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A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Saxagliptin or Dapagliflozin All Given as add-on Therapy to Metformin in Subject With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02681094
Recruitment Status : Completed
First Posted : February 12, 2016
Results First Posted : October 10, 2018
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Type 2 Diabetes Mellitus
Inadequate Glycaemic Control
Interventions Drug: Dapagliflozin
Drug: Placebo for Dapagliflozin
Drug: Saxagliptin
Drug: Placebo for Saxagliptin
Enrollment 905
Recruitment Details The study was conducted at 119 sites in 6 countries: Canada, Czech Republic, Germany, Mexico, Russia, and United States (US). Approximately 900 participants were to be randomized. Participants with Type 2 Diabetes (T2DM) inadequately controlled on metformin alone were randomized in this study.
Pre-assignment Details All participants had screening (Visit 0) at 1 week prior to enrolment to screen the eligibility based on non-fasting sample of Glycated haemoglobin (Hb A1c); results of HbA1c determined enrolment based on inclusion/exclusion criteria. An abbreviated informed consent was signed and review of concomitant or other medications/therapies were performed.
Arm/Group Title Dapagliflozin + Saxagliptin + Metformin Dapagliflozin + Metformin Saxagliptin + Metformin
Hide Arm/Group Description Randomized participants received orally once daily (QD) dapagliflozin 5 mg and saxagliptin 5 mg film coated tablets as an add-on to metformin (≥1500 mg/day orally) Randomized participants received orally QD dapagliflozin 5 mg film coated tablet and placebo for saxagliptin as an add-on to metformin (≥1500 mg/day orally) Randomized participants received orally QD saxagliptin 5 mg film coated tablet and placebo for dapagliflozin as an add-on to metformin (≥1500 mg/day orally)
Period Title: 1 -Modified Enrolled Participants Set
Started [1] 293 294 [2] 296 [2]
Participants Completed Treatment Period 273 276 283
Completed [3] 256 255 243
Not Completed 37 39 53
Reason Not Completed
Participant decision             7             10             9
Adverse Event             10             4             1
Severe non-compliance to protocol             2             0             1
Lack of therapeutic response             1             5             14
Study-specific discontinuation criteria             11             13             20
Not specified             6             6             7
No treatment given             0             1             1
[1]
7 participants of 1 US site were excluded due to serious Good Clinical Practice (GCP)
[2]
A participant was randomized but did not receive treatment
[3]
Participants who completed study treatment
Period Title: 2 - Enrolled Participants Set
Started [1] 301 [2] 302 [2] 302 [2]
Participants Completed Treatment Period 281 284 [3] 289 [3]
Completed [4] 261 261 248
Not Completed 40 41 54
Reason Not Completed
Participant decision             7             10             9
Adverse Event             10             4             1
Severe non-compliance to protocol             2             0             1
Lack of therapeutic response             1             5             14
Study specific discontinuation criteria             14             15             21
Not specified             6             6             7
No treatment given             0             1             1
[1]
Includes 7 participants of one US site which was excluded in Modified Enrolled participants set
[2]
Population was used for the sensitivity analysis to assess the robustness of the treatment effect.
[3]
A participant was randomized but did not receive treatment due to screen failure.
[4]
Participants who completed study treatment
Arm/Group Title Dapagliflozin + Saxagliptin + Metformin Dapagliflozin + Metformin Saxagliptin + Metformin Total
Hide Arm/Group Description Randomized participants received orally once daily (QD) dapagliflozin 5 mg and saxagliptin 5 mg film coated tablets as an add-on to metformin (≥1500 mg/day orally) Randomized participants received orally QD dapagliflozin 5 mg film coated tablet and placebo for saxagliptin as an add-on to metformin (≥1500 mg/day orally) Randomized participants received orally QD saxagliptin 5 mg film coated tablet and placebo for dapagliflozin as an add-on to metformin (≥1500 mg/day orally) Total of all reporting groups
Overall Number of Baseline Participants 290 289 291 870
Hide Baseline Analysis Population Description
Full analysis set (FAS): All randomized participants who took at least 1 dose of study drug & had baseline value for HbA1c. Analysis was based on randomized treatment. Modified FAS - all participants from FAS with the exception of participants from one site (United States; excluded due to serious Good Clinical Practice [GCP] violations).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 290 participants 289 participants 291 participants 870 participants
57.2  (10.68) 55.9  (10.94) 57.0  (9.94) 56.7  (10.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 290 participants 289 participants 291 participants 870 participants
Female
148
  51.0%
137
  47.4%
134
  46.0%
419
  48.2%
Male
142
  49.0%
152
  52.6%
157
  54.0%
451
  51.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 290 participants 289 participants 291 participants 870 participants
Hispanic or Latino
99
  34.1%
95
  32.9%
99
  34.0%
293
  33.7%
Not Hispanic or Latino
191
  65.9%
194
  67.1%
192
  66.0%
577
  66.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 290 participants 289 participants 291 participants 870 participants
American Indian or Alaska Native
1
   0.3%
3
   1.0%
0
   0.0%
4
   0.5%
Asian
9
   3.1%
9
   3.1%
6
   2.1%
24
   2.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
   3.4%
17
   5.9%
24
   8.2%
51
   5.9%
White
265
  91.4%
257
  88.9%
258
  88.7%
780
  89.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
5
   1.7%
3
   1.0%
3
   1.0%
11
   1.3%
1.Primary Outcome
Title Change From Baseline in HbA1c at Week 24
Hide Description

To demonstrate the superiority of the change from baseline HbA1c achieved with the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to either agent individually after 24 weeks. Results were presented for the modified full analysis set.

Note: Baseline was defined as the last assessment on or prior to the date of the first dose of the study medication.

Time Frame Baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: All randomized participants who took at least one dose of the study medication and had a baseline value for HbA1c. Analysis of the FAS was based on the randomized treatment. The modified FAS included all participants from FAS with the exception of participants from one site (excluded due to serious GCP violations).
Arm/Group Title Dapagliflozin + Saxagliptin + Metformin Dapagliflozin + Metformin Saxagliptin + Metformin
Hide Arm/Group Description:
Randomized participants received orally once daily (QD) dapagliflozin 5 mg and saxagliptin 5 mg film coated tablets as an add-on to metformin (≥1500 mg/day orally)
Randomized participants received orally QD dapagliflozin 5 mg film coated tablet and placebo for saxagliptin as an add-on to metformin (≥1500 mg/day orally)
Randomized participants received orally QD saxagliptin 5 mg film coated tablet and placebo for dapagliflozin as an add-on to metformin (≥1500 mg/day orally)
Overall Number of Participants Analyzed 290 289 291
Least Squares Mean (Standard Error)
Unit of Measure: Percentage (%)
-1.03  (0.0558) -0.63  (0.0560) -0.69  (0.0551)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dapagliflozin + Saxagliptin + Metformin, Dapagliflozin + Metformin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-0.55 to -0.24
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dapagliflozin + Saxagliptin + Metformin, Saxagliptin + Metformin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.50 to -0.19
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Proportion of Participants Achieving HbA1c <7.0% at 24 Weeks
Hide Description To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to either agent individually on proportion of participants achieving therapeutic glycaemic response after 24 weeks. Therapeutic glycaemic response was defined as an HbA1c value at Week 24 <7.0% irrespective of whether participant received rescue medication. Risk difference for each treatment was calculated as adjusted response rate. Participants who did not had an HbA1c measurement at Week 24 were regarded as non-responders. Results were presented for the modified full analysis set.
Time Frame Baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: All randomized participants who took at least one dose of the study medication and had a baseline value for HbA1c. Analysis of the FAS was based on the randomized treatment. The modified FAS included all participants from FAS with the exception of participants from one site (excluded due to serious GCP violations).
Arm/Group Title Dapagliflozin + Saxagliptin + Metformin Dapagliflozin + Metformin Saxagliptin + Metformin
Hide Arm/Group Description:
Randomized participants received orally once daily (QD) dapagliflozin 5 mg and saxagliptin 5 mg film coated tablets as an add-on to metformin (≥1500 mg/day orally)
Randomized participants received orally QD dapagliflozin 5 mg film coated tablet and placebo for saxagliptin as an add-on to metformin (≥1500 mg/day orally)
Randomized participants received orally QD saxagliptin 5 mg film coated tablet and placebo for dapagliflozin as an add-on to metformin (≥1500 mg/day orally)
Overall Number of Participants Analyzed 290 289 291
Measure Type: Number
Unit of Measure: Participants
124 63 83
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dapagliflozin + Saxagliptin + Metformin, Dapagliflozin + Metformin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Method of Zhang, Tsiatis, and Davidian
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 19.8
Confidence Interval (2-Sided) 95%
12.7 to 26.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dapagliflozin + Saxagliptin + Metformin, Saxagliptin + Metformin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0018
Comments [Not Specified]
Method Method of Zhang, Tsiatis, and Davidian
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 11.7
Confidence Interval (2-Sided) 95%
4.4 to 19.1
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Fasting Plasma Glucose at 24 Weeks
Hide Description To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5mg to either agent individually on fasting plasma glucose after 24 weeks. Results were presented for the modified full analysis set.
Time Frame Baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: All randomized participants who took at least one dose of the study medication and had a baseline value for HbA1c. Analysis of the FAS was based on the randomized treatment. The modified FAS included all participants from FAS with the exception of participants from one site (excluded due to serious GCP violations).
Arm/Group Title Dapagliflozin + Saxagliptin + Metformin Dapagliflozin + Metformin Saxagliptin + Metformin
Hide Arm/Group Description:
Randomized participants received orally once daily (QD) dapagliflozin 5 mg and saxagliptin 5 mg film coated tablets as an add-on to metformin (≥1500 mg/day orally)
Randomized participants received orally QD dapagliflozin 5 mg film coated tablet and placebo for saxagliptin as an add-on to metformin (≥1500 mg/day orally)
Randomized participants received orally QD saxagliptin 5 mg film coated tablet and placebo for dapagliflozin as an add-on to metformin (≥1500 mg/day orally)
Overall Number of Participants Analyzed 290 289 291
Least Squares Mean (Standard Error)
Unit of Measure: Milligrams per deciliter (mg/dL)
-27.53  (2.1557) -19.95  (2.1738) -12.66  (2.1373)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dapagliflozin + Saxagliptin + Metformin, Dapagliflozin + Metformin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0135
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -7.58
Confidence Interval (2-Sided) 95%
-13.59 to -1.57
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dapagliflozin + Saxagliptin + Metformin, Saxagliptin + Metformin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -14.88
Confidence Interval (2-Sided) 95%
-20.85 to -8.91
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Total Body Weight at 24 Weeks
Hide Description To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to saxagliptin 5 mg on total body weight after 24 weeks. Results were presented for the modified full analysis set.
Time Frame Baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: All randomized participants who took at least one dose of the study medication and had a baseline value for HbA1c. Analysis of the FAS was based on the randomized treatment. The modified FAS included all participants from FAS with the exception of participants from one site (excluded due to serious GCP violations).
Arm/Group Title Dapagliflozin + Saxagliptin + Metformin Saxagliptin + Metformin
Hide Arm/Group Description:
Randomized participants received orally once daily (QD) dapagliflozin 5 mg and saxagliptin 5 mg film coated tablets as an add-on to metformin (≥1500 mg/day orally)
Randomized participants received orally QD saxagliptin 5 mg film coated tablet and placebo for dapagliflozin as an add-on to metformin (≥1500 mg/day orally)
Overall Number of Participants Analyzed 290 291
Least Squares Mean (Standard Error)
Unit of Measure: Kilograms (Kg)
-2.01  (0.1829) -0.41  (0.1815)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dapagliflozin + Saxagliptin + Metformin, Saxagliptin + Metformin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.60
Confidence Interval (2-Sided) 95%
-2.11 to -1.09
Estimation Comments [Not Specified]
Time Frame From time of randomization, and throughout the treatment period and until end of treatment (Visit 5)/early termination + 4 days for non serious AEs and 30 days for SAEs.
Adverse Event Reporting Description An undesirable medical condition could be symptoms (eg, nausea, chest pain), signs (eg, tachycardia, enlarged liver)/abnormal results of an investigation (eg, laboratory findings, electrocardiogram). One participant was randomized but did not receive treatment in Dapagliflozin+Metformin and Saxagliptin + Metformin groups.
 
Arm/Group Title Dapagliflozin + Saxagliptin + Metformin Dapagliflozin + Metformin Saxagliptin + Metformin
Hide Arm/Group Description Randomized participants received orally once daily (QD) dapagliflozin 5 mg and saxagliptin 5 mg film coated tablets as an add-on to metformin (≥1500 mg/day orally) Randomized participants received orally QD dapagliflozin 5 mg film coated tablet and placebo for saxagliptin as an add-on to metformin (≥1500 mg/day orally) Randomized participants received orally QD saxagliptin 5 mg film coated tablet and placebo for dapagliflozin as an add-on to metformin (≥1500 mg/day orally)
All-Cause Mortality
Dapagliflozin + Saxagliptin + Metformin Dapagliflozin + Metformin Saxagliptin + Metformin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/293 (0.34%)      2/293 (0.68%)      0/295 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Dapagliflozin + Saxagliptin + Metformin Dapagliflozin + Metformin Saxagliptin + Metformin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/293 (2.39%)      8/293 (2.73%)      7/295 (2.37%)    
Cardiac disorders       
Angina unstable * 1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/295 (0.00%)  0
Coronary artery disease * 1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/295 (0.00%)  0
Myocardial infarction * 1  0/293 (0.00%)  0 1/293 (0.34%)  1 0/295 (0.00%)  0
Tachycardia * 1  0/293 (0.00%)  0 1/293 (0.34%)  1 0/295 (0.00%)  0
Ventricular arrhythmia * 1  0/293 (0.00%)  0 1/293 (0.34%)  1 0/295 (0.00%)  0
Eye disorders       
Cataract * 1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/295 (0.00%)  0
Gastrointestinal disorders       
Constipation * 1  0/293 (0.00%)  0 0/293 (0.00%)  0 1/295 (0.34%)  1
Small intestinal obstruction * 1  0/293 (0.00%)  0 1/293 (0.34%)  1 0/295 (0.00%)  0
Hepatobiliary disorders       
Cholelithiasis * 1  0/293 (0.00%)  0 0/293 (0.00%)  0 1/295 (0.34%)  1
Infections and infestations       
Osteomyelitis * 1  0/293 (0.00%)  0 0/293 (0.00%)  0 1/295 (0.34%)  1
Pneumonia * 1  0/293 (0.00%)  0 0/293 (0.00%)  0 1/295 (0.34%)  1
Pyelonephritis * 1  0/293 (0.00%)  0 1/293 (0.34%)  1 0/295 (0.00%)  0
Injury, poisoning and procedural complications       
Ankle fracture * 1  0/293 (0.00%)  0 0/293 (0.00%)  0 1/295 (0.34%)  1
Contusion * 1  0/293 (0.00%)  0 0/293 (0.00%)  0 1/295 (0.34%)  1
Radius fracture * 1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/295 (0.00%)  0
Road traffic accident * 1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/295 (0.00%)  0
Sternal fracture * 1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/295 (0.00%)  0
Tendon rupture * 1  0/293 (0.00%)  0 1/293 (0.34%)  1 0/295 (0.00%)  0
Metabolism and nutrition disorders       
Hypokalaemia * 1  0/293 (0.00%)  0 1/293 (0.34%)  1 0/295 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Intervertebral disc protrusion * 1  0/293 (0.00%)  0 0/293 (0.00%)  0 1/295 (0.34%)  1
Muscular weakness * 1  0/293 (0.00%)  0 1/293 (0.34%)  1 0/295 (0.00%)  0
Nervous system disorders       
Cerebrovascular accident * 1  0/293 (0.00%)  0 2/293 (0.68%)  2 0/295 (0.00%)  0
Basal ganglia haemorrhage * 1  0/293 (0.00%)  0 1/293 (0.34%)  1 0/295 (0.00%)  0
Lumbosacral radiculopathy * 1  0/293 (0.00%)  0 0/293 (0.00%)  0 1/295 (0.34%)  1
Reproductive system and breast disorders       
Benign prostatic hyperplasia * 1  0/293 (0.00%)  0 0/293 (0.00%)  0 1/295 (0.34%)  1
Skin and subcutaneous tissue disorders       
Angioedema * 1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/295 (0.00%)  0
Vascular disorders       
Arteritis * 1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/295 (0.00%)  0
Hypertensive crisis * 1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/295 (0.00%)  0
1
Term from vocabulary, MedDRA version 20.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Dapagliflozin + Saxagliptin + Metformin Dapagliflozin + Metformin Saxagliptin + Metformin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   41/293 (13.99%)      39/293 (13.31%)      29/295 (9.83%)    
Gastrointestinal disorders       
Nausea * 1  6/293 (2.05%)  6 5/293 (1.71%)  5 3/295 (1.02%)  3
Infections and infestations       
Urinary tract infection * 1  7/293 (2.39%)  7 3/293 (1.02%)  4 5/295 (1.69%)  5
Viral upper respiratory tract infection * 1  5/293 (1.71%)  5 9/293 (3.07%)  10 8/295 (2.71%)  8
Influenza * 1  3/293 (1.02%)  3 9/293 (3.07%)  9 3/295 (1.02%)  3
Upper respiratory tract infection * 1  3/293 (1.02%)  4 4/293 (1.37%)  4 6/295 (2.03%)  6
Investigations       
Glomerular filtration rate decreased * 1  12/293 (4.10%)  13 11/293 (3.75%)  11 5/295 (1.69%)  5
Renal and urinary disorders       
Pollakiuria * 1  7/293 (2.39%)  8 1/293 (0.34%)  1 0/295 (0.00%)  0
1
Term from vocabulary, MedDRA version 20.0
*
Indicates events were collected by non-systematic assessment
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.
All clinical study findings and documents will be regarded as confidential. The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Clinical Leader
Organization: AstraZeneca
Phone: +46 766 346712
EMail: clinicaltrialtransparency@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02681094     History of Changes
Other Study ID Numbers: D1683C00005
First Submitted: February 10, 2016
First Posted: February 12, 2016
Results First Submitted: July 6, 2018
Results First Posted: October 10, 2018
Last Update Posted: October 10, 2018