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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Integrated Medical Development, LLC
Information provided by (Responsible Party):
Valeritas, Inc.
ClinicalTrials.gov Identifier:
NCT01326598
First received: March 3, 2011
Last updated: February 25, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Device: V-Go™

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effectiveness of V-Go™ for Patients With Diabetes in a Real-world Setting: A Long-term, Prospective, Observational Registry (SIMPLE)

Resource links provided by NLM:


Further study details as provided by Valeritas, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glycemic control is measured by the HbA1C from the beginning of the study to the end. [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    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.

  • To describe the incidence of hypoglycemia in participants as measured by blood glucose of <70 mg/dl. [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Occurrence of hypoglycemia confirmed with self monitored plasma referenced glucose measurement <70 mg/dl.

  • Number of Participants with adverse events. [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • How well the participants follow their doctors prescriptions for diabetes care. [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    To describe frequency of self monitoring plasma glucose with V-Go therapy

  • To describe insulin dose requirements from the beginning to the end of the study , and concomitant drugs to lower blood glucose. [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Some of the insulin dose requirement that will described are: starting dose, dose titration, basal rate selection, dose conversion from previous therapy.

  • To describe changes in participants' weight from the beginning to the end of the study. [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: January 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
T2DM patients with A1C<7.0% Device: 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

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Type 2 Diabetes Mellitus

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326598

  Show 25 Study Locations
Sponsors and Collaborators
Valeritas, Inc.
Integrated Medical Development, LLC
Investigators
Principal Investigator: Nancy J. Bohannon, MD Nancy J. Bohannon Med. Corp
Principal Investigator: David Huffman, MD University Diabetes & Endocrine Consultants
Principal Investigator: George Grunberger, MD Grunberger Diabetes Institute
Principal Investigator: Kenneth Hershon, MD North Shore Diabetes & Endocrine Assoc.
Principal Investigator: Chip Reed, MD Endocrine Research Solutions, Inc.
Principal Investigator: Cheryl Rosenfeld, DO North Jersey Endocrine Consultants, LLCAND
Principal Investigator: Alan B. Schorr, DO Alan B. Schorr, DO FACE
Principal Investigator: Mark Warren, MD Physicians East, PA
Principal Investigator: Richard A. Guthrie, MD MidAmerica Diabetes Associates
Principal Investigator: Lenita Hanson, MD MEDSOL Clinical Research Center
Principal Investigator: Philip A. Levin, MD MODEL Clinical Research
Principal Investigator: Michael Shanik, MD Endocrine Associates of Long Island, PC
Principal Investigator: Kathryn Jean Lucas, MD Diabetes & Endocrinology Consultants
Principal Investigator: Mary Katherine Lawrence, MD Down East Medical Associates
Principal Investigator: Sherry Sussman, MD Middle Country Endocrinology, P.C.
Principal Investigator: Robert Bernstein, MD Regional Endocrinology Associates, PC
Principal Investigator: Albert Johary, MD Albert Johary M.D., P.C.
Principal Investigator: Jeffrey Rothman, MD University Physicians Group
Principal Investigator: Robert Savino, DO Western Connecticut Health Network, Inc.
Principal Investigator: Sarah Khan, MD Parsippany Endocrine, LLC
Principal Investigator: Jonathan Wilson, DO PMG Research of Winston-Salem
Principal Investigator: Stephanie Powell, MD PMG Research of Bristol
Principal Investigator: Rickey Manning, MD PMG Research of Knoxville
Principal Investigator: Georges M. Argoud, MD San Diego Coastal Endocrinology Group
  More Information

Additional Information:
No publications provided

Responsible Party: Valeritas, Inc.
ClinicalTrials.gov Identifier: NCT01326598     History of Changes
Other Study ID Numbers: V4006
Study First Received: March 3, 2011
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Valeritas, Inc.:
V Go™
Type 2 Diabetes
Insulin
Oral Anti Hypoglycemic Drugs

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 29, 2014