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| ID | Type | Description | Link |
|---|---|---|---|
| H9C-MC-BBDK | Other Identifier | Eli Lilly and Company |
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Study to evaluate the safety, tolerability and efficacy of LY2189102 in patients with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.6 milligrams (mg) LY2189102 | Experimental |
| |
| 18 mg LY2189102 | Experimental |
| |
| 180 mg LY2189102 | Experimental |
| |
| Placebo | Placebo Comparator | 0.9% Sodium Chloride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2189102 | Drug | Participants received 2 subcutaneous (SC) injections weekly for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at 12 Weeks | Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline HbA1c as a continuous covariate. | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Glucose at 12 Weeks | Change in fasting glucose following 12 weeks of therapy (that is, fasting glucose at week 12 minus fasting glucose at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate. | Baseline, 12 weeks |
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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 |
|---|---|---|---|---|---|---|
| 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. | Mobile | Alabama | 36689 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24912797 | Derived | Bihorel S, Fiedler-Kelly J, Ludwig E, Sloan-Lancaster J, Raddad E. Population pharmacokinetic modeling of LY2189102 after multiple intravenous and subcutaneous administrations. AAPS J. 2014 Sep;16(5):1009-17. doi: 10.1208/s12248-014-9623-6. Epub 2014 Jun 11. |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.6 mg LY2189102 | Participants received 2 subcutaneous (SC) injections weekly for 12 weeks. |
| FG001 | 18 mg LY2189102 | Participants received 2 SC injections weekly for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Participants received 2 SC injections weekly for 12 weeks. |
|
| Change From Baseline in Insulin Sensitivity (Fasting Insulin) at 12 Weeks | Change in serum fasting insulin from baseline to endpoint (that is, serum insulin at week 12 minus serum insulin at week 0). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate. | Baseline, 12 weeks |
| Number of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks | The number of participants with a change from baseline in glucose and insulin at 2 hours after the MMTT was analyzed. The MMTT measures glucose and insulin before and after a standardized meal is eaten. Glucose and insulin levels were measured before the MMTT and 2 hours after the MMTT. | Baseline, 12 weeks |
| Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12 | The change from baseline in HbA1c at week 10 (that is HbA1c at week 10 minus HbA1c at baseline) and week 12 (that is, HbA1c at week 12 minus HbA1c at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate. | Baseline, week 10, week 12 |
| Pharmacokinetics (PK) Maximum Serum Concentration (Cmax) of LY2189102 at End of Dosing (12 Weeks) | The Cmax value measures the maximum serum concentration and is estimated for LY2189102. The values were generated as individual estimates from a population pharmacokinetics (PK) model. Placebo samples were not assayed for serum concentration of LY2189102 because the participants in the placebo treatment arm did not receive LY2189102 study drug. | Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose |
| PK: Area Under the Concentration Time Curve for Dosing Interval (Tau) at Steady State (AUCτ,SS) at End of Dosing (12 Weeks) | Individual estimates of AUCtau at end of dosing generated from a population pharmacokinetic (PK) model. | Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose |
| Pharmacokinetics Measured by Serum Concentration at End of Dosing (12 Weeks) | Pharmacokinetics Measured by Serum Concentration at End of Dosing. | Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose |
| 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. | Anaheim | California | 92801 | 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. | Chula Vista | California | 91911 | 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. | La Mesa | California | 91942 | 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. | Walnut Creek | California | 94598 | 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. | Washington D.C. | District of Columbia | 20003 | 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. | Miami | Florida | 33169 | 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. | Miami Gardens | Florida | 33169 | 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. | Boise | Idaho | 83702 | 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. | Baltimore | Maryland | 21287 | 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. | Dearborn | Michigan | 48126 | 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. | Philadelphia | Pennsylvania | 19107 | 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. | Arlington | Texas | 76014 | 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. | Dallas | Texas | 75230 | 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. | San Antonio | Texas | 78229 | 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. | Tomball | Texas | 77375 | 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. | Salt Lake City | Utah | 84107 | 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. | Richmond | Virginia | 23294 | United States |
| FG002 | 180 mg LY2189102 | Participants received 2 SC injections weekly for 12 weeks. |
| FG003 | Placebo | Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.6 mg LY2189102 | Participants received 2 subcutaneous (SC) injections weekly for 12 weeks. |
| BG001 | 18 mg LY2189102 | Participants received 2 SC injections weekly for 12 weeks. |
| BG002 | 180 mg LY2189102 | Participants received 2 SC injections weekly for 12 weeks. |
| BG003 | Placebo | Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks. |
| BG004 | 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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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||
| Percentage of Glycosylated Fraction of Hemoglobin (HbA1c) | HbA1c: Hemoglobin A1c, glycosylated fraction of hemoglobin A (%) | Mean | Standard Deviation | percentage of glycosylated hemoglobin |
| ||||||||||||||
| Fasting Glucose | Mean | Standard Deviation | millimoles per liter (mmol/L) |
| |||||||||||||||
| Fasting Insulin | Mean | Standard Deviation | microinternational units per milliliter |
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| High-sensitivity C-reactive Protein (hsCRP) | Mean | Standard Deviation | milligrams per liter (mg/L) |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kilograms per square meter (kg/m^2) |
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| Number of Participants on Diet and Exercise Only | Count of Participants | Participants | No |
| |||||||||||||||
| Number of Participants on Anti-diabetic Medications | The number of participants on anti-diabetic medications does not equal the total number of participants because some participants reported taking more than 1 anti-diabetic medication. | Count of Participants | Participants | No |
|
| 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 the Glycosylated Hemoglobin (HbA1c) at 12 Weeks | Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline HbA1c as a continuous covariate. | Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned. | Posted | Least Squares Mean | Standard Error | percentage of glycosylated hemoglobin | Baseline, 12 weeks |
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| Secondary | Change From Baseline in Fasting Glucose at 12 Weeks | Change in fasting glucose following 12 weeks of therapy (that is, fasting glucose at week 12 minus fasting glucose at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate. | Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned. | Posted | Least Squares Mean | Standard Error | millimole per liter (mmol/L) | Baseline, 12 weeks |
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| Secondary | Change From Baseline in Insulin Sensitivity (Fasting Insulin) at 12 Weeks | Change in serum fasting insulin from baseline to endpoint (that is, serum insulin at week 12 minus serum insulin at week 0). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate. | Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned. | Posted | Least Squares Mean | Standard Error | microinternational Units per liter | Baseline, 12 weeks |
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| Secondary | Number of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks | The number of participants with a change from baseline in glucose and insulin at 2 hours after the MMTT was analyzed. The MMTT measures glucose and insulin before and after a standardized meal is eaten. Glucose and insulin levels were measured before the MMTT and 2 hours after the MMTT. | Full analysis set. All randomized participants who received at least 1 dose of the study drug according to the treatment they were assigned and for whom the data are considered sufficient and interpretable. Differences in Ns are due to either dropouts and no post-baseline measure or something occurred to the sample (for example, not taken, broke). | Posted | Number | participants | Baseline, 12 weeks |
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| Secondary | Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12 | The change from baseline in HbA1c at week 10 (that is HbA1c at week 10 minus HbA1c at baseline) and week 12 (that is, HbA1c at week 12 minus HbA1c at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate. | Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned. | Posted | Least Squares Mean | Standard Error | percentage glycosylated hemoglobin | Baseline, week 10, week 12 |
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| Secondary | Pharmacokinetics (PK) Maximum Serum Concentration (Cmax) of LY2189102 at End of Dosing (12 Weeks) | The Cmax value measures the maximum serum concentration and is estimated for LY2189102. The values were generated as individual estimates from a population pharmacokinetics (PK) model. Placebo samples were not assayed for serum concentration of LY2189102 because the participants in the placebo treatment arm did not receive LY2189102 study drug. | Full Analysis Set: All randomized participants who received at least 1 dose of the study drug according to the treatment they were assigned and for whom the data are considered sufficient and interpretable. Differences in Ns are due to either dropouts and no post-baseline measure or something occurred to the sample (for example, not taken, broke). | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose |
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| Secondary | PK: Area Under the Concentration Time Curve for Dosing Interval (Tau) at Steady State (AUCτ,SS) at End of Dosing (12 Weeks) | Individual estimates of AUCtau at end of dosing generated from a population pharmacokinetic (PK) model. | Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned. Placebo samples were not assayed for serum concentration of LY2189102 because the participants in the placebo treatment arm did not receive LY2189102 study drug. | Posted | Mean | Standard Deviation | nanogram*hour per milliliter (ng*h/mL) | Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics Measured by Serum Concentration at End of Dosing (12 Weeks) | Pharmacokinetics Measured by Serum Concentration at End of Dosing. | All participants who received at least one dose of study drug and had evaluable PK data. Placebo samples were not assayed for serum concentration of LY2189102 because the participants in the placebo treatment arm did not receive LY2189102 study drug. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.6 mg LY2189102 | Participants received 2 subcutaneous (SC) injections weekly for 12 weeks. | 1 | 26 | 19 | 26 | ||
| EG001 | 18 mg LY2189102 | Participants received 2 SC injections weekly for 12 weeks. | 1 | 26 | 19 | 26 | ||
| EG002 | 180 mg LY2189102 | Participants received 2 SC injections weekly for 12 weeks. | 0 | 27 | 23 | 27 | ||
| EG003 | Placebo | Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks. | 0 | 27 | 20 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorder | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection site irritation | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
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| 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 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C586827 | LY2189102 |
Not provided
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| Male |
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| African |
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| Hispanic |
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| East Asian |
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| Other |
|
| Diet and Exercise Only - No |
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| Glucagon-like Peptide (GLP) Analogs and Agonists |
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| DPP-4 Inhibitors |
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| Enhancers of Insulin Effects |
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| Sufonylureas |
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|
|
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| OG003 | Placebo | Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks. |
|
|
Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
|
|
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Participants received 2 SC injections weekly for 12 weeks.
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| Units | Counts |
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| Participants |
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| Participants |
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| Title | Measurements |
|---|---|
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