A Study of Multiple Doses of LY2922470 in Participants With Diabetes
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01867216
Collaborator
(none)
66
4
2
7
16.5
2.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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
Study Start Date
:
Jun 1, 2013
Actual Primary Completion Date
:
Jan 1, 2014
Actual Study Completion Date
:
Jan 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
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 [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.
Secondary Outcome Measures
- Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470 [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 [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 [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 [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 [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 [Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12 hours Postdose]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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 |
| 2 | 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 |
| 3 | 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 |
| 4 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01867216
Other Study ID Numbers:
- 14797
- I6K-FW-GLEB
First Posted:
Jun 3, 2013
Last Update Posted:
Jul 26, 2018
Last Verified:
Jul 1, 2018
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Placebo QD or BID | 60 mg LY2922470 QD | 200 mg LY2922470 QD | 500 mg LY2922470 QD | 1200 mg LY2922470 QD | 150 mg LY2922470 BID | 400 mg LY2922470 BID |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo administered orally once daily (QD) or twice daily (BID) for up to 28 days. | 60 mg LY2922470 administered orally QD for up to 28 days. | 200 mg LY2922470 administered orally QD for up to 28 days. | 500 mg LY2922470 administered orally QD for up to 28 days. | 1200 mg LY2922470 administered orally QD for up to 28 days. | 150 mg LY2922470 administered orally BID for up to 28 days. | 400 mg LY2922470 administered orally BID for up to 28 days. |
| Period Title: Overall Study | |||||||
| STARTED | 16 | 8 | 8 | 8 | 9 | 8 | 9 |
| Received Study Drug | 14 | 8 | 8 | 8 | 9 | 8 | 9 |
| COMPLETED | 12 | 8 | 8 | 8 | 8 | 8 | 8 |
| NOT COMPLETED | 4 | 0 | 0 | 0 | 1 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Placebo QD or BID | 60 mg LY2922470 QD | 200 mg LY2922470 QD | 500 mg LY2922470 QD | 1200 mg LY2922470 QD | 150 mg LY2922470 BID | 400 mg LY2922470 BID | Total |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo administered orally QD or BID for up to 28 days. | 60 mg LY2922470 administered orally QD for up to 28 days. | 200 mg LY2922470 administered orally QD for up to 28 days. | 500 mg LY2922470 administered orally QD for up to 28 days. | 1200 mg LY2922470 administered orally QD for up to 28 days. | 150 mg LY2922470 administered orally BID for up to 28 days. | 400 mg LY2922470 administered orally BID for up to 28 days. | Total of all reporting groups |
| Overall Participants | 14 | 8 | 8 | 8 | 9 | 8 | 9 | 64 |
| Age (years) [Mean (Standard Deviation) ] | ||||||||
| Mean (Standard Deviation) [years] |
51.4
(9.9)
|
59.9
(6.6)
|
52.8
(8.0)
|
58.6
(7.8)
|
59.8
(7.6)
|
54.0
(6.4)
|
50.2
(9.3)
|
54.9
(8.7)
|
| Sex: Female, Male (Count of Participants) | ||||||||
| Female |
4
28.6%
|
2
25%
|
3
37.5%
|
1
12.5%
|
4
44.4%
|
4
50%
|
4
44.4%
|
22
34.4%
|
| Male |
10
71.4%
|
6
75%
|
5
62.5%
|
7
87.5%
|
5
55.6%
|
4
50%
|
5
55.6%
|
42
65.6%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||||
| Hispanic or Latino |
8
57.1%
|
1
12.5%
|
1
12.5%
|
2
25%
|
4
44.4%
|
5
62.5%
|
6
66.7%
|
27
42.2%
|
| Not Hispanic or Latino |
6
42.9%
|
7
87.5%
|
7
87.5%
|
6
75%
|
5
55.6%
|
3
37.5%
|
3
33.3%
|
37
57.8%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
11.1%
|
1
1.6%
|
| Black or African American |
3
21.4%
|
5
62.5%
|
5
62.5%
|
5
62.5%
|
3
33.3%
|
3
37.5%
|
1
11.1%
|
25
39.1%
|
| White |
11
78.6%
|
3
37.5%
|
3
37.5%
|
3
37.5%
|
6
66.7%
|
5
62.5%
|
7
77.8%
|
38
59.4%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | ||||||||
| United States |
14
100%
|
8
100%
|
8
100%
|
8
100%
|
9
100%
|
8
100%
|
9
100%
|
64
100%
|
| Body Mass Index (BMI) (kilograms per square meter (kg/m²)) [Mean (Standard Deviation) ] | ||||||||
| Mean (Standard Deviation) [kilograms per square meter (kg/m²)] |
31.00
(4.86)
|
28.10
(3.19)
|
30.76
(3.74)
|
31.08
(3.40)
|
30.20
(6.56)
|
34.36
(4.04)
|
32.90
(6.08)
|
31.19
(4.89)
|
| Hemoglobin A1c (HbA1c) (percentage of glycosylated hemoglobin) [Mean (Standard Deviation) ] | ||||||||
| Mean (Standard Deviation) [percentage of glycosylated hemoglobin] |
8.29
(1.08)
|
8.58
(1.48)
|
7.74
(1.29)
|
7.91
(1.69)
|
7.24
(0.49)
|
8.09
(1.25)
|
7.96
(1.21)
|
7.99
(1.24)
|
| Fasting Blood Glucose (milligrams per deciliter (mg/dL)) [Mean (Standard Deviation) ] | ||||||||
| Mean (Standard Deviation) [milligrams per deciliter (mg/dL)] |
145.92
(50.50)
|
128.45
(39.38)
|
132.39
(37.09)
|
140.19
(49.53)
|
137.11
(26.19)
|
149.50
(38.40)
|
149.56
(44.21)
|
141.05
(40.99)
|
Outcome Measures
| Title | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
|---|---|
| Description | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is located in the Reported Adverse Events module. |
| Time Frame | Baseline through Study Completion (up to 56 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least one dose of study drug. |
| Arm/Group Title | Placebo QD or BID | 60 mg LY2922470 QD | 200 mg LY2922470 QD | 500 mg LY2922470 QD | 1200 mg LY2922470 QD | 150 mg LY2922470 BID | 400 mg LY2922470 BID |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo administered orally QD or BID for up to 28 days. | 60 mg LY2922470 administered orally QD for up to 28 days. | 200 mg LY2922470 administered orally QD for up to 28 days. | 500 mg LY2922470 administered orally QD for up to 28 days. | 1200 mg LY2922470 administered orally QD for up to 28 days. | 150 mg LY2922470 administered orally BID for up to 28 days. | 400 mg LY2922470 administered orally BID for up to 28 days. |
| Measure Participants | 14 | 8 | 8 | 8 | 9 | 8 | 9 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470 |
|---|---|
| Description | |
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received LY2922470 and had sufficient evaluable AUC(0-24) values. |
| Arm/Group Title | 60 mg LY2922470 QD | 200 mg LY2922470 QD | 500 mg LY2922470 QD | 1200 mg LY2922470 QD | 150 mg LY2922470 BID | 400 mg LY2922470 BID |
|---|---|---|---|---|---|---|
| Arm/Group Description | 60 mg LY2922470 administered orally QD for up to 28 days. | 200 mg LY2922470 administered orally QD for up to 28 days. | 500 mg LY2922470 administered orally QD for up to 28 days. | 1200 mg LY2922470 administered orally QD for up to 28 days. | 150 mg LY2922470 administered orally BID for up to 28 days. | 400 mg LY2922470 administered orally BID for up to 28 days. |
| Measure Participants | 8 | 8 | 8 | 8 | 8 | 9 |
| Day 1 |
4220
(52)
|
11,600
(27)
|
25,100
(30)
|
81,400
(34)
|
21,000
(47)
|
50,700
(45)
|
| Day 28 |
5660
(31)
|
15,300
(43)
|
25,000
(47)
|
65,300
(49)
|
21,300
(51)
|
44,800
(38)
|
| Title | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 |
|---|---|
| Description | |
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received LY2922470 and had sufficient evaluable Cmax values. For BID arms, Cmax from time 0-6 hours. |
| Arm/Group Title | 60 mg LY2922470 QD | 200 mg LY2922470 QD | 500 mg LY2922470 QD | 1200 mg LY2922470 QD | 150 mg LY2922470 BID | 400 mg LY2922470 BID |
|---|---|---|---|---|---|---|
| Arm/Group Description | 60 mg LY2922470 administered orally QD for up to 28 days. | 200 mg LY2922470 administered orally QD for up to 28 days. | 500 mg LY2922470 administered orally QD for up to 28 days. | 1200 mg LY2922470 administered orally QD for up to 28 days. | 150 mg LY2922470 administered orally BID for up to 28 days. | 400 mg LY2922470 administered orally BID for up to 28 days. |
| Measure Participants | 8 | 8 | 8 | 8 | 8 | 9 |
| Day 1 |
723
(39)
|
1540
(23)
|
2750
(42)
|
8200
(38)
|
1510
(54)
|
3150
(58)
|
| Day 28 |
1070
(32)
|
1630
(70)
|
3410
(33)
|
7900
(49)
|
1540
(42)
|
2980
(37)
|
| Title | Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470 |
|---|---|
| Description | |
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received LY2922470 and had sufficient evaluable Tmax values. For BID arms, Tmax from time 0-6 hours. |
| Arm/Group Title | 60 mg LY2922470 QD | 200 mg LY2922470 QD | 500 mg LY2922470 QD | 1200 mg LY2922470 QD | 150 mg LY2922470 BID | 400 mg LY2922470 BID |
|---|---|---|---|---|---|---|
| Arm/Group Description | 60 mg LY2922470 administered orally QD for up to 28 days. | 200 mg LY2922470 administered orally QD for up to 28 days. | 500 mg LY2922470 administered orally QD for up to 28 days. | 1200 mg LY2922470 administered orally QD for up to 28 days. | 150 mg LY2922470 administered orally BID for up to 28 days. | 400 mg LY2922470 administered orally BID for up to 28 days. |
| Measure Participants | 8 | 8 | 8 | 8 | 8 | 9 |
| Day 1 |
1.50
|
2.50
|
2.75
|
4.00
|
2.00
|
2.50
|
| Day 28 |
1.50
|
3.92
|
1.50
|
2.50
|
1.51
|
1.50
|
| Title | Change From Baseline in Hemoglobin A1c (HbA1c) at Day 28 |
|---|---|
| Description | |
| Time Frame | Baseline, Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received study drug and had sufficient evaluable HbA1c values. |
| Arm/Group Title | Placebo QD or BID | 60 mg LY2922470 QD | 200 mg LY2922470 QD | 500 mg LY2922470 QD | 1200 mg LY2922470 QD | 150 mg LY2922470 BID | 400 mg LY2922470 BID |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo administered orally QD or BID for up to 28 days. | 60 mg LY2922470 administered orally QD for up to 28 days. | 200 mg LY2922470 administered orally QD for up to 28 days. | 500 mg LY2922470 administered orally QD for up to 28 days. | 1200 mg LY2922470 administered orally QD for up to 28 days. | 150 mg LY2922470 administered orally BID for up to 28 days. | 400 mg LY2922470 administered orally BID for up to 28 days. |
| Measure Participants | 12 | 8 | 8 | 8 | 8 | 8 | 8 |
| Mean (Standard Deviation) [percentage of glycosylated hemoglobin] |
-0.38
(0.45)
|
-0.54
(0.32)
|
-0.43
(0.58)
|
-0.24
(0.52)
|
-0.16
(0.67)
|
-0.34
(0.38)
|
0.01
(0.44)
|
| Title | Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC₀-₂₄) During Mixed Meal Tolerance Test at Day 28 |
|---|---|
| Description | |
| Time Frame | Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12, 16, 24 hours Postdose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received study drug and had sufficient evaluable blood glucose values. |
| Arm/Group Title | Placebo QD or BID | 60 mg LY2922470 QD | 200 mg LY2922470 QD | 500 mg LY2922470 QD | 1200 mg LY2922470 QD | 150 mg LY2922470 BID | 400 mg LY2922470 BID |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo administered orally QD or BID for up to 28 days. | 60 mg LY2922470 administered orally QD for up to 28 days. | 200 mg LY2922470 administered orally QD for up to 28 days. | 500 mg LY2922470 administered orally QD for up to 28 days. | 1200 mg LY2922470 administered orally QD for up to 28 days. | 150 mg LY2922470 administered orally BID for up to 28 days. | 400 mg LY2922470 administered orally BID for up to 28 days. |
| Measure Participants | 10 | 5 | 8 | 8 | 8 | 8 | 8 |
| Mean (Standard Deviation) [mg*h/dL] |
21.7
(724)
|
-93
(165)
|
70.4
(1160)
|
-499
(493)
|
-205
(583)
|
-531
(549)
|
-621
(943)
|
| Title | Change From Baseline in C-Peptide Area Under the Effective Concentration Curve (AUEC₀-₁₂) During Mixed Meal Tolerance Test at Day 28 |
|---|---|
| Description | |
| Time Frame | Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12 hours Postdose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received study drug and had sufficient evaluable c-peptide values. |
| Arm/Group Title | Placebo QD or BID | 60 mg LY2922470 QD | 200 mg LY2922470 QD | 500 mg LY2922470 QD | 1200 mg LY2922470 QD | 150 mg LY2922470 BID | 400 mg LY2922470 BID |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo administered orally QD or BID for up to 28 days. | 60 mg LY2922470 administered orally QD for up to 28 days. | 200 mg LY2922470 administered orally QD for up to 28 days. | 500 mg LY2922470 administered orally QD for up to 28 days. | 1200 mg LY2922470 administered orally QD for up to 28 days. | 150 mg LY2922470 administered orally BID for up to 28 days. | 400 mg LY2922470 administered orally BID for up to 28 days. |
| Measure Participants | 12 | 8 | 6 | 8 | 7 | 6 | 8 |
| Mean (Standard Deviation) [picomoles*h per liter (pmol*h/L)] |
665
(4970)
|
147
(3560)
|
793
(4220)
|
-159
(3780)
|
-740
(2890)
|
1230
(1660)
|
-2230
(2810)
|
Adverse Events
| Time Frame | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | All participants who received at least one dose of study drug. | |||||||||||||
| Arm/Group Title | Placebo QD or BID | 60 mg LY2922470 QD | 200 mg LY2922470 QD | 500 mg LY2922470 QD | 1200 mg LY2922470 QD | 150 mg LY2922470 BID | 400 mg LY2922470 BID | |||||||
| Arm/Group Description | Placebo administered orally QD or BID for up to 28 days. | 60 mg LY2922470 administered orally QD for up to 28 days. | 200 mg LY2922470 administered orally QD for up to 28 days. | 500 mg LY2922470 administered orally QD for up to 28 days. | 1200 mg LY2922470 administered orally QD for up to 28 days. | 150 mg LY2922470 administered orally BID for up to 28 days. | 400 mg LY2922470 administered orally BID for up to 28 days. | |||||||
All Cause Mortality |
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| Placebo QD or BID | 60 mg LY2922470 QD | 200 mg LY2922470 QD | 500 mg LY2922470 QD | 1200 mg LY2922470 QD | 150 mg LY2922470 BID | 400 mg LY2922470 BID | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||
Serious Adverse Events |
||||||||||||||
| Placebo QD or BID | 60 mg LY2922470 QD | 200 mg LY2922470 QD | 500 mg LY2922470 QD | 1200 mg LY2922470 QD | 150 mg LY2922470 BID | 400 mg LY2922470 BID | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/14 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | |||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||
| Placebo QD or BID | 60 mg LY2922470 QD | 200 mg LY2922470 QD | 500 mg LY2922470 QD | 1200 mg LY2922470 QD | 150 mg LY2922470 BID | 400 mg LY2922470 BID | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/14 (35.7%) | 3/8 (37.5%) | 4/8 (50%) | 4/8 (50%) | 5/9 (55.6%) | 1/8 (12.5%) | 6/9 (66.7%) | |||||||
| Eye disorders | ||||||||||||||
| Asthenopia | 0/14 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 |
| Vitreous floaters | 0/14 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 0 | 0/9 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||
| Abdominal distension | 0/14 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Constipation | 0/14 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 0 | 0/9 (0%) | 0 |
| Diarrhoea | 0/14 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 2/8 (25%) | 2 | 1/9 (11.1%) | 2 | 0/8 (0%) | 0 | 2/9 (22.2%) | 3 |
| Dyspepsia | 0/14 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Faeces discoloured | 3/14 (21.4%) | 3 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 2/8 (25%) | 3 | 5/9 (55.6%) | 5 | 0/8 (0%) | 0 | 3/9 (33.3%) | 4 |
| Faeces pale | 0/14 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 |
| Frequent bowel movements | 0/14 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Infrequent bowel movements | 0/14 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Nausea | 1/14 (7.1%) | 1 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 |
| Paraesthesia oral | 0/14 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 0 | 0/9 (0%) | 0 |
| Vomiting | 1/14 (7.1%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 |
| General disorders | ||||||||||||||
| Fatigue | 1/14 (7.1%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 |
| Pain | 0/14 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 |
| Infections and infestations | ||||||||||||||
| Upper respiratory tract infection | 0/14 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Injury, poisoning and procedural complications | ||||||||||||||
| Procedural site reaction | 0/14 (0%) | 0 | 0/8 (0%) | 0 | 2/8 (25%) | 2 | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 0 | 0/9 (0%) | 0 |
| Wound | 1/14 (7.1%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Back pain | 0/14 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 |
| Neck pain | 0/14 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 |
| Nervous system disorders | ||||||||||||||
| Cervicobrachial syndrome | 0/14 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 |
| Dizziness | 0/14 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Headache | 1/14 (7.1%) | 1 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 2 | 2/9 (22.2%) | 2 | 1/8 (12.5%) | 2 | 1/9 (11.1%) | 1 |
| Somnolence | 0/14 (0%) | 0 | 1/8 (12.5%) | 2 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||||
| Haematuria | 0/14 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||||||
| Nipple disorder | 1/14 (7.1%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| Oropharyngeal pain | 0/14 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||
| Dermatitis contact | 1/14 (7.1%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 |
| Hyperhidrosis | 1/14 (7.1%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01867216
Other Study ID Numbers:
- 14797
- I6K-FW-GLEB
First Posted:
Jun 3, 2013
Last Update Posted:
Jul 26, 2018
Last Verified:
Jul 1, 2018