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
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.
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.
Inclusion Criteria:
Exclusion Criteria:
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
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.
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