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Japan Dose Regimen Study of AZD1656 in Japanese Type 2 Diabetes Mellitus Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01152385
Recruitment Status : Completed
First Posted : June 29, 2010
Results First Posted : August 27, 2012
Last Update Posted : August 27, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: AZD1656
Drug: Placebo
Enrollment 224
Recruitment Details 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)
Pre-assignment Details Wash-out period for patients treated with anti-diabetes treatment at enrolment.
Arm/Group Title High Dose Middle Dose Low Dose Placebo
Hide Arm/Group Description 200 mg (daily dose) 140 mg (daily dose) 80 mg (daily dose) Placebo
Period Title: Overall Study
Started 55 58 56 55
Completed 46 52 51 50
Not Completed 9 6 5 5
Reason Not Completed
Withdrawal by Subject             3             1             1             1
Protocol Violation             0             0             0             1
Adverse Event             1             1             0             0
Study-specific withdrawal criteria             1             1             2             0
Other             4             3             2             3
Arm/Group Title High Dose Middle Dose Low Dose Placebo Total
Hide Arm/Group Description 200 mg (daily dose) 140 mg (daily dose) 80 mg (daily dose) Placebo Total of all reporting groups
Overall Number of Baseline Participants 55 58 56 55 224
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 58 participants 56 participants 55 participants 224 participants
57  (9) 55  (9) 55  (10) 57  (9) 56  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 58 participants 56 participants 55 participants 224 participants
Female
7
  12.7%
8
  13.8%
8
  14.3%
9
  16.4%
32
  14.3%
Male
48
  87.3%
50
  86.2%
48
  85.7%
46
  83.6%
192
  85.7%
1.Primary Outcome
Title Change in Haemoglobin A1c (HbA1c)
Hide Description [Not Specified]
Time Frame from baseline to 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was prior to rescue treatment (FAS)
Arm/Group Title Arm 1 - High Dose Arm 2 - Middle Dose Arm 3 - Low Dose Arm 4 - Placebo Dose
Hide Arm/Group Description:
AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
Placebo
Overall Number of Participants Analyzed 55 58 54 55
Mean (Standard Deviation)
Unit of Measure: Percentage
0.0  (1.2) -0.3  (1.3) 0.1  (1.2) 0.2  (0.7)
2.Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG)
Hide Description [Not Specified]
Time Frame from baseline to 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was prior to rescue treatment (FAS)
Arm/Group Title Arm 1 - High Dose Arm 2 - Middle Dose Arm 3 - Low Dose Arm 4 - Placebo Dose
Hide Arm/Group Description:
AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
Placebo
Overall Number of Participants Analyzed 55 58 56 55
Mean (Standard Deviation)
Unit of Measure: mg/dL
9  (42) 6  (45) 1  (36) 16  (28)
3.Secondary Outcome
Title Number of Responders in Terms of HbA1C ≤ 7%
Hide Description [Not Specified]
Time Frame at 4th month
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was prior to rescue treatment (FAS)
Arm/Group Title Arm 1 - High Arm 2 - Middle Arm 3 - Low Arm 4 - Placebo
Hide Arm/Group Description:
AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
Placebo
Overall Number of Participants Analyzed 55 58 54 55
Measure Type: Number
Unit of Measure: Participants
7 16 7 1
4.Secondary Outcome
Title Number of Responders in Terms of HbA1C ≤ 6.5%
Hide Description [Not Specified]
Time Frame at 4th month
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was prior to rescue treatment (FAS)
Arm/Group Title Arm 1 - High Arm 2 - Middle Arm 3 - Low Arm 4 - Placebo
Hide Arm/Group Description:
AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
Placebo
Overall Number of Participants Analyzed 55 58 54 55
Measure Type: Number
Unit of Measure: Participants
2 8 2 0
5.Secondary Outcome
Title Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C)
Hide Description [Not Specified]
Time Frame from baseline to 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was prior to rescue treatment (FAS)
Arm/Group Title Arm 1 - High Arm 2 - Middle Arm 3 - Low Arm 4 - Placebo
Hide Arm/Group Description:
AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
Placebo
Overall Number of Participants Analyzed 55 58 56 55
Mean (Standard Deviation)
Unit of Measure: Percentage
8.9  (19.9) 7.7  (18.8) 4.0  (15.6) 5.8  (18.4)
6.Secondary Outcome
Title Percentage Change in High-density Lipoprotein Cholesterol (HDL-C)
Hide Description [Not Specified]
Time Frame from baseline to 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was prior to rescue treatment (FAS)
Arm/Group Title Arm 1 - High Arm 2 - Middle Arm 3 - Low Arm 4 - Placebo
Hide Arm/Group Description:
AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
Placebo
Overall Number of Participants Analyzed 55 58 56 55
Mean (Standard Deviation)
Unit of Measure: Percentage
8.8  (18.0) 8.7  (12.9) 11.6  (12.7) 8.5  (12.5)
7.Secondary Outcome
Title Percentage Change in Triglycerides
Hide Description [Not Specified]
Time Frame from baseline to 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was prior to rescue treatment (FAS)
Arm/Group Title Arm 1 - High Arm 2 - Middle Arm 3 - Low Arm 4 - Placebo
Hide Arm/Group Description:
AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
Placebo
Overall Number of Participants Analyzed 55 58 56 55
Mean (Standard Deviation)
Unit of Measure: Percentage
10.8  (44.0) 25.0  (58.5) 6.7  (29.4) 18.1  (46.8)
8.Secondary Outcome
Title Change in High-sensitivity C-reactive Protein (Hs-CRP)
Hide Description [Not Specified]
Time Frame from baseline to 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was prior to rescue treatment (FAS)
Arm/Group Title Arm 1 - High Arm 2 - Middle Arm 3 - Low Arm 4 - Placebo
Hide Arm/Group Description:
AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
Placebo
Overall Number of Participants Analyzed 55 58 54 55
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.058  (0.138) 0.021  (0.117) 0.033  (0.125) -0.007  (0.115)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Dose Middle Dose Low Dose Placebo
Hide Arm/Group Description 200 mg (daily dose) 140 mg (daily dose) 80 mg (daily dose) Placebo
All-Cause Mortality
High Dose Middle Dose Low Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
High Dose Middle Dose Low Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/23 (0.00%)   0/28 (0.00%)   0/23 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
High Dose Middle Dose Low Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   16/55 (29.09%)   19/58 (32.76%)   16/56 (28.57%)   16/55 (29.09%) 
Eye disorders         
Asthenopia  1  0/55 (0.00%)  0/58 (0.00%)  2/56 (3.57%)  0/55 (0.00%) 
Gastrointestinal disorders         
Diarrhoea  1  0/55 (0.00%)  2/58 (3.45%)  0/56 (0.00%)  0/55 (0.00%) 
Infections and infestations         
Nasopharyngitis  1  6/55 (10.91%)  9/58 (15.52%)  9/56 (16.07%)  11/55 (20.00%) 
Bronchitis  1  2/55 (3.64%)  1/58 (1.72%)  0/56 (0.00%)  1/55 (1.82%) 
Pharyngitis  1  2/55 (3.64%)  0/58 (0.00%)  1/56 (1.79%)  1/55 (1.82%) 
Investigations         
Aspartate Aminotransferase Increased  1  2/55 (3.64%)  2/58 (3.45%)  0/56 (0.00%)  0/55 (0.00%) 
Alanine Aminotransferase Increased  1  1/55 (1.82%)  2/58 (3.45%)  0/56 (0.00%)  0/55 (0.00%) 
Blood Triglycerides Increased  1  0/55 (0.00%)  2/58 (3.45%)  0/56 (0.00%)  0/55 (0.00%) 
Electrocardiogram T Wave Inversion  1  0/55 (0.00%)  0/58 (0.00%)  2/56 (3.57%)  0/55 (0.00%) 
Metabolism and nutrition disorders         
Diabetes Mellitus  1  2/55 (3.64%)  2/58 (3.45%)  1/56 (1.79%)  1/55 (1.82%) 
Musculoskeletal and connective tissue disorders         
Back Pain  2  2/55 (3.64%)  1/58 (1.72%)  1/56 (1.79%)  1/55 (1.82%) 
Nervous system disorders         
Headache  1  2/55 (3.64%)  0/58 (0.00%)  1/56 (1.79%)  0/55 (0.00%) 
Dizziness  1  2/55 (3.64%)  0/58 (0.00%)  0/56 (0.00%)  0/55 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Upper Respiratory Tract Inflammation  1  1/55 (1.82%)  2/58 (3.45%)  2/56 (3.57%)  0/55 (0.00%) 
Skin and subcutaneous tissue disorders         
Eczema Asteatotic  1  0/55 (0.00%)  0/58 (0.00%)  1/56 (1.79%)  2/55 (3.64%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
2
Term from vocabulary, MedDRA14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
Phone: +44 1625 518062
EMail: aztrial_results_posting@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01152385    
Other Study ID Numbers: D1020C00016
First Submitted: June 10, 2010
First Posted: June 29, 2010
Results First Submitted: July 24, 2012
Results First Posted: August 27, 2012
Last Update Posted: August 27, 2012