Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000486-38 | EudraCT Number | ||
| U1111-1113-2081 | Registry Identifier | WHO | |
| NL22649.029.08 | Registry Identifier | CCMO |
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The purpose of this study is to compare the efficacy of Alogliptin, once daily (QD), taken by itself and with pioglitazone on postprandial lipid measures in type 2 diabetes.
SYR-322 (alogliptin) is a selective, orally available inhibitor of dipeptidyl peptidase IV being developed as a treatment for type 2 diabetes mellitus. Dipeptidyl peptidase IV is the primary enzyme involved in the in vivo degradation of at least 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide.
Pioglitazone HCl (ACTOS®) is a thiazolidinedione developed by Takeda Chemical Industries, Ltd. (Osaka, Japan). Pioglitazone HCl depends on the presence of insulin for its mechanism of action.
This study will assess the effects of alogliptin and alogliptin coadministered with pioglitazone HCl on postprandial lipid and lipoprotein metabolism in participants with type 2 diabetes. Individuals who participate in this study will be required to commit to a screening visit and up to 6 additional visits at the study center. Study participation is anticipated to be about 20 weeks (or approximately 5 months). Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, physical examinations and electrocardiograms. At 3 of the visits a meal will be served that must be eaten within 10 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo QD | Placebo Comparator |
| |
| Alogliptin 25 mg QD | Experimental |
| |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alogliptin and Pioglitazone | Drug | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16. | The change in postprandial (after eating a meal) incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC (0-8h)) postdose at week 16 relative to baseline. | Baseline and Week 16. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 4. | The change in postprandial incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC(0-8h)) postdose at week 4 relative to baseline. | Baseline and Week 4. |
| Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
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Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam | Netherlands | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22237690 | Result | Eliasson B, Moller-Goede D, Eeg-Olofsson K, Wilson C, Cederholm J, Fleck P, Diamant M, Taskinen MR, Smith U. Lowering of postprandial lipids in individuals with type 2 diabetes treated with alogliptin and/or pioglitazone: a randomised double-blind placebo-controlled study. Diabetologia. 2012 Apr;55(4):915-25. doi: 10.1007/s00125-011-2447-3. Epub 2012 Jan 12. |
| Label | URL |
|---|---|
| ACTOS Package Insert. | View source |
Not provided
Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled in one of three, once-daily (QD) treatment groups.
Participants enrolled at 2 investigative sites in The Netherlands and Sweden from 16 July 2007 to 17 December 2009.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo QD | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks. |
| FG001 | Alogliptin 25 mg QD | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks. |
| FG002 | Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo QD | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks. |
| BG001 | Alogliptin 25 mg QD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16. | The change in postprandial (after eating a meal) incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC (0-8h)) postdose at week 16 relative to baseline. | The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward. | Posted | Least Squares Mean | Standard Error | mg.h/dL | Baseline and Week 16. |
|
Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory values or ECG findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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 | Placebo QD | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric ulcer | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. VP, Clinical Science | Takeda Global Research and Development Center, Inc. | 800-778-2860 | clinicaltrialregistry@tpna.com |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D003924 | Diabetes Mellitus, Type 2 |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D052439 | Lipid Metabolism Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C520853 | alogliptin |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
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|
| Alogliptin | Drug | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks. |
|
|
| Placebo | Drug | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks. |
|
|
The change in postprandial incremental area under the plasma concentration-time curve for very-low-density lipoprotein (VLDL) cholesterol, VLDL triglycerides, VLDL2 cholesterol, VLDL2 triglycerides, chylomicron cholesterol, chylomicron triglycerides, intermediate-density lipoprotein (IDL) cholesterol, and IDL triglycerides from 0 to 8 hours postdose at week 4 and week 16 relative to baseline. |
| Baseline, Week 4 and Week 16. |
| Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | Postprandial incremental area under the curve changes for very-low-density lipoprotein (VLDL) Apo B-48, VLDL Apo B 100, VLDL2 Apo B-48, VLDL2 Apo B 100, chylomicron Apo B-48, chylomicron Apo B 100, and intermediate density lipoprotein (IDL) Apo B-48, IDL Apo B 100, and triglyceride-rich remnant (TRR) lipoproteins from 0 to 8 hours postdose at week 4 and week 16 relative to baseline. | Baseline, Week 4 and Week 16. |
| Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Postprandial changes over time at each week indicated relative to baseline. | Baseline, Week 4 and Week 16. |
| Postprandial Changes Over Time From Baseline for Glucose | Postprandial changes over time at each week indicated relative to baseline. | Baseline, Week 4 and Week 16. |
| Postprandial Changes Over Time From Baseline for Insulin | Postprandial changes over time at each week indicated relative to baseline. | Baseline, Week 4 and Week 16. |
| Postprandial Changes Over Time From Baseline for Glucagon | Postprandial changes over time at each week indicated relative to baseline. | Baseline, Week 4 and Week 16. |
| Change From Baseline in Glycosylated Hemoglobin | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated relative to baseline. | Baseline, Week 8 and Week 16. |
| Change From Baseline in Fasting Plasma Glucose | The change in fasting plasma glucose collected at each week indicated relative to baseline. | Baseline, Week 4, Week 8 and Week 16. |
| Change From Baseline in Postprandial C-Peptide | The change in postprandial C-peptide collected at each week indicated relative to baseline. | Baseline, Week 4 and Week 16. |
| Change From Baseline in Postprandial Proinsulin | The change in postprandial proinsulin collected at each week indicated relative to baseline. | Baseline, Week 4 and Week 16. |
| Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP) | The change in hs-CRP collected at each week indicated relative to baseline. | Baseline, Week 4 and Week 16. |
| Change From Baseline in Adiponectin | The change in adiponectin collected at each week indicated relative to baseline. | Baseline, Week 4 and Week 16. |
| Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM) | The change in VCAM collected at each week indicated relative to baseline. | Baseline, Week 4 and Week 16. |
| Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM) | The change in ICAM collected at each week indicated relative to baseline. | Baseline, Week 4 and Week 16. |
| Change From Baseline in e-Selectin | The change in e-Selectin collected at each week indicated relative to baseline. | Baseline, Week 4 and Week 16. |
| Change From Baseline in Endothelial Function Through Pulse Wave Tonometry | Pulse wave tonometry performed before the meal and 2 hours postmeal using one recording consisting of 15 to 20 sequentially recorded radial artery waveforms collected at each assessment. | Baseline and Week 16. |
| Gothenburg |
| Sweden |
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
| BG002 | Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Race (NIH/OMB) | White | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
| Diabetes duration | Mean | Standard Deviation | years |
|
| OG001 | Alogliptin 25 mg QD | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks. |
| OG002 | Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks. |
|
|
|
| Secondary | Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 4. | The change in postprandial incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC(0-8h)) postdose at week 4 relative to baseline. | The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward. | Posted | Least Squares Mean | Standard Error | mg.h/dL | Baseline and Week 4. |
|
|
|
| Secondary | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | The change in postprandial incremental area under the plasma concentration-time curve for very-low-density lipoprotein (VLDL) cholesterol, VLDL triglycerides, VLDL2 cholesterol, VLDL2 triglycerides, chylomicron cholesterol, chylomicron triglycerides, intermediate-density lipoprotein (IDL) cholesterol, and IDL triglycerides from 0 to 8 hours postdose at week 4 and week 16 relative to baseline. | The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward. | Posted | Least Squares Mean | Standard Error | mg.h/dL | Baseline, Week 4 and Week 16. |
|
|
|
| Secondary | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | Postprandial incremental area under the curve changes for very-low-density lipoprotein (VLDL) Apo B-48, VLDL Apo B 100, VLDL2 Apo B-48, VLDL2 Apo B 100, chylomicron Apo B-48, chylomicron Apo B 100, and intermediate density lipoprotein (IDL) Apo B-48, IDL Apo B 100, and triglyceride-rich remnant (TRR) lipoproteins from 0 to 8 hours postdose at week 4 and week 16 relative to baseline. | The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward. | Posted | Least Squares Mean | Standard Error | mg.h/dL | Baseline, Week 4 and Week 16. |
|
|
|
| Secondary | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Postprandial changes over time at each week indicated relative to baseline. | The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward. | Posted | Least Squares Mean | Standard Error | pmol/L | Baseline, Week 4 and Week 16. |
|
|
|
| Secondary | Postprandial Changes Over Time From Baseline for Glucose | Postprandial changes over time at each week indicated relative to baseline. | The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, Week 4 and Week 16. |
|
|
|
| Secondary | Postprandial Changes Over Time From Baseline for Insulin | Postprandial changes over time at each week indicated relative to baseline. | The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward. | Posted | Least Squares Mean | Standard Error | uIU/mL | Baseline, Week 4 and Week 16. |
|
|
|
| Secondary | Postprandial Changes Over Time From Baseline for Glucagon | Postprandial changes over time at each week indicated relative to baseline. | The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward. | Posted | Least Squares Mean | Standard Error | pg/mL | Baseline, Week 4 and Week 16. |
|
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated relative to baseline. | The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward. | Posted | Least Squares Mean | Standard Error | percentage of glycosylated hemoglobin | Baseline, Week 8 and Week 16. |
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose | The change in fasting plasma glucose collected at each week indicated relative to baseline. | The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, Week 4, Week 8 and Week 16. |
|
|
|
| Secondary | Change From Baseline in Postprandial C-Peptide | The change in postprandial C-peptide collected at each week indicated relative to baseline. | The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward. | Posted | Least Squares Mean | Standard Error | ng/mL | Baseline, Week 4 and Week 16. |
|
|
|
| Secondary | Change From Baseline in Postprandial Proinsulin | The change in postprandial proinsulin collected at each week indicated relative to baseline. | The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward. | Posted | Least Squares Mean | Standard Error | pmol/L | Baseline, Week 4 and Week 16. |
|
|
|
| Secondary | Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP) | The change in hs-CRP collected at each week indicated relative to baseline. | The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward. | Posted | Least Squares Mean | Standard Error | mg/L | Baseline, Week 4 and Week 16. |
|
|
|
| Secondary | Change From Baseline in Adiponectin | The change in adiponectin collected at each week indicated relative to baseline. | The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward. | Posted | Least Squares Mean | Standard Error | µg/mL | Baseline, Week 4 and Week 16. |
|
|
|
| Secondary | Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM) | The change in VCAM collected at each week indicated relative to baseline. | The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward. | Posted | Least Squares Mean | Standard Error | ng/mL | Baseline, Week 4 and Week 16. |
|
|
|
| Secondary | Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM) | The change in ICAM collected at each week indicated relative to baseline. | The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward. | Posted | Least Squares Mean | Standard Error | ng/mL | Baseline, Week 4 and Week 16. |
|
|
|
| Secondary | Change From Baseline in e-Selectin | The change in e-Selectin collected at each week indicated relative to baseline. | The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward. | Posted | Least Squares Mean | Standard Error | ng/mL | Baseline, Week 4 and Week 16. |
|
|
|
| Secondary | Change From Baseline in Endothelial Function Through Pulse Wave Tonometry | Pulse wave tonometry performed before the meal and 2 hours postmeal using one recording consisting of 15 to 20 sequentially recorded radial artery waveforms collected at each assessment. | The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 16. |
|
|
|
| 0 |
| 24 |
| 15 |
| 24 |
| EG001 | Alogliptin 25 mg QD | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks. | 2 | 25 | 19 | 25 |
| EG002 | Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks. | 3 | 22 | 13 | 22 |
| Concussion | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Asymptomatic bacteriuria | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA (12.1) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dupuytren's contracture | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
|
No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
|
| VLDL cholesterol Week 4 (n=23; n=21; n=19) |
|
| VLDL cholesterol Week 16 (n=23; n=25; n=21) |
|
| VLDL 2 triglycerides Week 4 (n=23; n=20; n=19) |
|
| VLDL 2 triglycerides Week 16 (n=23; n=25; n=21) |
|
| VLDL 2 cholesterol Week 4 (n=23; n=20; n=19) |
|
| VLDL 2 cholesterol Week 16 (n=23; n=25; n=21) |
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| Chylomicron triglycerides Week 4 (n=23; n=21; n=1 |
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| Chylomicron triglycerides Week 16(n=23;n=25; n=21) |
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| Chylomicron cholesterol Week 4 (n=23; n=21; n=19) |
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| Chylomicron cholesterol Week 16 (n=23; n=25; n=21) |
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| IDL triglycerides Week 4 (n=22; n=18; n=17) |
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| IDL triglycerides Week 16 (n=22; n=23; n=19) |
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| IDL cholesterol Week 4 (n=22; n=18; n=17) |
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| IDL cholesterol Week 16 (n=22; n=23; n=19) |
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| VLDL apo B 100 Week 4 (n=19; n=12; n=15) |
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| VLDL apo B 100 Week 16 (n=19; n=16; n=16) |
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| VLDL2 apo B-48 Week 4 (n=19; n=12; n=15) |
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| VLDL2 apo B-48 Week 16 (n=19; n=16; n=16) |
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| VLDL2 apo B 100 Week 4 (n=19; n=12; n=15) |
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| VLDL2 apo B 100 Week 16 (n=19; n=16; n=16) |
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| Chylomicron apo B-48 Week 4 (n=19; n=12; n=14) |
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| Chylomicron apo B-48 Week 16 (n=19; n=16; n=16) |
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| Chylomicron apo B 100 Week 4(n=19; n=12; n=14) |
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| Chylomicron apo B 100 Week 16 (n=19; n=16; n=16) |
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| IDL apo B-48 Week 4 (n=18; n=10; n=13) |
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| IDL apo B-48 Week 16 (n=18; n=14; n=14) |
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| IDL apo B 100 Week 4 (n=18; n=10; n=13) |
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| IDL apo B 100 Week 16 (n=18; n=14; n=14) |
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| TRR lipoproteins Week 4 (n=24; n=21; n=19) |
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| TRR lipoproteins Week 16 (n=24; n=25; n=21) |
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| Week 4: 3 hours postprandial (n=21; n=17; n=16) |
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| Week 4: 4 hours postprandial (n=21; n=17; n=16) |
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| Week 4: 8 hours postprandial (n=19; n=16; n=16) |
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| Week 16: 1 hour postprandial (n=21 ; n=20; n=16) |
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| Week 16: 2 hours postprandial (n=21; n=21; n=17) |
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| Week 16: 3 hours postprandial (n=21; n=21; n=17) |
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| Week 16: 4 hours postprandial (n=21; n=21; n=17) |
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| Week 16: 8 hours postprandial (n=21; n=21; n=17) |
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| Week 4: 3 hours postprandial (n=24; n=21; n=18) |
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| Week 4: 4 hours postprandial (n=24; n=21; n=19) |
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| Week 4: 8 hours postprandial (n=22; n=21; n=19) |
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| Week 16: 1 hour postprandial (n=24; n=25; n=21) |
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| Week 16: 2 hours postprandial (n=23; n=25; n=21) |
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| Week 16: 3 hours postprandial (n=24; n=25; n=20) |
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| Week 16: 4 hours postprandial (n=24; n=25; n=21) |
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| Week 16: 8 hours postprandial (n=24; n=25; n=21) |
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| Week 4: 3 hours postprandial (n=24; n=21; n=19) |
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| Week 4: 4 hours postprandial (n=24; n=21; n=19) |
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| Week 4: 8 hours postprandial (n=23; n=21; n=19) |
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| Week 16: 1 hour postprandial (n=24; n=25; n=21) |
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| Week 16: 2 hours postprandial (n=24; n=25; n=21) |
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| Week 16: 3 hours postprandial (n=24; n=25; n=21) |
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| Week 16: 4 hours postprandial (n=24; n=25; n=21) |
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| Week 16: 8 hours postprandial (n=24; n=25; n=21) |
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| Week 4: 3 hours postprandial (n=24; n=21; n=19) |
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| Week 4: 4 hours postprandial (n=24; n=20; n=18) |
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| Week 4: 8 hours postprandial (n=22; n=20; n=19) |
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| Week 16: 1 hour postprandial (n=24; n=25; n=21) |
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| Week 16: 2 hours postprandial (n=24; n=25; n=21) |
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| Week 16: 3 hours postprandial (n=24; n=25; n=21) |
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| Week 16: 4 hours postprandial (n=24; n=24; n=21) |
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| Week 16: 8 hours postprandial (n=24; n=25; n=21) |
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| Week 16 (n=24; n=25; n=21) |
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| Week 4: 3 hours postprandial (n=24; n=21; n=19) |
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| Week 4: 4 hours postprandial (n=24; n=21; n=19) |
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| Week 4: 8 hours postprandial (n=23; n=20; n=19) |
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| Week 16: 1 hour postprandial (n=24; n=25; n=21) |
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| Week 16: 2 hours postprandial (n=24; n=25; n=21) |
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| Week 16: 3 hours postprandial (n=24; n=25; n=21) |
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| Week 16: 4 hours postprandial (n=24; n=25; n=21) |
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| Week 16: 8 hours postprandial (n=24; n=24; n=21) |
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| Week 4: 3 hours postprandial (n=24; n=21; n=19) |
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| Week 4: 4 hours postprandial (n=24; n=21; n=19) |
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| Week 4: 8 hours postprandial (n=23; n=21; n=19) |
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| Week 16: 1 hour postprandial (n=24; n=25; n=21) |
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| Week 16: 2 hours postprandial (n=24; n=25; n=21) |
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| Week 16: 3 hours postprandial (n=24; n=25; n=21) |
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| Week 16: 4 hours postprandial (n=24; n=25; n=21) |
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| Week 16: 8 hours postprandial (n=24; n=25; n=21) |
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