Type II Diabetes
Conditions
Interventions
Product Name: insulin lispro low mix prefilled pen B
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: insulin lispro
CAS Number: 13310
Sponsors
Eli Lilly and Company Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Have type 2 diabetes mellitus based on the disease diagnostic criteria (Protocol Attachment ITAB.3). [2] Are either already on any formulation of Lilly insulin (one or two injections a day of one or two types of insulin) or are beginning insulin therapy. [3] Have an HbA1c value up to 1.75 times the upper limit of normal (ULN) reference range at the local laboratory within 30 days prior to Visit 1 for patients already on insulin therapy. Have an HbA1c value from 1.25 to 1.75 times the ULN reference range at the local laboratory within 30 days prior to Visit 1 for patients new to insulin therapy. [4] Are 25 to 75 years old, inclusive, at the time of Visit 1. [5] In the investigator’s opinion, are well-motivated and intend to attain and maintain good blood glucose control using regular blood glucose monitoring and, as appropriate, dose adjustments. [6] As determined by the investigator, are capable of and willing to · self-inject with the Prefilled Pen B device and · use the patient diary as required in this protocol. [7] Have provided written informed consent to participate in this study, according to local regulations. Are the trial subjects under 18? no 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: [8] Are currently using, or had been using during the previous month, an OAM that is not approved for use in combination with insulin in the patient’s country. [9] Have a history of renal transplantation or are currently receiving renal dialysis. [10] Have received chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) within 6 months prior to Visit 1 or are currently on systemic glucocorticoid therapy. [11] Have had more than three unexplained episodes of severe hypoglycemia within 6 months prior to entering the study. Severe hypoglycemia is defined as hypoglycemia where the patient requires assistance from another person and which is associated with either a blood glucose level less than 2.8 mmol/L (50 mg/dL) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration. This definition includes all episodes in which neurologic impairment is severe enough to prevent self-treatment and which are therefore thought to put patients at risk of injuring themselves or others (DCCT 1991). [12] Are aware that they are pregnant or intend to become pregnant during the study. [13] Have a known malignancy other than basal cell or squamous cell skin cancer. [14] Have impaired vision that prevents them from operating the device without assistance. [15] 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. [16] Have previously completed or withdrawn from this study after providing written informed consent. [17] 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. [18] Are employed by Lilly (that is, employees, temporary contract workers, or designees responsible for conducting the study). Immediate family of Lilly employees may participate in Lilly?sponsored clinical trials, but are not permitted to participate at a Lilly facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. [19] 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 is to collect complaint data on the Prefilled Pen B when used by persons with type 2 diabetes to self-administer insulin in take-home situations for 2 months. These data will contribute to the evaluation of the Prefilled Pen B prior to launch.; Secondary Objective: The secondary objectives of the study are: · to monitor safety, including all adverse events, hypoglycemia, device related hypoglycemia, and device-related hyperglycemia · to assess overall patient perception of the device’s performance through a patient questionnaire. ;Primary end point(s): The primary objective is to collect complaint data on the Prefilled Pen B when used by persons with type 2 diabetes to self-administer insulin in take-home situations for 2 months. The purpose of the study is to assess the insulin pen, not the insulin in the delivery device. So no desease related primary end point is defined. The treatment period during the study will last for 7 - 9 weeks. | — |
Countries
Spain, United Kingdom
Outcome results
None listed