A Study of LY2922083 in Healthy Participants and Participants With Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01748552
First received: December 10, 2012
Last updated: August 22, 2013
Last verified: August 2013

December 10, 2012
August 22, 2013
December 2012
August 2013   (final data collection date for primary outcome measure)
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline up to study completion (estimated at 20 weeks) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01748552 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2922083 [ Time Frame: Baseline up to 72 hours after each dose of study drug ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximum Concentration (Cmax) of LY2922083 [ Time Frame: Baseline up to 72 hours after each dose of study drug ] [ Designated as safety issue: No ]
  • Change from Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC) [ Time Frame: Baseline, up to 24 hours postdose ] [ Designated as safety issue: No ]
  • Change from Baseline in C-peptide Area Under the Effective Concentration Curve (AUEC) [ Time Frame: Baseline, up to 6 hours postdose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of LY2922083 in Healthy Participants and Participants With Diabetes
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Oral Doses of LY2922083 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Diabetes Mellitus, Type 2
  • Drug: Placebo
    Administered orally as capsules
  • Drug: LY2922083
    Administered orally as capsules
  • 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
    Intervention: Drug: Placebo
  • Experimental: LY2922083 (Part A)
    Single ascending dose of LY2922083 (starting at 0.5 milligram [mg]) administered orally to healthy participants in up to 2 of 3 study periods in Part A
    Intervention: Drug: LY2922083
  • 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
    Intervention: Drug: Placebo
  • 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
    Intervention: Drug: LY2922083
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
August 2013
August 2013   (final data collection date for primary outcome measure)

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 Type 2 Diabetes Mellitus (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 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 e.g. frequent urination, always feeling thirsty, or unexpected weight loss
Both
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01748552
14793, I6J-FW-PRBA
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP