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A Study of Multiple Doses of LY2922470 in 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: NCT01867216
Recruitment Status : Completed
First Posted : June 3, 2013
Results First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE May 28, 2013
First Posted Date  ICMJE June 3, 2013
Results First Submitted Date  ICMJE September 27, 2017
Results First Posted Date  ICMJE July 26, 2018
Last Update Posted Date July 26, 2018
Study Start Date  ICMJE June 2013
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2018)
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 through Study Completion (up to 56 days) ]
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is located in the Reported Adverse Events module.
Original Primary Outcome Measures  ICMJE
 (submitted: May 29, 2013)
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) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2018)
  • Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470 [ Time Frame: Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose ]
  • Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 [ Time Frame: Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose ]
  • Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470 [ Time Frame: Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose ]
  • Change From Baseline in Hemoglobin A1c (HbA1c) at Day 28 [ Time Frame: Baseline, Day 28 ]
  • Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC₀₋₂₄) During Mixed Meal Tolerance Test at Day 28 [ Time Frame: Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12, 16, 24 hours Postdose ]
  • Change From Baseline in C-Peptide Area Under the Effective Concentration Curve (AUEC₀₋₁₂) During Mixed Meal Tolerance Test at Day 28 [ Time Frame: Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12 hours Postdose ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2013)
  • 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 ]
  • Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 [ Time Frame: Baseline up to 48 hours post dose of study drug on Day 1 and Day 28 ]
  • 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 ]
  • Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, up to Day 28 ]
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Multiple Doses of LY2922470 in Participants With Diabetes
Official Title  ICMJE Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of LY2922470 in Patients With Type 2 Diabetes Mellitus
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Placebo
    Administered orally as capsules
  • Drug: LY2922470
    Administered orally as capsules
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2018)
66
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2013)
70
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01867216
Other Study ID Numbers  ICMJE 14797
I6K-FW-GLEB ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date July 2018

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