The COMPLETE T1D Trial: COMParison of Insulin Lispro Protamine Suspension and DETEmir in Type 1 Diabetes Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Insulin Detemir) in Basal-Bolus Therapy for Patients with Type 1 Diabetes - COMPLETE T1D Trial
- Conditions
- type 1 diabetesMedDRA version: 8.1Level: LLTClassification code 10045228Term: Type I diabetes mellitus
- Registration Number
- EUCTR2006-006375-21-HU
- Lead Sponsor
- Eli Lilly and Company Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 335
[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) <=35 kg/m2.
[6] As determined by the investigator, are capable and willing to do the following:
•perform self monitoring of blood glucose (SMBG),
•complete patient diaries as required for this protocol,
•use the insulin injection device(s) according to the instructions provided,
•are receptive to diabetes education,
•comply with the required 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method