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A Study of LY2605541 and Glargine in Participants With Type 1 Diabetes

This study is currently recruiting participants.
Verified February 2013 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01769404
First received: January 14, 2013
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  Purpose

This study has two parts. Each participant will receive a daily injection of LY2605541 during one treatment period and a daily injection of insulin glargine during one treatment period. Each treatment period is 2 to 3 weeks and is followed by a procedure to lower blood sugar levels to see how the body recovers after each treatment.


Condition Intervention Phase
Diabetes Mellitus, Type 1
 Biological: LY2605541
Biological: Insulin Glargine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Evaluation of the Counter-Regulatory Response to Hypoglycaemia Following LY2605541 Administration Compared to Insulin Glargine in Patients With Type 1 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Time to Recovery Following Hypoglycemic Clamp [ Time Frame: Preclamp (baseline) through 2 hours post clamp procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood Glucose [ Time Frame: Preclamp (baseline) through 2 hours post clamp procedure ] [ Designated as safety issue: No ]
  • Cortisol [ Time Frame: Preclamp (baseline) through 2 hours post clamp procedure ] [ Designated as safety issue: No ]
  • Glucagon [ Time Frame: Preclamp (baseline) through 2 hours post clamp procedure ] [ Designated as safety issue: No ]
  • Growth Hormone [ Time Frame: Preclamp (baseline) through 2 hours post clamp procedure ] [ Designated as safety issue: No ]
  • Norepinephrine [ Time Frame: Preclamp (baseline) through 2 hours post clamp procedure ] [ Designated as safety issue: No ]
  • Epinephrine [ Time Frame: Preclamp (baseline) through 2 hours post clamp procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: February 2013
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2605541
Stable dose of LY2605541 (0.2 - 0.6 units per kilogram [U/kg]) administered subcutaneously (SQ) once daily for at least 14 days in one of two treatment periods. Dose based on prestudy basal insulin dosing regimen.
 Biological: LY2605541
Daily dose administered subcutaneously
Active Comparator: Insulin Glargine
Stable dose of insulin glargine (0.2 - 0.6 U/kg) administered SQ once daily for at least 14 days in one of two treatment periods. Dose based on prestudy basal insulin dosing regimen.
 Biological: Insulin Glargine
Daily dose administered subcutaneously

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetic for more than 1 year with glycated hemoglobin (HbA1c) less than 9%
  • Otherwise fit and healthy
  • Non smoker

Exclusion Criteria:

  • Taking medication or supplements other than insulin to control diabetes
  • Suffered a hypoglycemic event in the last 12 months that required hospitalization or have poor awareness of hypoglycemia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769404

Contacts
Contact: This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

Locations
Germany
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. Recruiting
Neuss, Germany, 41460
Contact: Eli Lilly            
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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01769404     History of Changes
Other Study ID Numbers: 14870, I2R-MC-BIDM
Study First Received: January 14, 2013
Last Updated: February 14, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 22, 2013