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Completed

NCT Number: NCT01640834

Study of LY2409021 in Participants With Type 1 Diabetes

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.

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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

  • 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

Treatment and study plan

LY2409021

Drug

Administered orally

Placebo

Drug

Administered orally

glucagon

Drug

Administered via intramuscular injection

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Pilot Study of the Effects of LY2409021 in Patients With Type 1 Diabetes Mellitus

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 16, 2012
Registry last updated
Oct 29, 2018

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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