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

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ClinicalTrials.gov Identifier: NCT02460978

Recruitment Status : Completed

First Posted : June 3, 2015

Results First Posted : November 6, 2018

Last Update Posted : March 5, 2019

View this study on Beta.ClinicalTrials.gov

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

Participant Flow

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
Arm/Group Description	Dapagliflozin 5 mg plus insulin	Dapagliflozin 10 mg plus insulin	Placebo plus insulin
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

Baseline Characteristics

Arm/Group Title		DAPA 5 MG + INS	DAPA 10 MG + INS	PLA + INS	Total
Arm/Group Description		Dapagliflozin 5 mg plus insulin	Dapagliflozin 10 mg plus insulin	Placebo plus insulin	Total of all reporting groups
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
Baseline Analysis Population Description		[Not Specified]
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

Outcome Measures

1.Primary Outcome


Title	Adjusted Mean Change From Baseline in HbA1c at Week 24
Description	To compare the change from baseline in HbA1c between dapagliflozin 5 m...
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

Outcome Measure Data

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
Arm/Group Description:	Dapagliflozin 5 mg plus insulin	Dapagliflozin 10 mg plus insulin	Placebo plus insulin
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)

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, weektreatment, and weekbaseline 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]

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, weektreatment, and weekbaseline 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
Description	To compare the percent change from baseline in total daily insulin dos...
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

Outcome Measure Data

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
Arm/Group Description:	Dapagliflozin 5 mg plus insulin	Dapagliflozin 10 mg plus insulin	Placebo plus insulin
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)

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, weektreatment, weekln(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]

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, weektreatment, and weekln(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
Description	To compare the percentage change from baseline in body weight with dap...
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

Outcome Measure Data

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
Arm/Group Description:	Dapagliflozin 5 mg plus insulin	Dapagliflozin 10 mg plus insulin	Placebo plus insulin
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)

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, weektreatment, and weekln(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]

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, weektreatment, and weekln(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
Description	To compare the change from baseline in mean value of 24-hour glucose r...
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

Outcome Measure Data

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
Arm/Group Description:	Dapagliflozin 5 mg plus insulin	Dapagliflozin 10 mg plus insulin	Placebo plus insulin
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)

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, weektreatment, and weekbaseline.

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]

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, weektreatment, and weekbaseline.

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
Description	To compare the change from baseline in mean amplitude of glucose excur...
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

Outcome Measure Data

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
Arm/Group Description:	Dapagliflozin 5 mg plus insulin	Dapagliflozin 10 mg plus insulin	Placebo plus insulin
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)

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, weektreatment, and weekbaseline.

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]

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, weektreatment, and weekbaseline.

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
Description	To compare the change from baseline in the percent of 24-hour glucose ...
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

Outcome Measure Data

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
Arm/Group Description:	Dapagliflozin 5 mg plus insulin	Dapagliflozin 10 mg plus insulin	Placebo plus insulin
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)

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, weektreatment, and weekbaseline.

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]

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, weektreatment, and weekbaseline.

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
Description	To compare dapagliflozin 5 mg or 10 mg plus adjustable insulin versus ...
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

Outcome Measure Data

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
Arm/Group Description:	Dapagliflozin 5 mg plus insulin	Dapagliflozin 10 mg plus insulin	Placebo plus insulin
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%

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]

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]

Adverse Events

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
Arm/Group Description	Dapagliflozin 5 mg plus insulin		Dapagliflozin 10 mg plus insulin		Placebo plus insulin
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%)
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

More Information

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:	AstraZeneca
Phone:	+46 31 7761000
EMail:	ClinicalTrialTransparency@astrazeneca.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Melin J, Tang W, Rekic D, Hamren B, Penland RC, Boulton DW, Parkinson J. Dapagliflozin Pharmacokinetics Is Similar in Adults With Type 1 and Type 2 Diabetes Mellitus. J Clin Pharmacol. 2022 Oct;62(10):1227-1235. doi: 10.1002/jcph.2062. Epub 2022 May 2.

Groop PH, Dandona P, Phillip M, Gillard P, Edelman S, Jendle J, Xu J, Scheerer MF, Thoren F, Iqbal N, Repetto E, Mathieu C. Effect of dapagliflozin as an adjunct to insulin over 52 weeks in individuals with type 1 diabetes: post-hoc renal analysis of the DEPICT randomised controlled trials. Lancet Diabetes Endocrinol. 2020 Oct;8(10):845-854. doi: 10.1016/S2213-8587(20)30280-1.

Mathieu C, Dandona P, Birkenfeld AL, Hansen TK, Iqbal N, Xu J, Repetto E, Scheerer MF, Thoren F, Phillip M. Benefit/risk profile of dapagliflozin 5 mg in the DEPICT-1 and -2 trials in individuals with type 1 diabetes and body mass index >/=27 kg/m2. Diabetes Obes Metab. 2020 Nov;22(11):2151-2160. doi: 10.1111/dom.14144. Epub 2020 Aug 20.

Parkinson J, Tang W, Astrand M, Melin J, Ekholm E, Hamren B, Boulton DW. Model-based characterization of the relationship between dapagliflozin systemic exposure and HbA1c response in patients with type 1 diabetes mellitus. Diabetes Obes Metab. 2019 Jun;21(6):1381-1387. doi: 10.1111/dom.13664. Epub 2019 Mar 14.

Mathieu C, Dandona P, Gillard P, Senior P, Hasslacher C, Araki E, Lind M, Bain SC, Jabbour S, Arya N, Hansen L, Thoren F, Langkilde AM; DEPICT-2 Investigators. Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes (the DEPICT-2 Study): 24-Week Results From a Randomized Controlled Trial. Diabetes Care. 2018 Sep;41(9):1938-1946. doi: 10.2337/dc18-0623. Epub 2018 Jul 19.

Layout table for additonal information

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT02460978
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

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