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Type 2 Diabetes MellitusSIMPLENCT01326598

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

An observational study of Type 2 Diabetes Mellitus, run by Valeritas, Inc. at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
V-Go™
How many people
270 participants
Where
25 sitesUnited States
Study dates
Jan 2012to May 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Type 2 Diabetes Mellitus

Who may be able to join

  • 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.
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  • 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%.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United States25 sites

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30309

  • MODEL Clinical Research

    Baltimore, Maryland, 21204

  • Grunberger Diabetes Institute

    Bloomfield Hills, Michigan, 48302

  • PMG Research of Bristol

    Bristol, Tennessee, 37620

  • University Diabetes & Endocrine Consultants

    Chattanooga, Tennessee, 37403

  • San Diego Coastal Endocrinology Group

    Chula Vista, California, 91911

  • Western Connecticut Health Network, Inc.

    Danbury, Connecticut, 06810

  • North Jersey Endocrine Consultants, LLCAND

    Denville, New Jersey, 07834

  • Albert Johary M.D., P.C.

    Dunwoody, Georgia, 30338

  • Physicians East, PA

    Greenville, North Carolina, 27834

  • PMG Research of Knoxville

    Knoxville, Tennessee, 37919

  • Alan B. Schorr, DO FACE

    Langhorne, Pennsylvania, 19047

  • Diabetes & Endocrinology Consultants

    Morehead City, North Carolina, 28557

  • Down East Medical Associates

    Morehead City, North Carolina, 28557

  • North Shore Diabetes & Endocrine Assoc.

    New Hyde Park, New York, 11042

  • Parsippany Endocrine, LLC

    Parsippany, New Jersey, 07054

  • MEDSOL Clinical Research Center

    Port Charlotte, Florida, 33952

  • Endocrine Research Solutions, Inc.

    Roswell, Georgia, 30076

  • Nancy J. Bohannon Med. Corp

    San Francisco, California, 94110

  • Regional Endocrinology Associates, PC

    Santa Fe, New Mexico, 87505

  • Endocrine Associates of Long Island, PC

    Smithtown, New York, 11787

  • Middle Country Endocrinology, P.C.

    Smithtown, New York, 11787

  • University Physicians Group

    Staten Island, New York, 10301

  • MidAmerica Diabetes Associates

    Wichita, Kansas, 67211

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: 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.

Being tested
V-Go™
Keywords
V Go™, Type 2 Diabetes, Insulin, Oral Anti Hypoglycemic Drugs
Medical subject headings
Diabetes Mellitus, Type 2, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • V-Go™Device

    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.

Study groups in NCT01326598
Study groupRoleWhat they receive
T2DM patients with A1C<7.0%Not described
Receives: Device: V-Go™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 month

Secondary outcomes (6)

  1. 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.

    Measured: 12 month

  2. 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.

    Measured: 12 month

  3. Number of Participants with adverse events.

    Measured: 12 month

  4. How well the participants follow their doctors prescriptions for diabetes care.

    To describe frequency of self monitoring plasma glucose with V-Go therapy

    Measured: 12 month

  5. 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.

    Measured: 12 month

  6. To describe changes in participants' weight from the beginning to the end of the study.

    Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionMar 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01326598
Sponsor's protocol ID
V4006
Acronym
SIMPLE
Status last verified
Jun 2015
First submitted
3 Mar 2011
Last updated
2 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31833010

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes Mellitus, run by Valeritas, Inc. at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01326598, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015.

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