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| ID | Type | Description | Link |
|---|---|---|---|
| I1R-MC-GLDI | Other Identifier | Eli Lilly and Company | |
| 2013-003834-33 | EudraCT Number |
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The main purpose of the trial is to determine the effect of a study drug known as LY2409021 on blood pressure and pulse rate in participants with type 2 diabetes mellitus (T2DM) when compared to placebo. The study has two periods. Each participant will receive LY2409021 or placebo in each period. At least 4 weeks will pass between periods. The study will last about 23 weeks for each participant. Participants may remain on stable dose metformin, as prescribed by their personal physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Single daily dose of placebo matching LY2409021 administered orally in 1 of 2 treatment periods. |
|
| LY2409021 | Experimental | Single daily dose of 20 milligrams (mg) LY2409021 administered orally in 1 of 2 treatment periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2409021 | Drug | Administered orally |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 6 Weeks in Mean 24-Hour Systolic Blood Pressure | Systolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM). | Baseline, 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 6 Weeks in Mean 24-Hour Diastolic Blood Pressure | Diastolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate. | Baseline, 6 Weeks |
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Inclusion Criteria:
Have type 2 diabetes mellitus (according to the World Health Organization diagnostic criteria) and use diet and exercise alone or in combination with a stable dose of metformin ( >/=1000 mg/day [or <1000 mg, if documented intolerance to 1000 mg or higher dosages] immediate-release metformin or extended-release metformin for at least 2 months before screening).
Have glycated hemoglobin (HbA1c) values >/=6.5% and </=8.5%, as determined by the central laboratory at screening.
Have mean blood pressures >90/60 millimeters of mercury (mm Hg) and <140/90 mm Hg at screening.
If being treated for hypertension, are taking 3 or fewer antihypertensive medications and have been taking stable doses of the same medications for at least 1 month before screening.
Stable body weights (±5%) for >/=3 months before screening.
Body mass indexes >/=20 kilograms/meters squared (kg/m²) and <40 kg/m².
In the investigator's opinion, are well motivated, capable, and willing to:
Are women not of child-bearing potential due to:
Males who are sexually active and/or have partners of child-bearing age must use reliable methods of birth control during the study and until 3 months after the last doses of study medication. These requirements do not apply if a participant or his partner has been surgically sterilized or is not between menarche and 1 year postmenopausal.
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 |
|---|---|---|---|---|---|---|
| Advanced Clinical Research Institute | Anaheim | California | 92801 | United States | ||
| National Research Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2409021/Placebo | Period 1: Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of placebo administered orally for 6 weeks. |
| FG001 | Placebo/LY2409021 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
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| Drug |
Administered orally |
|
| Metformin | Drug | Administered as background therapy. |
|
| Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Peripheral Pulse Rate | Pulse rate obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate. | Baseline, 6 Weeks |
| Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Pulse Pressures | Pulse Pressures obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate. | Baseline, 6 Weeks |
| Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Mean Arterial Pressures (MAP) | Mean Arterial Pressures obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate. | Baseline, 6 Weeks |
| Change From Baseline in Hemoglobin A1c (HbA1c) | LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate. | Baseline, 6 Weeks |
| Population Pharmacokinetics: Apparent Clearance of LY2409021 | Population pharmacokinetic parameter apparent clearance (CL/F) is the apparent volume of the body fluid cleared of the drug per unit of time and was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups. | Days 7, 21, 42, 70, 77, 91, 112, 140; 15 minute Predose and Days 7 and 77: 1 hour Postdose. |
| Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021 | Population pharmacokinetic parameter, apparent volume of distribution (V/F) is a theoretical volume that a drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. Apparent volume of distribution (V/F) was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups. | Days 7, 21, 42, 70, 77, 91, 112, 140; Predose and Days 7 and 77: 1 hour Postdose. |
| Los Angeles |
| California |
| 90057 |
| United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| Orange County Research Center | Tustin | California | 92780 | United States |
| University Clinical Investigators, Inc. | Tustin | California | 92780 | United States |
| Berma Research | Fort Lauderdale | Florida | 33316 | United States |
| East Coast Clinical Research | Jacksonville | Florida | 32204 | United States |
| Suncoast Research Group, LLC | Miami | Florida | 33135 | United States |
| Cedar-Crosse Research Center | Chicago | Illinois | 60607 | United States |
| Midwest Institute for Clinical Research | Indianapolis | Indiana | 46260 | United States |
| L-Marc Research Center | Louisville | Kentucky | 40213 | United States |
| Maine Research Associates | Auburn | Maine | 04210 | United States |
| Alzohaili Medical Consultants | Dearborn | Michigan | 48124 | United States |
| Premier Research | Trenton | New Jersey | 08611 | United States |
| Manhattan Medical Research | New York | New York | 10016 | 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. | Holešov | 76901 | Czechia |
| 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. | Krnov | 79401 | Czechia |
| 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. | Pardubice | 53002 | Czechia |
| 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. | Prague | 14059 | Czechia |
| 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. | Coatzacoalcos | 96400 | 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 | 44130 | 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. | Monterrey | 64460 | 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. | Monterrey | 64620 | 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. | 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. | 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. | Lublin | 20-538 | 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 |
| Manati Center for Clinical Research Inc | Manati | 00674 | Puerto Rico |
| Consultorio Medico | San Juan | 00921 | Puerto Rico |
Period 1: Single daily dose of placebo administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks.
| COMPLETED |
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| NOT COMPLETED |
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| Wash-out |
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|
| Period 2 |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LY2409021 20 mg | Period 1: Single daily dose of 20 mg LY2409021 administered orally for 6 Weeks; Wash-out: 4 weeks; Period 2: Single daily dose of placebo administered orally for 6 weeks. |
| BG001 | Placebo | Period 1: Single daily dose of placebo administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of 20 mg Ly2409021 administered orally for 6 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||
| Diagnosis of Hypertension | Count of Participants | Participants | No |
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| Hemoglobin A1c (HBA1c) | 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 to 6 Weeks in Mean 24-Hour Systolic Blood Pressure | Systolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM). | Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug. | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Baseline, 6 Weeks |
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| Secondary | Change From Baseline to 6 Weeks in Mean 24-Hour Diastolic Blood Pressure | Diastolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate. | Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug. | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Baseline, 6 Weeks |
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| Secondary | Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Peripheral Pulse Rate | Pulse rate obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate. | Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug. | Posted | Least Squares Mean | 95% Confidence Interval | beats/minute | Baseline, 6 Weeks |
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| Secondary | Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Pulse Pressures | Pulse Pressures obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate. | Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug. | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Baseline, 6 Weeks |
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| Secondary | Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Mean Arterial Pressures (MAP) | Mean Arterial Pressures obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate. | Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug. | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Baseline, 6 Weeks |
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| Secondary | Change From Baseline in Hemoglobin A1c (HbA1c) | LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate. | Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of HbA1c | Baseline, 6 Weeks |
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| Secondary | Population Pharmacokinetics: Apparent Clearance of LY2409021 | Population pharmacokinetic parameter apparent clearance (CL/F) is the apparent volume of the body fluid cleared of the drug per unit of time and was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups. | Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter per hour (L/hr) | Days 7, 21, 42, 70, 77, 91, 112, 140; 15 minute Predose and Days 7 and 77: 1 hour Postdose. |
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| Secondary | Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021 | Population pharmacokinetic parameter, apparent volume of distribution (V/F) is a theoretical volume that a drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. Apparent volume of distribution (V/F) was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups. | All randomized participants who received at least 1 one dose of study drug and had at least one measureable drug concentration. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Days 7, 21, 42, 70, 77, 91, 112, 140; Predose and Days 7 and 77: 1 hour Postdose. |
|
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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 | LY2409021 20 mg | AEs (Adverse Event) from Period 1 and 2 combined from LY2409021 20 mg administration | 4 | 258 | 49 | 258 | ||
| EG001 | Placebo | AEs from Period 1 and 2 combined from placebo administration. | 2 | 256 | 32 | 256 | ||
| EG002 | Wash-out | All AEs included during wash-out period. | 2 | 249 | 25 | 249 | ||
| EG003 | Follow-up | All AEs from follow-up period. | 4 | 253 | 30 | 253 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Blood pressure diastolic increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Heart rate decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000601762 | adomeglivant |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Withdrawal by Subject |
|
| 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 |
|
| United States |
|
| Poland |
|
| Mexico |
|
| No |
|
| < 7.5% |
|
|
|
|
|
|
|
|
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