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
Conditions
Interventions
Trade Name: Huminsulin Normal für Pen 3 ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: human insulin
CAS Number: 11061-68-0
Concentration unit: IU/ml international unit(s)/millili
Sponsors
Lilly Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to test the hypothesis that the HumaPen Memoir with memory function, when used over 24 weeks for prandial insulin injections in children, adolescents and adults with type 1 diabetes, achieves superior glycemic control, as measured by the difference in change in HbA1c, when compared to the conventional HumaPen Luxura without memory function.;Secondary Objective: The secondary objectives of the study are as follows: • to assess the proportion of patients achieving HbA1c targets of = 7.5% and = 7.0% at Week 24 in both treatment groups • to monitor safety of the pen devices in this patient population, as assessed by adverse events and complaints • to monitor hypoglycemia and hyperglycemia in both treatment arms • to evaluate patient acceptance of the HumaPen Memoir and HumaPen Luxura as insulin injection devices, as assessed by the "Insulin Delivery System Questionnaire" (IDSQ).;Primary end point(s): This is a 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) End of study (trial) is defined as the date of the last visit or last scheduled procedure at the last site shown in the Study Schedule for the last active subject in the study. The criteria for enrollment must be followed explicitly. If a patient who does not meet enrollment criteria is inadvertently enrolled, that patient is discontinued from the study, and Lilly or its designee must be contacted. In addition, patients will be discontinued from the study in the following circumstances. • If Exclusion Criterion [10], [11], [12], or [13] is observed, or develops, after entry or enrollment. In this case, the patient will be discontinued from the study at the next visit or sooner in the event of a safety exclusion criterion. • A female patient becomes pregn | — |
Countries
Germany
Outcome results
None listed