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Completed

NCT Number: NCT01769404

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

This study has 2 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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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 has poor awareness of hypoglycemia

Treatment and study plan

LY2605541

Biological

Insulin Glargine

Biological

Primary outcomes

  1. Concentration of Epinephrine

    Time frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp

    Epinephrine levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at blood glucose (BG) level attainment and +10, 20, and 30 minutes were averaged for the BG nadir value.

Secondary outcomes

  1. Amount of Glucose Required to Reach Blood Glucose (BG) of 72 mg/dL

    Time frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp

    The amount of infused glucose required to reach BG of 72 milligrams per deciliter (mg/dL) is presented.

  2. Amount of Glucose Required to Maintain BG of 72 mg/dL

    Time frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp

    The amount of infused glucose required to maintain BG of 72 mg/dL for 1 hour is presented.

  3. Concentration of Cortisol

    Time frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp

    Cortisol levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value.

  4. Concentration of Glucagon

    Time frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp

    Glucagon levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value.

  5. Concentration of Growth Hormone

    Time frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp

    Growth hormone levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value.

  6. Concentration of Norepinephrine

    Time frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp

    Norepinephrine values are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +10, 20, and 30 minutes were averaged for the BG nadir value.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Evaluation of the Counter-Regulatory Response to Hypoglycaemia Following LY2605541 Administration Compared to Insulin Glargine in Patients With Type 1 Diabetes Mellitus

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 16, 2013
Registry last updated
Jun 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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