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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This study is being carried out to see if dapagliflozin in addition to glimepiride (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared to glimepiride alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | dapagliflozin 2.5mg + Glimepiride |
|
| 2 | Experimental | dapagliflozin 5mg + Glimepiride |
|
| 3 | Experimental | dapagliflozin 10mg + Glimepiride |
|
| 4 | Placebo Comparator | Placebo + Glimepiride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dapagliflozin | Drug | tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change in HbA1c Levels | To assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycemic control in participants with type 2 diabetes, as determined by the change in HbA1C levels from baseline to the end of the 24-week double-blind treatment period. | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change in Body Weight | To show that dapagliflozin plus glimepiride results in greater reduction in body weight or less weight gain after 24 weeks of treatment when compared to placebo plus glimepiride. | Baseline to Week 24 |
| Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Krzysztof Strojek, Prof. Dr. | Silesian Medical University3-Maja 13/15, 41-800 Zabrze; Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Blansko | Czechia | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33368935 | Derived | Shah M, Stolbov L, Yakovleva T, Tang W, Sokolov V, Penland RC, Boulton D, Parkinson J. A model-based approach to investigating the relationship between glucose-insulin dynamics and dapagliflozin treatment effect in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Apr;23(4):991-1000. doi: 10.1111/dom.14305. Epub 2021 Jan 25. | |
| 23529567 |
Not provided
Not provided
Reasons for enrolled participants not being randomised: 229 incorrect enrollment, 4 adverse event, 23 withdrew consent, 2 lost to follow up and 4 other.
Enrollment: 859 (597 randomized and 592 in the Full Analysis Set) Study Start Date:April 2008 Study Completion Date:May 2010 Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dapagliflozin 2.5mg + Glimepiride | Dapagliflozin tablet 2.5 mg once daily plus glimepiride |
| FG001 | Dapagliflozin 5mg + Glimepiride | Dapagliflozin tablet 5 mg once daily plus glimepiride |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
| Glimepiride | Drug | tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks |
|
|
| metformin hydrochloride | Drug | rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice |
|
|
| pioglitazone hydrochloride | Drug | rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice |
|
|
| Rosiglitazone | Drug | rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice |
|
|
To show that dapagliflozin plus glimepiride results in greater reductions in the 2-h post-challenge plasma glucose rise as a response to an oral glucose tolerance test (OGTT) from baseline to Week 24. |
| Baseline to Week 24 |
| Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7% | To show that dapagliflozin plus glimepiride results in a larger proportion of participants achieving a therapeutic glycemic response, defined as HbA1c < 7% after 24 weeks of treatment, compared to placebo plus glimepiride. | At Week 24 |
| Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2 | To show that dapagliflozin plus glimepiride results in greater reductions in body weight or less weight gain in participants with baseline BMI ≥27 kg/m2 after 24 weeks of treatment when compared to placebo plus glimepiride. | Baseline to Week 24 |
| Adjusted Mean Change in Fasting Plasma Glucose (FPG) | To show that dapagliflozin plus glimepiride leads to greater reductions in FPG after 24 weeks of treatment compared to placebo plus glimepiride. | Baseline to Week 24 |
| Bruntál |
| Czechia |
| Research Site | Břeclav | Czechia |
| Research Site | Hodonín | Czechia |
| Research Site | Ostrava - Belsky Les | Czechia |
| Research Site | Pilsen | Czechia |
| Research Site | Prague | Czechia |
| Research Site | Pribram VIII | Czechia |
| Research Site | Rakovník | Czechia |
| Research Site | Semily | Czechia |
| Research Site | Balatonfüred | Hungary |
| Research Site | Békéscsaba | Hungary |
| Research Site | Budapest | Hungary |
| Research Site | Csongrád | Hungary |
| Research Site | Eger | Hungary |
| Research Site | Gyöngyös | Hungary |
| Research Site | Kecskemét | Hungary |
| Research Site | Makó | Hungary |
| Research Site | Miskolc | Hungary |
| Research Site | Mosonmagyaróvár | Hungary |
| Research Site | Siófok | Hungary |
| Research Site | Szentes | Hungary |
| Research Site | Tát | Hungary |
| Research Site | Zalaegerszeg | Hungary |
| Research Site | Cebu City | Philippines |
| Research Site | Manila | Philippines |
| Research Site | Marikina City | Philippines |
| Research Site | Pasig | Philippines |
| Research Site | Bielsko-Biala | Poland |
| Research Site | Bydgoszcz | Poland |
| Research Site | Chojnice | Poland |
| Research Site | Chrzanów | Poland |
| Research Site | Ciechocinek | Poland |
| Research Site | Czechowice-Dziedzice | Poland |
| Research Site | Elblag | Poland |
| Research Site | Gdansk | Poland |
| Research Site | Gniewkowo | Poland |
| Research Site | Grudziądz | Poland |
| Research Site | Iława | Poland |
| Research Site | Krakow | Poland |
| Research Site | Mrągowo | Poland |
| Research Site | Poznan | Poland |
| Research Site | Płock | Poland |
| Research Site | Ruda Śląska | Poland |
| Research Site | Sopot | Poland |
| Research Site | Torun | Poland |
| Research Site | Wroclaw | Poland |
| Research Site | Zabrze | Poland |
| Research Site | Zielona Góra | Poland |
| Research Site | Żory | Poland |
| Research Site | Wŏnju | Gangwon-do | South Korea |
| Research Site | Suwon | Gyeonggi-do | South Korea |
| Research Site | Jeonju | Jeollabuk-do | South Korea |
| Research Site | Bucheon-si | South Korea |
| Research Site | Incheon | South Korea |
| Research Site | Seongnam | South Korea |
| Research Site | Seoul | South Korea |
| Research Site | Uljeongbu | South Korea |
| Research Site | Bangkok | Thailand |
| Research Site | Chiang Mai | Thailand |
| Research Site | Dnipropetrov'sk | Ukraine |
| Research Site | Donetsk | Ukraine |
| Research Site | Kharkiv | Ukraine |
| Research Site | Kiev | Ukraine |
| Research Site | Vinnytsia | Ukraine |
| Research Site | Zaporizhzhya | Ukraine |
| Strojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. [Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride]. Dtsch Med Wochenschr. 2013 Apr;138 Suppl 1:S16-26. doi: 10.1055/s-0032-1305277. Epub 2013 Mar 25. German. |
| 21672123 | Derived | Strojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride: a randomized, 24-week, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2011 Oct;13(10):928-38. doi: 10.1111/j.1463-1326.2011.01434.x. |
| FG002 | Dapagliflozin 10mg + Glimepiride | Dapagliflozin tablet 10 mg once daily plus glimepiride |
| FG003 | Placebo + Glimepiride | Placebo comparator plus glimepiride |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set defined as all randomized participants (as randomized) who received at least one dose of double-blind study medication, who have a non-missing baseline value and at least one post-baseline efficacy value for at least one efficacy variable during double-blind treatment period.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dapagliflozin 2.5mg + Glimepiride | Dapagliflozin tablet 2.5 mg once daily plus glimepiride |
| BG001 | Dapagliflozin 5mg + Glimepiride | Dapagliflozin tablet 5 mg once daily plus glimepiride |
| BG002 | Dapagliflozin 10mg + Glimepiride | Dapagliflozin tablet 10 mg once daily plus glimepiride |
| BG003 | Placebo + Glimepiride | Placebo comparator plus glimepiride |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m2 |
| |||||||||||||||
| HbA1c | Mean | Standard Deviation | Percent |
|
| 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 | Adjusted Mean Change in HbA1c Levels | To assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycemic control in participants with type 2 diabetes, as determined by the change in HbA1C levels from baseline to the end of the 24-week double-blind treatment period. | Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline to Week 24 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adjusted Mean Change in Body Weight | To show that dapagliflozin plus glimepiride results in greater reduction in body weight or less weight gain after 24 weeks of treatment when compared to placebo plus glimepiride. | Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values | Posted | Least Squares Mean | 95% Confidence Interval | kg | Baseline to Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise | To show that dapagliflozin plus glimepiride results in greater reductions in the 2-h post-challenge plasma glucose rise as a response to an oral glucose tolerance test (OGTT) from baseline to Week 24. | Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline to Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7% | To show that dapagliflozin plus glimepiride results in a larger proportion of participants achieving a therapeutic glycemic response, defined as HbA1c < 7% after 24 weeks of treatment, compared to placebo plus glimepiride. | Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of participants | At Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2 | To show that dapagliflozin plus glimepiride results in greater reductions in body weight or less weight gain in participants with baseline BMI ≥27 kg/m2 after 24 weeks of treatment when compared to placebo plus glimepiride. | Full Analysis Set, participants with baseline BMI of 27 kg/m2 or more and Week 24 (LOCF) body weight value | Posted | Least Squares Mean | 95% Confidence Interval | kg | Baseline to Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adjusted Mean Change in Fasting Plasma Glucose (FPG) | To show that dapagliflozin plus glimepiride leads to greater reductions in FPG after 24 weeks of treatment compared to placebo plus glimepiride. | Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline to Week 24 |
|
Non-serious/serious adverse events on or after the first day and on or prior to the last day of the 24-week double-blind treatment period plus 4/30 days or up to follow-up visit if earlier, or up to and incl the start date of extension period if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
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 | Dapagliflozin 2.5mg + Glimepiride | Dapagliflozin tablet 2.5 mg once daily plus glimepiride | 11 | 154 | 22 | 154 | ||
| EG001 | Dapagliflozin 5mg + Glimepiride | Dapagliflozin tablet 5 mg once daily plus glimepiride | 10 | 145 | 19 | 145 | ||
| EG002 | Dapagliflozin 10mg + Glimepiride | Dapagliflozin tablet 10 mg once daily plus glimepiride | 9 | 151 | 18 | 151 | ||
| EG003 | Placebo + Glimepiride | Placebo comparator plus glimepiride | 7 | 146 | 15 | 146 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| AORTIC VALVE DISEASE MIXED | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK COMPLETE | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CORONARY ARTERY STENOSIS | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
| |
| GASTRODUODENITIS | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| MULTIPLE ALLERGIES | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| HAND FRACTURE | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| OBESITY | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| SPINAL COLUMN STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| BENIGN BREAST NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| CHRONIC LYMPHOCYTIC LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| RECTAL ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| RENAL COLIC | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| UTERINE POLYP | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypoglycemia | Endocrine disorders | MedDRA 12.1 | Systematic Assessment |
|
For participants who did not complete 24 weeks LOCF (last observation carried forward) was used. Only values prior to rescue medication were used.
If an Investigator requests permission to publish data from this study any such publication is to be agreed with AstraZeneca (AZ) in advance. The investigator agrees to provide AZ as soon as possible with drafts of proposed publications. Unless otherwise agreed, AZ shall have a period of 60 days from receipt of the proposed final manuscript to review it and may within such time require that submission for publication of the manuscript be delayed in order for AZ to file patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eva Johnsson | AstraZeneca | ClinicalTrialTransparency@astrazeneca.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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| C057619 | glimepiride |
| D008687 | Metformin |
| D000077205 | Pioglitazone |
| D000077154 | Rosiglitazone |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Asian |
|
| Superiority or Other |
| The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided). | ANCOVA | with treatment group as effect (all treatment groups included) and baseline value as covariate. | <0.0001 | significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints. | Mean Difference (Final Values) | -0.49 | Standard Error of the Mean | 0.0885 | 2-Sided | 95 | -0.67 | -0.32 | No | Superiority or Other |
| The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided). | ANCOVA | with treatment group as effect (all treatment groups included) and baseline value as covariate. | <0.0001 | significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints. | Mean Difference (Final Values) | -0.68 | Standard Error of the Mean | 0.0873 | 2-Sided | 95 | -0.86 | -0.51 | No | Superiority or Other |
| Units | Counts |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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