ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin Combined With Metformin in Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control

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: NCT02104804
Recruitment Status : Completed
First Posted : April 4, 2014
Results First Posted : October 2, 2017
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: Saxagliptin 5mg
Drug: Placebo for Saxagliptin
Enrollment 953
Recruitment Details This study was performed at 22 sites in the People’s Republic of China (PRC).The first patient was enrolled on 07 May 2014 and the last patient completed the study on 26 February 2016. The study was divided into a single-blind placebo lead-in period of 8 weeks, a treatment period of 24 weeks and a follow-up phase of 4 weeks.
Pre-assignment Details 953 patients were enrolled, of which 641 patients took at least 1 dose of study drug and entered the lead-in period. A total of 312 patients did not enter the lead-in period (289 did not fulfill eligibility criteria, 21 due to subject decision, 1 each for severe non-compliance to protocol and other reasons) and 466 patients were randomized.
Arm/Group Title Saxagliptin Plus Insulin Vs. Placebo Plus Insulin
Hide Arm/Group Description Saxagliptin 5 mg plus insulin Patients receiving placebo 5 mg plus insulin
Period Title: Overall Study
Started 234 [1] 232 [1]
Completed 218 [2] 213 [3]
Not Completed 16 19
Reason Not Completed
Did not take study medication             0             1
Study specific discontinuation criteria             6             1
Other listed             2             1
Protocol Violation             0             1
Adverse Event             4             3
Withdrawal by Subject             4             12
[1]
Number of patients who were randomized
[2]
Number of patients who completed 24 weeks of treatment
[3]
Of the 19 who did not complete, 1 did not take study medication after randomization.
Arm/Group Title Saxagliptin Plus Insulin Vs. Placebo Plus Insulin Total
Hide Arm/Group Description Saxagliptin 5 mg plus insulin Patients receiving placebo 5 mg plus insulin Total of all reporting groups
Overall Number of Baseline Participants 232 230 462
Hide Baseline Analysis Population Description
Note that 462 indicates the number of patients in the Full Analysis set (out of 466 randomized, 1 did not take study drug and 3 did not have 1 baseline or post baseline efficacy assessment).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 232 participants 230 participants 462 participants
59.3  (7.93) 58.9  (8.17) 59.1  (8.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 232 participants 230 participants 462 participants
Female
123
  53.0%
130
  56.5%
253
  54.8%
Male
109
  47.0%
100
  43.5%
209
  45.2%
Baseline HbA1C  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 232 participants 230 participants 462 participants
8.52  (0.69) 8.53  (0.70) 8.53  (0.69)
Duration of diabetes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 232 participants 230 participants 462 participants
13.4  (7.28) 13.3  (6.35) 13.4  (6.83)
Fasting Plasma Glucose (FPG)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 232 participants 230 participants 462 participants
167.94  (31.39) 167.34  (32.86) 167.64  (32.10)
0-180 min Post Prandial Glucose AUC  
Mean (Standard Deviation)
Unit of measure:  mg*min/dL
Number Analyzed 232 participants 230 participants 462 participants
45457.6  (8433.08) 43851.4  (9051.26) 44661.5  (8772.22)
120-min Post Prandial Glucose  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 232 participants 230 participants 462 participants
278.0  (58.00) 270.0  (63.30) 274.0  (60.76)
Fasting Glucagon  
Mean (Standard Deviation)
Unit of measure:  pg/dL
Number Analyzed 232 participants 230 participants 462 participants
40.007  (23.68) 40.231  (21.06) 40.119  (22.39)
Fasting C-peptide  
Mean (Standard Deviation)
Unit of measure:  ng/dL
Number Analyzed 232 participants 230 participants 462 participants
1.029  (0.52) 1.012  (0.58) 1.020  (0.55)
Metformin use at enrolment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 232 participants 230 participants 462 participants
Yes 155 154 309
No 77 76 153
Mean Tolerated Daily Dose of Insulin  
Mean (Standard Deviation)
Unit of measure:  Insulin Dose Units
Number Analyzed 232 participants 230 participants 462 participants
38.6  (16.49) 38.9  (14.68) 38.7  (15.60)
1.Primary Outcome
Title Change in HbA1c From Baseline to Week 24
Hide Description [Not Specified]
Time Frame Baseline to 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
229 and 227 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.
Arm/Group Title Saxagliptin Plus Insulin Vs. Placebo Plus Insulin
Hide Arm/Group Description:
Saxagliptin 5 mg plus insulin
Patients receiving placebo 5 mg plus insulin
Overall Number of Participants Analyzed 229 227
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage change
-0.64
(-0.74 to -0.55)
-0.06
(-0.16 to 0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vs. Placebo Plus Insulin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -0.58
Confidence Interval (2-Sided) 95%
-0.72 to -0.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.07
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Postprandial Glucose AUC From Baseline to Week 24 During a Meal Tolerance Test
Hide Description [Not Specified]
Time Frame Baseline to 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
213 and 206 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.
Arm/Group Title Saxagliptin Plus Insulin Vs. Placebo Plus Insulin
Hide Arm/Group Description:
Saxagliptin 5 mg plus insulin
Patients receiving placebo 5 mg plus insulin
Overall Number of Participants Analyzed 213 206
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg*min/dL
-4702.2
(-5813.3 to -3591.0)
1431.0
(294.4 to 2567.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vs. Placebo Plus Insulin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -6133.2
Confidence Interval (2-Sided) 95%
-7668.5 to -4597.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 781.06
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Analysis of Change in 120-minute PPG From Baseline to Week 24 During a Meal Tolerance Test
Hide Description [Not Specified]
Time Frame Baseline to 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
215 and 211 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.
Arm/Group Title Saxagliptin Plus Insulin Vs. Placebo Plus Insulin
Hide Arm/Group Description:
Saxagliptin 5 mg plus insulin
Patients receiving placebo 5 mg plus insulin
Overall Number of Participants Analyzed 215 211
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-30.28
(-37.76 to -22.80)
8.84
(1.25 to 16.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vs. Placebo Plus Insulin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least squares mean
Estimated Value -39.11
Confidence Interval (2-Sided) 95%
-49.41 to -28.82
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.24
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Patients Achieving a Therapeutic Glycaemic Response of HbA1c <7%
Hide Description [Not Specified]
Time Frame At Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
229 and 227 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.
Arm/Group Title Saxagliptin Plus Insulin Vs. Placebo Plus Insulin
Hide Arm/Group Description:
Saxagliptin 5 mg plus insulin
Patients receiving placebo 5 mg plus insulin
Overall Number of Participants Analyzed 229 227
Measure Type: Number
Unit of Measure: % of participants
11.4 3.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vs. Placebo Plus Insulin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Difference in proportions
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.8
Confidence Interval (2-Sided) 95%
3.1 to 12.6
Estimation Comments [Not Specified]
5.Secondary Outcome
Title The Analysis of Change in Fasting Plasma Glucose From Baseline to Week 24 (This Was the Average of Weeks 20 and 24)
Hide Description [Not Specified]
Time Frame Baseline to Average of Weeks 20 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
232 and 229 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 229 for this outcome measure respectively.
Arm/Group Title Saxagliptin Plus Insulin Vs. Placebo Plus Insulin
Hide Arm/Group Description:
Saxagliptin 5 mg plus insulin
Patients receiving placebo 5 mg plus insulin
Overall Number of Participants Analyzed 232 229
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-11.23
(-15.34 to -7.11)
4.65
(0.50 to 8.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vs. Placebo Plus Insulin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -15.88
Confidence Interval (2-Sided) 95%
-21.53 to -10.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.88
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Analysis of Change in Mean Total Daily Dose of Insulin From Baseline to Week 24
Hide Description [Not Specified]
Time Frame Baseline to 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
232 and 230 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.
Arm/Group Title Saxagliptin Plus Insulin Vs. Placebo Plus Insulin
Hide Arm/Group Description:
Saxagliptin 5 mg plus insulin
Patients receiving placebo 5 mg plus insulin
Overall Number of Participants Analyzed 232 230
Least Squares Mean (95% Confidence Interval)
Unit of Measure: IU
-0.09
(-0.32 to 0.14)
0.04
(-0.19 to 0.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vs. Placebo Plus Insulin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.430
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least squares mean
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-0.44 to 0.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.16
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Total numbers at risk indicate the number of participants in the Safety Analysis set. Out of 466 randomized, 1 did not take study drug.
 
Arm/Group Title PLACEBO QD + INSULIN WITH OR WITHOUT METFORMIN SAXAGLIPTIN 5 MG QD + INSULIN WITH OR WITHOUT METFORMIN
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
PLACEBO QD + INSULIN WITH OR WITHOUT METFORMIN SAXAGLIPTIN 5 MG QD + INSULIN WITH OR WITHOUT METFORMIN
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PLACEBO QD + INSULIN WITH OR WITHOUT METFORMIN SAXAGLIPTIN 5 MG QD + INSULIN WITH OR WITHOUT METFORMIN
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/231 (6.06%)      12/234 (5.13%)    
Cardiac disorders     
Acute myocardial infarction  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Cardiac failure  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Ear and labyrinth disorders     
Deafness neurosensory  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Eye disorders     
Vitreous haemorrhage  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Gastrointestinal disorders     
Intestinal obstruction  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Pancreatitis acute  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Infections and infestations     
Hepatitis E  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Urethritis  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Injury, poisoning and procedural complications     
Ankle fracture  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Fracture  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Lumbar vertebral fracture  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Road traffic accident  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Metabolism and nutrition disorders     
Diabetes mellitus  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Diabetes mellitus inadequate control  1  2/231 (0.87%)  2 1/234 (0.43%)  1
Hyperglycaemia  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Hypoglycaemia  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Ankylosing spondylitis  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Intervertebral disc protrusion  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastric cancer  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Gastrointestinal carcinoma  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Nervous system disorders     
Basal ganglia haemorrhage  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Cerebral infarction  1  0/231 (0.00%)  0 2/234 (0.85%)  2
Cerebral ischaemia  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Lacunar infarction  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Subarachnoid haemorrhage  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Renal and urinary disorders     
Calculus ureteric  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Vascular disorders     
Hypertension  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PLACEBO QD + INSULIN WITH OR WITHOUT METFORMIN SAXAGLIPTIN 5 MG QD + INSULIN WITH OR WITHOUT METFORMIN
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   96/231 (41.56%)      89/234 (38.03%)    
Blood and lymphatic system disorders     
Leukopenia  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Neutropenia  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Cardiac disorders     
Angina pectoris  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Arteriosclerosis coronary artery  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Coronary artery disease  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Myocardial ischaemia  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Endocrine disorders     
Hypothyroidism  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Eye disorders     
Asthenopia  1  0/231 (0.00%)  0 2/234 (0.85%)  2
Cataract  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Conjunctivitis allergic  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Diabetic retinopathy  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Vision blurred  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Gastrointestinal disorders     
Chronic gastritis  1  2/231 (0.87%)  2 1/234 (0.43%)  1
Constipation  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Diarrhoea  1  2/231 (0.87%)  3 3/234 (1.28%)  3
Duodenal ulcer  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Dysbacteriosis  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Dyspepsia  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Gastrooesophageal reflux disease  1  2/231 (0.87%)  2 1/234 (0.43%)  1
Gingival bleeding  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Nausea  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Periodontal disease  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Toothache  1  1/231 (0.43%)  1 5/234 (2.14%)  5
Vomiting  1  0/231 (0.00%)  0 1/234 (0.43%)  1
General disorders     
Pyrexia  1  1/231 (0.43%)  1 1/234 (0.43%)  1
Hepatobiliary disorders     
Cholecystitis  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Hepatic function abnormal  1  2/231 (0.87%)  2 0/234 (0.00%)  0
Hepatic steatosis  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Immune system disorders     
Drug hypersensitivity  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Infections and infestations     
Bronchitis  1  1/231 (0.43%)  1 2/234 (0.85%)  2
Conjunctivitis  1  1/231 (0.43%)  1 1/234 (0.43%)  1
Conjunctivitis bacterial  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Erysipelas  1  0/231 (0.00%)  0 2/234 (0.85%)  2
Gastroenteritis  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Helicobacter infection  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Hepatitis E  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Influenza  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Lung infection  1  1/231 (0.43%)  1 1/234 (0.43%)  1
Nasopharyngitis  1  3/231 (1.30%)  3 5/234 (2.14%)  5
Periodontitis  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Pharyngitis  1  1/231 (0.43%)  1 3/234 (1.28%)  4
Rhinitis  1  0/231 (0.00%)  0 2/234 (0.85%)  2
Tracheitis  1  3/231 (1.30%)  3 0/234 (0.00%)  0
Upper respiratory tract infection  1  10/231 (4.33%)  12 6/234 (2.56%)  6
Urinary tract infection  1  2/231 (0.87%)  2 6/234 (2.56%)  6
Viral upper respiratory tract infection  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Injury, poisoning and procedural complications     
Foreign body  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Joint injury  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Ligament injury  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Ligament sprain  1  0/231 (0.00%)  0 2/234 (0.85%)  2
Radius fracture  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Ulna fracture  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Investigations     
Creatinine renal clearance decreased  1  0/231 (0.00%)  0 2/234 (0.85%)  3
Eosinophil count increased  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Metabolism and nutrition disorders     
Hyperkalaemia  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Hyperlipidaemia  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Hypochloraemia  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Hypoglycaemia  1  55/231 (23.81%)  131 51/234 (21.79%)  171
Hyponatraemia  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/231 (0.00%)  0 2/234 (0.85%)  2
Back pain  1  2/231 (0.87%)  2 0/234 (0.00%)  0
Limb discomfort  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Osteoarthritis  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Pain in extremity  1  3/231 (1.30%)  3 0/234 (0.00%)  0
Periarthritis  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Spinal osteoarthritis  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Nervous system disorders     
Cerebrovascular insufficiency  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Diabetic neuropathy  1  2/231 (0.87%)  2 2/234 (0.85%)  2
Dizziness  1  1/231 (0.43%)  1 1/234 (0.43%)  1
Headache  1  2/231 (0.87%)  2 0/234 (0.00%)  0
Psychiatric disorders     
Insomnia  1  2/231 (0.87%)  2 0/234 (0.00%)  0
Sleep disorder  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Renal and urinary disorders     
Diabetic nephropathy  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Nephrolithiasis  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Nocturia  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Proteinuria  1  2/231 (0.87%)  2 1/234 (0.43%)  1
Renal failure  1  3/231 (1.30%)  3 0/234 (0.00%)  0
Renal impairment  1  2/231 (0.87%)  2 0/234 (0.00%)  0
Reproductive system and breast disorders     
Sexual dysfunction  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  5/231 (2.16%)  5 2/234 (0.85%)  2
Oropharyngeal pain  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Pleural effusion  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Rhinitis allergic  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatitis  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Dermatitis allergic  1  3/231 (1.30%)  3 0/234 (0.00%)  0
Erythema  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Pruritus  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Rash  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Vascular disorders     
Diabetic vascular disorder  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Hypertension  1  0/231 (0.00%)  0 1/234 (0.43%)  1
Peripheral arterial occlusive disease  1  1/231 (0.43%)  1 0/234 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Without limitation to any other right of AstraZeneca hereunder, Institution and Principal Investigator acknowledge and agree that only AZ as Sponsor will register the Study and post the Study results in accordance with AZ internal policy on one or more publicly-accessible trial registries and websites (including the publicly-funded website http://www.clinicaltrials.gov/ and on its own website http://www.astrazenecaclinicaltrials.com) to avoid duplication.
Results Point of Contact
Name/Title: Eva Johnsson, MD, PhD, Global Clinical Lead
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02104804     History of Changes
Other Study ID Numbers: D1680C00010
2014L00001 ( Other Identifier: China: State Food and Drug Administration )
First Submitted: April 2, 2014
First Posted: April 4, 2014
Results First Submitted: February 24, 2017
Results First Posted: October 2, 2017
Last Update Posted: October 2, 2017