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The purpose of this study is to compare the effect on glucose control of 3 different AZD1656 dosing regimens with placebo in Japanese type 2 diabetes mellitus (T2DM) patients, as evaluated by the change in HbA1c from baseline to the end of treatment at 4 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high | Experimental | AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose) |
|
| Middle | Experimental | AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose) |
|
| low | Experimental | AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose) |
|
| 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1656 | Drug | Oral tablet administered twice daily during 4 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Haemoglobin A1c (HbA1c) | from baseline to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Plasma Glucose (FPG) | from baseline to 4 months | |
| Number of Responders in Terms of HbA1C ≤ 7% | at 4th month | |
| Number of Responders in Terms of HbA1C ≤ 6.5% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Leonsson-Zachrisson | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Osaka | Japan | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23522182 | Derived | Kiyosue A, Hayashi N, Komori H, Leonsson-Zachrisson M, Johnsson E. Dose-ranging study with the glucokinase activator AZD1656 as monotherapy in Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2013 Oct;15(10):923-30. doi: 10.1111/dom.12100. Epub 2013 Apr 22. |
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Wash-out period for patients treated with anti-diabetes treatment at enrolment.
Enrollment: 224 Study Start Date: May 2010 Study Completion Date: May 2011 Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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| ID | Title | Description |
|---|---|---|
| FG000 | High Dose | 200 mg (daily dose) |
| FG001 | Middle Dose | 140 mg (daily dose) |
| FG002 | Low Dose | 80 mg (daily dose) |
| FG003 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose | 200 mg (daily dose) |
| BG001 | Middle Dose | 140 mg (daily dose) |
| BG002 |
| 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 in Haemoglobin A1c (HbA1c) | The analysis population was prior to rescue treatment (FAS) | Posted | Mean | Standard Deviation | Percentage | from baseline to 4 months |
|
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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 | High Dose | 200 mg (daily dose) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | +44 1625 518062 | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C576407 | AZD1656 |
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| Placebo | Drug | administered twice daily during 4 months |
|
| at 4th month |
| Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) | from baseline to 4 months |
| Percentage Change in High-density Lipoprotein Cholesterol (HDL-C) | from baseline to 4 months |
| Percentage Change in Triglycerides | from baseline to 4 months |
| Change in High-sensitivity C-reactive Protein (Hs-CRP) | from baseline to 4 months |
| Suita |
| Japan |
| Research Site | Tokyo | Japan |
| Protocol Violation |
|
| Adverse Event |
|
| Study-specific withdrawal criteria |
|
| Other |
|
| Low Dose |
80 mg (daily dose) |
| BG003 | Placebo | Placebo |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG003 | Arm 4 - Placebo Dose | Placebo |
|
|
| Secondary | Change in Fasting Plasma Glucose (FPG) | The analysis population was prior to rescue treatment (FAS) | Posted | Mean | Standard Deviation | mg/dL | from baseline to 4 months |
|
|
|
| Secondary | Number of Responders in Terms of HbA1C ≤ 7% | The analysis population was prior to rescue treatment (FAS) | Posted | Number | Participants | at 4th month |
|
|
|
| Secondary | Number of Responders in Terms of HbA1C ≤ 6.5% | The analysis population was prior to rescue treatment (FAS) | Posted | Number | Participants | at 4th month |
|
|
|
| Secondary | Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) | The analysis population was prior to rescue treatment (FAS) | Posted | Mean | Standard Deviation | Percentage | from baseline to 4 months |
|
|
|
| Secondary | Percentage Change in High-density Lipoprotein Cholesterol (HDL-C) | The analysis population was prior to rescue treatment (FAS) | Posted | Mean | Standard Deviation | Percentage | from baseline to 4 months |
|
|
|
| Secondary | Percentage Change in Triglycerides | The analysis population was prior to rescue treatment (FAS) | Posted | Mean | Standard Deviation | Percentage | from baseline to 4 months |
|
|
|
| Secondary | Change in High-sensitivity C-reactive Protein (Hs-CRP) | The analysis population was prior to rescue treatment (FAS) | Posted | Mean | Standard Deviation | mg/dL | from baseline to 4 months |
|
|
|
| 0 |
| 22 |
| 16 |
| 55 |
| EG001 | Middle Dose | 140 mg (daily dose) | 0 | 23 | 19 | 58 |
| EG002 | Low Dose | 80 mg (daily dose) | 0 | 28 | 16 | 56 |
| EG003 | Placebo | Placebo | 0 | 23 | 16 | 55 |
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA14.0 | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Blood Triglycerides Increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Electrocardiogram T Wave Inversion | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Upper Respiratory Tract Inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Eczema Asteatotic | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Asthenopia | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |