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Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes (DEPICT 2)

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: NCT02460978
Recruitment Status : Completed
First Posted : June 3, 2015
Results First Posted : November 6, 2018
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
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 1 Diabetes Mellitus
Interventions Drug: Dapagliflozin
Other: Placebo for dapagliflozin
Enrollment 815
Recruitment Details The results on this form are from the 24 week short-term double-blind treatment period. This study was conducted at 148 centers in 13 countries from 8 July 2015 to 2 Sep 2017.
Pre-assignment Details 815 participants were randomized. Of the 195 participants not randomized: 97 No longer met study criteria, 44 withdrew consent, 13 were lost to follow-up, and 41 did not continue for other reasons. Two participants did not receive any study drug and were excluded from analyses. Thus, the total number of subjects is 813.
Arm/Group Title DAPA 5 MG + INS DAPA 10 MG + INS PLA + INS
Hide Arm/Group Description Dapagliflozin 5 mg plus insulin Dapagliflozin 10 mg plus insulin Placebo plus insulin
Period Title: Overall Study
Started 271 270 272
Completed 244 245 239
Not Completed 27 25 33
Reason Not Completed
Adverse Event             17             11             11
Withdrawal by Subject             5             5             14
Lost to Follow-up             2             3             1
Protocol Violation             1             1             1
Discontinued due to DKA/hypoglycemia             2             5             4
Pregnancy             0             0             2
Arm/Group Title DAPA 5 MG + INS DAPA 10 MG + INS PLA + INS Total
Hide Arm/Group Description Dapagliflozin 5 mg plus insulin Dapagliflozin 10 mg plus insulin Placebo plus insulin Total of all reporting groups
Overall Number of Baseline Participants 271 270 272 813
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 271 participants 270 participants 272 participants 813 participants
42.7  (13.35) 42.4  (12.80) 43.0  (13.73) 42.7  (13.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 271 participants 270 participants 272 participants 813 participants
Female
153
  56.5%
149
  55.2%
153
  56.3%
455
  56.0%
Male
118
  43.5%
121
  44.8%
119
  43.8%
358
  44.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 271 participants 270 participants 272 participants 813 participants
White 210 219 208 637
Black or African-American 4 7 1 12
Asian 57 44 59 160
Other 0 0 4 4
1.Primary Outcome
Title Adjusted Mean Change From Baseline in HbA1c at Week 24
Hide Description To compare the change from baseline in HbA1c between dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population for this endpoint is the number of subjects in the full analysis set with non-missing baseline and at least one post-baseline value. The full analysis set consists of all randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period.
Arm/Group Title DAPA 5 MG + INS DAPA 10 MG + INS PLA + INS
Hide Arm/Group Description:
Dapagliflozin 5 mg plus insulin
Dapagliflozin 10 mg plus insulin
Placebo plus insulin
Overall Number of Participants Analyzed 266 267 267
Least Squares Mean (95% Confidence Interval)
Unit of Measure: HbA1c (%)
-0.34
(-0.43 to -0.25)
-0.39
(-0.48 to -0.30)
0.03
(-0.06 to 0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DAPA 5 MG + INS, PLA + INS
Comments Difference vs. placebo in adjusted mean change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model is adjusted for baseline HbA1c, treatment, week, randomization stratum, week*treatment, and week*baseline HbA1c.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-0.49 to -0.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0579
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DAPA 10 MG + INS, PLA + INS
Comments Difference vs. placebo in adjusted mean change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model is adjusted for baseline HbA1c, treatment, week, randomization stratum, week*treatment, and week*baseline HbA1c.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-0.53 to -0.30
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0578
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Adjusted Mean Percentage Change From Baseline in Total Daily Insulin Dose at Week 24
Hide Description To compare the percent change from baseline in total daily insulin dose with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects in full analysis set with non-missing baseline and at least one post-baseline value
Arm/Group Title DAPA 5 MG + INS DAPA 10 MG + INS PLA + INS
Hide Arm/Group Description:
Dapagliflozin 5 mg plus insulin
Dapagliflozin 10 mg plus insulin
Placebo plus insulin
Overall Number of Participants Analyzed 270 267 266
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage change
-8.73
(-11.09 to -6.31)
-9.05
(-11.43 to -6.60)
2.29
(-0.41 to 5.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DAPA 5 MG + INS, PLA + INS
Comments Difference vs. placebo in adjusted mean percentage change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Adjusted for ln(baseline), treatment, week, randomization stratum, week*treatment, week*ln(baseline).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.78
Confidence Interval (2-Sided) 95%
-13.73 to -7.72
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.5291
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DAPA 10 MG + INS, PLA + INS
Comments Difference vs. placebo in adjusted mean percentage change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Adjusted for ln(baseline), treatment, week, randomization stratum, week*treatment, and week*ln(baseline).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.08
Confidence Interval (2-Sided) 95%
-14.04 to -8.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.5331
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Adjusted Mean Percentage Change From Baseline in Body Weight at Week 24
Hide Description To compare the percentage change from baseline in body weight with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects in full analysis set with non-missing baseline and at least one post-baseline value
Arm/Group Title DAPA 5 MG + INS DAPA 10 MG + INS PLA + INS
Hide Arm/Group Description:
Dapagliflozin 5 mg plus insulin
Dapagliflozin 10 mg plus insulin
Placebo plus insulin
Overall Number of Participants Analyzed 269 269 272
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage change
-3.22
(-3.76 to -2.69)
-3.76
(-4.29 to -3.22)
-0.02
(-0.57 to 0.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DAPA 5 MG + INS, PLA + INS
Comments Difference vs. placebo in adjusted mean percentage change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Adjusted for ln(baseline), treatment, week, randomization stratum, week*treatment, and week*ln(baseline).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.21
Confidence Interval (2-Sided) 95%
-3.96 to -2.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.3829
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DAPA 10 MG + INS, PLA + INS
Comments Difference vs. placebo in adjusted mean percentage change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Adjusted for ln(baseline), treatment, week, randomization stratum, week*treatment, and week*ln(baseline).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.74
Confidence Interval (2-Sided) 95%
-4.49 to -2.99
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.3812
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Adjusted Mean Change From Baseline in 24-hour Continuous Glucose Monitoring (CGM) Mean Value at Week 24
Hide Description To compare the change from baseline in mean value of 24-hour glucose readings obtained from CGM with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of subjects in the full analysis set with non-missing baseline and at least one post-baseline value
Arm/Group Title DAPA 5 MG + INS DAPA 10 MG + INS PLA + INS
Hide Arm/Group Description:
Dapagliflozin 5 mg plus insulin
Dapagliflozin 10 mg plus insulin
Placebo plus insulin
Overall Number of Participants Analyzed 252 255 257
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-6.46
(-10.04 to -2.87)
-10.54
(-14.14 to -6.94)
9.20
(5.57 to 12.83)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DAPA 5 MG + INS, PLA + INS
Comments Difference vs. placebo in adjusted mean change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Adjusted for baseline, treatment, week, randomization stratum, week*treatment, and week*baseline.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15.66
Confidence Interval (2-Sided) 95%
-20.26 to -11.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.3468
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DAPA 10 MG + INS, PLA + INS
Comments Difference vs. placebo in adjusted mean change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Adjusted for baseline, treatment, week, randomization stratum, week*treatment, and week*baseline.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -19.74
Confidence Interval (2-Sided) 95%
-24.34 to -15.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.3419
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Adjusted Mean Change From Baseline in 24-hour CGM Mean Amplitude of Glycemic Excursion (MAGE) Value at Week 24
Hide Description To compare the change from baseline in mean amplitude of glucose excursions (MAGE) of 24-hour glucose readings obtained from CGM with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects in the full analysis set with non-missing baseline and at least one post-baseline value
Arm/Group Title DAPA 5 MG + INS DAPA 10 MG + INS PLA + INS
Hide Arm/Group Description:
Dapagliflozin 5 mg plus insulin
Dapagliflozin 10 mg plus insulin
Placebo plus insulin
Overall Number of Participants Analyzed 252 255 257
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-10.17
(-13.90 to -6.45)
-9.68
(-13.44 to -5.93)
-0.33
(-4.12 to 3.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DAPA 5 MG + INS, PLA + INS
Comments Difference vs. placebo in adjusted mean change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Adjusted for baseline, treatment, week, randomization stratum, week*treatment, and week*baseline.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.85
Confidence Interval (2-Sided) 95%
-14.66 to -5.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.4519
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DAPA 10 MG + INS, PLA + INS
Comments Difference vs. placebo in adjusted mean change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Adjusted for baseline, treatment, week, randomization stratum, week*treatment, and week*baseline.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.36
Confidence Interval (2-Sided) 95%
-14.16 to -4.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.4487
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in the Percent of 24-hour Glucose Readings Obtained From CGM That Falls Within the Target Range of > 70 mg/dL and <= 180 mg/dL (%) at Week 24
Hide Description To compare the change from baseline in the percent of 24-hour glucose readings obtained from CGM that falls within the target range of >70 mg/dL and <=180 mg/dL with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects in the full analysis set with non-missing baseline and at least one post-baseline value
Arm/Group Title DAPA 5 MG + INS DAPA 10 MG + INS PLA + INS
Hide Arm/Group Description:
Dapagliflozin 5 mg plus insulin
Dapagliflozin 10 mg plus insulin
Placebo plus insulin
Overall Number of Participants Analyzed 252 255 257
Least Squares Mean (95% Confidence Interval)
Unit of Measure: % of readings
5.92
(4.32 to 7.52)
7.60
(5.98 to 9.21)
-3.10
(-4.73 to -1.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DAPA 5 MG + INS, PLA + INS
Comments Difference vs. placebo in adjusted mean change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Adjusted for baseline, treatment, week, randomization stratum, week*treatment, and week*baseline.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.02
Confidence Interval (2-Sided) 95%
6.97 to 11.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.0415
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DAPA 10 MG + INS, PLA + INS
Comments Difference vs. placebo in adjusted mean change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Adjusted for baseline, treatment, week, randomization stratum, week*treatment, and week*baseline.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10.70
Confidence Interval (2-Sided) 95%
8.66 to 12.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.0396
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Subjects With HbA1c Reduction From Baseline to Week 24 Last Observation Carried Forward (LOCF) >= 0.5% and Without Severe Hypoglycemia Events at Week 24
Hide Description To compare dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin for the proportion of subjects achieving an HbA1c reduction from baseline to Week 24 visit >=0.5% without severe hypoglycemia events
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects in the full analysis set with non-missing baseline and Week 24 (LOCF) values.
Arm/Group Title DAPA 5 MG + INS DAPA 10 MG + INS PLA + INS
Hide Arm/Group Description:
Dapagliflozin 5 mg plus insulin
Dapagliflozin 10 mg plus insulin
Placebo plus insulin
Overall Number of Participants Analyzed 266 267 269
Measure Type: Count of Participants
Unit of Measure: Participants
Number of Responders
105
  39.5%
111
  41.6%
54
  20.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DAPA 5 MG + INS, PLA + INS
Comments Odds Ratio vs. Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Adjusted for baseline HbA1c and randomization strata
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.71
Confidence Interval (2-Sided) 95%
1.81 to 4.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2058
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DAPA 10 MG + INS, PLA + INS
Comments Odds Ratio vs. Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Adjusted for baseline HbA1c and randomization strata
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.07
Confidence Interval (2-Sided) 95%
2.05 to 4.60
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2054
Estimation Comments [Not Specified]
Time Frame All adverse events (AEs), including serious adverse events (SAEs), were collected from the time informed consent was signed throughout the treatment period (through week 24).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DAPA 5 MG + INS DAPA 10 MG + INS PLA + INS
Hide Arm/Group Description Dapagliflozin 5 mg plus insulin Dapagliflozin 10 mg plus insulin Placebo plus insulin
All-Cause Mortality
DAPA 5 MG + INS DAPA 10 MG + INS PLA + INS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/271 (0.00%)      0/270 (0.00%)      0/272 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
DAPA 5 MG + INS DAPA 10 MG + INS PLA + INS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/271 (6.64%)      7/270 (2.59%)      5/272 (1.84%)    
Cardiac disorders       
Cardiac arrest  1  0/271 (0.00%)  0 1/270 (0.37%)  1 0/272 (0.00%)  0
Angina pectoris  1  0/271 (0.00%)  0 0/270 (0.00%)  0 1/272 (0.37%)  1
Gastrointestinal disorders       
Enteritis  1  0/271 (0.00%)  0 1/270 (0.37%)  1 0/272 (0.00%)  0
General disorders       
Chest pain  1  0/271 (0.00%)  0 1/270 (0.37%)  1 0/272 (0.00%)  0
Infections and infestations       
Cellulitis  1  1/271 (0.37%)  1 0/270 (0.00%)  0 0/272 (0.00%)  0
Labyrinthitis  1  1/271 (0.37%)  1 0/270 (0.00%)  0 0/272 (0.00%)  0
Pneumonia  1  1/271 (0.37%)  1 0/270 (0.00%)  0 0/272 (0.00%)  0
Pyelonephritis  1  1/271 (0.37%)  1 0/270 (0.00%)  0 0/272 (0.00%)  0
Sepsis  1  1/271 (0.37%)  1 0/270 (0.00%)  0 0/272 (0.00%)  0
Urinary tract infection  1  1/271 (0.37%)  1 0/270 (0.00%)  0 0/272 (0.00%)  0
Injury, poisoning and procedural complications       
Femur fracture  1  0/271 (0.00%)  0 1/270 (0.37%)  1 0/272 (0.00%)  0
Subarachnoid haemorrhage  1  0/271 (0.00%)  0 1/270 (0.37%)  1 0/272 (0.00%)  0
Foot fracture  1  1/271 (0.37%)  1 0/270 (0.00%)  0 0/272 (0.00%)  0
Metabolism and nutrition disorders       
Diabetic ketoacidosis  1  7/271 (2.58%)  7 3/270 (1.11%)  3 0/272 (0.00%)  0
Hypoglycemia  1  3/271 (1.11%)  4 0/270 (0.00%)  0 1/272 (0.37%)  1
Ketoacidosis  1  1/271 (0.37%)  1 0/270 (0.00%)  0 0/272 (0.00%)  0
Ketosis  1  1/271 (0.37%)  1 0/270 (0.00%)  0 0/272 (0.00%)  0
Lactic acidosis  1  0/271 (0.00%)  0 0/270 (0.00%)  0 1/272 (0.37%)  1
Nervous system disorders       
Cerebral haemorrhage  1  0/271 (0.00%)  0 1/270 (0.37%)  1 0/272 (0.00%)  0
Coma  1  0/271 (0.00%)  0 1/270 (0.37%)  1 0/272 (0.00%)  0
Diabetic hyperglycaemic coma  1  0/271 (0.00%)  0 1/270 (0.37%)  1 0/272 (0.00%)  0
Seizure  1  0/271 (0.00%)  0 1/270 (0.37%)  1 0/272 (0.00%)  0
Cerebral infarction  1  1/271 (0.37%)  1 0/270 (0.00%)  0 0/272 (0.00%)  0
Cerebrovascular accident  1  0/271 (0.00%)  0 0/270 (0.00%)  0 1/272 (0.37%)  1
Hypoglycaemic coma  1  1/271 (0.37%)  1 0/270 (0.00%)  0 0/272 (0.00%)  0
Hypoglycaemic seizure  1  2/271 (0.74%)  2 0/270 (0.00%)  0 0/272 (0.00%)  0
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous  1  0/271 (0.00%)  0 0/270 (0.00%)  0 1/272 (0.37%)  1
Renal and urinary disorders       
Acute prerenal failure  1  1/271 (0.37%)  1 0/270 (0.00%)  0 0/272 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism  1  0/271 (0.00%)  0 1/270 (0.37%)  1 0/272 (0.00%)  0
Acute respiratory failure  1  1/271 (0.37%)  1 0/270 (0.00%)  0 0/272 (0.00%)  0
1
Term from vocabulary, MedDRA version 20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DAPA 5 MG + INS DAPA 10 MG + INS PLA + INS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   79/271 (29.15%)      77/270 (28.52%)      63/272 (23.16%)    
General disorders       
Thirst  1  6/271 (2.21%)  7 14/270 (5.19%)  14 1/272 (0.37%)  1
Infections and infestations       
Viral upper respiratory tract infection  1  39/271 (14.39%)  46 44/270 (16.30%)  56 42/272 (15.44%)  51
Upper respiratory tract infection  1  16/271 (5.90%)  21 12/270 (4.44%)  12 12/272 (4.41%)  12
Nervous system disorders       
Headache  1  10/271 (3.69%)  11 15/270 (5.56%)  15 10/272 (3.68%)  11
Renal and urinary disorders       
Pollakiuria  1  22/271 (8.12%)  23 14/270 (5.19%)  15 6/272 (2.21%)  6
1
Term from vocabulary, MedDRA version 20.0
Indicates events were collected by 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.
If an Investigator requests permission to publish data from this study any such publication is to be agreed with AstraZeneca (AZ) in advance. The investigator agrees to provide AZ as soon as possible with drafts of proposed publications. Unless otherwise agreed, AZ shall have a period of 60 days from receipt of the proposed final manuscript to review it and may within such time require that submission for publication of the manuscript be delayed in order for AZ to file patent applications.
Results Point of Contact
Name/Title: Anna Maria Langkilde
Organization: AstraZeneca
Phone: +46 31 7761000
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02460978     History of Changes
Other Study ID Numbers: MB102-230
2014-004599-49 ( EudraCT Number )
D1695C00007 ( Other Identifier: AstraZeneca )
First Submitted: June 1, 2015
First Posted: June 3, 2015
Results First Submitted: August 24, 2018
Results First Posted: November 6, 2018
Last Update Posted: March 5, 2019