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Type 1 DiabetesPhase 4NCT00453934

Patient Preference of h-Patch vs. Pen or Needle/Syringe as Insulin Administration Device

A Phase 4 study testing h-Patch in people with Type 1 Diabetes and Type 2 Diabetes, run by Valeritas, Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective of this study is to compare patient preference of the h-Patch as delivery device for insulin lispro compared with either an insulin pen or needle and syringe in patients with diabetes, either Type 1 or Type 2, on stable multiple daily injection regimens. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 1 Diabetes, Type 2 Diabetes
What is being tested?
h-Patch
Type of treatment
Medical device
How many people
11 participants
Where
1 siteUnited States
Study dates
May 2007to Sep 2007
Phase
Phase 4
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of Type 1or Type 2 diabetes mellitus for at least a year
  • Stable insulin regimen for at least 3 months consisting of multiple daily injections of human regular or rapid acting insulin at meal times and long or intermediate acting insulin as basal. In this protocol multiple daily injections requires at least three injections daily.
  • Total daily insulin dose between 50 and 80 units.
  • If patient is Type 2, can be treated with metformin and/or a thiazolidinedione and/or a sulfonylurea, but other diabetes drugs including α-glucosidase inhibitors, meglitinides, pramlintide exenatide, and DPP-IV's are excluded.
  • HbA1c > 7.0% and < 9.0%.

Who cannot join

  • Recurrent major hypoglycemia or prolonged unstable blood glucose control (as judged by the Investigator).
  • Use of other diabetes drugs including α-glucosidase inhibitors, meglitinides, pramlintide, exenatide or DPP-IV inhibitors (metformin and/or a thiazolidinedione and/or a sulfonylurea are allowed).
  • Intend to use any other concomitant drug therapy (prescription or over-the-counter medications) that can affect blood glucose levels.
  • Have used systemic glucocorticoids within 1 month prior to Screening or currently on glucocorticoids.
  • Have a history of drug or alcohol abuse within 1 year prior to Screening Visit.
  • Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, or neurological disease that would, in the investigator's opinion, preclude safe participation in the study.
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  • Have a history of major surgery, e.g. laparotomy, thoracotomy, open orthopedic procedure, etc. within 3 months prior to Screening Visit.
  • Evidence of significant neuropsychiatric disease.
  • Have participated in a medical, surgical, or pharmaceutical investigational new drug/device study in the last 30 days or ≤ 5 half-lives of the investigational drug, whichever is longer, prior to Screening Visit.
  • Blood donation of 500 ml or more in the last 2 months prior to Screening Visit.
  • Evidence of significant active hematological disease.
  • Acute infection with fever.
  • Hemoglobin < 10 g/dL; AST, ALT ≥ 1.5 times the upper reference limit at Screening.
  • Uncontrolled treated/untreated hypertension (systolic blood pressure > 155 mmHg and diastolic blood pressure > 90 mmHg).
  • History of proliferative retinopathy or maculopathy requiring acute treatment
  • Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation.
  • Any condition that the Investigator and/or Sponsor feel would interfere with trial participation or evaluation of results
  • Pregnancy, breast-feeding, intention of becoming pregnant for female patients of child-bearing potential.
  • -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Diabetes and Glandular Research

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: h-Patch vs. Pen or Needle and Syringe as Insulin Administration Device in Type 1 or 2 Diabetes Patients Using MDI: Patient Preference and Glycemic Control After Switch in an Open-Label, Randomized Cross-Over Study

The primary objective of this study is to compare patient preference of the h-Patch as delivery device for insulin lispro compared with either an insulin pen or needle and syringe in patients with diabetes, either Type 1 or Type 2, on stable multiple daily injection regimens. This will be assessed using an accepted preference scale.

Read the detailed description

Patients with Type 1 Diabetes have an absolute deficiency in insulin production and benefit from physiologic insulin replacement, defined as administration of background and mealtime insulin. More than half of patients with Type 2 diabetes (T2DM) have less than 50% of their beta cell function at the time of diagnosis. Because of this, these patients would also benefit from the physiologic delivery of insulin. Currently, 4 or more injections per day are required to deliver the various different available insulins in a physiologic manner. Valeritas has developed the h-Patch, a device suitable to make the delivery of basal and bolus insulin effective, simple and discrete. This study will measure patient preference, glucose control and safety of the h-Patch compared with patients' previous therapy. Patients previous therapy will be multiple daily injections delivered either by pens or needle and syringe.

Being tested
h-Patch
Keywords
Diabetes, Type 1 Diabetes, Type 2 Diabetes, Physiologic Insulin, Basal Insulin, Bolus Insulin, Mealtime insulin, Insulin patch, Multiple daily injections
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

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

  • h-PatchDevice

Timeline

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

  1. First posted29 Mar 2007 (estimated)
  2. Study startMay 2007
  3. Study completionSep 2007

Why it stopped: Endpoint no longer deemed meaningful

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00453934
Sponsor's protocol ID
V4001
Status last verified
Mar 2007
First submitted
27 Mar 2007
Last updated
6 Dec 2007
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing h-Patch in people with Type 1 Diabetes and Type 2 Diabetes, run by Valeritas, Inc. at 1 site 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 5 inclusion and 19 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: stopped early, as of the sponsor's last update on 6 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Endpoint no longer deemed meaningful). Results are not available in the source record.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00453934.

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 6 Dec 2007.

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