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

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ClinicalTrials.gov Identifier: NCT01769404
Recruitment Status : Completed
First Posted : January 16, 2013
Last Update Posted : December 17, 2013
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Biological: LY2605541 Biological: Insulin Glargine Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : February 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Time to Recovery Following Hypoglycemic Clamp [ Time Frame: Preclamp (baseline) through 2 hours post clamp procedure ]

Secondary Outcome Measures :
  1. Blood Glucose [ Time Frame: Preclamp (baseline) through 2 hours post clamp procedure ]
  2. Cortisol [ Time Frame: Preclamp (baseline) through 2 hours post clamp procedure ]
  3. Glucagon [ Time Frame: Preclamp (baseline) through 2 hours post clamp procedure ]
  4. Growth Hormone [ Time Frame: Preclamp (baseline) through 2 hours post clamp procedure ]
  5. Norepinephrine [ Time Frame: Preclamp (baseline) through 2 hours post clamp procedure ]
  6. Epinephrine [ Time Frame: Preclamp (baseline) through 2 hours post clamp procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01769404     History of Changes
Other Study ID Numbers: 14870
I2R-MC-BIDM ( Other Identifier: Eli Lilly and Company )
First Posted: January 16, 2013    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: December 2013

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
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs