Clinical trial NCT01326598: Effectiveness of V-Go™ for Patients With Diabetes in a Real-world Setting
Official title: Effectiveness of V-Go™ for Patients With Diabetes in a Real-world Setting: A Long-term, Prospective, Observational Registry (SIMPLE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: V Go™
Type 2 Diabetes
Insulin
Oral Anti Hypoglycemic Drugs
Lead sponsor: Valeritas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Integrated Medical Development
First posted: 2011-03-31
Enrollment: 270
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 Diabetes Mellitus

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 12 month
Secondary outcomes:
measure: Glycemic control is measured by the HbA1C from the beginning of the study to the end.
timeFrame: 12 month
measure: To describe the incidence of hypoglycemia in participants as measured by blood glucose of <70 mg/dl.
timeFrame: 12 month
measure: Number of Participants with adverse events.
timeFrame: 12 month
measure: How well the participants follow their doctors prescriptions for diabetes care.
timeFrame: 12 month
measure: To describe insulin dose requirements from the beginning to the end of the study , and concomitant drugs to lower blood glucose.
timeFrame: 12 month
measure: To describe changes in participants' weight from the beginning to the end of the study.
timeFrame: 12 month
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: San Diego Coastal Endocrinology Group
state: California
city: San Francisco
country: United States
facility: Nancy J. Bohannon Med. Corp
state: California
city: Danbury
country: United States
facility: Western Connecticut Health Network, Inc.
state: Connecticut
city: Port Charlotte
country: United States
facility: MEDSOL Clinical Research Center
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Dunwoody
country: United States
facility: Albert Johary M.D., P.C.
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions, Inc.
state: Georgia
city: Wichita
country: United States
facility: MidAmerica Diabetes Associates
state: Kansas
city: Baltimore
country: United States
facility: MODEL Clinical Research
state: Maryland
city: Bloomfield Hills
country: United States
facility: Grunberger Diabetes Institute
state: Michigan
city: Denville
country: United States
facility: North Jersey Endocrine Consultants, LLCAND
state: New Jersey
city: Parsippany
country: United States
facility: Parsippany Endocrine, LLC
state: New Jersey
city: Santa Fe
country: United States
facility: Regional Endocrinology Associates, PC
state: New Mexico
city: New Hyde Park
country: United States
facility: North Shore Diabetes & Endocrine Assoc.
state: New York
city: Smithtown
country: United States
facility: Endocrine Associates of Long Island, PC
state: New York
city: Smithtown
country: United States
facility: Middle Country Endocrinology, P.C.
state: New York
city: Staten Island
country: United States
facility: University Physicians Group
state: New York
city: Greenville
country: United States
facility: Physicians East, PA
state: North Carolina
city: Morehead City
country: United States
facility: Diabetes & Endocrinology Consultants
state: North Carolina
city: Morehead City
country: United States
facility: Down East Medical Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Langhorne
country: United States
facility: Alan B. Schorr, DO FACE
state: Pennsylvania
city: Bristol
country: United States
facility: PMG Research of Bristol
state: Tennessee
city: Chattanooga
country: United States
facility: University Diabetes & Endocrine Consultants
state: Tennessee
city: Knoxville
country: United States
facility: PMG Research of Knoxville
state: Tennessee
Study officials:
affiliation: Nancy J. Bohannon Med. Corp
name: Nancy J. Bohannon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Diabetes & Endocrine Consultants
name: David Huffman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Grunberger Diabetes Institute
name: George Grunberger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: North Shore Diabetes & Endocrine Assoc.
name: Kenneth Hershon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Endocrine Research Solutions, Inc.
name: Chip Reed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: North Jersey Endocrine Consultants, LLCAND
name: Cheryl Rosenfeld, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Alan B. Schorr, DO FACE
name: Alan B. Schorr, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Physicians East, PA
name: Mark Warren, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MidAmerica Diabetes Associates
name: Richard A. Guthrie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MEDSOL Clinical Research Center
name: Lenita Hanson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MODEL Clinical Research
name: Philip A. Levin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Endocrine Associates of Long Island, PC
name: Michael Shanik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diabetes & Endocrinology Consultants
name: Kathryn Jean Lucas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Down East Medical Associates
name: Mary Katherine Lawrence, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Middle Country Endocrinology, P.C.
name: Sherry Sussman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Regional Endocrinology Associates, PC
name: Robert Bernstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Albert Johary M.D., P.C.
name: Albert Johary, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Physicians Group
name: Jeffrey Rothman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Western Connecticut Health Network, Inc.
name: Robert Savino, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Parsippany Endocrine, LLC
name: Sarah Khan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: PMG Research of Winston-Salem
name: Jonathan Wilson, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: PMG Research of Bristol
name: Stephanie Powell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: PMG Research of Knoxville
name: Rickey Manning, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego Coastal Endocrinology Group
name: Georges M. Argoud, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.