A Randomized, Open-label Study on the Effects of Insulin Pen Devices on Glycemic Control in Children, Adolescents and Adults with Type 1 Diabetes: Novel Pen with Memory Function (HumaPen® Memoir) vs. Conventional Pen without Memory Function(HumaPen® Luxura) - ITAE

• Conditions: Pts with type 1 diabetes mellitus based on the WHO criteria, at least 8 years old, used an insulin pen device to inject at least 4 insulin doses/day for at least 2 months prior to the study and currently have at least 3 prandial injections/day with a short-acting insulin/insulin analogue; HbA1c = 8% at Visit 1; capability of self-injecting insulin with HumaPen Memoir or HumaPen Luxura and usage of a disease-related documentation tool (patient diary); ability to give informed consent; MedDRA version: 9.1Level: HLTClassification code 10012602Term: Diabetes mellitus (incl subtypes)

• Registration Number: EUCTR2008-007769-21-DE
• Lead Sponsor: illy Deutschland GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

[1] Present with type 1 diabetes mellitus based on the World Health Organization (WHO) criteria (Bennett 1991).
[2] Are at least 8 years old at the date of Visit 1.
[3] Have used an insulin pen device to inject at least 4 insulin doses per day for at least 2 months immediately prior to the study.
[4] Are currently receiving at least 3 prandial injections per day with a short-acting insulin or insulin analogue.
[5] Have inadequate glycemic control evidenced by HbA1c equal to or above 8% at Visit 1.
[6] In the investigator’s opinion, patients (and parents/legal representatives, if applicable), are well-motivated to improve their glycemic control.
[7] As determined by the investigator, patients are capable of, and willing to
• self-inject insulin with the HumaPen Memoir or HumaPen Luxura,
• use a disease-related documentation tool (patient diary).
[8] Inclusion criterion [8] applies to female patients of child-bearing potential (not
surgically sterilized and between menarche and one year post menopause) only; they must
• not be breastfeeding
• test negative for pregnancy at the time of screening based on a urine or serum test,
• intend not to become pregnant during the study,
• agree to use a highly reliable method of birth control (failure rate less than 1% per year; sexual abstinence; vasectomized partner) during the study.
[9] Have provided written informed consent/assent to participate in this study, according to local regulations (see Section 9.1).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

[10] Are currently using a continuous subcutaneous insulin infusion therapy (CSII)
[11] Are receiving insulin treatment with pre-mixed insulin preparations
[12] Have impaired vision that prevents them from operating the HumaPen Memoir without assistance .
[13] Have any other condition (including known drug abuse, alcohol abuse, or psychiatric disorder) that, in the opinion of the investigator, precludes the patient from following and completing the protocol.
[14] Have previously completed or withdrawn from this study after providing written informed consent.
[15] Are investigator site personnel directly affiliated with the study, or are
immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
[16] Are Lilly employees.
[17] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified