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

Type 2 Diabetes Mellitus Clinical Trial

— SIMPLE  

Official title:

Effectiveness of V-Go™ for Patients With Diabetes in a Real-world Setting: A Long-term, Prospective, Observational Registry (SIMPLE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326598
• Other study ID #: V4006
• Status: Completed
• Phase: N/A
• First received: March 3, 2011
• Last updated: June 1, 2015
• Start date: January 2012
• Est. completion date: May 2014

Study information

• Verified date: June 2015
• Source: Valeritas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	MODEL Clinical Research	Baltimore	Maryland
United States	Grunberger Diabetes Institute	Bloomfield Hills	Michigan
United States	PMG Research of Bristol	Bristol	Tennessee
United States	University Diabetes & Endocrine Consultants	Chattanooga	Tennessee
United States	San Diego Coastal Endocrinology Group	Chula Vista	California
United States	Western Connecticut Health Network, Inc.	Danbury	Connecticut
United States	North Jersey Endocrine Consultants, LLCAND	Denville	New Jersey
United States	Albert Johary M.D., P.C.	Dunwoody	Georgia
United States	Physicians East, PA	Greenville	North Carolina
United States	PMG Research of Knoxville	Knoxville	Tennessee
United States	Alan B. Schorr, DO FACE	Langhorne	Pennsylvania
United States	Diabetes & Endocrinology Consultants	Morehead City	North Carolina
United States	Down East Medical Associates	Morehead City	North Carolina
United States	North Shore Diabetes & Endocrine Assoc.	New Hyde Park	New York
United States	Parsippany Endocrine, LLC	Parsippany	New Jersey
United States	MEDSOL Clinical Research Center	Port Charlotte	Florida
United States	Endocrine Research Solutions, Inc.	Roswell	Georgia
United States	Nancy J. Bohannon Med. Corp	San Francisco	California
United States	Regional Endocrinology Associates, PC	Santa Fe	New Mexico
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	MidAmerica Diabetes Associates	Wichita	Kansas
United States	PMG Research of Winston-Salem	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Valeritas, Inc.	Integrated Medical Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Number of Participants with adverse events.		12 month	No
Secondary	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	No
Secondary	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	No
Secondary	To describe changes in participants' weight from the beginning to the end of the study.		12 month	No

External Links

•   American Diabetes Association
•   V-Go™