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

NCT01326598 | Completed

• 1 other identifier: V4006
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 25

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

V Go™; Type 2 Diabetes; Insulin; Oral Anti Hypoglycemic Drugs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Glycemic control is measured by the HbA1C from the beginning of the study to the end.

  12 month

• To describe the incidence of hypoglycemia in participants as measured by blood glucose of <70 mg/dl.

  12 month

• Number of Participants with adverse events.

  12 month

• How well the participants follow their doctors prescriptions for diabetes care.

  12 month

• To describe insulin dose requirements from the beginning to the end of the study , and concomitant drugs to lower blood glucose.

  12 month

Study Arms (1)

T2DM patients with A1C<7.0%

Device: V-Go™

Interventions

V-Go™ DEVICE

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.

T2DM patients with A1C<7.0%

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type 2 Diabetes Mellitus

You may qualify if:

• Diagnosed type 2 diabetes mellitus for at least 12 months.
• 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).
• Must be willing to self monitor glucose at least twice a day.
• The patient must be willing and able in the opinion of the investigator to try V-Go as therapy.
• Age between 21 and 80 years old, inclusive.
• A1C greater than or equal to 7.0%.

You may not qualify if:

• Acute infection with fever.
• 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.
• 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.
• Any medical history of malignant melanoma or breast cancer.
• Medical history of any other cancers within the last five years except adequately treated basal cell carcinoma or cervical carcinoma in-situ.
• History of alcohol or drug abuse within the last year.
• Any medical condition that in the opinion of the investigator may preclude safe and successful completion of the trial.
• Participation in other clinical trials involving receipt of investigational drug that cannot be disclosed within the last 30 days.
• Unwillingness and/or inability to comply with study procedures.
• 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.
• History of hypersensitivity or hyperreactivity to adhesives.

Sponsors & Collaborators

• Valeritas, Inc.: lead
• Integrated Medical Development: collaborator

Study Sites (25)

San Diego Coastal Endocrinology Group

Chula Vista, California, 91911, United States

Location

Nancy J. Bohannon Med. Corp

San Francisco, California, 94110, United States

Location

Western Connecticut Health Network, Inc.

Danbury, Connecticut, 06810, United States

Location

MEDSOL Clinical Research Center

Port Charlotte, Florida, 33952, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30309, United States

Location

Albert Johary M.D., P.C.

Dunwoody, Georgia, 30338, United States

Location

Endocrine Research Solutions, Inc.

Roswell, Georgia, 30076, United States

Location

MidAmerica Diabetes Associates

Wichita, Kansas, 67211, United States

Location

MODEL Clinical Research

Baltimore, Maryland, 21204, United States

Location

Grunberger Diabetes Institute

Bloomfield Hills, Michigan, 48302, United States

Location

North Jersey Endocrine Consultants, LLCAND

Denville, New Jersey, 07834, United States

Location

Parsippany Endocrine, LLC

Parsippany, New Jersey, 07054, United States

Location

Regional Endocrinology Associates, PC

Santa Fe, New Mexico, 87505, United States

Location

North Shore Diabetes & Endocrine Assoc.

New Hyde Park, New York, 11042, United States

Location

Endocrine Associates of Long Island, PC

Smithtown, New York, 11787, United States

Location

Middle Country Endocrinology, P.C.

Smithtown, New York, 11787, United States

Location

University Physicians Group

Staten Island, New York, 10301, United States

Location

Physicians East, PA

Greenville, North Carolina, 27834, United States

Location

Diabetes & Endocrinology Consultants

Morehead City, North Carolina, 28557, United States

Location

Down East Medical Associates

Morehead City, North Carolina, 28557, United States

Location

PMG Research of Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Alan B. Schorr, DO FACE

Langhorne, Pennsylvania, 19047, United States

Location

PMG Research of Bristol

Bristol, Tennessee, 37620, United States

Location

University Diabetes & Endocrine Consultants

Chattanooga, Tennessee, 37403, United States

Location

PMG Research of Knoxville

Knoxville, Tennessee, 37919, United States

Location

Related Publications (1)

• 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.

  PMID: 31833010 DERIVED

Related Links

• V-Go™

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: March 31, 2011
• Study Start: January 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 2, 2015

Record last verified: 2015-06

Locations

US (25)