The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

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: NCT03736785
Recruitment Status : Completed
First Posted : November 9, 2018
Results First Posted : March 8, 2021
Last Update Posted : March 8, 2021
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: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: LY3209590
Drug: Insulin Degludec
Enrollment 399
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LY3209590 Algorithm 1 LY3209590 Algorithm 2 Insulin Degludec
Hide Arm/Group Description Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of <140 mg/dL. Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of <120 mg/dL. Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%.
Period Title: Overall Study
Started 135 132 132
Completed 118 115 118
Not Completed 17 17 14
Reason Not Completed
Adverse Event             1             1             1
Death             1             0             1
Lost to Follow-up             0             2             3
Non compliance with study drug             1             1             0
Physician Decision             0             1             1
Protocol Violation             1             4             3
Sponsor Decision             1             0             0
Unknown/Missing data             3             2             1
Withdrawal by Subject             9             6             4
Arm/Group Title LY3209590 Algorithm 1 LY3209590 Algorithm 2 Insulin Degludec Total
Hide Arm/Group Description Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of <140 milligram mg.dL Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of <120 mg/dL. Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%. Total of all reporting groups
Overall Number of Baseline Participants 135 132 132 399
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 135 participants 132 participants 132 participants 399 participants
60.2  (9.9) 59.6  (11.3) 60.8  (10.0) 60.2  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants 132 participants 132 participants 399 participants
Female 67 70 65 202
Male 68 62 67 197
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants 132 participants 132 participants 399 participants
Hispanic or Latino 67 78 73 218
Not Hispanic or Latino 68 54 59 181
Unknown or Not Reported 0 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants 132 participants 132 participants 399 participants
American Indian or Alaska Native 16 18 19 53
Asian 4 5 6 15
Native Hawaiian or Other Pacific Islander 1 1 1 3
Black or African American 16 10 10 36
White 97 97 94 288
More than one race 1 0 2 3
Unknown or Not Reported 0 1 0 1
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 135 participants 132 participants 132 participants 399 participants
Puerto Rico 18 16 15 49
United States 96 97 96 289
Mexico 21 19 21 61
Haemoglobin A1c (HbA1c)   [1] 
Mean (Standard Deviation)
Unit of measure:  HbA1C percentage (%)
Number Analyzed 135 participants 132 participants 132 participants 399 participants
8.20  (0.87) 8.03  (0.89) 8.13  (0.88) 8.12  (0.88)
[1]
Measure Description: HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
1.Primary Outcome
Title Change From Baseline in HbA1c
Hide Description

HbA1c is the glycosylated fraction of haemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

Change from baseline in HbA1c was analysed by mixed model repeated measures (MMRM) including fixed effects of treatment, stratification factors (country, BMI group [> 30 or ≤ 30], sulfonylureas use at study entry), visit and treatment by visit interaction and baseline HbA1c as the covariate.
Time Frame Baseline, Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
The data after using rescue medication or stopping study medication were censored. Participants with non-missing baseline value and at least one post baseline value of response were included.
Arm/Group Title LY3209590 Algorithm 1 LY3209590 Algorithm 2 Insulin Degludec
Hide Arm/Group Description:
Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of <140 mg/dL.
Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of <120 mg/dL.
Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%.
Overall Number of Participants Analyzed 130 125 124
Least Squares Mean (Standard Error)
Unit of Measure: HbA1C %
-0.58  (0.083) -0.57  (0.085) -0.66  (0.084)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY3209590 Algorithm 1
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Equivalence margin is zero.
Statistical Test of Hypothesis P-Value <0.001
Comments P-value reported is within group comparison between Week 32 and baseline.
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY3209590 Algorithm 2
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Equivalence margin is zero.
Statistical Test of Hypothesis P-Value <0.001
Comments P-value reported is within group comparison between Week 32 and baseline.
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Insulin Degludec
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Equivalence margin is zero.
Statistical Test of Hypothesis P-Value <0.001
Comments P-value reported is within group comparison between Week 32 and baseline.
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in HbA1c Compared to Insulin Degludec
Hide Description

HbA1c is the glycosylated fraction of haemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

Change from baseline in HbA1c was analysed by MMRM including fixed effects of treatment, stratification factors (country, BMI group [> 30 or ≤ 30], sulfonylureas use at study entry), visit and treatment by visit interaction, and baseline HbA1c as the covariate.
Time Frame Baseline, Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
The data after using rescue medication or stopping study medication were excluded. Participants with non-missing baseline value and at least one post baseline value of response were included.
Arm/Group Title LY3209590 Algorithm 1 LY3209590 Algorithm 2 Insulin Degludec
Hide Arm/Group Description:
Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of <140 mg/dL.
Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of <120 mg/dL.
Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%.
Overall Number of Participants Analyzed 130 125 124
Least Squares Mean (Standard Error)
Unit of Measure: HbA1C %
-0.58  (0.083) -0.57  (0.085) -0.66  (0.084)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY3209590 Algorithm 1, Insulin Degludec
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority margin is 0.4%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value 0.08
Confidence Interval (2-Sided) 90%
-0.11 to 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY3209590 Algorithm 2, Insulin Degludec
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority margin is 0.4%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value 0.09
Confidence Interval (2-Sided) 90%
-0.10 to 0.29
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Fasting Glucose
Hide Description Change from baseline in fasting glucose was analysed by MMRM including fixed effects of treatment, stratification factors (country, BMI group [> 30 or ≤ 30], sulfonylureas use at study entry, HbA1c strata [<8.5% or ≥8.5%]), visit and treatment by visit interaction, and baseline fasting glucose as the covariate.
Time Frame Baseline, Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
The data after using rescue medication or stopping study medication were excluded. Participants with non-missing baseline value and at least one post baseline value of response were included.
Arm/Group Title LY3209590 Algorithm 1 LY3209590 Algorithm 2 Insulin Degludec
Hide Arm/Group Description:
Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of <140 mg/dL.
Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of <120 mg/dL.
Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%.
Overall Number of Participants Analyzed 130 125 124
Least Squares Mean (Standard Error)
Unit of Measure: Milligram per deicliter (mg/dL)
-13.1  (4.01) -18.6  (4.14) -31.5  (4.03)
4.Secondary Outcome
Title Change From Baseline in Insulin Dose (LY3209590)
Hide Description The baseline for both LY3209590 arms was the first regular weekly dose at Week 1.
Time Frame Week 1, Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with non-missing value at the specified timepoint were included.The data after using rescue medication or stopping study medication were excluded.
Arm/Group Title LY3209590 Algorithm 1 LY3209590 Algorithm 2
Hide Arm/Group Description:
Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of <140 mg/dL.
Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of <120 mg/dL.
Overall Number of Participants Analyzed 118 115
Mean (Standard Deviation)
Unit of Measure: Milligrams (mg)
0.12  (4.86) 0.60  (3.75)
5.Secondary Outcome
Title Change From Baseline in Insulin Dose (Insulin Degludec)
Hide Description Change from Baseline in Insulin Dose for Insulin Degludec arm was reported.
Time Frame Baseline, Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with non-missing value at the specified timepoint were included.The data after using rescue medication or stopping study medication were excluded.
Arm/Group Title Insulin Degludec
Hide Arm/Group Description:
Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: International Units (IU)
16.40  (26.06)
6.Secondary Outcome
Title Rate of Total Documented Symptomatic Hypoglycemia
Hide Description The hypoglycemia events were defined by participant reported events with glucose ≤54 mg/dL (3.0 millimole per liter (mmol/L)). Relative Rate was calculated based on Group Mean. Group Mean was estimated by first taking the inverse link function on individual patient covariates, then averaging over all participants.
Time Frame Baseline through week 32
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized study participants who received at least one dose of study medication and had evaluable hypoglycaemic data.
Arm/Group Title LY3209590 Algorithm 1 LY3209590 Algorithm 2 Insulin Degludec
Hide Arm/Group Description:
Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of <140 mg/dL.
Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of <120 mg/dL.
Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%.
Overall Number of Participants Analyzed 135 131 132
Mean (Standard Error)
Unit of Measure: Events per participant per year
0.73  (0.119) 1.22  (0.378) 1.56  (0.375)
7.Secondary Outcome
Title Change From Baseline in Body Weight
Hide Description Change from baseline in body weight was analysed by MMRM including fixed effects of treatment, visit and treatment by visit interaction, and baseline body weight as the covariate.
Time Frame Baseline, Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study medication and with non-missing baseline value and at least one post baseline value of response were included.
Arm/Group Title LY3209590 Algorithm 1 LY3209590 Algorithm 2 Insulin Degludec
Hide Arm/Group Description:
Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of <140 mg/dL.
Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of <120 mg/dL.
Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%.
Overall Number of Participants Analyzed 135 130 129
Least Squares Mean (Standard Error)
Unit of Measure: Kilogram (kg)
1.0  (0.33) 1.0  (0.33) 2.0  (0.33)
8.Secondary Outcome
Title Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590
Hide Description PK: AUC of LY3209590 was reported for LY3209590 Algorithm 1 and LY3209590 Algorithm 2 arms. AUC was calculated for individual participants using the participant's Week 32 LY3209590 dose amount and the participant's estimated clearance value.
Time Frame Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of LY3209590 and had evaluable PK data.
Arm/Group Title LY3209590 Algorithm 1 LY3209590 Algorithm 2
Hide Arm/Group Description:
Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of <140 mg/dL.
Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of <120 mg/dL.
Overall Number of Participants Analyzed 119 112
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanomole * hour per Liter (nmol * hr/L)
5360
(67%)
5430
(60%)
Time Frame Up to 37 weeks
Adverse Event Reporting Description All randomized participants.
 
Arm/Group Title LY3209590 Algorithm 1 LY3209590 Algorithm 2 Insulin Degludec
Hide Arm/Group Description Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of <140 mg/dL. Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of <120 mg/dL. Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%.
All-Cause Mortality
LY3209590 Algorithm 1 LY3209590 Algorithm 2 Insulin Degludec
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/135 (0.74%)      0/132 (0.00%)      1/132 (0.76%)    
Hide Serious Adverse Events
LY3209590 Algorithm 1 LY3209590 Algorithm 2 Insulin Degludec
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/135 (5.19%)      8/132 (6.06%)      10/132 (7.58%)    
Cardiac disorders       
Acute myocardial infarction † 1  0/135 (0.00%)  0 0/132 (0.00%)  0 1/132 (0.76%)  1
Gastrointestinal disorders       
Chronic gastritis † 1  0/135 (0.00%)  0 1/132 (0.76%)  1 0/132 (0.00%)  0
Nausea † 1  0/135 (0.00%)  0 1/132 (0.76%)  1 0/132 (0.00%)  0
Pancreatitis acute † 1  0/135 (0.00%)  0 1/132 (0.76%)  1 0/132 (0.00%)  0
Vomiting † 1  0/135 (0.00%)  0 1/132 (0.76%)  1 0/132 (0.00%)  0
General disorders       
Chest pain † 1  1/135 (0.74%)  1 1/132 (0.76%)  2 0/132 (0.00%)  0
Non-cardiac chest pain † 1  0/135 (0.00%)  0 0/132 (0.00%)  0 1/132 (0.76%)  1
Sudden cardiac death † 1  0/135 (0.00%)  0 0/132 (0.00%)  0 1/132 (0.76%)  1
Hepatobiliary disorders       
Cholelithiasis † 1  0/135 (0.00%)  0 1/132 (0.76%)  1 0/132 (0.00%)  0
Infections and infestations       
Abscess limb † 1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/132 (0.00%)  0
Cellulitis † 1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/132 (0.00%)  0
Meningitis viral † 1  0/135 (0.00%)  0 0/132 (0.00%)  0 1/132 (0.76%)  1
Osteomyelitis † 1  1/135 (0.74%)  1 1/132 (0.76%)  1 0/132 (0.00%)  0
Pneumonia † 1  0/135 (0.00%)  0 1/132 (0.76%)  1 0/132 (0.00%)  0
Psoas abscess † 1  0/135 (0.00%)  0 0/132 (0.00%)  0 1/132 (0.76%)  1
Sepsis † 1  0/135 (0.00%)  0 1/132 (0.76%)  1 0/132 (0.00%)  0
Injury, poisoning and procedural complications       
Femur fracture † 1  0/135 (0.00%)  0 0/132 (0.00%)  0 1/132 (0.76%)  1
Metabolism and nutrition disorders       
Dehydration † 1  0/135 (0.00%)  0 1/132 (0.76%)  1 0/132 (0.00%)  0
Hypoglycaemia † 1  0/135 (0.00%)  0 2/132 (1.52%)  2 0/132 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Osteoarthritis † 1  0/135 (0.00%)  0 0/132 (0.00%)  0 1/132 (0.76%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast cancer † 1  0/135 (0.00%)  0 0/132 (0.00%)  0 1/132 (0.76%)  1
Metastatic neoplasm † 1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/132 (0.00%)  0
Transitional cell carcinoma † 1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/132 (0.00%)  0
Nervous system disorders       
Ischaemic stroke † 1  0/135 (0.00%)  0 0/132 (0.00%)  0 1/132 (0.76%)  1
Syncope † 1  0/135 (0.00%)  0 0/132 (0.00%)  0 1/132 (0.76%)  1
Psychiatric disorders       
Mental status changes † 1  0/135 (0.00%)  0 0/132 (0.00%)  0 1/132 (0.76%)  1
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease † 1  0/135 (0.00%)  0 1/132 (0.76%)  1 0/132 (0.00%)  0
Skin and subcutaneous tissue disorders       
Diabetic foot † 1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/132 (0.00%)  0
Vascular disorders       
Arteriosclerosis † 1  1/135 (0.74%)  1 0/132 (0.00%)  0 0/132 (0.00%)  0
Hypertensive emergency † 1  0/135 (0.00%)  0 1/132 (0.76%)  1 0/132 (0.00%)  0
1
Term from vocabulary, MedDRA 22.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LY3209590 Algorithm 1 LY3209590 Algorithm 2 Insulin Degludec
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/135 (12.59%)      29/132 (21.97%)      13/132 (9.85%)    
Gastrointestinal disorders       
Diarrhoea † 1  9/135 (6.67%)  10 8/132 (6.06%)  9 2/132 (1.52%)  2
Infections and infestations       
Upper respiratory tract infection † 1  8/135 (5.93%)  8 14/132 (10.61%)  14 6/132 (4.55%)  6
Nervous system disorders       
Dizziness † 1  1/135 (0.74%)  1 7/132 (5.30%)  7 1/132 (0.76%)  1
Respiratory, thoracic and mediastinal disorders       
Cough † 1  1/135 (0.74%)  1 5/132 (3.79%)  5 7/132 (5.30%)  8
1
Term from vocabulary, MedDRA 22.1
†
Indicates events were collected by systematic assessment
[Not Specified]
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
EMail: ClinicalTrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03736785    
Other Study ID Numbers: 17059
I8H-MC-BDCM ( Other Identifier: Eli Lilly and Company )
First Submitted: November 2, 2018
First Posted: November 9, 2018
Results First Submitted: February 12, 2021
Results First Posted: March 8, 2021
Last Update Posted: March 8, 2021