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

Completed

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01326598

Run by

Valeritas, Inc.

People needed

270

Starts

2012-01-01

Expected to finish

2014-05-01

Last updated by the study team

2015-06-02

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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