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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-002456-41 | EudraCT Number | EudraCT |
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The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (Linagliptin) (5 mg / once daily) compared to placebo given for 24 weeks as initial combination therapy with pioglitazone 30 mg in patients with type 2 diabetes mellitus with insufficient glycaemic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1356 (5 mg) | Experimental | BI 1356 5mg in initial combination therapy with pioglitazone 30 mg |
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| Placebo matching BI 1356 5 mg | Placebo Comparator | Placebo in initial combination therapy with pioglitazone 30 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo + pioglitazone (30 mg) | Drug | placebo + overcapsulated 30 mg tablet, once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Change From Baseline to Week 24 | HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. | Baseline and week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Change From Baseline to Week 6 | HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. | Baseline and week 6 |
| HbA1c Change From Baseline to Week 12 |
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Inclusion criteria:
Exclusion criteria:
Myocardial infarction, stroke or Transient Isquemic Atack (TIA) within 6 months prior to Inform Consent (IC)
Impaired hepatic function, defined by serum levels of either Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or alkaline phosphatase above 3 x upper limit of normal (ULN) determined at Visit 1a.
Known hypersensitivity or allergy to the investigational product or its excipients and/or to hydrochloride of pioglitazone or its excipients
Treatment with Glucagon-like peptide-1 (GLP-1) analogue / agonist within 3 months prior to IC.
Treatment with insulin within 3 months prior to IC
Treatment with anti-obesity drugs 3 months prior to IC.
Alcohol abuse within the 3 months prior to IC that would interfere with trial participation or drug abuse.
Participation in another trial with an investigational drug within 2 months prior to IC.
Fasting blood glucose > 240 mg/dl (=13.3 mmol/L) at screening (Visit 1).
Pre-menopausal women (last menstruation < or =1 year prior to signing IC) who:
Treatment with systemic steroids or change in the dosage of thyroid hormone within six weeks prior to IC
Heart failure New York Heart Asociation (NYHA) class I-IV, or history of heart failure.
Diabetic ketoacidosis within 6 months prior to IC.
Hemodialyzed patients due to limited experience with Thiazolidinediones (TZDs)
Any other clinical condition wich, in the opinion of the investigator, would not alow safe completion of the protocol and safe administration of BI1356 and pioglitazone.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1218.15.43004 Boehringer Ingelheim Investigational Site | Feldkirch | Austria | ||||
| 1218.15.43001 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22234149 | Derived | Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + Pioglitazone | Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg |
| FG001 | Linagliptin + Pioglitazone | Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Linagliptin + pioglitazone (30 mg) | Drug | 5 mg tablet + overcapsulated 30 mg tablet, once daily |
|
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. |
| Baseline and week 12 |
| HbA1c Change From Baseline to Week 18 | HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. | Baseline and week 18 |
| FPG Change From Baseline to Week 24 | This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication. | Baseline and week 24 |
| FPG Change From Baseline to Week 6 | This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication. | Baseline and week 6 |
| FPG Change From Baseline to Week 12 | This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication. | Baseline and week 12 |
| FPG Change From Baseline to Week 18 | This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetes medication. | Baseline and week 18 |
| Percentage of Patients With HbA1c <7.0% at Week 24 | The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. Only patients with baseline HbA1c >= 7% | Baseline and Week 24 |
| Percentage of Patients With HbA1c<7.0 at Week 24 | The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. | Baseline and Week 24 |
| Percentage of Patients With HbA1c <6.5% at Week 24 | The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c >= 6.5% | Baseline and Week 24 |
| Percentage of Patients With HbA1c<6.5% at Week 24 | The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5% | Baseline and week 24 |
| Percentage of Patients Who Have an HbA1c Lowering by 0.5% at Week 24 | The percentage of patients with an HbA1c reduction from baseline greater than 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%. | Baseline and Week 24 |
| Graz |
| Austria |
| 1218.15.43003 Boehringer Ingelheim Investigational Site | Vienna | Austria |
| 1218.15.43005 Boehringer Ingelheim Investigational Site | Vienna | Austria |
| 1218.15.30004 Boehringer Ingelheim Investigational Site | Athens | Greece |
| 1218.15.30007 Boehringer Ingelheim Investigational Site | Athens | Greece |
| 1218.15.30017 Boehringer Ingelheim Investigational Site | Ioannina | Greece |
| 1218.15.30002 Boehringer Ingelheim Investigational Site | Melissia-Athens | Greece |
| 1218.15.30003 Boehringer Ingelheim Investigational Site | Nikaia | Greece |
| 1218.15.30006 Boehringer Ingelheim Investigational Site | Thessaloniki | Greece |
| 1218.15.30014 Boehringer Ingelheim Investigational Site | Thessaloniki | Greece |
| 1218.15.30016 Boehringer Ingelheim Investigational Site | Thessaloniki | Greece |
| 1218.15.36003 Boehringer Ingelheim Investigational Site | Budapest | Hungary |
| 1218.15.36004 Boehringer Ingelheim Investigational Site | Budapest | Hungary |
| 1218.15.36006 Boehringer Ingelheim Investigational Site | Budapest | Hungary |
| 1218.15.36008 Boehringer Ingelheim Investigational Site | Debrecen | Hungary |
| 1218.15.36005 Boehringer Ingelheim Investigational Site | Győr | Hungary |
| 1218.15.36002 Boehringer Ingelheim Investigational Site | Szombathely | Hungary |
| 1218.15.81001 Boehringer Ingelheim Investigational Site | Amagasaki, Hyogo | Japan |
| 1218.15.81005 Boehringer Ingelheim Investigational Site | Koganei, Tokyo | Japan |
| 1218.15.81002 Boehringer Ingelheim Investigational Site | Osaka, Osaka | Japan |
| 1218.15.81004 Boehringer Ingelheim Investigational Site | Shinjyuku-ku,Tokyo | Japan |
| 1218.15.81003 Boehringer Ingelheim Investigational Site | Suita, Osaka, | Japan |
| 1218.15.35007 Boehringer Ingelheim Investigational Site | Aveiro | Portugal |
| 1218.15.35001 Boehringer Ingelheim Investigational Site | Lisbon | Portugal |
| 1218.15.40504 Boehringer Ingelheim Investigational Site | Alba Iulia | Romania |
| 1218.15.40501 Boehringer Ingelheim Investigational Site | Bucharest | Romania |
| 1218.15.40502 Boehringer Ingelheim Investigational Site | Bucharest | Romania |
| 1218.15.40503 Boehringer Ingelheim Investigational Site | Sibiu | Romania |
| 1218.15.40505 Boehringer Ingelheim Investigational Site | Târgu Mureş | Romania |
| 1218.15.34002 Boehringer Ingelheim Investigational Site | Badalona | Spain |
| 1218.15.34011 Boehringer Ingelheim Investigational Site | Badia Del Vallés | Spain |
| 1218.15.34001 Boehringer Ingelheim Investigational Site | Bercelona | Spain |
| 1218.15.34012 Boehringer Ingelheim Investigational Site | Borges Del Camp | Spain |
| 1218.15.34013 Boehringer Ingelheim Investigational Site | Centelles | Spain |
| 1218.15.34007 Boehringer Ingelheim Investigational Site | Granada | Spain |
| 1218.15.34008 Boehringer Ingelheim Investigational Site | L'Hospitalet de Llobregat (Barcelona) | Spain |
| 1218.15.34009 Boehringer Ingelheim Investigational Site | L'Hospitalet de Llobregat (Barcelona) | Spain |
| 1218.15.34004 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1218.15.34006 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1218.15.34010 Boehringer Ingelheim Investigational Site | Sant Adrià Del Besós (Barcelona) | Spain |
| 1218.15.34005 Boehringer Ingelheim Investigational Site | Seville | Spain |
| 1218.15.34014 Boehringer Ingelheim Investigational Site | Vic (Barcelona) | Spain |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + Pioglitazone | Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg |
| BG001 | Linagliptin + Pioglitazone | Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Body mass index continuous | Mean | Standard Deviation | kg/m^2 |
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| Glycosylated haemoglobin A1 (HbA1c) | Mean | Standard Deviation | Percent |
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| Fasting Plasma Glucose (FPG) | Mean | Standard Deviation | mg/dL |
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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 | HbA1c Change From Baseline to Week 24 | HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. | The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Mean | Standard Error | Percent | Baseline and week 24 |
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| Secondary | HbA1c Change From Baseline to Week 6 | HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. | The Full Analysis Set (FAS) included all randomised and treated patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Mean | Standard Error | Percent | Baseline and week 6 |
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| Secondary | HbA1c Change From Baseline to Week 12 | HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. | The Full Analysis Set (FAS) included all randomised and treated patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Mean | Standard Error | Percent | Baseline and week 12 |
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| Secondary | HbA1c Change From Baseline to Week 18 | HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. | The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Mean | Standard Error | Percent | Baseline and week 18 |
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| Secondary | FPG Change From Baseline to Week 24 | This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication. | This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value. | Posted | Mean | Standard Error | mg/dL | Baseline and week 24 |
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| Secondary | FPG Change From Baseline to Week 6 | This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication. | This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value. | Posted | Mean | Standard Error | mg/dL | Baseline and week 6 |
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| Secondary | FPG Change From Baseline to Week 12 | This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication. | This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value. | Posted | Mean | Standard Error | mg/dL | Baseline and week 12 |
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| Secondary | FPG Change From Baseline to Week 18 | This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetes medication. | This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value. | Posted | Mean | Standard Error | mg/dL | Baseline and week 18 |
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| Secondary | Percentage of Patients With HbA1c <7.0% at Week 24 | The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. Only patients with baseline HbA1c >= 7% | This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF). | Posted | Number | percentage of patients | Baseline and Week 24 |
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| Secondary | Percentage of Patients With HbA1c<7.0 at Week 24 | The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. | This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF). | Posted | Number | percentage of patients | Baseline and Week 24 |
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| Secondary | Percentage of Patients With HbA1c <6.5% at Week 24 | The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c >= 6.5% | This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF). | Posted | Number | percentage of patients | Baseline and Week 24 |
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| Secondary | Percentage of Patients With HbA1c<6.5% at Week 24 | The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5% | This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF). | Posted | Number | percentage of patients | Baseline and week 24 |
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| Secondary | Percentage of Patients Who Have an HbA1c Lowering by 0.5% at Week 24 | The percentage of patients with an HbA1c reduction from baseline greater than 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%. | The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF). | Posted | Number | percentage of patients | Baseline and Week 24 |
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From day of first dose until 7 days after last dose, up to 202 days
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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 | Placebo + Pioglitazone | Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg | 3 | 130 | 21 | 130 | ||
| EG001 | Linagliptin + Pioglitazone | Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg | 8 | 259 | 33 | 259 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Glaucoma | Eye disorders | MedDRA 12.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Colonic polyp | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
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| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Meniscus removal | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
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| Varicose vein | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| 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 |
|---|---|
| D000077205 | Pioglitazone |
| D000069476 | Linagliptin |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011799 | Quinazolines |
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