A Study to Compare LY2963016 to Lantus After a Single Dose to Subjects With Type 1 Diabetes Mellitus
Overview[ - collapse ][ - ]
| Purpose | The study involves a single injection of LY2963016 and a single injection of Lantus, on 2 separate occasions in participants with type I diabetes. Following each dose, participants will undergo a glucose clamp which lasts for 42 hours each time. There will be at least 7 days between the two periods, during which time there will be no study treatment, but participants will resume their regular therapy. The duration of this study can be up to 9.5 weeks. The purposes of this study are to understand how the blood sugar lowering effect of LY2963016 compares to that of Lantus, and to determine how LY2963016 and Lantus are metabolized by participants with type I diabetes. |
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| Condition | Diabetes Mellitus, Type 1 |
| Intervention | Drug: LY2963016 Drug: Lantus |
| Phase | Phase 1 |
| Sponsor | Eli Lilly and Company |
| Responsible Party | Eli Lilly and Company |
| ClinicalTrials.gov Identifier | NCT01600950 |
| First Received | May 15, 2012 |
| Last Updated | July 30, 2012 |
| Last verified | July 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 15, 2012 |
|---|---|
| Last Updated Date | July 30, 2012 |
| Start Date | May 2012 |
| Estimated Primary Completion Date | July 2012 |
| Current Primary Outcome Measures | Pharmacodynamics: Duration of action of LY2963016 and Lantus [Time Frame: Periods 1 and 2: Baseline up to 42 hours] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | A Study to Compare LY2963016 to Lantus After a Single Dose to Subjects With Type 1 Diabetes Mellitus |
|---|---|
| Official Title | Pharmacodynamics of LY2963016 Compared to LANTUS® in Subjects With Type 1 Diabetes Mellitus |
| Brief Summary | The study involves a single injection of LY2963016 and a single injection of Lantus, on 2 separate occasions in participants with type I diabetes. Following each dose, participants will undergo a glucose clamp which lasts for 42 hours each time. There will be at least 7 days between the two periods, during which time there will be no study treatment, but participants will resume their regular therapy. The duration of this study can be up to 9.5 weeks. The purposes of this study are to understand how the blood sugar lowering effect of LY2963016 compares to that of Lantus, and to determine how LY2963016 and Lantus are metabolized by participants with type I diabetes. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Diabetes Mellitus, Type 1 |
| Intervention | Drug: LY2963016 Single 0.3 U/kg dose administered SQ Drug: Lantus Single 0.3 U/kg dose administered SQ |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 20 |
| Estimated Completion Date | July 2012 |
| Estimated Primary Completion Date | July 2012 |
| Eligibility Criteria | Inclusion Criteria: - have type 1 diabetes mellitus (T1DM) based on the disease diagnostic criteria - have had a duration of diabetes ≥1 year - have hemoglobin A1c ≤10.0% - have fasting C-peptide ≤0.3 nanomoles (nmol/L) - have a body mass index ≤29 kg/m^2 - have venous access sufficient to allow blood sampling and cannulation for clamp procedures Exclusion Criteria: - are currently enrolled in, have completed, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device - have a total insulin requirement > 1.2 U/kg per day - have a history of proliferative retinopathy - have known allergies to insulin glargine, insulin lispro, heparin, or related compounds - have an electrocardiogram (ECG) reading considered outside the normal limits - have an abnormal blood pressure - have abnormal clinical laboratory tests - have a history or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs - history of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in first-degree relatives - show evidence of significant active neuropsychiatric disease - regular use of known drugs of abuse and/or show positive findings on drug screening - show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies - show evidence of hepatitis C and/or positive hepatitis C antibody - show evidence of hepatitis B and/or positive hepatitis B surface antigen - are women with a positive pregnancy test or women who are lactating - have an average weekly alcohol intake that exceeds 21 units per week (males) or 14 units per week (females) - had more than 1 episode of severe hypoglycemia within 6 months prior to study - undergoing therapy for a malignancy other than basal cell or squamous cell skin cancer - had a blood transfusion or severe blood loss within 3 months; made a blood donation within 30 days prior to study entry; or have known hemoglobinopathy, haemolytic anemia, or sickle cell anemia - are receiving systemic glucocorticoid therapy - have irregular sleep/wake cycle (for example, subjects who sleep during the day and work during the night) - show a history of adverse reactions to heparin, including heparin-induced thrombocytopenia - smoke more than 10 cigarettes (or equivalent other tobacco products) per day |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Germany |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01600950 |
|---|---|
| Other Study ID Numbers | 13831 |
| Has Data Monitoring Committee | No |
| Information Provided By | Eli Lilly and Company |
| Study Sponsor | Eli Lilly and Company |
| Collaborators | Not Provided |
| Investigators | Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company |
| Verification Date | July 2012 |
Locations[ + expand ][ + ]
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Neuss, Germany, 41460 |
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