type 2 diabetes MedDRA version: 14.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Humalog
Product Name: Humalog
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN LISPRO
CAS Number: 133107-64-9
Current Sponsor code: LY275585
Other descriptive name:
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Have type 2 diabetes (per World Health Organization [WHO] Classification of Diabetes). [2] Are =18 and =85 years of age at the time of Visit 1. [3] Have been treated for at least 90 days with insulin (glargine, NPH, NPL, or detemir) in combination with oral antihyperglycemic agents as monotherapy, dual, or triple therapy (sulfonylurea, meglitinide, metformin, pioglitazone, or dipeptidyl peptidase-4 [DPP-4] inhibitor [sitagliptin only]) and, in the opinion of the investigator, requires further intensification of therapy. [4] Are treated with insulin (glargine, NPH, NPL or detemir) at least 20 U/day at study entry. [5] Have an HbA1c value >7.0% and =12.0% according to the central laboratory at Visit 1 or Visit 6. Note: for patients who enter the study on NPH, NPL or detemir, BID glargine; or on QD glargine with HbA1c >7.0% and fasting blood glucose >120 mg/dL, a 6-week lead-in period will be required for glargine optimization. For a patient on QD glargine with HbA1c >7.0% and fasting blood glucose =120 mg/dL, no leadin period is required and he or she may be randomized at Visit 2.(The FBG measurements are based upon the 3 morning BG measurements from the 7-point SMBG profiles collected on 3 days prior to Visit 2.) [6] Capable of, and willing, to do the following: inject insulin with a prefilled pen and perform self blood glucose monitoring and record keeping as required by this protocol, as determined by the investigator. [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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [8] Prior rapid- or short-acting insulin therapy: patients receiving scheduled long-term short-acting or rapid-acting or premixed insulin therapy within the past 6 months will not be eligible to participate in the study. Patients who have previously received short- or rapid-acting insulin as part of short-term insulin therapy (during gestational diabetes, or during an acute hospitalization or illness) or occasional use will be allowed to participate in this study. Occasional use (e.g., used to treat acute hyperglycemia) shall be defined as less than daily administration of not more than 1 dose per day of short- or rapid-acting insulin. [9] Concomitant medications: glucagon-like peptide-1 (GLP-1) receptor agonist (e.g., exenatide or liraglutide), alpha-glucosidase inhibitor (e.g., acarbose, miglitol, or voglibose), DPP-4 inhibitors other than sitagliptin or rosiglitazone use concurrently or within 3 months prior to entry into study. [10] Severe hypoglycemia: have had more than one episode of severe hypoglycemia (defined as requiring assistance of a third party due to disabling hypoglycemia) within 6 months prior to entry into the study. [11] Excessive insulin resistance: received a total daily dose of insulin >2.0 U/kg at the time of randomization. [12] Morbid obesity: defined as a body mass index =45 kg/m2. [13] Malignancy: have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years [14] Cardiovascular: have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association [NYHA] Cardiac Disease Classification) or have congestive heart failure (CHF) requiring pharmacologic treatment or, in the investigator’s opinion, have severe dependent edema (i.e., edema of the feet or ankles) or have any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis. [15] Renal: have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine =2 mg/dL if not on metformin. [16] Hepatic: have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) >3x the upper limit of the reference range as defined by the central laboratory. [17] Hematologic: have known hemoglobinopathy or chronic anemia or other known blood disorder. [18] Reproductive: (for women) are pregnant or intend to become pregnant during the course of the study; are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable; or are breastfeeding. [19] Allergy: have known allergy to insulin lispro, insulin glargine, or excipients contained in these products. [20] Glucocorticoid therapy: receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately before Visit 1. [21] Adherence to protocol: have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the protocol. [22] Prior participation: are currently enrolled in, or have participated in, an interventional medical, surgical, or pharmaceutical drug or device or off-label use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the change in HbA1c from baseline (randomization) after 24 weeks of treatment with one of two basal bolus titration algorithms, in adult patients with type 2 diabetes mellitus who have not achieved adequate glycemic control on basal insulin (glargine, NPH, or detemir) with oral antihyperglycemic medications.;Secondary Objective: Frequency and rate of self-reported hypoglycemic episodes per 30 days and per year (total, nocturnal, and severe) (overall and in subjects =65 years of age) ? change in body weight ? proportions of subjects achieving HbA1c target values (HbA1c =7.0% and =6.5%) at end of study (overall and in subjects =65 years of age) ? time to reach HbA1c target values (HbA1c =7.0% and =6.5%) ? HbA1c change from baseline (randomization) within each treatment algorithm ? change in fasting glucose (overall and in subjects =65 years of age) ? change in 1,5-AG ? 7-point SMBG profile data including average blood glucose values for each timepoint measurement ? insulin dose: total, basal (glargine), and prandial (lispro) (24-hour total measured in U/d and U/kg) at end of study.;Primary end point(s): No primary end points;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
Austria, Denmark, France, Lithuania
Contacts
Public ContactCarsten Rehn
Eli Lilly and Company
Outcome results
None listed