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Bioequivalence of Two Lispro Formulations
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01133392
First received: May 27, 2010
Last updated: December 29, 2014
Last verified: December 2014
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Purpose
This study will compare how the body treats 2 different forms of insulin lispro and how they affect blood sugar levels.
| Condition | Intervention | Phase |
|---|---|---|
| Healthy Volunteers | Drug: Insulin lispro A Drug: Insulin lispro B | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Evaluation of the Bioequivalence of Two Formulations of Insulin Lispro in Healthy Subjects |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC0-tlast] [ Time Frame: 0 up to 8 hours post dose ]Primary outcome measure is based on the pharmacokinetic area under the concentration-time curve from time 0 to the last time point with a measurable concentration.
Secondary Outcome Measures:
- Pharmacokinetic Parameter: Maximum Serum Insulin Concentration [Cmax] [ Time Frame: 0 to 8 hours post dose ]The maximum observed insulin lispro concentration following dosing.
- Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax) [ Time Frame: 0 to 8 hours post dose ]The maximum observed glucose infusion rate during the euglycemic clamp procedure.
- Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax) [ Time Frame: 0 to 8 hours post dose ]Time of maximal glucose infusion rate.
- Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot) [ Time Frame: 0 to 8 hours post dose ]The total amount of glucose infused during the euglycemic clamp procedure.
| Enrollment: | 41 |
| Study Start Date: | May 2010 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Insulin Lispro A
20 units (U) subcutaneously (SC)
|
Drug: Insulin lispro A
20 units (U) subcutaneously (SC).
Other Name: LY275585
|
|
Active Comparator: Insulin lispro B
20 units (U) subcutaneously (SC)
|
Drug: Insulin lispro B
20 U subcutaneously (SC).
Other Name: LY275585
|
Detailed Description:
The 2 formulations of insulin lispro will be referred to here as:
Lispro A
Lispro B
Eligibility| Ages Eligible for Study: | 21 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Are healthy males or females.
- Body mass index (BMI) between 18.5 and 29.9 kilograms per meter squared (kg/m^2)
- Are nonsmokers.
- Have normal blood pressure and pulse rate, a normal electrocardiogram (ECG), and clinical laboratory test results within normal reference range at screening.
Exclusion Criteria:
- History of first-degree relatives known to have diabetes mellitus.
- Evidence of significant active neuropsychiatric disease.
- Evidence of an acute infection with fever or infectious disease.
- Intend to use over-the-counter or prescription medication (apart from vitamin/mineral supplements, occasional paracetamol, or birth control methods).
- Have used systemic glucocorticoids within 3 months prior to entry into the study.
- Have donated blood of 1 unit or more within the last 3 months prior to study entry.
- Excessive alcohol intake
- Have a fasting venous blood glucose (FBG, plasma) >6 millimoles/liter (mmol/L) at screening.
- Have positive hepatitis B surface antigen.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133392
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133392
Locations
| Singapore | |
| 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 | |
Sponsors and Collaborators
Eli Lilly and Company
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 |
More Information
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT01133392 History of Changes |
| Other Study ID Numbers: |
13300 F3Z-EW-IOPY ( Other Identifier: Eli Lilly and Company ) |
| Study First Received: | May 27, 2010 |
| Results First Received: | October 10, 2014 |
| Last Updated: | December 29, 2014 |
Keywords provided by Eli Lilly and Company:
|
insulin lispro |
Additional relevant MeSH terms:
|
Insulin, Globin Zinc Insulin Insulin Lispro Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on August 23, 2017