The Effects of LY2409021 on the Liver
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ClinicalTrials.gov Identifier: NCT01588366 |
Recruitment Status
:
Completed
First Posted
: May 1, 2012
Last Update Posted
: September 11, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Drug: Placebo Drug: LY2409021 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Basic Science |
Official Title: | Effects of LY2409021 on Hepatic Metabolism in Healthy Volunteers and Patients With Type 2 Diabetes Mellitus |
Study Start Date : | April 2012 |
Actual Primary Completion Date : | September 2013 |
Actual Study Completion Date : | September 2013 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Part A and B - Up to 4 capsules of placebo administered orally once a day for 28 days.
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Drug: Placebo
Administered orally
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Experimental: 15 mg LY2409021
Part B - 1 capsule of 15 mg LY2409021 orally once a day for 28 days. (Arm added in September, 2012, per protocol amendment.)
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Drug: LY2409021
Administered orally
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Experimental: 60 mg LY2409021
Part A - 4 capsules of 15 mg LY2409021 administered orally once a day for 28 days.
|
Drug: LY2409021
Administered orally
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- Change from Baseline to Day 28 in hepatic lipid content [ Time Frame: Baseline, Day 28 ]
- Change from Baseline to Day 28 in hepatic glycogen content [ Time Frame: Baseline, Day 28 ]
- Change from Baseline to Day 28 in transaminase levels [ Time Frame: Baseline, Day 28 ]
- Glucose response to an Arginine Stimulation Test (Part A) [ Time Frame: Baseline and Day 29 ]
- Glucagon response to an Arginine Stimulation Test (Part A) [ Time Frame: Baseline and Day 29 ]
- Insulin response to an Arginine Stimulation Test (Part A) [ Time Frame: Baseline and Day 29 ]

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Ages Eligible for Study: | 21 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
For all participants:
- Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes
- Must have a body mass index (BMI) of 18.5 to 29.9 kilograms per square meter (kg/m^2) if a healthy participant, or a BMI of 18.5 to 35.0 kg/m^2 if diabetic
For participants with type 2 diabetes mellitus (T2DM):
- On diet and exercise treatment, or taking metformin
Exclusion Criteria:
For all participants:
- Have signs or symptoms of liver disease
- Are infected with hepatitis B or hepatitis C
- Have donated more than 450 mL of blood in the last 3 months or if have donated any blood in the last month
- Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
- Have had surgery with metallic clips, staples or stents, or have had a cardiac pacemaker (or other surgical implants) inserted in any part of the body, or have fear of enclosed spaces or have symptoms that prevent them from being sent for an magnetic resonance imaging (MRI) scan
For participants with T2DM:
- Are using insulin

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): NCT01588366
Singapore | |
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. | |
Singapore, Singapore |
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: | NCT01588366 History of Changes |
Other Study ID Numbers: |
13107 I1R-FW-GLBK ( Other Identifier: Eli Lilly and Company ) |
First Posted: | May 1, 2012 Key Record Dates |
Last Update Posted: | September 11, 2013 |
Last Verified: | September 2013 |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |