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

Valeritas

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Device: V-Go™

Study type: Observational

Funder types: Industry

Identifiers

NCT01326598

V4006

Details and patient eligibility

About

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.

Enrollment: 270 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

270 participants in 1 patient group

T2DM patients with A1C<7.0%

Treatment:

Device: V-Go™