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A Study of Insulin Lispro With BioChaperone Excipient in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01638325
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : June 16, 2014
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Adocia

Brief Summary:
BC106 is a molecule that when injected with insulin lispro may change the speed of absorption of insulin lispro. The purpose of this study will be to evaluate the safety of BC106 insulin lispro and any side effects that might be associated with it, blood levels of insulin lispro after injection under the skin and how BC106 insulin lispro affects blood sugar after injection under the skin. There is a minimum 7 day washout between single doses.

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: Insulin Lispro Drug: BC106 insulin lispro Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: A Study to Assess the Pharmacokinetics, Glucodynamics, Safety, and Tolerability of Single Subcutaneous Injections of Insulin Lispro With BioChaperone Excipient in Healthy Volunteers
Study Start Date : July 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Insulin Lispro
15 international units (IU) insulin lispro administered once subcutaneously (SC) during 1 of 3 dosing periods. There is a minimum 7 day washout between dosing periods.
Drug: Insulin Lispro
Administered SC
Other Names:
  • Humalog
  • LY275585

Experimental: BC106 Insulin Lispro
15 up to 30 IU BC106 insulin lispro administered once SC during 2 of 3 dosing periods. There is a minimum 7 day washout between dosing periods.
Drug: BC106 insulin lispro
Administered SC
Other Name: BioChaperone insulin lispro




Primary Outcome Measures :
  1. Pharmacokinetics: Area under the concentration curve (AUC) [ Time Frame: Baseline up to 8 hours post administration of study drug ]
  2. Pharmacokinetics: Maximum concentration (Cmax) [ Time Frame: Baseline up to 8 hours post administration of study drug ]
  3. Pharmacokinetics: Time of maximum concentration (Tmax) [ Time Frame: Baseline up to 8 hours post administration of study drug ]

Secondary Outcome Measures :
  1. Glucodynamic response: Time to maximum infusion rate (tRmax) during euglycemic clamps of BC106 insulin lispro [ Time Frame: Baseline up to 30 days ]
  2. Pharmacokinetics: Within-participant variability of time to maximum drug concentration (tmax) of BC106 insulin lispro [ Time Frame: Baseline up to 30 days ]
  3. Glucodynamic within-participant variability of time to maximum glucose infusion rate (tRmax) for BC106 insulin lispro [ Time Frame: Baseline up to 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are not of child-bearing potential
  • Have a body mass index (BMI) between 18 and 29.9 kilograms per square meter (kg/m^2), inclusive
  • Are nonsmokers or have not smoked for at least 6 months prior to entering the study
  • Have a fasting plasma glucose less than 6.0 millimoles per liter (mmol/L) at screening

Exclusion Criteria:

  • Have known allergies to insulin or its excipients, or related drugs, or history of relevant allergic reactions of any origin including allergies to dextrans
  • Have a history of first-degree relatives known to have diabetes mellitus
  • Have used systemic glucocorticoids within 3 months prior to entry into the study
  • Have donated or had a blood loss of 450 milliliters (mL) 3 months prior to study enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01638325


Locations
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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, 117597
Sponsors and Collaborators
Adocia
Eli Lilly and Company
Investigators
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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
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Responsible Party: Adocia
ClinicalTrials.gov Identifier: NCT01638325    
Other Study ID Numbers: 14771
H9D-MC-ITAG ( Other Identifier: Eli Lilly and Company )
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: June 16, 2014
Last Verified: February 2013
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs