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
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo
Drug: LY2922083
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 36
Study Start Date: December 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 milligram [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

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748552

Locations
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
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01748552     History of Changes
Other Study ID Numbers: 14793, I6J-FW-PRBA
Study First Received: December 10, 2012
Last Updated: August 22, 2013
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 21, 2014