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A Study of LY2922083 in Healthy Participants and Participants With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01748552
Recruitment Status : Completed
First Posted : December 12, 2012
Results First Posted : August 8, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:

The aim of this trial is to evaluate the safety of the study drug in healthy participants and participants with diabetes. It will investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.

The study consists of two parts. Part A will study healthy participants in up to 3 dosing periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3 dosing periods over approximately 6 weeks.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Placebo Drug: LY2922083 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Oral Doses of LY2922083 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus
Study Start Date : December 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo (Part A)
Single oral dose of placebo administered to healthy participants in up to 1 of 3 study periods in Part A
Drug: Placebo
Administered orally as capsules

Experimental: LY2922083 (Part A)
Single ascending dose of LY2922083 (starting at 0.5 milligrams [mg]) administered orally to healthy participants in up to 2 of 3 study periods in Part A
Drug: LY2922083
Administered orally as capsules

Placebo Comparator: Placebo (Part B)
Single oral dose of placebo administered to participants with type 2 diabetes mellitus (T2DM) in up to 1 of 3 study periods in Part B
Drug: Placebo
Administered orally as capsules

Experimental: LY2922083 (Part B)
Single ascending dose of LY2922083 administered orally to participants with T2DM in up to 2 of 3 study periods in Part B. Dose determined by Part A
Drug: LY2922083
Administered orally as capsules




Primary Outcome Measures :
  1. Number of Participants With 1 or More Serious Adverse Event(s) (SAEs) [ Time Frame: Baseline through study completion (up to 70 days) ]
    Events deemed by the Investigator to be SAEs related to study drug administration are reported. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.


Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Area Under the Concentration Curve From Time 0 to Infinite Time [AUC(0-∞)] of LY2922083 [ Time Frame: Predose up to 72 hours (h) after each dose of study drug (Part A: predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose. Part B: predose, 0.5, 1.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose.) ]
  2. PK: Maximum Concentration (Cmax) of LY2922083 [ Time Frame: Predose up to 72 h after each dose of study drug (Part A: predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose. Part B: predose, 0.5, 1.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose.) ]
  3. Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time 0 to 24 h Postdose [AUEC(0-24)] [ Time Frame: Baseline (predose for Part A and Day -1 time-matched for Part B), up to 24 h postdose (1.5, 2.5, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18, and 24 h postdose) ]
    Least Squares (LS) mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.

  4. Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time 0 to 6 h Postdose [AUEC(0-6)] [ Time Frame: Baseline (predose for Part A and Day -1 time-matched for Part B), up to 6 h postdose (1.5, 2.5, 4, 4.5, 5, and 6 h postdose) ]
    LS mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Have a screening body mass index (BMI) of at least 18.0 kilograms per square meter (kg/m^2)
  • Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study

For participants with T2DM:

  • Do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening
  • Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6% and less than or equal to 11% at screening

Exclusion Criteria:

For all participants :

  • Are currently participating in another clinical study or completed one in the last 30 days
  • Are allergic to LY2922083 or other related drugs
  • Have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study
  • Have electrocardiogram (ECG) readings that are not suitable for the study
  • Have a history of hepatitis or jaundice
  • Are infected with hepatitis B
  • Are infected with hepatitis C
  • Are infected with human immunodeficiency virus (HIV)
  • Have donated more than 450 milliliters (mL) of blood in the last 3 months or have donated any blood in 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)
  • Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic

For participants with T2DM :

  • Have had heart disease or stroke within 6 months before entering the study
  • Have health complications due to poorly controlled diabetes as shown by blood and urine laboratory test results or based on physical examination and medical assessment as determined by the study doctor
  • Have been hospitalized for poor control of diabetes (keto-acidotic episode) in the last 6 months
  • Have used insulin to control diabetes in the last 1 year
  • Show symptoms of high blood sugar (for example, frequent urination, always feeling thirsty, or unexpected weight loss)

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): NCT01748552


Locations
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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, 117597
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: NCT01748552    
Other Study ID Numbers: 14793
I6J-FW-PRBA ( Other Identifier: Eli Lilly and Company )
First Posted: December 12, 2012    Key Record Dates
Results First Posted: August 8, 2019
Last Update Posted: August 8, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases