type 1 diabetes MedDRA version: 8.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
Conditions
Sponsors
Eli Lilly and Company Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Have type 1 diabetes based on the disease diagnostic criteria (World Health Organization [WHO] Classification, see Protocol Attachment IOOZ.2). [2] Aged >=18 years. [3] Duration of diabetes >=1 year. [4] Have a hemoglobin A1c (HbA1c) 1.2 to 2.0 times the upper limit of the normal (ULN) reference range within 30 days prior to Visit 1 or collected and analyzed at a local laboratory at Visit 1. [5] Body mass index (BMI) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 9] Are taking any oral antihyperglycemic medications (OAMs). [10] Have had more than one episode of severe hypoglycemia, as defined in the Abbreviations and Definitions section of the protocol, within 6 months prior to entry into the study. [11] 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. [12] Women who are breastfeeding. [13] Have one of the following concomitant diseases: presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease. [14] Have a history of renal transplantation or are currently receiving renal dialysis or creatinine greater than 2.0 mg/dL (177 µmol/L). [15] 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. [16] Are undergoing therapy for a malignancy other than basal cell or squamous cell skin cancer. [17] Have known hypersensitivity or allergy to any of the study insulins or excipients of the study insulins. [18] 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. [19] Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding Visit 1. [20] Have an irregular sleep/wake cycle (for example, patients who sleep during the day and work during the night). [21] Have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the protocol. [22] 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. [23] 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. [24] Are Lilly employees. [25] Have previously completed or withdrawn from this study after having signed the informed consent document.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to test the hypothesis that basal analog insulin lispro protamine suspension injected two times a day is noninferior to basal analog insulin detemir injected two times a day, as measured by change in hemoglobin A1c (HbA1c) from baseline (Visit 2) to 32 weeks in adult patients with type 1 diabetes when used in combination with bolus insulin lispro injected three times a day. The noninferiority margin is 0.4%.;Secondary Objective: •NPL is noninferior to detemir within a basal-bolus regimen as measured by standard deviation of fasting blood glucose as a measure of intrapatient glycemic variability •NPL is noninferior to insulin detemir within a basal-bolus regimen as measured by change in absolute body weight Additional secondary objectives are to compare efficacy and safety with respect to •actual and change from baseline HbA1c value at 8, 16, and 24 weeks and at endpoint •percentage of patients with HbA1c =7.0% and HbA1c =6.5% at endpoint •7-point self-monitored blood glucose profiles and glycemic variability from these profiles at endpoint •safety, as measured by + the incidence, rate of hypoglycemic episodes and severe hypoglycemia + absolute body weight and incremental weight change from baseline to endpoint + treatment-emergent adverse events •insulin dose at endpoint;Primary end point(s): The primary objective of this study is to test the hypothesis that basal analog insulin lispro protamine suspension injected two times a day is noninferior to basal analog insulin detemir injected two times a day, as measured by change in hemoglobin A1c (HbA1c) from baseline (Visit 2) to 32 weeks in adult patients with type 1 diabetes when used in combination with bolus insulin lispro injected three times a day. The noninferiority margin is 0.4%. Discontinuation of Patients The criteria for enrollment must be followed explicitly. If a patient who does not meet enrollment criteria is inadvertently enrolled, that p | — |
Countries
Hungary
Outcome results
None listed