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

May 28, 2013
January 28, 2014
June 2013
January 2014   (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 10 weeks) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01867216 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of Multiple Doses of LY2922470 in Participants With Diabetes
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of LY2922470 in Patients With Type 2 Diabetes Mellitus

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Diabetes Mellitus, Type 2
  • Drug: Placebo
    Administered orally as capsules
  • Drug: LY2922470
    Administered orally as capsules
  • Placebo Comparator: Placebo
    Multiple oral dose of placebo administered to participants with diabetes once or twice daily for 28 days
    Intervention: Drug: Placebo
  • Experimental: LY2922470
    Multiple ascending dose of LY292470 (starting at 60 mg) administered orally to participants with diabetes once or twice daily for 28 days
    Intervention: Drug: LY2922470
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01867216
14797, I6K-FW-GLEB
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
January 2014

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