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A Study of LY2605541 and Glargine and Exercise in Participants With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT01784211
Recruitment Status : Completed
First Posted : February 5, 2013
Results First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Diabetes Mellitus, Type 1
Interventions Drug: LY2605541
Drug: Insulin Glargine
Enrollment 76
Recruitment Details

Part A is 2- arm parallel open label.

Part B is a crossover study with 2 treatment arms (LY2605541 & Glargine), each treatment arm consists of 2 sequences.

Sequence 1: participants received treatment on days 16,17,18,19 & 20 with exercise on day 17.

Sequence 2: participants received treatment on days 16,17,18,19, & 20 with exercise on day 20.

Pre-assignment Details  
Arm/Group Title LY2605541 (Part A) Glargine (Part A) First LY2605541 + Exercise, Then LY2605541 Alone (Part B) First LY2605541 Alone, Then LY2605541 + Exercise (Part B) First Glargine + Exercise, Then Glargine Alone (Part B) First Glargine Alone, Then Glargine + Exercise (Part B)
Hide Arm/Group Description 0.5 units per kilogram (U/kg) LY2605541 subcutaneously (SC) once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14. 0.5 U/kg insulin glargine SC once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14. 0.5 U/kg LY2605541 SC once daily for an additional 6 days, beginning on Day 16. Exercise challenge on Day 17 (no exercise on Day 20). 0.5 U/kg LY2605541 SC once daily for an additional 6 days, beginning on Day 16. Exercise challenge on Day 20 (no exercise on Day 17). 0.5 U/kg insulin glargine SC once daily for an additional 6 days, beginning on Day 16. Exercise challenge on Day 17 (no exercise on Day 20). 0.5 U/kg insulin glargine SC once daily for an additional 6 days, beginning on Day 16. Exercise challenge on Day 20 (no exercise on Day 17).
Period Title: Part A (Days 1-15)
Started 38 38 0 0 0 0
Received at Least 1 Dose of Study Drug 37 38 0 0 0 0
Entered Part B 19 [1] 21 [1] 0 0 0 0
Completed 35 36 0 0 0 0
Not Completed 3 2 0 0 0 0
Reason Not Completed
Adverse Event             1             1             0             0             0             0
Withdrawal by Subject             2             1             0             0             0             0
[1]
Participants who completed Part A and met certain criteria had the option of continuing to Part B.
Period Title: Part B (Days 16-21)
Started 0 [1] 0 [1] 10 9 11 10
Completed 0 0 10 9 11 10
Not Completed 0 0 0 0 0 0
[1]
Participants who completed Part A and met certain criteria had the option of continuing to Part B.
Arm/Group Title LY2605541 (Part A) Glargine (Part A) Total
Hide Arm/Group Description 0.5 units per kilogram (U/kg) LY2605541 subcutaneously (SC) once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14. 0.5 U/kg insulin Glargine SC once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14. Total of all reporting groups
Overall Number of Baseline Participants 37 38 75
Hide Baseline Analysis Population Description
All participants who were randomized and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 38 participants 75 participants
43.2  (10.8) 42.0  (12.1) 42.6  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 75 participants
Female 4 11 15
Male 33 27 60
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 75 participants
White 36 38 74
Multiple 1 0 1
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Germany Number Analyzed 37 participants 38 participants 75 participants
37 38 75
1.Primary Outcome
Title Part A: Pharmacokinetics: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUCτ) of LY2605541 and Insulin Glargine: Intra-Participant Variability
Hide Description Venous blood samples for pharmacokinetic analysis were collected during the euglycemic glucose clamps during Part A. The intra-participant percentage of coefficient of variation (%CV) is presented. %CV was calculated by dividing the standard deviation by the mean, multiplied by 100.
Time Frame Part A: Predose and 4, 8, 12, and 24 hours postdose on Days 8, 11, and 14
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Part A who received at least 1 dose of study drug and had evaluable AUCτ data.
Arm/Group Title LY2605541 (Part A) Glargine (Part A)
Hide Arm/Group Description:
0.5 U/kg LY2605541 SC once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14.
0.5 U/kg insulin glargine SC once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14.
Overall Number of Participants Analyzed 37 23
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: %CV
11.3
(9.89 to 13.2)
19.2
(15.5 to 25.5)
2.Primary Outcome
Title Part A: Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2605541 and Insulin Glargine: Intra-Participant Variability
Hide Description Venous blood samples for pharmacokinetic analysis were collected during the euglycemic glucose clamps during Part A. The intra-participant percentage of coefficient of variation (%CV) is presented. %CV was calculated by dividing the standard deviation by the mean, multiplied by 100.
Time Frame Part A: Predose and 4, 8, 12, and 24 hours postdose on Days 8, 11, and 14
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Part A who received at least 1 dose of study drug and had evaluable Cmax data.
Arm/Group Title LY2605541 (Part A) Glargine (Part A)
Hide Arm/Group Description:
0.5 U/kg LY2605541 SC once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14.
0.5 U/kg insulin glargine SC once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14.
Overall Number of Participants Analyzed 37 35
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: %CV
12.6
(11.0 to 14.7)
27.7
(23.8 to 33.3)
3.Secondary Outcome
Title Part A: Pharmacodynamics: Total Amount of Glucose Infused Over the Duration of the Clamp (Gtot): Intra-Participant Variability
Hide Description Glucodynamic measurements were collected during the euglycemic glucose clamps during Part A. The intra-participant percentage of coefficient of variation (%CV) is presented. %CV was calculated by dividing the standard deviation by the mean, multiplied by 100.
Time Frame Part A: Predose up to 24 hours postdose on Days 8, 11, and 14
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Part A who received at least 1 dose of study drug and had evaluable Gtot data.
Arm/Group Title LY2605541 (Part A) Glargine (Part A)
Hide Arm/Group Description:
0.5 U/kg LY2605541 SC once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14.
0.5 U/kg insulin glargine SC once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14.
Overall Number of Participants Analyzed 37 37
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: %CV
41.4
(36.1 to 49.0)
63.9
(55.2 to 76.6)
4.Secondary Outcome
Title Part B: Pharmacokinetics: AUCτ of LY2605541 and Insulin Glargine: Exercise Versus Non-Exercise
Hide Description Venous blood samples for pharmacokinetic analysis were collected in Part B. Results were stratified by whether or not the participant was undergoing an exercise challenge (+ Exercise) at the time of sample collection.
Time Frame Part B: Predose, 11 hours postdose, every 30 minutes from 16.5 to 20 hours postdose, and 24 hours postdose on Day 16 or 19
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Part B who received at least 1 dose of study drug and had evaluable AUCτ data.
Arm/Group Title LY2605541 + Exercise (Part B) LY2605541 (Part B) Glargine + Exercise (Part B) Glargine (Part B)
Hide Arm/Group Description:
0.5 U/kg LY2605541 SC once daily for an additional 6 days. Exercise challenge on Day 17 or 20.
0.5 U/kg LY2605541 SC once daily for an additional 6 days.
0.5 U/kg insulin glargine SC once daily for an additional 6 days. Exercise challenge on Day 17 or 20.
0.5 U/kg insulin glargine SC once daily for an additional 6 days.
Overall Number of Participants Analyzed 18 18 10 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: picomoles*hour per liter (pmol*h/L)
147000
(25%)
130000
(23%)
2950
(24%)
2650
(23%)
5.Secondary Outcome
Title Part B: Pharmacokinetics: Cmax of LY2605541 and Insulin Glargine: Exercise Versus Non-Exercise
Hide Description Venous blood samples for pharmacokinetic analysis were collected in Part B. Results were stratified by whether or not the participant was undergoing an exercise challenge (+ Exercise) at the time of sample collection.
Time Frame Part B: Predose, 11 hours postdose, every 30 minutes from 16.5 to 20 hours postdose, and 24 hours postdose on Day 16 or 19
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Part B who received at least 1 dose of study drug and had evaluable Cmax data.
Arm/Group Title LY2605541 + Exercise (Part B) LY2605541 - No Exercise (Part B) Glargine + Exercise (Part B) Glargine - No Exercise (Part B)
Hide Arm/Group Description:
0.5 U/kg LY2605541 SC once daily for an additional 6 days. Exercise challenge on Day 17 or 20.
0.5 U/kg LY2605541 SC once daily for an additional 6 days.
0.5 U/kg insulin glargine SC once daily for an additional 6 days. Exercise challenge on Day 17 or 20.
0.5 U/kg insulin glargine SC once daily for an additional 6 days.
Overall Number of Participants Analyzed 19 19 14 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: picomoles per liter (pmol/L)
11100
(27%)
6760
(28%)
166
(51%)
153
(35%)
Time Frame [Not Specified]
Adverse Event Reporting Description As per planned analysis adverse events were reported per intervention irrespective of exercise/ no exercise..
 
Arm/Group Title LY2605541 (Part A and Part B) Glargine (Part A and Part B)
Hide Arm/Group Description

Part A: 0.5 U/kg LY2605541 SC once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14.

Participants who completed Part A and met certain criteria had the option of continuing to Part B.

Part B: 0.5 U/kg LY2605541 SC once daily for an additional 6 days. Exercise challenge on Day 17 or 20.

Part A: 0.5 U/kg insulin glargine SC once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14.

Participants who completed Part A and met certain criteria had the option of continuing to Part B.

Part B: 0.5 U/kg insulin glargine SC once daily for an additional 6 days. Exercise challenge on Day 17 or 20.

All-Cause Mortality
LY2605541 (Part A and Part B) Glargine (Part A and Part B)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LY2605541 (Part A and Part B) Glargine (Part A and Part B)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/37 (2.70%)      0/38 (0.00%)    
Metabolism and nutrition disorders     
Hypoglycaemia  1  1/37 (2.70%)  1 0/38 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LY2605541 (Part A and Part B) Glargine (Part A and Part B)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/37 (27.03%)      12/38 (31.58%)    
Gastrointestinal disorders     
Diarrhoea  1  0/37 (0.00%)  0 2/38 (5.26%)  2
Musculoskeletal and connective tissue disorders     
Back pain  1  1/37 (2.70%)  1 2/38 (5.26%)  2
Nervous system disorders     
Headache  1  8/37 (21.62%)  14 7/38 (18.42%)  19
Presyncope  1  1/37 (2.70%)  1 2/38 (5.26%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
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: NCT01784211     History of Changes
Other Study ID Numbers: 14183
I2R-MC-BIAW ( Other Identifier: Eli Lilly and Company )
First Submitted: February 1, 2013
First Posted: February 5, 2013
Results First Submitted: March 16, 2018
Results First Posted: March 15, 2019
Last Update Posted: March 15, 2019