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

NCT00453934 | Terminated Phase 4

• 1 other identifier: V4001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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. This will be assessed using an accepted preference scale.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Keywords

Diabetes; Type 1 Diabetes; Type 2 Diabetes; Physiologic Insulin; Basal Insulin; Bolus Insulin; Mealtime insulin; Insulin patch; Multiple daily injections

Outcome Measures

Secondary Outcomes (6)

• Mean glucose using CGM.

  4 weeks

• Glucose SD, MAGE, Proportion of 24 hours in euglycemic range 70-160 mg/dl, using CGM.

  4 weeks

• End of Study Patient Questions

  4 weeks

• Hypoglycemia

  4 weeks

• Proportion of time with glucose < 70 mg/dl, from CGM.

  4 weeks

Interventions

h-Patch DEVICE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Valeritas, Inc.: lead

Study Sites (1)

Diabetes and Glandular Research

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mark S Kipnes, MD

  Diabetes and Glandular Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 27, 2007
• First Posted: March 29, 2007
• Study Start: May 1, 2007
• Study Completion: September 1, 2007
• Last Updated: December 6, 2007

Record last verified: 2007-03

Locations

US (1)