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A Study on the Effects of LY2409021 on the Electrical Impulses of the Heart

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ClinicalTrials.gov Identifier: NCT01460368
Recruitment Status : Completed
First Posted : October 26, 2011
Results First Posted : October 18, 2018
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Diabetes Mellitus, Type 2
Interventions Drug: LY2409021
Drug: Placebo
Drug: Moxifloxacin
Enrollment 67
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Part A: LY2409021 Part B: LY2409021, Placebo, Moxifloxacin Part B: Moxifloxacin, LY2409021, Placebo Part B: Placebo, Moxifloxacin, LY2409021 Part B: Moxifloxacin, Placebo, LY2409021 Part B: Placebo, LY2409021, Moxifloxacin Part B: LY2409021, Moxifloxacin, Placebo
Hide Arm/Group Description Participants received 2 standard meals; one alone without LY2409021, and one along with a single dose of 300 milligrams (mg) LY2409021 administered orally to determine the effects of a meal on electrocardiogram (ECG) activity. Participants enrolled in Part A were not allowed to participate in Part B.

Period 1: 300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1.

Period 2: Placebo administered orally as a single dose on Day 1.

Period 3: 400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1.

Period 1: 400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1.

Period 2: 300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1.

Period 3: Placebo administered orally as a single dose on Day 1.

Period 1: Placebo administered orally as a single dose on Day 1.

Period 2: 400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1.

Period 3: 300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1.

Period 1: 400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1.

Period 2: Placebo administered orally as a single dose on Day 1.

Period 3: 300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1.

Period 1: Placebo administered orally as a single dose on Day 1.

Period 2: 300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1.

Period 3: 400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1.

Period 1: 300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1.

Period 2: 400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1.

Period 3: Placebo administered orally as a single dose on Day 1.

Period Title: Part A
Started 7 0 0 0 0 0 0
Received at Least One Dose of Study Drug 7 0 0 0 0 0 0
Completed 7 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0
Period Title: Part B: First Intervention (Period 1)
Started 0 10 10 10 10 10 10
Received at Least One Dose of Study Drug 0 10 10 10 10 10 10
Completed 0 10 10 10 9 10 10
Not Completed 0 0 0 0 1 0 0
Reason Not Completed
Lost to Follow-up             0             0             0             0             1             0             0
Period Title: Part B: Washout (up to 15 Days)
Started 0 10 10 10 9 10 10
Completed 0 10 10 10 9 10 10
Not Completed 0 0 0 0 0 0 0
Period Title: Part B: Second Intervention (Period 2)
Started 0 10 10 10 9 10 10
Completed 0 8 10 10 9 10 9
Not Completed 0 2 0 0 0 0 1
Reason Not Completed
Withdrawal by Subject             0             1             0             0             0             0             1
Lost to Follow-up             0             1             0             0             0             0             0
Period Title: Part B: Washout (up to 15 Days)
Started 0 8 10 10 9 10 9
Completed 0 8 9 10 9 10 9
Not Completed 0 0 1 0 0 0 0
Reason Not Completed
Protocol Violation             0             0             1             0             0             0             0
Period Title: Part B: Third Interventions (Period 3)
Started 0 8 9 10 9 10 9
Completed 0 8 8 9 9 9 9
Not Completed 0 0 1 1 0 1 0
Reason Not Completed
Withdrawal by Subject             0             0             1             1             0             1             0
Arm/Group Title Part A Part B Total
Hide Arm/Group Description A single dose of 300 milligrams (mg) LY2409021 administered orally on Day 1. Participants enrolled in Part A were not allowed to participate in Part B. Participants received a single dose of either 300 milligrams (mg) LY2409021, 400 mg Moxifloxacin, or Placebo on Day 1 in 1 of 3 Study Periods so that after the completion of the 3 study periods, each participant received a single dose of each drug. Total of all reporting groups
Overall Number of Baseline Participants 7 60 67
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study drug (Part A or Part B).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 60 participants 67 participants
47.3  (7.7) 39.7  (12.8) 40.4  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 60 participants 67 participants
Female 0 14 14
Male 7 46 53
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 60 participants 67 participants
Hispanic or Latino 3 20 23
Not Hispanic or Latino 4 40 44
Unknown or Not Reported 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 60 participants 67 participants
American Indian or Alaska Native 0 2 2
Asian 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 3 23 26
White 4 35 39
More than one race 0 0 0
Unknown or Not Reported 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 7 participants 60 participants 67 participants
7 60 67
1.Primary Outcome
Title Part B: Mean Change From Baseline in 12-lead Electrocardiogram (ECG) Corrected QT Intervals (LY2409021)
Hide Description The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. Least Squares (LS) means were calculated using mixed effects model with fixed effects for treatment, time, period, sequence, and the time-by-treatment interaction, random effects for participant, the participant-by-treatment interaction, and participant-by-time interaction.
Time Frame Baseline, 2, 4, 6, 8, 12, and 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of LY2409021 or Placebo with evaluable Fridericia Correction Formula (QTcF) data.
Arm/Group Title Part B: LY2409021 Part B: Placebo
Hide Arm/Group Description:
300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1 of the relevant treatment period.
Placebo: Administered orally as a single dose on Day 1 of the relevant treatment period.
Overall Number of Participants Analyzed 58 56
Least Squares Mean (90% Confidence Interval)
Unit of Measure: milliseconds
2 hours postdose Number Analyzed 57 participants 54 participants
-14.72
(-16.44 to -13.00)
-15.35
(-17.10 to -13.59)
4 hours postdose Number Analyzed 57 participants 53 participants
-5.43
(-7.15 to -3.72)
-9.12
(-10.89 to -7.35)
6 hours postdose Number Analyzed 56 participants 54 participants
6.13
(4.40 to 7.85)
-3.01
(-4.77 to -1.26)
8 hours postdose Number Analyzed 58 participants 56 participants
7.80
(6.09 to 9.51)
-1.29
(-3.02 to 0.45)
12 hours postdose Number Analyzed 58 participants 55 participants
-13.45
(-15.15 to -11.74)
-13.30
(-15.05 to -11.55)
24 hours postdose Number Analyzed 57 participants 55 participants
-1.32
(-3.04 to 0.40)
-4.95
(-6.70 to -3.20)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B: LY2409021, Part B: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.63
Confidence Interval (2-Sided) 90%
-1.38 to 2.63
Estimation Comments Treatment comparison at 2 hours.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part B: LY2409021, Part B: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Means Difference
Estimated Value 3.69
Confidence Interval (2-Sided) 90%
1.67 to 5.71
Estimation Comments Treatment comparison at 4 hours.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part B: LY2409021, Part B: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Means Difference
Estimated Value 9.14
Confidence Interval (2-Sided) 90%
7.12 to 11.16
Estimation Comments Treatment comparison at 6 hours.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part B: LY2409021, Part B: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Means Difference
Estimated Value 9.08
Confidence Interval (2-Sided) 90%
7.10 to 11.07
Estimation Comments Treatment comparison at 8 hours.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Part B: LY2409021, Part B: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Means Difference
Estimated Value -0.15
Confidence Interval (2-Sided) 90%
-2.14 to 1.85
Estimation Comments Treatment comparison at 12 hours.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Part B: LY2409021, Part B: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Means Difference
Estimated Value 3.63
Confidence Interval (2-Sided) 90%
1.63 to 5.63
Estimation Comments Treatment comparison at 24 hours.
2.Secondary Outcome
Title Part B: Mean Change From Baseline in 12-lead Electrocardiogram (ECG) Corrected QT Intervals (Moxifloxacin)
Hide Description The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. Least Squares (LS) means were calculated using mixed effects model with fixed effects for treatment, time, period, sequence, and the time-by-treatment interaction, random effects for participant, the participant-by-treatment interaction, and participant-by-time interaction.
Time Frame Baseline, 2 and 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of Moxifloxacin or Placebo with evaluable QTcF data.
Arm/Group Title Part B: Moxifloxacin Part B: Placebo
Hide Arm/Group Description:
400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1 of the relevant treatment period.
Placebo: Administered orally as a single dose on Day 1 of the relevant treatment period.
Overall Number of Participants Analyzed 56 54
Least Squares Mean (90% Confidence Interval)
Unit of Measure: milliseconds
2 hours postdose Number Analyzed 55 participants 54 participants
-7.39
(-9.13 to -5.64)
-15.46
(-17.22 to -13.70)
4 hours postdose Number Analyzed 56 participants 53 participants
1.45
(-0.28 to 3.18)
-9.11
(-10.88 to -7.34)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B: Moxifloxacin, Part B: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 8.07
Confidence Interval (2-Sided) 90%
5.21 to 10.94
Estimation Comments Treatment comparison at 2 hours.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part B: Moxifloxacin, Part B: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 10.56
Confidence Interval (2-Sided) 90%
7.69 to 13.43
Estimation Comments Treatment comparison at 4 hours.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part A: LY2409021 Part B: Placebo Part B: Moxifloxacin Part B: LY2409021
Hide Arm/Group Description A single dose of 300 milligrams (mg) LY2409021 administered orally on Day 1. Participants enrolled in Part A were not allowed to participate in Part B. Administered orally as a single dose on Day 1 of the relevant treatment period. 400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1 of the relevant treatment period. 300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1 of the relevant treatment period.
All-Cause Mortality
Part A: LY2409021 Part B: Placebo Part B: Moxifloxacin Part B: LY2409021
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Part A: LY2409021 Part B: Placebo Part B: Moxifloxacin Part B: LY2409021
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/57 (0.00%)      0/58 (0.00%)      0/59 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Part A: LY2409021 Part B: Placebo Part B: Moxifloxacin Part B: LY2409021
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/7 (14.29%)      12/57 (21.05%)      11/58 (18.97%)      9/59 (15.25%)    
Eye disorders         
Eyelid oedema  1  0/7 (0.00%)  0 0/57 (0.00%)  0 1/58 (1.72%)  1 0/59 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain  1  0/7 (0.00%)  0 1/57 (1.75%)  1 0/58 (0.00%)  0 1/59 (1.69%)  1
Abdominal pain lower  1  0/7 (0.00%)  0 1/57 (1.75%)  1 0/58 (0.00%)  0 0/59 (0.00%)  0
Abdominal pain upper  1  0/7 (0.00%)  0 0/57 (0.00%)  0 0/58 (0.00%)  0 1/59 (1.69%)  1
Diarrhoea  1  0/7 (0.00%)  0 0/57 (0.00%)  0 1/58 (1.72%)  1 0/59 (0.00%)  0
Dyspepsia  1  0/7 (0.00%)  0 0/57 (0.00%)  0 2/58 (3.45%)  2 0/59 (0.00%)  0
Nausea  1  0/7 (0.00%)  0 0/57 (0.00%)  0 0/58 (0.00%)  0 1/59 (1.69%)  1
Toothache  1  0/7 (0.00%)  0 1/57 (1.75%)  1 0/58 (0.00%)  0 0/59 (0.00%)  0
General disorders         
Application site rash  1  0/7 (0.00%)  0 1/57 (1.75%)  1 1/58 (1.72%)  1 0/59 (0.00%)  0
Application site reaction  1  0/7 (0.00%)  0 0/57 (0.00%)  0 1/58 (1.72%)  1 1/59 (1.69%)  1
Vessel puncture site pain  1  0/7 (0.00%)  0 1/57 (1.75%)  1 0/58 (0.00%)  0 0/59 (0.00%)  0
Infections and infestations         
Influenza  1  0/7 (0.00%)  0 0/57 (0.00%)  0 0/58 (0.00%)  0 1/59 (1.69%)  1
Upper respiratory tract infection  1  0/7 (0.00%)  0 1/57 (1.75%)  1 3/58 (5.17%)  3 0/59 (0.00%)  0
Injury, poisoning and procedural complications         
Excoriation  1  0/7 (0.00%)  0 1/57 (1.75%)  1 0/58 (0.00%)  0 0/59 (0.00%)  0
Joint sprain  1  0/7 (0.00%)  0 1/57 (1.75%)  1 0/58 (0.00%)  0 0/59 (0.00%)  0
Investigations         
Cardiac murmur  1  1/7 (14.29%)  1 0/57 (0.00%)  0 0/58 (0.00%)  0 0/59 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/7 (0.00%)  0 0/57 (0.00%)  0 0/58 (0.00%)  0 1/59 (1.69%)  1
Back pain  1  0/7 (0.00%)  0 1/57 (1.75%)  1 2/58 (3.45%)  2 1/59 (1.69%)  1
Muscle spasms  1  0/7 (0.00%)  0 0/57 (0.00%)  0 1/58 (1.72%)  2 0/59 (0.00%)  0
Neck pain  1  0/7 (0.00%)  0 0/57 (0.00%)  0 0/58 (0.00%)  0 1/59 (1.69%)  1
Pain in extremity  1  0/7 (0.00%)  0 1/57 (1.75%)  1 0/58 (0.00%)  0 0/59 (0.00%)  0
Nervous system disorders         
Dizziness  1  0/7 (0.00%)  0 0/57 (0.00%)  0 1/58 (1.72%)  1 0/59 (0.00%)  0
Headache  1  0/7 (0.00%)  0 3/57 (5.26%)  3 1/58 (1.72%)  1 1/59 (1.69%)  1
Tremor  1  0/7 (0.00%)  0 0/57 (0.00%)  0 0/58 (0.00%)  0 1/59 (1.69%)  1
Psychiatric disorders         
Abnormal dreams  1  0/7 (0.00%)  0 0/57 (0.00%)  0 0/58 (0.00%)  0 2/59 (3.39%)  2
Anxiety  1  0/7 (0.00%)  0 0/57 (0.00%)  0 0/58 (0.00%)  0 1/59 (1.69%)  1
Renal and urinary disorders         
Pollakiuria  1  0/7 (0.00%)  0 0/57 (0.00%)  0 1/58 (1.72%)  1 0/59 (0.00%)  0
Skin and subcutaneous tissue disorders         
Drug eruption  1  0/7 (0.00%)  0 1/57 (1.75%)  1 0/58 (0.00%)  0 0/59 (0.00%)  0
Hangnail  1  0/7 (0.00%)  0 0/57 (0.00%)  0 1/58 (1.72%)  1 0/59 (0.00%)  0
Hyperhidrosis  1  0/7 (0.00%)  0 0/57 (0.00%)  0 0/58 (0.00%)  0 1/59 (1.69%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01460368    
Other Study ID Numbers: 14149
I1R-FW-GLBP ( Other Identifier: Eli Lilly and Company )
First Submitted: October 7, 2011
First Posted: October 26, 2011
Results First Submitted: March 24, 2018
Results First Posted: October 18, 2018
Last Update Posted: January 7, 2019