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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01769404
First received: January 14, 2013
Last updated: December 16, 2013
Last verified: December 2013
  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:


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
Study Completion Date: December 2013
Primary Completion Date: December 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
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: NCT01769404

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.
Neuss, Germany, 41460
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: December 16, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

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