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



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:January 2012
End Date:July 2013
Contact:Oksana Lupak, BSc.
Email:olupak@imdcro.com
Phone:(609)897-0505

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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.


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.
We found this trial at
17
sites
Smithtown, New York 11787
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Smithtown, NY
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Atlanta, Georgia 30309
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Atlanta, GA
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Baltimore, Maryland 21204
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Baltimore, MD
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Bloomfield Hills, Michigan 48302
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Bloomfield Hills, MI
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Chattanooga, Tennessee 37403
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Chattanooga, TN
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Denville, New Jersey 07834
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Denville, NJ
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Greenville, North Carolina 27834
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Greenville, NC
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Langhorne, Pennsylvania 19047
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Langhorne, PA
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Morehead City, North Carolina 28557
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Morehead City, NC
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Morehead City, North Carolina 28557
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Morehead City, NC
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New Hyde Park, New York 11042
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New Hyde Park, NY
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Port Charlotte, Florida 33952
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Port Charlotte, FL
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Roswell, Georgia 30076
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Roswell, GA
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San Francisco, California 94110
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San Francisco, CA
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Santa Fe, New Mexico 87505
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Santa Fe, NM
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Smithtown, New York 11787
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Smithtown, NY
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Wichita, Kansas 67211
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Wichita, KS
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