PRINCIPAL_INVESTIGATOR
Albert Johary M.D., P.C.
Jeffrey Rothman, MD
Role: PRINCIPAL_INVESTIGATOR
University Physicians Group
Robert Savino, DO
Role: PRINCIPAL_INVESTIGATOR
Western Connecticut Health Network, Inc.
Sarah Khan, MD
Role: PRINCIPAL_INVESTIGATOR
Parsippany Endocrine, LLC
Jonathan Wilson, DO
Role: PRINCIPAL_INVESTIGATOR
PMG Research of Winston-Salem
Stephanie Powell, MD
Role: PRINCIPAL_INVESTIGATOR
PMG Research of Bristol
Rickey Manning, MD
Role: PRINCIPAL_INVESTIGATOR
PMG Research of Knoxville
Georges M. Argoud, MD
Role: PRINCIPAL_INVESTIGATOR
San Diego Coastal Endocrinology Group
Locations
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San Diego Coastal Endocrinology Group
Chula Vista, California, United States
Nancy J. Bohannon Med. Corp
San Francisco, California, United States
Western Connecticut Health Network, Inc.
Danbury, Connecticut, United States
MEDSOL Clinical Research Center
Port Charlotte, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Albert Johary M.D., P.C.
Dunwoody, Georgia, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States
MidAmerica Diabetes Associates
Wichita, Kansas, United States
MODEL Clinical Research
Baltimore, Maryland, United States
Grunberger Diabetes Institute
Bloomfield Hills, Michigan, United States
North Jersey Endocrine Consultants, LLCAND
Denville, New Jersey, United States
Parsippany Endocrine, LLC
Parsippany, New Jersey, United States
Regional Endocrinology Associates, PC
Santa Fe, New Mexico, United States
North Shore Diabetes & Endocrine Assoc.
New Hyde Park, New York, United States
Endocrine Associates of Long Island, PC
Smithtown, New York, United States
Middle Country Endocrinology, P.C.
Smithtown, New York, United States
University Physicians Group
Staten Island, New York, United States
Physicians East, PA
Greenville, North Carolina, United States
Diabetes & Endocrinology Consultants
Morehead City, North Carolina, United States
Down East Medical Associates
Morehead City, North Carolina, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States
Alan B. Schorr, DO FACE
Langhorne, Pennsylvania, United States
PMG Research of Bristol
Bristol, Tennessee, United States
University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, United States
PMG Research of Knoxville
Knoxville, Tennessee, United States
Countries
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References
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Grunberger G, Rosenfeld CR, Bode BW, Abbott SD, Nikkel C, Shi L, Strange P. Effectiveness of V-Go(R) for Patients with Type 2 Diabetes in a Real-World Setting: A Prospective Observational Study. Drugs Real World Outcomes. 2020 Mar;7(1):31-40. doi: 10.1007/s40801-019-00173-8.
Related Links
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V-Go™
Other Identifiers
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V4006
Identifier Type: -
Identifier Source: org_study_id
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