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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Device: V-Go™

• Study Type: Observational
• Enrollment (Actual): 270

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Type 2 Diabetes Mellitus

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic control is measured by the HbA1C from the beginning of the study to the end.	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.	Occurrence of hypoglycemia confirmed with self monitored plasma referenced glucose measurement <70 mg/dl.	12 month
Number of Participants with adverse events.		12 month
How well the participants follow their doctors prescriptions for diabetes care.	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.	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.		12 month

Collaborators and Investigators

• Sponsor: Valeritas, Inc.
• Collaborators: Integrated Medical Development
• Investigators: Principal Investigator: Rickey Manning, MD, PMG Research of Knoxville; 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: Georges M. Argoud, MD, San Diego Coastal Endocrinology Group

Publications and helpful links

General Publications

• 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.

Helpful Links

• V-Go™
• American Diabetes Association

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: March 3, 2011
• First Submitted That Met QC Criteria: March 30, 2011
• First Posted (Estimate): March 31, 2011

Study Record Updates

• Last Update Posted (Estimate): June 2, 2015
• Last Update Submitted That Met QC Criteria: June 1, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Insulin; Type 2 Diabetes; V Go™; Oral Anti Hypoglycemic Drugs
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: V4006