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

December 5, 2007 updated by: Valeritas, Inc.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • Diabetes and Glandular Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis of Type 1or Type 2 diabetes mellitus for at least a year
  2. 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.
  3. Total daily insulin dose between 50 and 80 units.
  4. 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.
  5. HbA1c > 7.0% and < 9.0%.

Exclusion Criteria:

  1. Recurrent major hypoglycemia or prolonged unstable blood glucose control (as judged by the Investigator).
  2. 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).
  3. Intend to use any other concomitant drug therapy (prescription or over-the-counter medications) that can affect blood glucose levels.
  4. Have used systemic glucocorticoids within 1 month prior to Screening or currently on glucocorticoids.
  5. Have a history of drug or alcohol abuse within 1 year prior to Screening Visit.
  6. 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.
  7. Have a history of major surgery, e.g. laparotomy, thoracotomy, open orthopedic procedure, etc. within 3 months prior to Screening Visit.
  8. Evidence of significant neuropsychiatric disease.
  9. 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.
  10. Blood donation of 500 ml or more in the last 2 months prior to Screening Visit.
  11. Evidence of significant active hematological disease.
  12. Acute infection with fever.
  13. Hemoglobin < 10 g/dL; AST, ALT ≥ 1.5 times the upper reference limit at Screening.
  14. Uncontrolled treated/untreated hypertension (systolic blood pressure > 155 mmHg and diastolic blood pressure > 90 mmHg).
  15. History of proliferative retinopathy or maculopathy requiring acute treatment
  16. Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation.
  17. Any condition that the Investigator and/or Sponsor feel would interfere with trial participation or evaluation of results

  18. Pregnancy, breast-feeding, intention of becoming pregnant for female patients of child-bearing potential.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean glucose using CGM.
Time Frame: 4 weeks
4 weeks
Glucose SD, MAGE, Proportion of 24 hours in euglycemic range 70-160 mg/dl, using CGM.
Time Frame: 4 weeks
4 weeks
End of Study Patient Questions
Time Frame: 4 weeks
4 weeks
Hypoglycemia
Time Frame: 4 weeks
4 weeks
Proportion of time with glucose < 70 mg/dl, from CGM.
Time Frame: 4 weeks
4 weeks
Number and type of adverse events.
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valeritas, Inc.

Investigators

  • Principal Investigator: Mark S Kipnes, MD, Diabetes and Glandular Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

March 27, 2007

First Submitted That Met QC Criteria

March 28, 2007

First Posted (Estimate)

March 29, 2007

Study Record Updates

Last Update Posted (Estimate)

December 6, 2007

Last Update Submitted That Met QC Criteria

December 5, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V4001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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