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This study was designed to compare the efficacy and safety of BRL49653C versus placebo with concomitant use of sulfonyl urea (SU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm 1 | Experimental | study drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosiglitazone (BRL49653C) | Drug | study drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 16 Weeks of Treatment in Rosiglitazone Group and Placebo Group | Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. The full analysis set used which was defined as remaining after participant who infringed on the following events were excluded from the randomized participants, who did not take the investigational drug during or after the treatment period (amount of investigational drug taken was zero tablets) and who were not measured for HbA1c even once as the observation period Baseline value or in the treatment period (after the investigational drug was prescribed), or for whom the above were unavailable (including cases that the above were considered missing measurements due to a defective sample). | Baseline (Day 0) and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline After 16 Weeks of Treatment in Fasting Plasma Glucose (FPG) | Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. | Baseline (Day 0) and Week 16 |
| Change From Baseline After 16 Weeks of Treatment in Fasting Insulin |
Not provided
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Kanagawa | 212-0024 | Japan | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | This study has not been published in the scientific literature. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| AVD105248 | Dataset Specification | View IPD |
Not provided
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Out of 172 participants given consent to participate in the study, 23 participants were withdrawn from the study before randomization.
From 19 April 2006 to 28 March 2007, total of 149 participants were randomized at 22 centers in Japan.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Rosiglitazone 4 mg Orally Once Daily | Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 milligrams (mg) tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study. |
| FG001 | Placebo | Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rosiglitazone 4 mg Orally Once Daily | Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study. |
| 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 Glycosylated Hemoglobin (HbA1c) After 16 Weeks of Treatment in Rosiglitazone Group and Placebo Group | Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. The full analysis set used which was defined as remaining after participant who infringed on the following events were excluded from the randomized participants, who did not take the investigational drug during or after the treatment period (amount of investigational drug taken was zero tablets) and who were not measured for HbA1c even once as the observation period Baseline value or in the treatment period (after the investigational drug was prescribed), or for whom the above were unavailable (including cases that the above were considered missing measurements due to a defective sample). | Full analysis set used. | Posted | Mean | Standard Deviation | Percentage of Glycosylated Hemoglobin | Baseline (Day 0) and Week 16 |
|
All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).
Full analysis set was used for reporting non-SAE and SAE.
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 | Rosiglitazone 4 mg Orally Once Daily | Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Liposacromal recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood creatine phosphokinase increased | Investigations | MedDRA version | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077154 | Rosiglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
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Not provided
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Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. |
| Baseline (Day 0) and Week 16 |
| Change From Baseline After 16 Weeks of Treatment in Fasting Proinsulin | Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. | Baseline (Day 0) and Week 16 |
| Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. | Baseline (Day 0) and Week 16 |
| Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Beta-cell Function (HOMA-beta) | Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. | Baseline (Day 0) and Week 16 |
| Change From Baseline After 16 Weeks of Treatment in Adiponectin | Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. | Baseline (Day 0) and Week 16 |
| Change From Baseline After 16 Weeks of Treatment in Leptin and High Sensitivity C-reactive Protein (Hs-CRP) | Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. | Baseline (Day 0) and Week 16 |
| Percentage of Participants With Changes in HbA1c and FPG Meeting Specified Criteria After 16 Weeks of Treatment | The specified criteria for HbA1c was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease from the observation period Baseline value is 0.7% or more; 2) fell below 6.5%; 3) satisfied either 1 or 2 noted above. And for FPG was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease of 30 mg per decilliter or more from the observation period Baseline value; 2) fell below 126 mg per deciliter; 3) satisfied either 1 or 2 noted above. | Up to Week 16 |
| Kumamoto |
| 862-0976 |
| Japan |
| GSK Investigational Site | Ōita | 870-0039 | Japan |
| GSK Investigational Site |
For additional information about this study please refer to the GSK Clinical Study Register |
| AVD105248 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVD105248 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVD105248 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVD105248 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVD105248 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVD105248 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BG001 |
| Placebo |
Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants in this arm were randomized to receive rosiglitazone (BRL49653C) 4 mg tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study. |
| OG001 | Placebo | Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study. |
|
|
|
| Secondary | Change From Baseline After 16 Weeks of Treatment in Fasting Plasma Glucose (FPG) | Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. | Full analysis set used. | Posted | Mean | Standard Deviation | Mg per decilliter | Baseline (Day 0) and Week 16 |
|
|
|
|
| Secondary | Change From Baseline After 16 Weeks of Treatment in Fasting Insulin | Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. | Full analysis set used. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Microunits per millilliter | Baseline (Day 0) and Week 16 |
|
|
|
|
| Secondary | Change From Baseline After 16 Weeks of Treatment in Fasting Proinsulin | Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. | Full analysis set used. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Picomoles per millilliter | Baseline (Day 0) and Week 16 |
|
|
|
|
| Secondary | Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. | Full analysis set used. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | MilliUnit per liter*millimoles per liter | Baseline (Day 0) and Week 16 |
|
|
|
|
| Secondary | Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Beta-cell Function (HOMA-beta) | Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. | Full analysis set used. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Percentage of normal beta cells function | Baseline (Day 0) and Week 16 |
|
|
|
|
| Secondary | Change From Baseline After 16 Weeks of Treatment in Adiponectin | Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. | Full analysis set used. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Micrograms per millilliter | Baseline (Day 0) and Week 16 |
|
|
|
|
| Secondary | Change From Baseline After 16 Weeks of Treatment in Leptin and High Sensitivity C-reactive Protein (Hs-CRP) | Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. | Full analysis set used. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Nanograms per millilliter | Baseline (Day 0) and Week 16 |
|
|
|
|
| Secondary | Percentage of Participants With Changes in HbA1c and FPG Meeting Specified Criteria After 16 Weeks of Treatment | The specified criteria for HbA1c was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease from the observation period Baseline value is 0.7% or more; 2) fell below 6.5%; 3) satisfied either 1 or 2 noted above. And for FPG was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease of 30 mg per decilliter or more from the observation period Baseline value; 2) fell below 126 mg per deciliter; 3) satisfied either 1 or 2 noted above. | Full analysis set used. | Posted | Number | Percentage of participants | Up to Week 16 |
|
|
|
|
| 0 |
| 74 |
| 1 |
| 74 |
| 61 |
| 74 |
| EG001 | Placebo | Participants in this arm were randomized to receive rosiglitazone placebo tablets orally once daily before or after breakfast for 16 weeks. Participants also received either of concomitant medication (sulphonylureas) glibenclamide (1.25 to 5 mg), gliclazide (40 to 80 mg) or glimepiride (1 to 3 mg) per day during study. | 0 | 75 | 1 | 75 | 53 | 75 |
| Brain stem infarction | Nervous system disorders | MedDRA version | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA version | Systematic Assessment |
|
| Blood triglyccrides increased | Investigations | MedDRA version | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA version | Systematic Assessment |
|
| Brain natriuretic peptide increased | Investigations | MedDRA version | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA version | Systematic Assessment |
|
| Urine ketone body present | Investigations | MedDRA version | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA version | Systematic Assessment |
|
| Hjgh density lipoprotein decreased | Investigations | MedDRA version | Systematic Assessment |
|
| Low density lipoprotein increased | Investigations | MedDRA version | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA version | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA version | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA version | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA version | Systematic Assessment |
|
| Monocyte count increased | Investigations | MedDRA version | Systematic Assessment |
|
| Neutrophll count decreased | Investigations | MedDRA version | Systematic Assessment |
|
| Reticulocyte count increased | Investigations | MedDRA version | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA version | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA version | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA version | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA version | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA version | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA version | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA version | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA version | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA version | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA version | Systematic Assessment |
|
| Bronchitis acute | Infections and infestations | MedDRA version | Systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA version | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA version | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA version | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA version | Systematic Assessment |
|
| lnfluenza | Infections and infestations | MedDRA version | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA version | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
|
| Reflux ocsophagitis | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
|
| Duodenal scarring | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA version | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA version | Systematic Assessment |
|
| Pharyngolaryngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA version | Systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
|
| Joint contracture | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
|
| Myajgia | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA version | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA version | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA version | Systematic Assessment |
|
| Feeling abnonnal | General disorders | MedDRA version | Systematic Assessment |
|
| Malaise | General disorders | MedDRA version | Systematic Assessment |
|
| Oedema | General disorders | MedDRA version | Systematic Assessment |
|
| Pain | General disorders | MedDRA version | Systematic Assessment |
|
| Thirst | General disorders | MedDRA version | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA version | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA version | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA version | Systematic Assessment |
|
| Back injury | Injury, poisoning and procedural complications | MedDRA version | Systematic Assessment |
|
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA version | Systematic Assessment |
|
| Tooth injury | Injury, poisoning and procedural complications | MedDRA version | Systematic Assessment |
|
| Thennal bum | Injury, poisoning and procedural complications | MedDRA version | Systematic Assessment |
|
| Neck injury | Injury, poisoning and procedural complications | MedDRA version | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA version | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version | Systematic Assessment |
|
| Hypoaesthcsia | Nervous system disorders | MedDRA version | Systematic Assessment |
|
| Areflexia | Nervous system disorders | MedDRA version | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA version | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA version | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA version | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA version | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA version | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA version | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA version | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA version | Systematic Assessment |
|
| Corneal epithelium disorder | Eye disorders | MedDRA version | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA version | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA version | Systematic Assessment |
|
| Punctate keratitis | Eye disorders | MedDRA version | Systematic Assessment |
|
| Corneal exfoliation | Eye disorders | MedDRA version | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA version | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA version | Systematic Assessment |
|
| Anxiety disorder | Psychiatric disorders | MedDRA version | Systematic Assessment |
|
| Bundle branch block right | Cardiac disorders | MedDRA version | Systematic Assessment |
|
| Extrasystoles | Cardiac disorders | MedDRA version | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA version | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA version | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA version | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA version | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version | Systematic Assessment |
|
| Hyperaemia | Vascular disorders | MedDRA version | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA version | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA version | Systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA version | Systematic Assessment |
|
| Adrenal mass | Endocrine disorders | MedDRA version | Systematic Assessment |
|
| Uterine polyp | Reproductive system and breast disorders | MedDRA version | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 0.271 |
| Mean Difference (Net) |
| -888.8 |
| Standard Error of the Mean |
| 803.96 |
| 2-Sided |
| 95 |
| -2477.7 |
| 700.1 |
Comparison of hs-CRP |
| Superiority or Other (legacy) |
| HbA1c, satisfied either 1 or 2 |
|
| FPG, decrease of 30 milligrams per decilliter |
|
| FPG, fell below 126 milligrams per deciliter |
|
| FPG, satisfied either 1 or 2 |
|
| Mean Difference (Final Values) |
| 6.8 |
| 2-Sided |
| 95 |
| -0.3 |
| 13.8 |
Comparison of HbA1c, fell below 6.5% |
| Superiority or Other (legacy) |
| Mean Difference (Final Values) | 40.6 | 2-Sided | 95 | 27.1 | 54.1 | Comparison of HbA1c, satisfied either 1 or 2 | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 23.1 | 2-Sided | 95 | 9.5 | 36.6 | Comparison of FPG, decrease of 30 milligrams per decilliter | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 6.9 | 2-Sided | 95 | -5.1 | 18.9 | Comparison of FPG, fell below 126 milligrams per deciliter | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 20.5 | 2-Sided | 95 | 5.6 | 35.3 | Comparison of FPG, satisfied either 1 or 2 | Superiority or Other (legacy) |