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A Study of Multiple Increasing Doses of LY2409021 in Participants With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Placebo
LY2409021
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must be either a male, or a female who cannot become pregnant, who has type 2 diabetes and is either controlling diabetes through diet and exercise, or taking metformin
  • Have an hemoglobin A1c (HbA1c) value at screening of greater than or equal to 6.5% and less than or equal to 10.0% on a stable treatment regimen at the time of measurement
  • Have a screening body mass index (BMI) of 20 to 40 kg/m^2 inclusive
  • Have a blood pressure reading at screening of between 90 to 160 millimeters of mercury (mmHg) (systolic) and 40 to 95 mmHg (diastolic)

Exclusion Criteria:

  • Have used insulin for diabetic control within 1 year of study entry
  • Have used thiazolidinediones within 3 months, or any other drugs for treatment of hyperglycemia (except metformin) within 1 month, prior to first planned dosing. Metformin is acceptable for this study.
  • Have clinically significant coronary artery disease
  • Have clinically significant peripheral vascular disease
  • Have clinical evidence of active diabetic proliferative retinopathy
  • Have known significant autonomic neuropathy as evidenced by urinary retention, orthostatic hypotension, diabetic diarrhea or gastroparesis
  • Impaired renal function (serum creatinine greater than 115 micromoles/liter [μmol/L] [1.3 mg/dL] in women, greater than 130 μmol/L [1.5 mg/dL] in men)
  • Have triglycerides greater than 4.5 millimoles per liter (mmol/L) [approximately 400 mg/dL] at screening
  • Were hospitalized for poor control of diabetes (keto-acidotic episode) in the last 6 months
  • Are allergic to LY2409021 or similar drugs
  • Have history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (other than diabetes), hematological, or neurological disorders capable of significantly altering the absorption, or metabolism or elimination of drugs or of constituting a risk when taking the study medication or interfering with the interpretation of data
  • Have used systemic glucocorticoids within 1 month prior to first dosing
  • Have donated 450 mL or more of blood in the last 3 months or have donated any blood within the last month
  • Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)

Sites / Locations

  • 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.
  • 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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

5 mg LY2409021

30 mg LY2409021

60 mg LY2409021

90 mg LY2409021

Arm Description

Placebo administered orally once daily for 4 weeks

5 mg LY2409021 administered orally once daily for 4 weeks

30 mg LY2409021 administered orally once daily for 4 weeks

60 mg LY2409021 administered orally once daily for 4 weeks

90 mg LY2409021 administered orally once daily for 4 weeks

Outcomes

Primary Outcome Measures

Number of participants with one or more drug related adverse events (AEs) or any serious AEs

Secondary Outcome Measures

Pharmacokinetics: Area under the concentration curve (AUC) of LY2409021
Pharmacokinetics: Maximum concentration (Cmax) of LY2409021
Change in fasting blood glucose level
Change in incremental area under the curve (AUC) for glucose
Change in homeostasis model assessment of beta cell function (HOMA-B)
Change in fasting glucagon level
Change in fasting insulin level
Change in fasting C-peptide level
Change in fasting glucagon-like peptide-1 (GLP-1) level

Full Information

First Posted
May 23, 2012
Last Updated
May 23, 2012
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01606397
Brief Title
A Study of Multiple Increasing Doses of LY2409021 in Participants With Type 2 Diabetes
Official Title
The Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Multiple Escalating Doses of LY2409021 in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study drug LY2409021 is being evaluated as a possible treatment for diabetes. The primary purpose of this study is to help answer the following research questions, and not to provide treatment for diabetes : The safety of LY2409021 and any side effects that might be associated with it following 4 weeks of doses How long it takes the body to absorb and remove LY2409021 following dosing over 4 weeks How daily dosing of LY2409021 affects blood levels of sugar (glucose), insulin and other naturally occurring substances before and after a meal How LY2409021 works when given with metformin How daily dosing of LY2409021 affects the cells that produce insulin

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered orally once daily for 4 weeks
Arm Title
5 mg LY2409021
Arm Type
Experimental
Arm Description
5 mg LY2409021 administered orally once daily for 4 weeks
Arm Title
30 mg LY2409021
Arm Type
Experimental
Arm Description
30 mg LY2409021 administered orally once daily for 4 weeks
Arm Title
60 mg LY2409021
Arm Type
Experimental
Arm Description
60 mg LY2409021 administered orally once daily for 4 weeks
Arm Title
90 mg LY2409021
Arm Type
Experimental
Arm Description
90 mg LY2409021 administered orally once daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally (capsule)
Intervention Type
Drug
Intervention Name(s)
LY2409021
Intervention Description
Administered orally (capsule)
Primary Outcome Measure Information:
Title
Number of participants with one or more drug related adverse events (AEs) or any serious AEs
Time Frame
From first dose of study drug up to discharge (at least 28 days after last dose)
Secondary Outcome Measure Information:
Title
Pharmacokinetics: Area under the concentration curve (AUC) of LY2409021
Time Frame
From first study drug dose to Day 28 post last dose
Title
Pharmacokinetics: Maximum concentration (Cmax) of LY2409021
Time Frame
From first study drug dose to Day 28 post last dose
Title
Change in fasting blood glucose level
Time Frame
From Day -1 to Day 28 of dosing
Title
Change in incremental area under the curve (AUC) for glucose
Time Frame
From Day -1 to Day 28 of dosing
Title
Change in homeostasis model assessment of beta cell function (HOMA-B)
Time Frame
From baseline to Day 28
Title
Change in fasting glucagon level
Time Frame
From Day -1 to Day 28 of dosing
Title
Change in fasting insulin level
Time Frame
From Day -1 to Day 28 of dosing
Title
Change in fasting C-peptide level
Time Frame
From Day -1 to Day 28 of dosing
Title
Change in fasting glucagon-like peptide-1 (GLP-1) level
Time Frame
From Day -1 to Day 28 of dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be either a male, or a female who cannot become pregnant, who has type 2 diabetes and is either controlling diabetes through diet and exercise, or taking metformin Have an hemoglobin A1c (HbA1c) value at screening of greater than or equal to 6.5% and less than or equal to 10.0% on a stable treatment regimen at the time of measurement Have a screening body mass index (BMI) of 20 to 40 kg/m^2 inclusive Have a blood pressure reading at screening of between 90 to 160 millimeters of mercury (mmHg) (systolic) and 40 to 95 mmHg (diastolic) Exclusion Criteria: Have used insulin for diabetic control within 1 year of study entry Have used thiazolidinediones within 3 months, or any other drugs for treatment of hyperglycemia (except metformin) within 1 month, prior to first planned dosing. Metformin is acceptable for this study. Have clinically significant coronary artery disease Have clinically significant peripheral vascular disease Have clinical evidence of active diabetic proliferative retinopathy Have known significant autonomic neuropathy as evidenced by urinary retention, orthostatic hypotension, diabetic diarrhea or gastroparesis Impaired renal function (serum creatinine greater than 115 micromoles/liter [μmol/L] [1.3 mg/dL] in women, greater than 130 μmol/L [1.5 mg/dL] in men) Have triglycerides greater than 4.5 millimoles per liter (mmol/L) [approximately 400 mg/dL] at screening Were hospitalized for poor control of diabetes (keto-acidotic episode) in the last 6 months Are allergic to LY2409021 or similar drugs Have history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (other than diabetes), hematological, or neurological disorders capable of significantly altering the absorption, or metabolism or elimination of drugs or of constituting a risk when taking the study medication or interfering with the interpretation of data Have used systemic glucocorticoids within 1 month prior to first dosing Have donated 450 mL or more of blood in the last 3 months or have donated any blood within the last month Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Singapore
Country
Singapore
Facility Name
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.
City
Plymouth
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25656305
Citation
Kelly RP, Garhyan P, Raddad E, Fu H, Lim CN, Prince MJ, Pinaire JA, Loh MT, Deeg MA. Short-term administration of the glucagon receptor antagonist LY2409021 lowers blood glucose in healthy people and in those with type 2 diabetes. Diabetes Obes Metab. 2015 Apr;17(4):414-22. doi: 10.1111/dom.12446. Epub 2015 Mar 2.
Results Reference
derived

Learn more about this trial

A Study of Multiple Increasing Doses of LY2409021 in Participants With Type 2 Diabetes

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