ot available

• Conditions: type 1 diabetes; MedDRA version: 14.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-000829-73-BE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-23
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

[1] Have T1DM based on the disease diagnostic criteria (World Health Organization [WHO] Classification)
[2] Aged =18 years
[3] Have duration of diabetes =1 year.
[4] Have HbA1c =11.0 %
[5] On basal-bolus insulin therapy for at least 1 year
Basal insulin must be QD injection of NPH, Lantus, or detemir for at least 3 months (90 days) prior to Visit 1 and combined with mealtime injections of human regular insulin, or insulin analog lispro, aspart, or glulisine. See also Exclusion Criterion [32].
[6] Have body mass index (BMI) =35 kg/m2.
[7] As determined by the investigator, are capable and willing to do the following:
o perform SMBG
o complete patient diaries as required for this protocol
o use the insulin injection device(s) according to the instructions
provided
o are receptive to diabetes education
o comply with the required study insulins and study visits.
[8] Have given written informed consent to participate in this study in accordance with 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

[9] Exposure to a biosimilar insulin glargine.
[10] Excessive insulin resistance at entry into the study (total daily insulin dose [TDID] =1.5 U/kg).
[11] Have had more than one episode of severe hypoglycemia, as defined in Section 9.9 of the protocol, within 6 months prior to entry into the study.
[12] Have had more than one episode of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within 6 months prior to entry into the study.
[13] Have known hypersensitivity or allergy to any of the study insulins (insulin glargine or insulin lispro) or to excipients of the study insulins.
[14] Are pregnant or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically
acceptable.
[15] Women who are breastfeeding.
[16] Have taken any oral antihyperglycemic medications (OAMs) within 3 months prior to Visit 1.
[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.
[18] Have received treatment with pramlintide or with continuous subcutaneous insulin infusion within 3-months prior to Visit 1.
[19] Have congestive heart failure Class III and IV
[20] Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] greater than 2.5 times the upper limit of the reference range, as defined by the central laboratory); or albumin value remarkably above or below the normal reference range, as defined by the central laboratory.
[21] Have any active cancer, or a personal history of cancer within the previous 5 years (except basal-cell cancer or carcinoma in situ).
[22] Have presence of clinically significant gastrointestinal disease (eg, clinically active gastroparesis associated with wide glucose fluctuations).
[23] Have a history of renal transplantation, or are currently receiving renal dialysis, or have creatinine greater than 2.0 mg/dL (177 µmol/L).
[24] Have had a blood transfusion or severe blood loss within 3 months prior to Visit 1, or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia.
[25] Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy at pharmacological doses (excluding topical, intraarticular, intraocular, or inhaled preparations, and physiologic replacement doses for Addison’s disease or adrenal deficiency) or have received such therapy within the 4 weeks immediately preceding Visit 1.
[26] Have an irregular sleep/wake cycle (eg, patients who sleep during the day and work during the night).
[27] Have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the protocol.
[28] Are investigator-site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
[29] Are Lilly employees.
[30] Have previously completed or withdrawn from this study after having signed the ICD.
[31] Are currently enrolled in, or discontinued from within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device other than LY2963016, or concurren

Study & Design

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