A Study of Multiple Doses of LY2922470 in Participants With Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01867216
First received: May 28, 2013
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

The main purpose of this study is to determine the safety of LY2922470, taken as oral capsules, once or twice daily for approximately 28 days, in participants with diabetes. It also aims to determine how long the drug stays in the body and how it affects blood sugar levels. A screening appointment is required within 28 days before the start of the study and a follow up appointment is required approximately 14 days after the last study dose is taken.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo
Drug: LY2922470
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of LY2922470 in 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 10 weeks) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2922470 [ Time Frame: Baseline up to 48 hours post dose of study drug on Day 1 and Day 28 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 [ Time Frame: Baseline up to 48 hours post dose of study drug on Day 1 and Day 28 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470 [ Time Frame: Baseline up to 48 hours post dose of study drug on Day 1 and Day 28 ] [ Designated as safety issue: No ]
  • Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, up to Day 28 ] [ Designated as safety issue: No ]
  • Change from Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC) During Mixed Meal Tolerance Test [ Time Frame: Baseline, up to 2.5 hours post dose of study drug on Day 28 ] [ Designated as safety issue: No ]
  • Change from Baseline in C-Peptide Area Under the Effective Concentration Curve (AUEC) During Mixed Meal Tolerance Test [ Time Frame: Baseline, up to 2.5 hours post dose of study drug on Day 28 ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: June 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Multiple oral dose of placebo administered to participants with diabetes once or twice daily for 28 days
Drug: Placebo
Administered orally as capsules
Experimental: LY2922470
Multiple ascending dose of LY292470 (starting at 60 mg) administered orally to participants with diabetes once or twice daily for 28 days
Drug: LY2922470
Administered orally as capsules

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be a male, or a female who cannot become pregnant, and who has type 2 diabetes
  • Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6.5% and less than or equal to 11% at screening
  • Do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening
  • Have a screening body mass index (BMI) of 18.0 to 45.0 kilograms per square meter (kg/m^2)
  • Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study

Exclusion Criteria:

  • Are currently participating in another clinical study or completed one in the last 30 days
  • 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
  • Are infected with hepatitis B or hepatitis C
  • Are infected with human immunodeficiency virus (HIV)
  • Have donated blood equal to or more than 500 mL within 56 days before the first dose of drug or have donated plasma within 7 days before the first dose or provided any blood donation within the last month from screening
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01867216

Locations
United States, California
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.
Chula Vista, California, United States, 91911
United States, New Jersey
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.
Eatontown, New Jersey, United States, 07724
United States, New York
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.
New York, New York, United States, 10013
United States, Texas
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.
Dallas, Texas, United States, 75247
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: NCT01867216     History of Changes
Other Study ID Numbers: 14797, I6K-FW-GLEB
Study First Received: May 28, 2013
Last Updated: January 28, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 16, 2014