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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003552-21 | EudraCT Number | ||
| I7I-MC-XNAA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to compare the safety and effectiveness of the study drug known as LY2944876 to exenatide extended-release and placebo in participants with type 2 diabetes mellitus. All drugs will be given by an injection under the skin. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Participants' involvement in the study is expected to last about 30 weeks.
The study will include a 12 week blinded treatment period, where neither the participant nor the investigator will know to which treatment each individual is assigned. Thereafter follows a 12 week period where participants and the investigator will know which treatment they are assigned to. Participants' on LY2944876 and on exenatide extended-release continue treatment in this period, those who received placebo will be followed without treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 mg LY2944876 | Experimental | 10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. |
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| 15 mg LY2944876 | Experimental | 15 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. |
|
| 30 mg LY2944876 | Experimental | 30 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. |
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| 50 mg LY2944876 | Experimental | 50 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. |
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| Exenatide extended-release | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2944876 | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c at Week 24 | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. | Baseline, Week 24 |
| Percent Change From Baseline in Body Weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Muir Physician Network Clinical Research Center | Concord | California | 94520 | United States | ||
| Valley Endocrine, Fresno |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30957581 | Derived | Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19. |
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Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.
This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 10 mg LY2944876 | 10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks, plus background PO metformin. |
| FG001 | 15 mg LY2944876 | 15 mg LY2944876 given SC once weekly for 24 weeks, plus background PO metformin.. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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2 mg exenatide extended-release given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
|
| Placebo | Placebo Comparator | Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. |
|
| Exenatide extended-release | Drug | Administered SC |
|
| Placebo | Drug | Administered SC |
|
| Metformin | Drug | Oral |
|
| Baseline, Week 12; Baseline, Week 24 |
| Change From Baseline in Fasting Blood Glucose | Least square means (LSM) was calculated from mixed-effects model with repeated measures (MMRM) analysis using restricted maximum likelihood (REML) with metformin use, baseline body mass index (BMI) category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect. | Baseline, Week 12; Baseline, Week 24 |
| Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values | SMBG 7-point profiles were measured at morning pre-meal, morning 2 hours post-meal, mid-day pre-meal, mid-day 2 hours post-meal, evening pre-meal, evening 2 hours post-meal, and at bedtime. LSM were calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect. | Baseline, Week (Wk) 12; Baseline, Week 24 |
| Change From Baseline in Lipids | Change from baseline in high-density lipoprotein cholesterol (HDL-C), total cholesterol, triglycerides, and low-density lipoprotein cholesterol (LDL-C). LSM was calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant an a random effect. | Baseline, Week 24 |
| Change From Baseline in Fasting Fibroblast Growth Factor 21 | LSM was calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect. | Baseline, Week 12; Baseline, Week 24 |
| Percentage of Participants Requiring Rescue Therapy | Participants who received rescue medication with non-study antihyperglycemic medications or change their stable dose of metformin. | Baseline through Therapy Completion (Week 24) |
| Percentage of Participants Developing Anti-Drug Antibodies to LY2944876 | Percentage of participants developing anti-drug antibodies to LY2944876. | Week 12 and Week 24 |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2944876 | Evaluable pharmacokinetic concentrations from the specified timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state. | Baseline, Week 8, Week 12, Week 16, Week 20, Week 24 |
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2944876 | Evaluable pharmacokinetic concentrations from the specified timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state. | Baseline, Week 8, Week 12, Week 16, Week 20, Week 24 |
| Change From Baseline in Adiponectin Levels | LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect. | Baseline, Week 12; Baseline, Week 24 |
| Change From Baseline in Beta-Hydroxy Butyrate Levels | LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect. | Baseline, Week 12; Baseline, Week 24 |
| Change From Baseline in Glucagon Levels | LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect. | Baseline, Week 12; Baseline, Week 24 |
| Change From Baseline in Insulin Levels | LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect. | Baseline, Week 12; Baseline, Week 24 |
| Fresno |
| California |
| 93720 |
| United States |
| National Research Institute | Los Angeles | California | 90057 | United States |
| Desert Medical Group Inc | Palm Springs | California | 92262 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| Meridien Research | Bradenton | Florida | 34208 | United States |
| M & O Clinical Research, LLC | Fort Lauderdale | Florida | 33316 | United States |
| Suncoast Research Group, LLC | Miami | Florida | 33135 | United States |
| Suncoast Clinical Research | New Port Richey | Florida | 34652 | United States |
| Compass Research | Oviedo | Florida | 32765 | United States |
| Clinical Research of Central Florida | Winter Haven | Florida | 33880 | United States |
| University of Hawaii | Honolulu | Hawaii | 96813 | United States |
| East West Medical Institute | Honolulu | Hawaii | 96814 | United States |
| Rocky Mountain Diabetes and Osteoporosis Center | Idaho Falls | Idaho | 83404 | United States |
| Iderc, P.L.C. | Des Moines | Iowa | 50314 | United States |
| Cotton O'Neil Diabetes and Endocrinology Center | Topeka | Kansas | 66606 | United States |
| Mercy Medical Research Institute | Springfield | Missouri | 65807 | United States |
| St John's Mercy Medical Center | St Louis | Missouri | 63141 | United States |
| Mercy Health Research | Washington | Missouri | 63090 | United States |
| Southern New Hampshire Diabetes and Endocrinology | Nashua | New Hampshire | 03063 | United States |
| High Point Clinical Trials Center | High Point | North Carolina | 27265 | United States |
| Lillestol Research LLC | Fargo | North Dakota | 58103 | United States |
| The Corvallis Clinic P.C. | Corvallis | Oregon | 97330 | United States |
| Blair Medical Associates, Inc. | Altoona | Pennsylvania | 16602 | United States |
| Texas Diabetes and Endocrinology | Austin | Texas | 78731 | United States |
| Dallas Diabetes Endocrine Center | Dallas | Texas | 75230 | United States |
| San Gabriel Clinical Research | Georgetown | Texas | 78626 | United States |
| Oakwell Clinical Research | San Antonio | Texas | 78218 | United States |
| Southwest Health Associates, P.A. | Sugar Land | Texas | 77478 | United States |
| Wade Family Medicine | Bountiful | Utah | 84010 | United States |
| 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. | Ampelokipoi | 11527 | Greece |
| 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. | Athens | 11527 | Greece |
| 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. | Thessaloniki | 57010 | Greece |
| 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. | Chihuahua City | 31238 | Mexico |
| 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. | Guadalajara | 44690 | Mexico |
| 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. | Tampico | 89000 | Mexico |
| 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. | Bialystok | 15-351 | Poland |
| 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. | Gdansk | 80-546 | Poland |
| 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. | Gdynia | 81-553 | Poland |
| 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. | Lodz | 90-242 | Poland |
| 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. | Poznan | 61-853 | Poland |
| 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. | Szczecin | 70-506 | Poland |
| 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. | Warsaw | 01-518 | Poland |
| Manati Medical Center | Manati | 00674 | Puerto Rico |
| American Telemedicine Center | San Juan | 00917-3104 | Puerto Rico |
| 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. | Cluj-Napoca | 400349 | Romania |
| 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. | Iași | 700547 | Romania |
| 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. | Ploieşti | 100342 | Romania |
| 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. | Târgu Mureş | 540098 | Romania |
| 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. | Timișoara | 300456 | Romania |
| FG002 | 30 mg LY2944876 | 30 mg LY2944876 given SC once weekly for 24 weeks, plus background PO metformin.. |
| FG003 | 50 mg LY2944876 | 50 mg LY2944876 given SC once weekly for 24 weeks, plus background PO metformin.. |
| FG004 | Exenatide Extended-release | 2 mg exenatide extended-release given SC once weekly for 24 weeks, plus background PO metformin.. |
| FG005 | Placebo | Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks,plus background PO metformin. Participants assigned to placebo will have no injections during the second 12 weeks of the study. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 10 mg LY2944876 | 10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks. |
| BG001 | 15 mg LY2944876 | 15 mg LY2944876 given SC once weekly for 24 weeks. |
| BG002 | 30 mg LY2944876 | 30 mg LY2944876 given SC once weekly for 24 weeks. |
| BG003 | 50 mg LY2944876 | 50 mg LY2944876 given SC once weekly for 24 weeks. |
| BG004 | Exenatide Extended-release | 2 mg exenatide extended-release given SC once weekly for 24 weeks. |
| BG005 | Placebo | Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. | All randomized participants with baseline and at least one post-baseline HbA1c data at Week 12. Missing observations are imputed using the Bayesian simple linear regression longitudinal model. | Posted | Mean | Standard Error | percentage of HbA1c | Baseline, Week 12 |
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| Secondary | Change From Baseline in HbA1c at Week 24 | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. | All randomized participants with baseline and at least one post-baseline HbA1c data at Week 24. Missing observations are imputed using the Bayesian simple linear regression longitudinal model. | Posted | Mean | Standard Error | percentage of HbA1c | Baseline, Week 24 |
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| Secondary | Percent Change From Baseline in Body Weight | All randomized participants with baseline and at least one post-baseline data for body weight. Missing observations are imputed using the Bayesian simple linear regression longitudinal model. | Posted | Mean | Standard Error | Percentage change | Baseline, Week 12; Baseline, Week 24 |
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| Secondary | Change From Baseline in Fasting Blood Glucose | Least square means (LSM) was calculated from mixed-effects model with repeated measures (MMRM) analysis using restricted maximum likelihood (REML) with metformin use, baseline body mass index (BMI) category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect. | All randomized participants with baseline and at least one post-baseline data for fasting blood glucose. Missing observations are imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | milligrams per deciliter (mg/dL) | Baseline, Week 12; Baseline, Week 24 |
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| Secondary | Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values | SMBG 7-point profiles were measured at morning pre-meal, morning 2 hours post-meal, mid-day pre-meal, mid-day 2 hours post-meal, evening pre-meal, evening 2 hours post-meal, and at bedtime. LSM were calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect. | All randomized participants with baseline and at least one post-baseline data for SMBG. Missing observations are imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, Week (Wk) 12; Baseline, Week 24 |
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| Secondary | Change From Baseline in Lipids | Change from baseline in high-density lipoprotein cholesterol (HDL-C), total cholesterol, triglycerides, and low-density lipoprotein cholesterol (LDL-C). LSM was calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant an a random effect. | All randomized participants with baseline and at least one post-baseline data for lipids. Missing observations are imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, Week 24 |
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| Secondary | Change From Baseline in Fasting Fibroblast Growth Factor 21 | LSM was calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect. | All randomized participants with baseline and at least one post-baseline data for fasting fibroblast growth factor 21. Missing observations are imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | microgram per liter (µg/L) | Baseline, Week 12; Baseline, Week 24 |
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| Secondary | Percentage of Participants Requiring Rescue Therapy | Participants who received rescue medication with non-study antihyperglycemic medications or change their stable dose of metformin. | All randomized participants with baseline and at least one post-baseline data for participants requiring rescue therapy. | Posted | Number | percentage of participants | Baseline through Therapy Completion (Week 24) |
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| Secondary | Percentage of Participants Developing Anti-Drug Antibodies to LY2944876 | Percentage of participants developing anti-drug antibodies to LY2944876. | All randomized participants who received study drug and had evaluable immunogenicity. | Posted | Number | percentage of participants | Week 12 and Week 24 |
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| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2944876 | Evaluable pharmacokinetic concentrations from the specified timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state. | All randomized participants who received study drug LY2944876 and had evaluable PK data. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Baseline, Week 8, Week 12, Week 16, Week 20, Week 24 |
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| Secondary | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2944876 | Evaluable pharmacokinetic concentrations from the specified timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state. | All randomized participants who received study drug LY2944876 and had evaluable PK data. | Posted | Mean | Standard Deviation | nanograms*hour per milliliter (ng*h/mL) | Baseline, Week 8, Week 12, Week 16, Week 20, Week 24 |
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| Secondary | Change From Baseline in Adiponectin Levels | LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect. | All randomized participants with baseline and at least one post-baseline data for adiponectin levels. Missing observations are imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | µg/L | Baseline, Week 12; Baseline, Week 24 |
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| Secondary | Change From Baseline in Beta-Hydroxy Butyrate Levels | LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect. | All randomized participants with baseline and at least one post-baseline data for beta-hydroxy butyrate levels. Missing observations are imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, Week 12; Baseline, Week 24 |
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| Secondary | Change From Baseline in Glucagon Levels | LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect. | All randomized participants with baseline and at least one post-baseline data for glucagon levels. Missing observations are imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | picomol per liter (pmol/L) | Baseline, Week 12; Baseline, Week 24 |
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| Secondary | Change From Baseline in Insulin Levels | LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect. | All randomized participants with baseline and at least one post-baseline data for insulin levels. Missing observations are imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | micro-international units/milliliter | Baseline, Week 12; Baseline, Week 24 |
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All randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 10 mg LY2944876 | 10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks. | 0 | 66 | 34 | 66 | ||
| EG001 | 15 mg LY2944876 | 15 mg LY2944876 given SC once weekly for 24 weeks. | 2 | 71 | 47 | 71 | ||
| EG002 | 30 mg LY2944876 | 30 mg LY2944876 given SC once weekly for 24 weeks. | 2 | 73 | 39 | 73 | ||
| EG003 | 50 mg LY2944876 | 50 mg LY2944876 given SC once weekly for 24 weeks. | 3 | 70 | 46 | 70 | ||
| EG004 | Exenatide Extended-release | 2 mg exenatide extended-release given SC once weekly for 24 weeks. | 3 | 69 | 38 | 69 | ||
| EG005 | Placebo | Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study. | 2 | 71 | 16 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA18.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA18.1 | Systematic Assessment |
| |
| Branchial cyst | Congenital, familial and genetic disorders | MedDRA18.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA18.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA18.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA18.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA18.1 | Systematic Assessment |
| |
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.1 | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA18.1 | Systematic Assessment |
| |
| Blood blister | Skin and subcutaneous tissue disorders | MedDRA18.1 | Systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | MedDRA18.1 | Systematic Assessment |
| |
| Vessel perforation | Vascular disorders | MedDRA18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA18.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA18.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA18.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA18.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA18.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA18.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA18.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA18.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA18.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA18.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA18.1 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA18.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA18.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA18.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA18.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA18.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA18.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Puerto Rico |
|
| Romania |
|
| United States |
|
| Poland |
|
| Mexico |
|
| Posterior Mean Difference |
| -0.80 |
| Standard Error of the Mean |
| 0.16 |
| 2-Sided |
| 90 |
| -1.07 |
| -0.54 |
| Superiority |
| Bayesian | 0.988 | Posterior Mean Difference | -1.15 | Standard Error of the Mean | 0.16 | 2-Sided | 90 | -1.41 | -0.89 | Superiority |
| Bayesian | 0.934 | Posterior Mean Difference | -1.04 | Standard Error of the Mean | 0.16 | 2-Sided | 90 | -1.30 | -0.78 | Superiority |
| Bayesian | 0.373 | Posterior Mean Difference | 0.35 | Standard Error of the Mean | 0.16 | 2-Sided | 90 | 0.08 | 0.61 | Superiority |
| Bayesian | 0.433 | Posterior Mean Difference | 0.33 | Standard Error of the Mean | 0.16 | 2-Sided | 90 | 0.07 | 0.59 | Superiority |
| Bayesian | 0.978 | Posterior Mean Difference | -0.02 | Standard Error of the Mean | 0.16 | 2-Sided | 90 | -0.28 | 0.24 | Superiority |
| Bayesian | 0.904 | Posterior Mean Difference | 0.09 | Standard Error of the Mean | 0.16 | 2-Sided | 90 | -0.17 | 0.35 | Superiority |
| Exenatide Extended-release |
2 mg exenatide extended-release given SC once weekly for 24 weeks. |
| OG005 | Placebo | Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study. |
|
|
| OG005 | Placebo | Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study. |
|
|
50 mg LY2944876 given SC once weekly for 24 weeks. |
| OG004 | Exenatide Extended-release | 2 mg exenatide extended-release given SC once weekly for 24 weeks. |
| OG005 | Placebo | Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study. |
|
|
| 50 mg LY2944876 |
50 mg LY2944876 given SC once weekly for 24 weeks. |
| OG004 | Exenatide Extended-release | 2 mg exenatide extended-release given SC once weekly for 24 weeks. |
| OG005 | Placebo | Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study. |
|
|
50 mg LY2944876 given SC once weekly for 24 weeks. |
| OG004 | Exenatide Extended-release | 2 mg exenatide extended-release given SC once weekly for 24 weeks. |
| OG005 | Placebo | Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study. |
|
|
50 mg LY2944876 given SC once weekly for 24 weeks.
| OG004 | Exenatide Extended-release | 2 mg exenatide extended-release given SC once weekly for 24 weeks. |
| OG005 | Placebo | Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study. |
|
|
2 mg exenatide extended-release given SC once weekly for 24 weeks. |
| OG005 | Placebo | Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study. |
|
|
2 mg exenatide extended-release given SC once weekly for 24 weeks.
| OG005 | Placebo | Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG004 | Exenatide Extended-release | 2 mg exenatide extended-release given SC once weekly for 24 weeks. |
| OG005 | Placebo | Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study. |
|
|
| OG004 | Exenatide Extended-release | 2 mg exenatide extended-release given SC once weekly for 24 weeks. |
| OG005 | Placebo | Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study. |
|
|
| OG004 | Exenatide Extended-release | 2 mg exenatide extended-release given SC once weekly for 24 weeks. |
| OG005 | Placebo | Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study. |
|
|
| OG004 | Exenatide Extended-release | 2 mg exenatide extended-release given SC once weekly for 24 weeks. |
| OG005 | Placebo | Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study. |
|
|
|
|