A Study of LY2605541 Versus Insulin Glargine on Blood Sugar

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01654380
First received: July 27, 2012
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Healthy Volunteers
Diabetes Mellitus, Type 1
Drug: LY2605541
Other: Insulin glargine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Part B: Glucodynamics: Endogenous glucose output [ Time Frame: Up to 8 hours, duration of the euglycemic glucose clamp ] [ Designated as safety issue: No ]
  • Part B: Glycodynamics: Glucose disposal [ Time Frame: Up to 10 hours, duration of the euglycemic glucose clamp ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: July 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A, Cohort A: LY2605541
Healthy participants will receive LY2605541 (22 up to 66 nanomoles [nmol]) intravenously (IV) over 8 hours in 3 of 4 study periods. Each dose is separated by a minimum 6 day washout period.
Drug: LY2605541
LY2605541 is a solution. The concentration of LY2605541 is 100 U/mL
Active Comparator: Part A, Cohort A; Insulin Glargine
Healthy participants will receive insulin glargine (30 milliunits/meter squared/minute [mU/m^2/min]) IV over 8 hours in 1 of 4 study periods, separated by a minimum 6 day washout period.
Other: Insulin glargine
Insulin glargine is a 100 U/mL solution in 10 mL glass vial
Experimental: Part A, Cohort B; LY2605541
Healthy participants will receive LY2605541 (22 up to 66 nmol) administered IV over 8 hours in 3 of 4 study periods. Dose may be adjusted based on Cohort A results. Each dose is separated by a minimum 6 day washout period.
Drug: LY2605541
LY2605541 is a solution. The concentration of LY2605541 is 100 U/mL
Active Comparator: Part A, Cohort B; Insulin Glargine
Healthy participants will receive insulin glargine (60 mU/m^2/min) IV over 8 hours in 1 of 4 study periods. Dose may be adjusted based on Cohort A results. Each dose is separated by a minimum 6 day washout period.
Other: Insulin glargine
Insulin glargine is a 100 U/mL solution in 10 mL glass vial
Experimental: Part B; LY2605541
Participants with T1DM will receive LY2605541 administered IV up to 10 hours in 2 of 4 study periods. Dose determined by Part A results. Each dose is separated by a minimum 6 day washout period.
Drug: LY2605541
LY2605541 is a solution. The concentration of LY2605541 is 100 U/mL
Active Comparator: Part B; Insulin Glargine
Participants with T1DM will receive insulin glargine administered IV over 8 hours in 2 of 4 study periods. Dose determined by Part A results. Each dose is separated by a minimum 6 day washout period.
Other: Insulin glargine
Insulin glargine is a 100 U/mL solution in 10 mL glass vial

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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 nanogram/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 (severe hypoglycemia is defined as having neurological symptoms consistent with neuroglycopenia and having required assistance in treatment by a second party)

Exclusion Criteria:

All Participants

  • Have a hemoglobin level <12.0 grams/deciliter (g/dL) at screening
  • Is currently a smoker or used tobacco products on a regular basis in the 6 months prior to screening, or 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). If this situation arises, inclusion of an otherwise suitable participants may be at the discretion of the investigator

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
  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: NCT01654380

Locations
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
Boehringer Ingelheim
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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01654380     History of Changes
Other Study ID Numbers: 12157, I2R-MC-BIAV
Study First Received: July 27, 2012
Last Updated: October 18, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014