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Study of LY2409021 in Participants With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT01640834
Recruitment Status : Completed
First Posted : July 16, 2012
Results First Posted : October 29, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This study involves taking a single dose of 100 milligrams (mg) or 300 mg LY2409021 or placebo (an inactive medicine) taken as up to 3 capsules by mouth. The study will evaluate if this drug will reduce the amount of insulin a type 1 diabetic needs over 24 hours. This study includes a 7-day hospitalization period at the clinical research unit (CRU) and will involve screening within 30 days of the start of the study as well as telephone consultations within 5 days after discharge from the CRU.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: LY2409021 Drug: Placebo Drug: Glucagon Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study of the Effects of LY2409021 in Patients With Type 1 Diabetes Mellitus
Study Start Date : July 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Glucagon

Arm Intervention/treatment
Experimental: 100 mg LY2409021

LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.

Placebo: 2 capsules, administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

Drug: LY2409021
Administered orally

Drug: Placebo
Administered orally

Drug: Glucagon
Administered via intramuscular injection

Experimental: 300 mg LY2409021

LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

Drug: LY2409021
Administered orally

Drug: Glucagon
Administered via intramuscular injection

Placebo Comparator: Placebo

Placebo: 3 capsules administered as a single oral dose on Day 2.

Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.

Drug: Placebo
Administered orally

Drug: Glucagon
Administered via intramuscular injection




Primary Outcome Measures :
  1. Pharmacodynamics: Change From Baseline to Day 2 in 24-hour Insulin Dose [ Time Frame: Baseline (Day 1), Day 2 ]
    The mean absolute change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.


Secondary Outcome Measures :
  1. Pharmacodynamics: Percentage Change From Baseline to Day 2 in 24-hour Insulin [ Time Frame: Baseline (Day 1), Day 2 ]
    The percentage change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.

  2. Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021 [ Time Frame: Predose (Day 2) through 120 hours postdose (Day 7) ]
  3. Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021 [ Time Frame: Predose (Day 2) through 120 hours postdose (Day 7) ]
    Exposure in terms of AUC of LY2409021 from time 0 extrapolated to infinity (AUCinf) is reported.

  4. Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose During Drug Washout Period [ Time Frame: Baseline (Day 1), Day 3 up to Day 6 ]
    Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis.

  5. Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose Needed to Maintain Euglycemia [ Time Frame: Baseline (Day 1), Day 3 up to Day 6 ]
    Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis.

  6. Pharmacodynamics: Maximum Concentration (Cmax) of Glucose Concentration After 1 Milligram (mg) Glucagon Injection on Day 3 [ Time Frame: Day 3 ]
    The Cmax of glucose following a single dose of glucagon (1 mg) administered via an intramuscular injection is reported.

  7. Pharmacodynamics: Area Under the Glucose Concentration Curve After a Single Dose of Glucagon on Day 3 [ Time Frame: Day 3 ]
    Area under the glucose concentration curve from time 0 through 2 hours after a single dose of glucagon (1 milligram) administered via an intramuscular injection is reported.



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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:

  • Have had type 1 diabetes mellitus (T1DM) based on the World Health Organization classification for at least 1 year and have a daily insulin dose ≤1.5 international units (IU) per kilogram (kg) of body weight
  • Have a glycated hemoglobin A1c (HbA1c) of no greater than 9.0% as measured at screening
  • Have a body mass index (BMI) ≥19.0 and ≤35.0 kilograms per meter squared (kg/m^2)
  • Have given written informed consent approved by Lilly

Exclusion Criteria:

  • Received any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 3 months prior to screening
  • Have had more than 1 episode of severe hypoglycemia within 3 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness
  • Are pregnant or intend to become pregnant during the course of the study
  • Women who are breastfeeding
  • Have a history of stroke, myocardial infarction, heart failure, unstable angina, or a coronary revascularization procedure within 6 months of screening
  • Have fasting triglycerides >500 milligrams per deciliter (mg/dL) (5.65 millimoles per liter [mmol/L])
  • Have obvious clinical signs, symptoms, or laboratory evidence of liver disease (alanine transaminase [ALT] or aspartate transaminase [AST] greater than 2 times the upper limit of normal at screening)
  • Have a history of renal transplantation or are currently receiving renal dialysis or have a screening creatinine >2.0 mg/dL (177 micromoles per liter [μmol/L])
  • Have had any other disease, illness, or condition (including known diabetic autonomic neuropathy, drug or alcohol abuse, or psychiatric disorder) within the 6 months prior to screening that precludes the participant from following and completing the study or could increase their risk for hypoglycemia, according to the investigator's judgment
  • Are currently enrolled in, have completed, or have discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

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): NCT01640834


Locations
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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
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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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01640834     History of Changes
Other Study ID Numbers: 14576
I1R-MC-GLBR ( Other Identifier: Eli Lilly and Company )
2011-006178-19 ( EudraCT Number )
First Posted: July 16, 2012    Key Record Dates
Results First Posted: October 29, 2018
Last Update Posted: October 29, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucagon-Like Peptide 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glucagon
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins