type 2 diabetes mellitus MedDRA version: 13.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Have T2DM based on the disease diagnostic criteria World Health Organization (WHO) classification. [2] Are =18 years of age. [3] Have been receiving 2 or more OAMs at stable doses for the 12 weeks prior to Visit 1, with or without Lantus. Note: use and dose of oral agents in combination with insulin must be in accordance with the local product label. Patients taking metformin and who are found to have a contraindicated serum creatinine level (=1.4 mg/dL for females, =1.5 mg/dL for males, or based on country-specific label) must be willing to discontinue use of metformin at randomization. If on two OAMs at study entry and there is a need to discontinue one of those agents due to country labeling requirements or clinical parameters, that patient would not meet entry criteria. [4] Have an HbA1c =7.0% and =11.0% if insulin naïve; if previously on Lantus, then HbA1c =11.0%. [5] Body mass index (BMI) =45 kg/m2. [6] As determined by the investigator, are capable and willing to do the following: ? perform SMBG ? complete patient diaries as required ? use covered insulin vial and syringe according to study instructions ? are receptive to diabetes education ? comply with required study treatment and study visits. [7] 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: [8] Have used any other insulin except Lantus, including commercial and investigational insulins within the previous 30 days. [9] Have been exposed to a biosimilar insulin glargine within the previous 90 days. [10] Have a history of taking basal bolus therapy or who, in the investigator's opinion, require mealtime insulin in order to achieve target control. [11] Have used short-acting glucagon like peptide (GLP-1) agonist (eg, exenatide) or long-acting GLP-1 agonist (eg, liraglutide) within the previous 90 days. [12] Have used pramlintide (eg, Symlin®) within the previous 30 days. [13] Have excessive insulin resistance at study entry (total insulin dose =1.5 U/kg). [14] Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study. [15] Have known hypersensitivity or allergy to Lantus or its excipients. [16] Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, intraocular, and inhaled preparations) or have received such therapy within 4 weeks immediately preceding Visit 1. [17] Have obvious signs or symptoms, or laboratory evidence, of liver disease (alanine aminotransferase [ALT]; or aspartate minotransferase [AST] greater than 2.5 times the upper limit of the reference range, as defined by the central laboratory); or albumin value above or below the normal reference range, as defined by the central laboratory. [18] Have one of the following concomitant diseases: significant cardiac (eg, congestive heart failure Class III or IV) or gastrointestinal disease (eg, significant gastroparesis). [19] Have a history of renal transplantation, are currently receiving renal dialysis or have a serum creatinine greater than 2.0 mg/dL [20] 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. [21] Patients with active cancer or personal history of cancer within the previous 5 years (with the exception of basal cell carcinoma or carcinoma in situ). [22] 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. [23] Have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the protocol. [24] Are Lilly employees. [25] Are currently enrolled in, or discontinued 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 concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. [26] Have previously completed or withdrawn from this study. [27] 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. [28] Women who are breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to test the hypothesis that LY2963016 administered once daily (QD) is noninferior to Lantus administered QD, as measured by change in hemoglobin A1c (HbA1c) from baseline to 24 weeks, when used in combination with OAMs.;Secondary Objective: ? To compare safety of LY2963016 relative to Lantus (eg, incidence of anti-insulin antibodies, hypoglycemia, adverse events [AEs]) when used in combination with OAMs. ? To compare LY2963016 relative to Lantus for other efficacy variables (eg, change in HbA1c at 4, 8, 12, 16, and 20 weeks, 7-point self-monitored blood glucose profiles [as plasma equivalent values], percentage of patients with HbA1c <7%, percentage of patients with HbA1c =6.5%). ? To compare LY2963016 relative to Lantus with regard to intrapatient blood glucose (BG) variability, basal insulin dose, and weight, when used in combination with OAMs. ? To test the hypothesis that Lantus is noninferior to LY2963016 (QD), as measured by change in HbA1c from baseline to 24 weeks, when used in combination with OAMs. ? To compare LY2963016 relative to Lantus for patient-reported outcomes (PRO) as measured by responses to the Adult Low Blood Sugar Survey (ALBSS) and the Insulin Treatment Satisfaction Questionnaire (ITSQ).;Primary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Czech Republic, France, Germany, Greece, Hungary, Italy, Korea, Republic of, Mexico, Poland, Romania, Russian Federation, Slovakia, Spain, Taiwan, United States
Contacts
Public ContactClinical Trial Information
Eli Lilly and Company
Outcome results
None listed