A study to compare long acting basal insulin analog to lantus in adult patients with Type 2 Diabetes Mellitus
- Conditions
- Health Condition 1: null- Diabetes Mellitus, Type 2
- Registration Number
- CTRI/2015/02/005536
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 492
Have type 2 diabetes mellitus (T2DM).
-Have been receiving 2 or more OAMs at stable doses for the 12 weeks prior to screening, with or without basal insulin.
-If currently on basal insulin, must be taking LANTUS® QD or NPH or insulin detemir either QD or twice a day for at least 90 days prior to study entry.
-Have an HbA1c >=7.0% and <=11.0% if insulin naïve; if previously on basal insulin, then HbA1c <=11.0%.
-Body mass index (BMI) <=45 kilograms per meter squared (kg/m2).
-As determined by the investigator, are capable and willing to do the following:
Perform self monitored blood glucose (SMBG)
Complete participant diaries as instructed
Are receptive to diabetes education
Comply with required study treatment and study visits
-Have been on LANTUS® more than once daily within the previous 30 days.
-Have used any other insulin except the entry insulin [LANTUS®, insulin detemir, or NPH] including commercial (includes any premixed insulins) and investigational insulins within the previous 30 days.
-Have been exposed to a biosimilar insulin glargine within the previous 90 days.
-Have participated in a LY2963016 study.
-Have taken basal plus mealtime insulin (basal bolus therapy) within the last year for greater than 4 continuous weeks.
-Have used any glucagon like peptide (GLP-1) receptor agonists within the previous 90 days.
-Have used pramlintide within the previous 30 days.
-Have excessive insulin resistance at study entry (total insulin dose >=1.5 units/kg).
-Have more than 1 episode of severe hypoglycemia within 6 months prior to screening.
-Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening.
-Have known hypersensitivity or allergy to LANTUS® or its excipients.
-Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy or have received such therapy within 4 weeks immediately preceding screening.
-Have obvious signs or symptoms, or laboratory evidence, of liver disease.
-Have one of the following concomitant diseases: significant cardiac (e.g., congestive heart failure Class III or IV) or gastrointestinal disease (e.g., significant gastroparesis).
-Have a history of renal transplantation or are currently receiving renal dialysis.
-Have a serum creatinine greater than 2.0 milligrams/deciliter (177 micromoles/liter).
-Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia.
-Participants with active cancer or personal history of cancer within the previous 5 years (with the exception of basal cell carcinoma or carcinoma in situ).
-Have a history or diagnosis of Human Immunodeficiency Virus (HIV) infection.
-Have any other condition (including known drug or alcohol abuse or psychiatric disorder including dementia) that precludes the participant from following and completing the protocol.
-Are pregnant or intend to become pregnant during the course of the study.
-Women who are breastfeeding.
-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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method