Trial Outcomes & Findings for Japan Dose Regimen Study of AZD1656 in Japanese Type 2 Diabetes Mellitus Patients (NCT NCT01152385)
NCT ID: NCT01152385
Last Updated: 2012-08-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
224 participants
Primary outcome timeframe
from baseline to 4 months
Results posted on
2012-08-27
Participant Flow
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)
Wash-out period for patients treated with anti-diabetes treatment at enrolment.
Participant milestones
| Measure |
High Dose
200 mg (daily dose)
|
Middle Dose
140 mg (daily dose)
|
Low Dose
80 mg (daily dose)
|
Placebo
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
55
|
58
|
56
|
55
|
|
Overall Study
COMPLETED
|
46
|
52
|
51
|
50
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
5
|
5
|
Reasons for withdrawal
| Measure |
High Dose
200 mg (daily dose)
|
Middle Dose
140 mg (daily dose)
|
Low Dose
80 mg (daily dose)
|
Placebo
Placebo
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
0
|
|
Overall Study
Study-specific withdrawal criteria
|
1
|
1
|
2
|
0
|
|
Overall Study
Other
|
4
|
3
|
2
|
3
|
Baseline Characteristics
Japan Dose Regimen Study of AZD1656 in Japanese Type 2 Diabetes Mellitus Patients
Baseline characteristics by cohort
| Measure |
High Dose
n=55 Participants
200 mg (daily dose)
|
Middle Dose
n=58 Participants
140 mg (daily dose)
|
Low Dose
n=56 Participants
80 mg (daily dose)
|
Placebo
n=55 Participants
Placebo
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
57 Years
STANDARD_DEVIATION 9 • n=5 Participants
|
55 Years
STANDARD_DEVIATION 9 • n=7 Participants
|
55 Years
STANDARD_DEVIATION 10 • n=5 Participants
|
57 Years
STANDARD_DEVIATION 9 • n=4 Participants
|
56 Years
STANDARD_DEVIATION 9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
192 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: from baseline to 4 monthsPopulation: The analysis population was prior to rescue treatment (FAS)
Outcome measures
| Measure |
Arm 1 - High Dose
n=55 Participants
AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
|
Arm 2 - Middle Dose
n=58 Participants
AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
|
Arm 3 - Low Dose
n=54 Participants
AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
|
Arm 4 - Placebo Dose
n=55 Participants
Placebo
|
|---|---|---|---|---|
|
Change in Haemoglobin A1c (HbA1c)
|
0.0 Percentage
Standard Deviation 1.2
|
-0.3 Percentage
Standard Deviation 1.3
|
0.1 Percentage
Standard Deviation 1.2
|
0.2 Percentage
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: from baseline to 4 monthsPopulation: The analysis population was prior to rescue treatment (FAS)
Outcome measures
| Measure |
Arm 1 - High Dose
n=55 Participants
AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
|
Arm 2 - Middle Dose
n=58 Participants
AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
|
Arm 3 - Low Dose
n=56 Participants
AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
|
Arm 4 - Placebo Dose
n=55 Participants
Placebo
|
|---|---|---|---|---|
|
Change in Fasting Plasma Glucose (FPG)
|
9 mg/dL
Standard Deviation 42
|
6 mg/dL
Standard Deviation 45
|
1 mg/dL
Standard Deviation 36
|
16 mg/dL
Standard Deviation 28
|
SECONDARY outcome
Timeframe: at 4th monthPopulation: The analysis population was prior to rescue treatment (FAS)
Outcome measures
| Measure |
Arm 1 - High Dose
n=55 Participants
AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
|
Arm 2 - Middle Dose
n=58 Participants
AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
|
Arm 3 - Low Dose
n=54 Participants
AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
|
Arm 4 - Placebo Dose
n=55 Participants
Placebo
|
|---|---|---|---|---|
|
Number of Responders in Terms of HbA1C ≤ 7%
|
7 Participants
|
16 Participants
|
7 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: at 4th monthPopulation: The analysis population was prior to rescue treatment (FAS)
Outcome measures
| Measure |
Arm 1 - High Dose
n=55 Participants
AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
|
Arm 2 - Middle Dose
n=58 Participants
AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
|
Arm 3 - Low Dose
n=54 Participants
AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
|
Arm 4 - Placebo Dose
n=55 Participants
Placebo
|
|---|---|---|---|---|
|
Number of Responders in Terms of HbA1C ≤ 6.5%
|
2 Participants
|
8 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from baseline to 4 monthsPopulation: The analysis population was prior to rescue treatment (FAS)
Outcome measures
| Measure |
Arm 1 - High Dose
n=55 Participants
AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
|
Arm 2 - Middle Dose
n=58 Participants
AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
|
Arm 3 - Low Dose
n=56 Participants
AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
|
Arm 4 - Placebo Dose
n=55 Participants
Placebo
|
|---|---|---|---|---|
|
Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C)
|
8.9 Percentage
Standard Deviation 19.9
|
7.7 Percentage
Standard Deviation 18.8
|
4.0 Percentage
Standard Deviation 15.6
|
5.8 Percentage
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: from baseline to 4 monthsPopulation: The analysis population was prior to rescue treatment (FAS)
Outcome measures
| Measure |
Arm 1 - High Dose
n=55 Participants
AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
|
Arm 2 - Middle Dose
n=58 Participants
AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
|
Arm 3 - Low Dose
n=56 Participants
AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
|
Arm 4 - Placebo Dose
n=55 Participants
Placebo
|
|---|---|---|---|---|
|
Percentage Change in High-density Lipoprotein Cholesterol (HDL-C)
|
8.8 Percentage
Standard Deviation 18.0
|
8.7 Percentage
Standard Deviation 12.9
|
11.6 Percentage
Standard Deviation 12.7
|
8.5 Percentage
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: from baseline to 4 monthsPopulation: The analysis population was prior to rescue treatment (FAS)
Outcome measures
| Measure |
Arm 1 - High Dose
n=55 Participants
AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
|
Arm 2 - Middle Dose
n=58 Participants
AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
|
Arm 3 - Low Dose
n=56 Participants
AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
|
Arm 4 - Placebo Dose
n=55 Participants
Placebo
|
|---|---|---|---|---|
|
Percentage Change in Triglycerides
|
10.8 Percentage
Standard Deviation 44.0
|
25.0 Percentage
Standard Deviation 58.5
|
6.7 Percentage
Standard Deviation 29.4
|
18.1 Percentage
Standard Deviation 46.8
|
SECONDARY outcome
Timeframe: from baseline to 4 monthsPopulation: The analysis population was prior to rescue treatment (FAS)
Outcome measures
| Measure |
Arm 1 - High Dose
n=55 Participants
AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
|
Arm 2 - Middle Dose
n=58 Participants
AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
|
Arm 3 - Low Dose
n=54 Participants
AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
|
Arm 4 - Placebo Dose
n=55 Participants
Placebo
|
|---|---|---|---|---|
|
Change in High-sensitivity C-reactive Protein (Hs-CRP)
|
0.058 mg/dL
Standard Deviation 0.138
|
0.021 mg/dL
Standard Deviation 0.117
|
0.033 mg/dL
Standard Deviation 0.125
|
-0.007 mg/dL
Standard Deviation 0.115
|
Adverse Events
High Dose
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Middle Dose
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Low Dose
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Dose
n=55 participants at risk；n=22 participants at risk
200 mg (daily dose)
|
Middle Dose
n=58 participants at risk；n=23 participants at risk
140 mg (daily dose)
|
Low Dose
n=56 participants at risk；n=28 participants at risk
80 mg (daily dose)
|
Placebo
n=55 participants at risk；n=23 participants at risk
Placebo
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
10.9%
6/55
|
15.5%
9/58
|
16.1%
9/56
|
20.0%
11/55
|
|
Infections and infestations
Bronchitis
|
3.6%
2/55
|
1.7%
1/58
|
0.00%
0/56
|
1.8%
1/55
|
|
Infections and infestations
Pharyngitis
|
3.6%
2/55
|
0.00%
0/58
|
1.8%
1/56
|
1.8%
1/55
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/55
|
3.4%
2/58
|
0.00%
0/56
|
0.00%
0/55
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.6%
2/55
|
1.7%
1/58
|
1.8%
1/56
|
1.8%
1/55
|
|
Investigations
Aspartate Aminotransferase Increased
|
3.6%
2/55
|
3.4%
2/58
|
0.00%
0/56
|
0.00%
0/55
|
|
Investigations
Alanine Aminotransferase Increased
|
1.8%
1/55
|
3.4%
2/58
|
0.00%
0/56
|
0.00%
0/55
|
|
Investigations
Blood Triglycerides Increased
|
0.00%
0/55
|
3.4%
2/58
|
0.00%
0/56
|
0.00%
0/55
|
|
Investigations
Electrocardiogram T Wave Inversion
|
0.00%
0/55
|
0.00%
0/58
|
3.6%
2/56
|
0.00%
0/55
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
3.6%
2/55
|
3.4%
2/58
|
1.8%
1/56
|
1.8%
1/55
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
1.8%
1/55
|
3.4%
2/58
|
3.6%
2/56
|
0.00%
0/55
|
|
Skin and subcutaneous tissue disorders
Eczema Asteatotic
|
0.00%
0/55
|
0.00%
0/58
|
1.8%
1/56
|
3.6%
2/55
|
|
Eye disorders
Asthenopia
|
0.00%
0/55
|
0.00%
0/58
|
3.6%
2/56
|
0.00%
0/55
|
|
Nervous system disorders
Headache
|
3.6%
2/55
|
0.00%
0/58
|
1.8%
1/56
|
0.00%
0/55
|
|
Nervous system disorders
Dizziness
|
3.6%
2/55
|
0.00%
0/58
|
0.00%
0/56
|
0.00%
0/55
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place