Type II diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10063624 Term: Type II diabetes mellitus inadequate control
Conditions
Interventions
Trade Name: Humalog NPL
Product Name: Insulin Lispro Protamin
Product Code: LY275585[P]
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: insulin lispro protamin suspension
CAS Number
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible to be included in the study only if they meet all of the following criteria: Have type 2 diabetes mellitus (T2DM; World Health Organization [WHO] classification, Protocol Attachment 2) for at least 1 year. Are =18 years old. Have been receiving oral antihyperglycemic medications (OAMs), with insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1, at or above the doses defined in the following table: Oral Antihyperglycemic Medication (OAM) Minimum Dose Metformin 1500 mg/day Sulfonylureas; Dipeptidyl peptidase-IV (DPP-IV) inhibitors 1/2 the maximum daily dose, according to the local package insert. Thiazolidinediones (TZDs) 30 mg/day pioglitazone or 4 mg/day rosiglitazone The OAMs also must have been used in accordance with the product label. (Note: Combination treatments of the OAMs listed above are acceptable if they meet the above criteria. For example, Avandamet® [rosiglitazone maleate and metformin hydrochloride] would cover the categories of a thiazolidinedione (TZD) and metformin.) Have a hemoglobin A1c (HbA1c) =7.5% and =11.0%, as measured by a central laboratory before Visit 2. Body mass index (BMI) =25 and =45 kg/m2. As determined by the investigator, are capable and willing to do the following: • use the insulin injection device according to the instructions provided; • perform self monitoring of blood glucose (SMBG); • complete the study diary as required for this protocol; • are receptive to diabetes education, including continuing their prestudy diet and activity levels, or following dietary advice recording as requested in the protocol; • comply with the required study visits and willing to receive regular telephone calls between visits. 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: Patients will be excluded from the study if they meet any of the following criteria: Have taken any glucose-lowering medications not included in Inclusion Criterion [3] (for example, acarbose, miglitol, pramlintide, exenatide) in the past 3 months before Visit 1. Have had more than 1 episode of severe hypoglycemia, as defined in the Abbreviations and Definitions section of the protocol, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness. Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months. 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. Women who are breastfeeding. Have cardiac disease with functional status that is Class III or IV (see Protocol Attachment.3); Have a history of renal transplantation or are currently receiving renal dialysis or creatinine >1.3 mg/dL (115 µmol/L). Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase [ALT], or aspartate transaminase [AST] greater than 2 times the upper limit of the reference range, as defined by the local laboratory) or have albumin value above or below the normal reference range, as defined by the local laboratory. Patients with a malignancy other than basal cell or squamous cell skin cancer who have not yet been treated, are currently being treated, or who were diagnosed less than 5 years ago. Have 1 of the following concomitant diseases: presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease or any other serious disease considered by the investigator to be exclusionary. Have known hypersensitivity or allergy to any of the study insulins or their excipients. 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, or any other traits of hemoglobin abnormalities known to interfere with the HbA1c methodology. 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 the 4 weeks immediately preceding Visit 1. Have an irregular sleep/wake cycle (for example, patients who sleep during the day and work during the night), in the investigator’s opinion. Have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the protocol, according to the investigator’s judgment. 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. 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. Are Lilly employees. Have previously completed or withdrawn from this study after having signed the informed consent document.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that, in T2DM, a basal bolus regimen containing analog insulin lispro protamine suspension provides noninferior glycemic control to a basal bolus regimen containing analog insulin glargine, when these basal insulins are injected once daily together with insulin lispro injected 2-3 times daily. Glycemic control will be assessed by the change of HbA1c from baseline to 24 weeks,;Secondary Objective: To compare the efficacy, safety of insulin lispro protamine suspension and glargine when used in a basal bolus regimen together with insulin Lispro in relation to: • Change in HbA1c at 12 weeks and at 24 weeks; • percentage of patients with HbA1c <7.0% and HbA1c =6.5% at 24 weeks; • 7-point self-monitored blood glucose (SMBG) profile at 24 weeks; • glycemic variability at 24 weeks; • to compare the safety of insulin lispro suspension and glargine when used in a basal bolus regimen together with insulin lispro in relation to: o the incidence of self-reported hypoglycemic episodes o absolute body weight (kg) and incremental weight change from baseline to 24 weeks o treatment-emergent adverse events (TEAEs); • to compare total daily insulin dose and number of injections at 24 weeks. ;Primary end point(s): | — |
Countries
Belgium, Czech Republic, Germany, Greece, Italy, Slovakia, United Kingdom
Outcome results
None listed