A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects
Overview[ - collapse ][ - ]
Purpose | The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of LY2963016 compared to those of basal insulin. The study will also gather information on the safety and tolerability of LY2963016 in healthy subjects. The study is approximately 12 weeks. |
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Condition | Diabetes Mellitus |
Intervention | Drug: LY2963016 Drug: Lantus |
Phase | Phase 1 |
Sponsor | Eli Lilly and Company |
Responsible Party | Eli Lilly and Company |
ClinicalTrials.gov Identifier | NCT01374178 |
First Received | June 13, 2011 |
Last Updated | August 1, 2011 |
Last verified | August 2011 |
Tracking Information[ + expand ][ + ]
First Received Date | June 13, 2011 |
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Last Updated Date | August 1, 2011 |
Start Date | June 2011 |
Estimated Primary Completion Date | July 2011 |
Current Primary Outcome Measures | Pharmacokinetics: area under the concentration-time curve (AUC) [Time Frame: Periods 1 and 2: Baseline up to 24 hours] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects |
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Official Title | Relative Bioavailability of LY2963016 to LANTUS® After Single Dose Subcutaneous Administration to Healthy Subjects |
Brief Summary | The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of LY2963016 compared to those of basal insulin. The study will also gather information on the safety and tolerability of LY2963016 in healthy subjects. The study is approximately 12 weeks. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Diabetes Mellitus |
Intervention | Drug: LY2963016 Administered subcutaneously Drug: Lantus Administered subcutaneously |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 16 |
Estimated Completion Date | July 2011 |
Estimated Primary Completion Date | July 2011 |
Eligibility Criteria | Inclusion Criteria: - Are overtly healthy males or females - Have a body mass index (BMI) between 18.5 and 29.9 kg/m2 - Are nonsmokers - Have normal blood pressure and pulse rate - Have an ECG considered as within normal limits - Have clinical laboratory test results within normal reference range Exclusion Criteria: - Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device - Have known allergies to insulin or its excipients - Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders - Show evidence of significant active neuropsychiatric disease - Have a history of first-degree relatives known to have diabetes mellitus - Have a fasting venous blood glucose >6.0 mmol/L - Intend to use over-the-counter or prescription medication - Have donated or had a blood loss of 450 mL or more in the past 3 months - Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) |
Gender | Both |
Ages | 21 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | Singapore |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01374178 |
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Other Study ID Numbers | 14094 |
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 | August 2011 |
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. | Singapore, Singapore |
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