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A Study of LY2605541 Versus Insulin Glargine on Blood Sugar

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ClinicalTrials.gov Identifier: NCT01654380
Recruitment Status : Completed
First Posted : July 31, 2012
Results First Posted : March 8, 2019
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus. This study is designed to understand how the body handles the investigational drug, what effect this investigational drug has on the body, and how much should be given. This study will also measure how much of the investigational drug gets into the blood stream and how long it takes the body to get rid of it. The study has 2 parts: Part A will be conducted in healthy participants. Part B will be conducted in participants with type 1 diabetes mellitus (T1DM). This study will take approximately 10-14 days spread over 6-20 weeks, not including screening. Screening will be performed within 30 days of the start of the study.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Diabetes Mellitus, Type 1 Drug: LY2605541 Other: Insulin glargine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparison of the Effects of LY2605541 and Insulin Glargine on Endogenous Glucose Output and Peripheral Glucose Disposal in Healthy Subjects and Patients With Type 1 Diabetes Mellitus
Study Start Date : July 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Part A, Cohort A; LY2605541
Healthy participants received 5.1 milliunits/minute (mU/min) in Period 1, 10.2 mU/min in Period 2, and 15.3 mU/min in Period 3, administered intravenously (IV) over 8 hours. All periods were separated by a minimum 6-day washout period
Drug: LY2605541
LY2605541 is a solution. The concentration of LY2605541 is 100 units/milliliter (U/mL).

Active Comparator: Part A, Cohort A; Insulin Glargine
Healthy participants received insulin glargine (30 milliunits/meter squared/minute [mU/m^2/min]) administered IV over 8 hours in Period 4. All periods were separated by a minimum 6-day washout period
Other: Insulin glargine
Insulin glargine is a 100 U/mL solution in 10 milliliter (mL) glass vial.

Experimental: Part A, Cohort B; LY2605541
Healthy participants received 15.3 mU/min in Period 1, 37.0 mU/min in Period 2, and 74.1 mU/min in Period 3, administered IV over 8 hours. All periods were separated by a minimum 6-day washout period.
Drug: LY2605541
LY2605541 is a solution. The concentration of LY2605541 is 100 units/milliliter (U/mL).

Active Comparator: Part A, Cohort B; Insulin Glargine
Healthy participants received insulin glargine (60 mU/m^2/min) administered IV over 8 hours in Period 4. All periods were separated by a minimum 6-day washout period.
Other: Insulin glargine
Insulin glargine is a 100 U/mL solution in 10 milliliter (mL) glass vial.

Experimental: Part B; LY2605541
Participants with T1DM received 15.3 mU/min in 1 of 4 study periods, administered IV up to 8 hours and received 74.1 mU/min in 1 of 4 Periods, administered IV up to 10 hours. Each dose was separated by a minimum 6-day washout period.
Drug: LY2605541
LY2605541 is a solution. The concentration of LY2605541 is 100 units/milliliter (U/mL).

Active Comparator: Part B; Insulin Glargine
Participants with T1DM received 1 insulin glargine dose per study period (10 and 20 mU/m^2/min) administered IV over 8 hours in 2 of 4 study periods. Each dose was separated by a minimum 6-day washout period.
Other: Insulin glargine
Insulin glargine is a 100 U/mL solution in 10 milliliter (mL) glass vial.




Primary Outcome Measures :
  1. Part B: Glucodynamics: Endogenous Glucose Output [ Time Frame: Baseline, up to 10 hours (duration of the euglycemic glucose clamp) ]

    The percent suppression from baseline in endogenous glucose production (EGP) is presented. Percent EGP change from baseline was calculated by (1-[last 2 hours of EGP/basal EGP])*100.

    The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours.


  2. Part B: Glycodynamics: Glucose Disposal [ Time Frame: Baseline, up to 10 hours (duration of the euglycemic glucose clamp) ]

    The fold change from baseline in glucose disappearance rate (GDR) is presented. The fold GDR increase from baseline was calculated by last 2 hours of GDR/basal GDR.

    The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours.


  3. Part B: Glycodynamics: Maximum Rate of Glucose Disposal [ Time Frame: Baseline, up to 10 hours (duration of the euglycemic glucose clamp) ]
    The maximum rate of glucose disposal (Rdmax) is presented. The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All Participants

  • Are healthy males or participants with T1DM
  • Have a screening body mass index (BMI) of 20.0-29.9 kilograms per square meter (kg/m^2)

Healthy Participants ONLY

  • Are overtly healthy, as determined by medical history and physical examination
  • Have a fasting blood glucose <108 milligrams/deciliter (mg/dL) (6.0 millimoles/liter [mmol/L]) at screening

Participants with T1DM ONLY

  • Have a diagnosis of T1DM for at least 1 year based on medical history
  • Have a screening c-peptide <0.5 nanograms/milliliter (ng/mL)
  • Have a hemoglobin A1c (HbA1c) of 6.0 to 9.0% at screening
  • Have had no episodes of severe hypoglycemia in the past 6 months

Exclusion Criteria:

All Participants

  • Have a hemoglobin level <12.0 grams/deciliter (g/dL)
  • Are currently a smoker, used tobacco products on a regular basis in the 6 months prior to screening, or are intending to smoke during the study

Healthy Participants ONLY

• Regular use or intended use of over-the counter or prescription medication within 7 and 14 days, respectively, prior to dosing (apart from vitamin/mineral supplements or occasional use of acetaminophen or ibuprofen).

Participants with T1DM ONLY

  • Regular use or intended use of any over-the-counter or prescription medications or nutritional supplements that affect blood glucose or the body's sensitivity to insulin or that promote weight loss within 14 days prior to dosing
  • Are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations) or have received such therapy within the 4 weeks before dosing
  • Require a total daily insulin dose exceeding 100 units (U)
  • Have fasting triglycerides >400 mg/dL

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): NCT01654380


Locations
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United States, California
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.
San Diego, California, United States
Sponsors and Collaborators
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: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01654380     History of Changes
Other Study ID Numbers: 12157
I2R-MC-BIAV ( Other Identifier: Eli Lilly and Company )
First Posted: July 31, 2012    Key Record Dates
Results First Posted: March 8, 2019
Last Update Posted: March 8, 2019
Last Verified: November 2018
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs