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

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: NCT02268214
Recruitment Status : Completed
First Posted : October 20, 2014
Results First Posted : March 29, 2018
Last Update Posted : September 13, 2018
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
Drug: Placebo for dapagliflozin
Enrollment 833
Recruitment Details The first subject was enrolled on 11 November 2014. The last subject completed the 24-week short-term treatment period 04 January 2017 and the last subject completed the study 25 August 2017. This study was conducted at 138 sites in 17 countries.
Pre-assignment Details 833 participants were randomized to a treatment group. Of the 771 participants not randomized to a treatment group: 585 No longer met study criteria, 125 withdrew consent, 26 were lost to follow-up, and 35 did not continue for other reasons
Arm/Group Title Dapagliflozin 5 mg + Insulin Dapagliflozin 10 mg + Insulin Placebo + Insulin
Hide Arm/Group Description Dapagliflozin 5 mg oral tablet once daily + background insulin Dapagliflozin 10 mg oral tablet once daily + background insulin Placebo oral tablet once daily + background insulin
Period Title: Overall Study
Started 277 296 260
COMPLETED 24 WEEK PERIOD 252 273 232
Completed 235 255 218
Not Completed 42 41 42
Reason Not Completed
Subject no longer meets study criteria             0             2             0
Pregnancy             2             2             1
Lost to Follow-up             3             3             4
Lack of Efficacy             1             0             2
Adverse Event             11             14             9
Withdrawal by Subject             4             5             10
Subject request to discontinue treatment             10             8             6
Poor/non-compliance             2             1             2
Other reasons             7             3             3
Not entering long-term period             2             3             5
Arm/Group Title Dapagliflozin 5 mg + Insulin Dapagliflozin 10 mg + Insulin Placebo + Insulin Total
Hide Arm/Group Description Dapagliflozin 5 mg oral tablet once daily + background insulin Dapagliflozin 10 mg oral tablet once daily + background insulin Placebo oral tablet once daily + background insulin Total of all reporting groups
Overall Number of Baseline Participants 277 296 260 833
Hide Baseline Analysis Population Description
Safety Analysis Set: It consists of all subjects who received at least one dose of double-blind study medication during the short-term double-blind treatment period.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 277 participants 296 participants 260 participants 833 participants
42.1  (13.94) 43.4  (13.89) 42.7  (13.57) 42.7  (13.80)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 277 participants 296 participants 260 participants 833 participants
< 65 years
262
  94.6%
279
  94.3%
246
  94.6%
787
  94.5%
Between 65 and 75 years
15
   5.4%
16
   5.4%
14
   5.4%
45
   5.4%
>= 75 years
0
   0.0%
1
   0.3%
0
   0.0%
1
   0.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 277 participants 296 participants 260 participants 833 participants
Female
158
  57.0%
144
  48.6%
128
  49.2%
430
  51.6%
Male
119
  43.0%
152
  51.4%
132
  50.8%
403
  48.4%
1.Primary Outcome
Title Adjusted Mean Change in HbA1c From Baseline at Week 24
Hide Description Adjusted mean change from baseline in HbA1c at Week 24 (Repeated Measures Model[RMM]).
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.
Arm/Group Title Dapagliflozin 5 mg + Insulin Dapagliflozin 10 mg + Insulin Placebo + Insulin
Hide Arm/Group Description:
Dapagliflozin 5 mg oral tablet once daily + background insulin
Dapagliflozin 10 mg oral tablet once daily + background insulin
Placebo oral tablet once daily + background insulin
Overall Number of Participants Analyzed 254 254 257
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of hemoglobin
-0.45  (0.0537) -0.47  (0.0538) -0.03  (0.0540)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dapagliflozin 5 mg + Insulin, Placebo + Insulin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method RMM
Comments Repeated Measures Model
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-0.56 to -0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0697
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dapagliflozin 10 mg + Insulin, Placebo + Insulin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method RMM
Comments Repeated Measures Model
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.45
Confidence Interval (2-Sided) 95%
-0.58 to -0.31
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0696
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Adjusted Mean Percent Change in Total Daily Insulin Dose From Baseline at Week 24
Hide Description Adjusted mean change from baseline in Total Daily Insulin Dose at Week 24 (Repeated Measures Model[RMM])
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.
Arm/Group Title Dapagliflozin 5 mg + Insulin Dapagliflozin 10 mg + Insulin Placebo + Insulin
Hide Arm/Group Description:
Dapagliflozin 5 mg oral tablet once daily + background insulin
Dapagliflozin 10 mg oral tablet once daily + background insulin
Placebo oral tablet once daily + background insulin
Overall Number of Participants Analyzed 258 254 258
Least Squares Mean (Standard Error)
Unit of Measure: IU
-7.74  (1.4881) -12.16  (1.4326) 1.16  (1.6593)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dapagliflozin 5 mg + Insulin, Placebo + Insulin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method RMM
Comments Repeated Measures Model
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.80
Confidence Interval (2-Sided) 95%
-12.56 to -4.88
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.9555
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dapagliflozin 10 mg + Insulin, Placebo + Insulin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method RMM
Comments Repeated Measures Model
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.17
Confidence Interval (2-Sided) 95%
-16.75 to -9.43
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.8643
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Adjusted Mean Percent Change in Body Weight From Baseline at Week 24
Hide Description Adjusted mean percent change from baseline in body weight at Week 24 (Repeated Measures Model[RMM])
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.
Arm/Group Title Dapagliflozin 5 mg + Insulin Dapagliflozin 10 mg + Insulin Placebo + Insulin
Hide Arm/Group Description:
Dapagliflozin 5 mg oral tablet once daily + background insulin
Dapagliflozin 10 mg oral tablet once daily + background insulin
Placebo oral tablet once daily + background insulin
Overall Number of Participants Analyzed 259 258 259
Least Squares Mean (Standard Error)
Unit of Measure: Kg
-3.00  (0.2330) -3.67  (0.2299) 0.05  (0.2407)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dapagliflozin 5 mg + Insulin, Placebo + Insulin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method RMM
Comments Repeated Measures Model
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.05
Confidence Interval (2-Sided) 95%
-3.68 to -2.41
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.3251
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dapagliflozin 10 mg + Insulin, Placebo + Insulin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method RMM
Comments Repeated Measures Model
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.72
Confidence Interval (2-Sided) 95%
-4.34 to -3.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.3213
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Adjusted Mean Change in 24-hour Mean Continuous Glucose Monitoring Glucose From Baseline at Week 24
Hide Description Adjusted mean change in 24-hour mean Continuous Glucose Monitoring glucose from baseline at Week 24 (Repeated Measures Model[RMM])
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.
Arm/Group Title Dapagliflozin 5 mg + Insulin Dapagliflozin 10 mg + Insulin Placebo + Insulin
Hide Arm/Group Description:
Dapagliflozin 5 mg oral tablet once daily + background insulin
Dapagliflozin 10 mg oral tablet once daily + background insulin
Placebo oral tablet once daily + background insulin
Overall Number of Participants Analyzed 238 239 234
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-10.28  (1.8862) -12.97  (1.9231) 5.06  (1.9320)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dapagliflozin 5 mg + Insulin, Placebo + Insulin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method RMM
Comments Repeated Measures Model
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15.34
Confidence Interval (2-Sided) 95%
-20.22 to -10.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.4859
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dapagliflozin 10 mg + Insulin, Placebo + Insulin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method RMM
Comments Repeated Measures Model
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -18.03
Confidence Interval (2-Sided) 95%
-22.95 to -13.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.5050
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Adjusted Mean Change in 24-hour Continuous Glucose Monitoring MAGE From Baseline at Week 24
Hide Description Adjusted Mean Change in 24-hour Continuous Glucose Monitoring Mean Amplitude of Glucose Excursions (MAGE) from Baseline at Week 24 (Repeated Measures Model[RMM])
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.
Arm/Group Title Dapagliflozin 5 mg + Insulin Dapagliflozin 10 mg + Insulin Placebo + Insulin
Hide Arm/Group Description:
Dapagliflozin 5 mg oral tablet once daily + background insulin
Dapagliflozin 10 mg oral tablet once daily + background insulin
Placebo oral tablet once daily + background insulin
Overall Number of Participants Analyzed 238 239 234
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-14.92  (1.9915) -16.55  (2.0419) 2.38  (2.0477)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dapagliflozin 5 mg + Insulin, Placebo + Insulin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method RMM
Comments Repeated Measures Model
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -17.30
Confidence Interval (2-Sided) 95%
-22.46 to -12.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.6273
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dapagliflozin 10 mg + Insulin, Placebo + Insulin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method RMM
Comments Repeated Measures Model
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -18.93
Confidence Interval (2-Sided) 95%
-24.13 to -13.73
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.6482
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) From Baseline at Week 24
Hide Description Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) from Baseline at Week 24 (Repeated Measures Model[RMM])
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.
Arm/Group Title Dapagliflozin 5 mg + Insulin Dapagliflozin 10 mg + Insulin Placebo + Insulin
Hide Arm/Group Description:
Dapagliflozin 5 mg oral tablet once daily + background insulin
Dapagliflozin 10 mg oral tablet once daily + background insulin
Placebo oral tablet once daily + background insulin
Overall Number of Participants Analyzed 238 239 234
Least Squares Mean (Standard Error)
Unit of Measure: Percentage
6.98  (0.8824) 8.52  (0.9000) -2.13  (0.9032)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dapagliflozin 5 mg + Insulin, Placebo + Insulin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method RMM
Comments Repeated Measures Model
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.11
Confidence Interval (2-Sided) 95%
6.83 to 11.39
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.1611
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dapagliflozin 10 mg + Insulin, Placebo + Insulin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method RMM
Comments Repeated Measures Model
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10.65
Confidence Interval (2-Sided) 95%
8.35 to 12.94
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.1689
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Subjects With HbA1c Reduction From Baseline to Week 24 (LOCF) >= 0.5% and Without Severe Hypoglycemia Events
Hide Description Subjects with HbA1c reduction from baseline to week 24 (LOCF) >= 0.5% and without severe hypoglycemia events
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.
Arm/Group Title Dapagliflozin 5 mg + Insulin Dapagliflozin 10 mg + Insulin Placebo + Insulin
Hide Arm/Group Description:
Dapagliflozin 5 mg oral tablet once daily + background insulin
Dapagliflozin 10 mg oral tablet once daily + background insulin
Placebo oral tablet once daily + background insulin
Overall Number of Participants Analyzed 256 254 257
Measure Type: Count of Participants
Unit of Measure: Participants
Responders
127
  49.6%
129
  50.8%
65
  25.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dapagliflozin 5 mg + Insulin, Placebo + Insulin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.09
Confidence Interval (2-Sided) 95%
2.10 to 4.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1980
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dapagliflozin 10 mg + Insulin, Placebo + Insulin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.29
Confidence Interval (2-Sided) 95%
2.23 to 4.85
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1979
Estimation Comments [Not Specified]
Time Frame Onset on or after the first date of double-blind treatment and on or prior to the last day of treatment 24-week short-term period, 28-week extension period and the 30-day folllow-up period
Adverse Event Reporting Description Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
 
Arm/Group Title Dapagliflozin 5 mg + Insulin Dapagliflozin 10 mg + Insulin Placebo + Insulin
Hide Arm/Group Description Dapagliflozin 5 mg oral tablet once daily + background insulin Dapagliflozin 10 mg oral tablet once daily + background insulin Placebo oral tablet once daily + background insulin
All-Cause Mortality
Dapagliflozin 5 mg + Insulin Dapagliflozin 10 mg + Insulin Placebo + Insulin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/277 (0.00%)      0/296 (0.00%)      1/260 (0.38%)    
Show Serious Adverse Events Hide Serious Adverse Events
Dapagliflozin 5 mg + Insulin Dapagliflozin 10 mg + Insulin Placebo + Insulin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/277 (13.36%)      40/296 (13.51%)      30/260 (11.54%)    
Cardiac disorders       
Myocardial infarction  1  0/277 (0.00%)  1/296 (0.34%)  1 0/260 (0.00%) 
Angina pectoris  1  1/277 (0.36%)  1 0/296 (0.00%)  1/260 (0.38%)  1
Sinus tachycardia  1  0/277 (0.00%)  1/296 (0.34%)  1 0/260 (0.00%) 
Endocrine disorders       
Hyperparathyroidism primary  1  0/277 (0.00%)  0/296 (0.00%)  1/260 (0.38%)  1
Eye disorders       
Blindness unilateral  1  1/277 (0.36%)  1 0/296 (0.00%)  0/260 (0.00%) 
Cataract  1  1/277 (0.36%)  1 0/296 (0.00%)  0/260 (0.00%) 
Vitreous haemorrhage  1  2/277 (0.72%)  3 0/296 (0.00%)  0/260 (0.00%) 
Ophthalmoplegia  1  0/277 (0.00%)  0/296 (0.00%)  1/260 (0.38%)  1
Gastrointestinal disorders       
Gastrointestinal hypomotility  1  0/277 (0.00%)  1/296 (0.34%)  1 0/260 (0.00%) 
Pancreatitis chronic  1  0/277 (0.00%)  1/296 (0.34%)  1 0/260 (0.00%) 
Oesophagitis  1  0/277 (0.00%)  1/296 (0.34%)  1 0/260 (0.00%) 
Oesophagitis haemorrhagic  1  0/277 (0.00%)  0/296 (0.00%)  1/260 (0.38%)  1
Vomiting  1  0/277 (0.00%)  1/296 (0.34%)  1 0/260 (0.00%) 
Abdominal pain  1  0/277 (0.00%)  1/296 (0.34%)  1 0/260 (0.00%) 
Abdominal pain upper  1  0/277 (0.00%)  1/296 (0.34%)  1 0/260 (0.00%) 
Cyclic vomiting syndrome  1  0/277 (0.00%)  1/296 (0.34%)  1 0/260 (0.00%) 
Diabetic gastroparesis  1  1/277 (0.36%)  2 0/296 (0.00%)  0/260 (0.00%) 
Gastritis  1  1/277 (0.36%)  1 0/296 (0.00%)  0/260 (0.00%) 
General disorders       
Chest pain  1  1/277 (0.36%)  1 2/296 (0.68%)  2 1/260 (0.38%)  1
Impaired healing  1  0/277 (0.00%)  1/296 (0.34%)  1 0/260 (0.00%) 
Pyrexia  1  0/277 (0.00%)  0/296 (0.00%)  1/260 (0.38%)  1
Hepatobiliary disorders       
Cholecystitis  1  0/277 (0.00%)  0/296 (0.00%)  1/260 (0.38%)  1
Hepatic haematoma  1  1/277 (0.36%)  1 0/296 (0.00%)  0/260 (0.00%) 
Infections and infestations       
Abscess limb  1  0/277 (0.00%)  0/296 (0.00%)  1/260 (0.38%)  1
Bronchitis  1  0/277 (0.00%)  0/296 (0.00%)  1/260 (0.38%)  1
Cellulitis  1  0/277 (0.00%)  0/296 (0.00%)  1/260 (0.38%)  1
Chronic sinusitis  1  1/277 (0.36%)  1 0/296 (0.00%)  0/260 (0.00%) 
Influenza  1  0/277 (0.00%)  1/296 (0.34%)  1 0/260 (0.00%) 
Localised infection  1  1/277 (0.36%)  1 0/296 (0.00%)  0/260 (0.00%) 
Nasal abscess  1  0/277 (0.00%)  0/296 (0.00%)  1/260 (0.38%)  1
Perineal abscess  1  0/277 (0.00%)  0/296 (0.00%)  1/260 (0.38%)  1
Peritonsillar abscess  1  0/277 (0.00%)  1/296 (0.34%)  1 0/260 (0.00%) 
Pneumonia  1  1/277 (0.36%)  1 0/296 (0.00%)  0/260 (0.00%) 
Tooth infection  1  1/277 (0.36%)  1 0/296 (0.00%)  0/260 (0.00%) 
Upper respiratory tract infection  1  0/277 (0.00%)  0/296 (0.00%)  1/260 (0.38%)  1
Urinary tract infection  1  1/277 (0.36%)  2 1/296 (0.34%)  1 0/260 (0.00%) 
Urosepsis  1  0/277 (0.00%)  1/296 (0.34%)  2 0/260 (0.00%) 
Injury, poisoning and procedural complications       
Ankle fracture  1  0/277 (0.00%)  1/296 (0.34%)  1 2/260 (0.77%)  2
Femoral neck fracture  1  0/277 (0.00%)  1/296 (0.34%)  1 1/260 (0.38%)  1
Foot fracture  1  1/277 (0.36%)  1 1/296 (0.34%)  1 0/260 (0.00%) 
Hand fracture  1  1/277 (0.36%)  1 0/296 (0.00%)  0/260 (0.00%) 
Intentional overdose  1  0/277 (0.00%)  1/296 (0.34%)  1 0/260 (0.00%) 
Limb injury  1  0/277 (0.00%)  0/296 (0.00%)  1/260 (0.38%)  1
Lower limb fracture  1  0/277 (0.00%)  0/296 (0.00%)  1/260 (0.38%)  1
Overdose  1  0/277 (0.00%)  1/296 (0.34%)  1 0/260 (0.00%) 
Procedural pain  1  1/277 (0.36%)  1 0/296 (0.00%)  0/260 (0.00%) 
Road traffic accident  1  0/277 (0.00%)  0/296 (0.00%)  1/260 (0.38%)  1
Tendon rupture  1  1/277 (0.36%)  1 0/296 (0.00%)  0/260 (0.00%) 
Investigations       
Liver function test increased  1  0/277 (0.00%)  1/296 (0.34%)  1 0/260 (0.00%) 
Metabolism and nutrition disorders       
Diabetic ketoacidosis  1  10/277 (3.61%)  11 7/296 (2.36%)  7 3/260 (1.15%)  3
Hypoglycaemia  1  2/277 (0.72%)  2 4/296 (1.35%)  4 3/260 (1.15%)  4
Ketoacidosis  1  2/277 (0.72%)  2 4/296 (1.35%)  4 0/260 (0.00%) 
Ketosis  1  2/277 (0.72%)  2 2/296 (0.68%)  2 0/260 (0.00%) 
Obesity  1  1/277 (0.36%)  1 1/296 (0.34%)  1 0/260 (0.00%) 
Musculoskeletal and connective tissue disorders       
Foot deformity  1  0/277 (0.00%)  1/296 (0.34%)  1 0/260 (0.00%) 
Intervertebral disc protrusion  1  1/277 (0.36%)  1 0/296 (0.00%)  0/260 (0.00%) 
Osteoarthritis  1  0/277 (0.00%)  0/296 (0.00%)  1/260 (0.38%)  1
Periarthritis  1  0/277 (0.00%)  0/296 (0.00%)  1/260 (0.38%)  1
Spinal column stenosis  1  0/277 (0.00%)  0/296 (0.00%)  1/260 (0.38%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adenocarcinoma of colon  1  1/277 (0.36%)  1 0/296 (0.00%)  0/260 (0.00%) 
Bone cancer  1  0/277 (0.00%)  1/296 (0.34%)  1 0/260 (0.00%) 
Breast cancer  1  1/277 (0.36%)  1 1/296 (0.34%)  1 0/260 (0.00%) 
Intraductal proliferative breast lesion  1  1/277 (0.36%)  1 0/296 (0.00%)  0/260 (0.00%) 
Keratoacanthoma  1  0/277 (0.00%)  1/296 (0.34%)  1 0/260 (0.00%) 
Lung neoplasm malignant  1  0/277 (0.00%)  1/296 (0.34%)  1 0/260 (0.00%) 
Nervous system disorders       
Carpal tunnel syndrome  1  0/277 (0.00%)  0/296 (0.00%)  1/260 (0.38%)  1
Cubital tunnel syndrome  1  0/277 (0.00%)  0/296 (0.00%)  1/260 (0.38%)  1
Hypoglycaemic seizure  1  1/277 (0.36%)  1 0/296 (0.00%)  0/260 (0.00%) 
Multiple sclerosis  1  1/277 (0.36%)  1 0/296 (0.00%)  0/260 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous  1  1/277 (0.36%)  1 0/296 (0.00%)  0/260 (0.00%) 
Psychiatric disorders       
Adjustment disorder  1  0/277 (0.00%)  0/296 (0.00%)  1/260 (0.38%)  1
Renal and urinary disorders       
Obstructive uropathy  1  1/277 (0.36%)  1 0/296 (0.00%)  0/260 (0.00%) 
Renal colic  1  1/277 (0.36%)  1 0/296 (0.00%)  0/260 (0.00%) 
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1  0/277 (0.00%)  1/296 (0.34%)  1 0/260 (0.00%) 
Gynaecomastia  1  1/277 (0.36%)  1 0/296 (0.00%)  0/260 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary mass  1  0/277 (0.00%)  0/296 (0.00%)  1/260 (0.38%)  1
Skin and subcutaneous tissue disorders       
Diabetic foot  1  0/277 (0.00%)  1/296 (0.34%)  1 0/260 (0.00%) 
Vascular disorders       
Embolism  1  0/277 (0.00%)  0/296 (0.00%)  1/260 (0.38%)  1
Peripheral artery occlusion  1  0/277 (0.00%)  1/296 (0.34%)  1 0/260 (0.00%) 
Thrombosis  1  0/277 (0.00%)  1/296 (0.34%)  2 0/260 (0.00%) 
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%
Dapagliflozin 5 mg + Insulin Dapagliflozin 10 mg + Insulin Placebo + Insulin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   123/277 (44.40%)      118/296 (39.86%)      99/260 (38.08%)    
Gastrointestinal disorders       
Diarrhoea  1  11/277 (3.97%)  13 21/296 (7.09%)  25 9/260 (3.46%)  10
Nausea  1  14/277 (5.05%)  18 15/296 (5.07%)  20 7/260 (2.69%)  7
Infections and infestations       
Gastroenteritis  1  15/277 (5.42%)  16 10/296 (3.38%)  13 8/260 (3.08%)  10
Influenza  1  15/277 (5.42%)  18 15/296 (5.07%)  17 17/260 (6.54%)  23
Upper respiratory tract infection  1  19/277 (6.86%)  26 28/296 (9.46%)  36 15/260 (5.77%)  28
Urinary tract infection  1  27/277 (9.75%)  37 10/296 (3.38%)  12 19/260 (7.31%)  20
Viral upper respiratory tract infection  1  51/277 (18.41%)  67 46/296 (15.54%)  65 48/260 (18.46%)  66
Nervous system disorders       
Headache  1  14/277 (5.05%)  17 20/296 (6.76%)  27 13/260 (5.00%)  13
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
Layout table for Results Point of Contact information
Name/Title: Anna Maria Langkilde
Organization: AstraZenenca
Phone: +46 31 7761000
EMail: ClinicalTrialTransparency@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02268214     History of Changes
Other Study ID Numbers: MB102-229
2013-004674-97 ( EudraCT Number )
D1695C00006 ( Other Identifier: AstraZenenca )
First Submitted: October 15, 2014
First Posted: October 20, 2014
Results First Submitted: March 2, 2018
Results First Posted: March 29, 2018
Last Update Posted: September 13, 2018