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Trial record 25 of 1485 for:    Type 1 Diabetes Mellitus 5

Study of LY2409021 in Participants With Type 1 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: NCT01640834
Recruitment Status : Completed
First Posted : July 16, 2012
Results First Posted : October 29, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 1
Interventions Drug: LY2409021
Drug: Placebo
Drug: Glucagon
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 100 mg LY2409021 300 mg LY2409021 Placebo
Hide Arm/Group Description

LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.

Placebo: 2 capsules, administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

Placebo: 3 capsules administered as a single oral dose on Day 2.

Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.

Period Title: Overall Study
Started 8 8 4
Received at Least 1 Dose of Study Drug 8 8 4
Completed 8 8 4
Not Completed 0 0 0
Arm/Group Title 100 mg LY2409021 300 mg LY2409021 Placebo Total
Hide Arm/Group Description

LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.

Placebo: 2 capsules, administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

Placebo: 3 capsules administered as a single oral dose on Day 2.

Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.

Total of all reporting groups
Overall Number of Baseline Participants 8 8 4 20
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 4 participants 20 participants
38.6  (12.8) 47.1  (5.7) 43.3  (10.6) 43.0  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 4 participants 20 participants
Female 0 0 0 0
Male 8 8 4 20
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 8 participants 8 participants 4 participants 20 participants
8 8 4 20
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Germany Number Analyzed 8 participants 8 participants 4 participants 20 participants
8 8 4 20
1.Primary Outcome
Title Pharmacodynamics: Change From Baseline to Day 2 in 24-hour Insulin Dose
Hide Description The mean absolute change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.
Time Frame Baseline (Day 1), Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received a dose of LY2409021 or placebo and had evaluable 24-hour insulin data.
Arm/Group Title 100 mg LY2409021 300 mg LY2409021 Placebo
Hide Arm/Group Description:

LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.

Placebo: 2 capsules, administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

Placebo: 3 capsules administered as a single oral dose on Day 2.

Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.

Overall Number of Participants Analyzed 8 8 4
Mean (Standard Deviation)
Unit of Measure: insulin units
1.85  (7.15) 0.80  (9.63) 7.69  (2.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 100 mg LY2409021
Comments The mean change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 100-mg LY2409021 dose group using a 1 sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0542
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5.84
Confidence Interval (2-Sided) 95%
-11.82 to 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 300 mg LY2409021
Comments The mean change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 300-mg LY2409021 dose group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0826
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -6.89
Confidence Interval (2-Sided) 95%
-14.95 to 1.16
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Pharmacodynamics: Percentage Change From Baseline to Day 2 in 24-hour Insulin
Hide Description The percentage change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.
Time Frame Baseline (Day 1), Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received a dose of LY2409021 or placebo and had evaluable 24-hour insulin data.
Arm/Group Title 100 mg LY2409021 300 mg LY2409021 Placebo
Hide Arm/Group Description:

LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.

Placebo: 2 capsules, administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

Placebo: 3 capsules administered as a single oral dose on Day 2.

Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.

Overall Number of Participants Analyzed 8 8 4
Mean (Standard Deviation)
Unit of Measure: percentage of insulin units
5.71  (19.90) 3.12  (18.34) 22.75  (22.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 100 mg LY2409021
Comments Analysis was performed using the percent change in insulin dose, which takes into account absolute differences in individual insulin doses. The mean percent change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's percent change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 100-mg LY2409021 dose group using a 1 sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0460
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -17.0
Confidence Interval (2-Sided) 95%
-33.7 to -0.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 300 mg LY2409021
Comments Analysis was performed using the percent change in insulin dose, which takes into account absolute differences in individual insulin doses. The mean percent change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's percent change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 300-mg LY2409021 dose group using a 1 sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0192
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -19.6
Confidence Interval (2-Sided) 95%
-35.0 to -4.3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021
Hide Description [Not Specified]
Time Frame Predose (Day 2) through 120 hours postdose (Day 7)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received a dose of LY2409021 and had evaluable pharmacokinetic data.
Arm/Group Title 100 mg LY2409021 300 mg LY2409021
Hide Arm/Group Description:

LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.

Placebo: 2 capsules, administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

Overall Number of Participants Analyzed 8 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms per milliliter
2620
(23%)
6090
(23%)
4.Secondary Outcome
Title Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021
Hide Description Exposure in terms of AUC of LY2409021 from time 0 extrapolated to infinity (AUCinf) is reported.
Time Frame Predose (Day 2) through 120 hours postdose (Day 7)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received a dose of LY2409021 and had evaluable pharmacokinetic data.
Arm/Group Title 100 mg LY2409021 300 mg LY2409021
Hide Arm/Group Description:

LY2409021: 100 milligrams (mg), capsule, administered as a single oral dose on Day 2.

Placebo: 2 capsules, administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

LY2409021: 300 milligrams (mg), capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

Overall Number of Participants Analyzed 8 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms * hours per milliliter
209000
(30%)
506000
(22%)
5.Secondary Outcome
Title Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose During Drug Washout Period
Hide Description Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis.
Time Frame Baseline (Day 1), Day 3 up to Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not analyzed.
Arm/Group Title 100 mg LY2409021 300 mg LY2409021 Placebo
Hide Arm/Group Description:

LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.

Placebo: 2 capsules, administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

Placebo: 3 capsules administered as a single oral dose on Day 2.

Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose Needed to Maintain Euglycemia
Hide Description Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis.
Time Frame Baseline (Day 1), Day 3 up to Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not analyzed.
Arm/Group Title 100 mg LY2409021 300 mg LY2409021 Placebo
Hide Arm/Group Description:

LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.

Placebo: 2 capsules, administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

Placebo: 3 capsules administered as a single oral dose on Day 2.

Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Pharmacodynamics: Maximum Concentration (Cmax) of Glucose Concentration After 1 Milligram (mg) Glucagon Injection on Day 3
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received a dose of LY2409021 or placebo and had evaluable post-glucagon injection glucose concentration data.
Arm/Group Title 100 mg LY2409021 300 mg LY2409021 Placebo
Hide Arm/Group Description:

LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.

Placebo: 2 capsules, administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

Placebo: 3 capsules administered as a single oral dose on Day 2.

Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.

Overall Number of Participants Analyzed 8 8 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: milligrams per deciliter
154.9
(19%)
141.3
(19%)
201.8
(11%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 100 mg LY2409021, Placebo
Comments Statistical analysis of the effect of LY2409021 treatment on peak glucose concentration after an intramuscular injection of glucagon (1 milligram).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0187
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -46
Confidence Interval (2-Sided) 95%
-82 to -9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 300 mg LY2409021, Placebo
Comments Statistical analysis of the effect of LY2409021 treatment on peak glucose concentration after an intramuscular injection of glucagon (1 milligram).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0048
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -59
Confidence Interval (2-Sided) 95%
-96 to -23
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Pharmacodynamics: Area Under the Glucose Concentration Curve After a Single Dose of Glucagon on Day 3
Hide Description Area under the glucose concentration curve from time 0 through 2 hours after a single dose of glucagon (1 milligram) administered via an intramuscular injection is reported.
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received a dose of LY2409021 or placebo and had evaluable post-glucagon injection glucose concentration data.
Arm/Group Title 100 mg LY2409021 300 mg LY2409021 Placebo
Hide Arm/Group Description:

LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.

Placebo: 2 capsules, administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

Placebo: 3 capsules administered as a single oral dose on Day 2.

Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.

Overall Number of Participants Analyzed 8 8 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: milligrams * minutes per deciliter
15534.3
(21%)
14885.5
(16%)
20189.7
(9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 100 mg LY2409021, Placebo
Comments Statistical analysis of the effect of LY2409021 treatment on area under the glucose concentration curve from time 0 to 2 hours postdose following an intramuscular injection of glucagon (1 milligram).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0278
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4423
Confidence Interval (2-Sided) 95%
-8256 to -590
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 300 mg LY2409021, Placebo
Comments Statistical analysis of the effect of LY2409021 treatment on area under the glucose concentration curve from time 0 to 2 hours postdose following an intramuscular injection of glucagon (1 milligram).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0046
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5187
Confidence Interval (2-Sided) 95%
-8371 to -2004
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 100 mg LY2409021 300 mg LY2409021 Placebo
Hide Arm/Group Description

LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.

Placebo: 2 capsules, administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3.

Placebo: 3 capsules administered as a single oral dose on Day 2.

Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.

All-Cause Mortality
100 mg LY2409021 300 mg LY2409021 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
100 mg LY2409021 300 mg LY2409021 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/8 (0.00%)      0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
100 mg LY2409021 300 mg LY2409021 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/8 (75.00%)      6/8 (75.00%)      4/4 (100.00%)    
Gastrointestinal disorders       
Constipation  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0
Diarrhoea  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0
Toothache  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0
General disorders       
Discomfort  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0
Metabolism and nutrition disorders       
Hypoglycaemia  1  6/8 (75.00%)  19 6/8 (75.00%)  13 3/4 (75.00%)  6
Musculoskeletal and connective tissue disorders       
Muscle spasms  1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0
Pain in extremity  1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/4 (25.00%)  1
Nervous system disorders       
Headache  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0
Skin and subcutaneous tissue disorders       
Hyperhidrosis  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
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: NCT01640834     History of Changes
Other Study ID Numbers: 14576
I1R-MC-GLBR ( Other Identifier: Eli Lilly and Company )
2011-006178-19 ( EudraCT Number )
First Submitted: July 12, 2012
First Posted: July 16, 2012
Results First Submitted: March 24, 2018
Results First Posted: October 29, 2018
Last Update Posted: October 29, 2018