CompletedNCT02460978DEPICT 2Updated Mar 5, 2019Results posted

Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes

A Phase 3 interventional study of Dapagliflozin and Placebo for dapagliflozin in Type 1 Diabetes Mellitus, sponsored by AstraZeneca. Completed at 137 sites in 13 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-03-05.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 815
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.

Read the detailed description

Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics

Conditions studied

Type 1 Diabetes Mellitus

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Keywords

Dapagliflozin
Efficacy
Safety
Add on to insulin
Oral Antidiabetic
Type 1 diabetes

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 815 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Diagnosis of Type 1 Diabetes mellitus (T1DM)
Central laboratory C-peptide \< 0.7 ng/ml (0.23 nmol/L)
Insulin use for at least 12 months per patient reported or medical records
Method of insulin administration (MDI or CSII) must have been unchanged for at least 3 months prior to screening
Subjects must be on a total insulin dose of ≥ 0.3 U/kg/day for at least 3 months prior to screening
If on MDI insulin administration, subject must be on ≥ 3x injections per day
Screening Visit: Central laboratory HbA1c ≥ 7.7% and ≤ 11.0%
Body mass index (BMI) ≥ 18.5 kg/m2

Exclusion criteria

Exclusion Criteria:

History of Type 2 Diabetes mellitus (T2DM) or maturity onset diabetes of the young (MODY), pancreatic surgery, or chronic pancreatitis that could result in decreased beta cell capacity
Taking any non-insulin antihyperglicemic agent within 1 month prior to screening
Taking GLP-1 receptor agonist within 2 months prior to screening for once weekly administration and within 1 month prior to screening for once or twice daily administration
Taking metformin and/or thiazolidinediones within 2 months prior to screening
History of diabetes ketoacidosis requiring medical intervention within 1 month prior to screening
History of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 1 month prior to screening
Frequent episodes of severe hypoglycemia (more than one episode requiring medical assistance, emergency care), and/or glucagon therapy administered by a third-party individual within 1 month prior to screening
History of Addison's disease

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 815 participants (actual)

Study arms

Experimental
Dapagliflozin 5 mg
Dapagliflozin 5 mg tablet orally, once daily for 52 weeks
Drug: Dapagliflozin
Experimental
Dapagliflozin 10 mg
Dapagliflozin 10 mg tablet orally, once daily for 52 weeks
Drug: Dapagliflozin
Placebo comparator
Placebo
Placebo tablet orally, once daily for 52 weeks
Other: Placebo for dapagliflozin

Interventions

DrugDapagliflozin
Tablets
OtherPlacebo for dapagliflozin
Tablets

What researchers measure

Primary outcomes

Adjusted Mean Change From Baseline in HbA1c at Week 24
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

Secondary outcomes

Adjusted Mean Percentage Change From Baseline in Total Daily Insulin Dose at Week 24
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
Adjusted Mean Percentage Change From Baseline in Body Weight at Week 24
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
Adjusted Mean Change From Baseline in 24-hour Continuous Glucose Monitoring (CGM) Mean Value at Week 24
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
Adjusted Mean Change From Baseline in 24-hour CGM Mean Amplitude of Glycemic Excursion (MAGE) Value at Week 24
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
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
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
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
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

Results

Posted Nov 6, 2018

Participant flow

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.

Participant flow — Overall Study
Milestone	DAPA 5 MG + INS	DAPA 10 MG + INS	PLA + INS
Started	271	270	272
Completed	244	245	239
Not completed	27	25	33
Withdrew: Adverse event	17	11	11
Withdrew: Withdrawal by subject	5	5	14
Withdrew: Lost to follow-up	2	3	1
Withdrew: Protocol violation	1	1	1
Withdrew: Discontinued due to dka/hypoglycemia	2	5	4
Withdrew: Pregnancy	0	0	2

Outcome measures

PrimaryAdjusted Mean Change From Baseline in HbA1c at Week 24

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
Reported as:: Least squares mean · HbA1c (%)

Adjusted Mean Change From Baseline in HbA1c at Week 24
HbA1c (%)	DAPA 5 MG + INS	DAPA 10 MG + INS	PLA + INS
Adjusted Mean Change From Baseline in HbA1c at Week 24	-0.34 (-0.43 to -0.25)	-0.39 (-0.48 to -0.30)	0.03 (-0.06 to 0.12)

Statistical analysis

DAPA 5 MG + INS vs PLA + INS · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -0.37 · 95% CI -0.49 to -0.26Model is adjusted for baseline HbA1c, treatment, week, randomization stratum, week\*treatment, and week\*baseline HbA1c.
DAPA 10 MG + INS vs PLA + INS · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -0.42 · 95% CI -0.53 to -0.30Model is adjusted for baseline HbA1c, treatment, week, randomization stratum, week\*treatment, and week\*baseline HbA1c.

SecondaryAdjusted Mean Percentage Change From Baseline in Total Daily Insulin Dose at Week 24

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
Reported as:: Least squares mean · Percentage change

Adjusted Mean Percentage Change From Baseline in Total Daily Insulin Dose at Week 24
Percentage change	DAPA 5 MG + INS	DAPA 10 MG + INS	PLA + INS
Adjusted Mean Percentage Change From Baseline in Total Daily Insulin Dose at Week 24	-8.73 (-11.09 to -6.31)	-9.05 (-11.43 to -6.60)	2.29 (-0.41 to 5.06)

Statistical analysis

DAPA 5 MG + INS vs PLA + INS · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -10.78 · 95% CI -13.73 to -7.72Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, week\*ln(baseline).
DAPA 10 MG + INS vs PLA + INS · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -11.08 · 95% CI -14.04 to -8.02Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, and week\*ln(baseline).

SecondaryAdjusted Mean Percentage Change From Baseline in Body Weight at Week 24

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
Reported as:: Least squares mean · Percentage change

Adjusted Mean Percentage Change From Baseline in Body Weight at Week 24
Percentage change	DAPA 5 MG + INS	DAPA 10 MG + INS	PLA + INS
Adjusted Mean Percentage Change From Baseline in Body Weight at Week 24	-3.22 (-3.76 to -2.69)	-3.76 (-4.29 to -3.22)	-0.02 (-0.57 to 0.54)

Statistical analysis

DAPA 5 MG + INS vs PLA + INS · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -3.21 · 95% CI -3.96 to -2.45Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, and week\*ln(baseline).
DAPA 10 MG + INS vs PLA + INS · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -3.74 · 95% CI -4.49 to -2.99Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, and week\*ln(baseline).

SecondaryAdjusted Mean Change From Baseline in 24-hour Continuous Glucose Monitoring (CGM) Mean Value at Week 24

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
Reported as:: Least squares mean · mg/dL

Adjusted Mean Change From Baseline in 24-hour Continuous Glucose Monitoring (CGM) Mean Value at Week 24
mg/dL	DAPA 5 MG + INS	DAPA 10 MG + INS	PLA + INS
Adjusted Mean Change From Baseline in 24-hour Continuous Glucose Monitoring (CGM) Mean Value at Week 24	-6.46 (-10.04 to -2.87)	-10.54 (-14.14 to -6.94)	9.20 (5.57 to 12.83)

Statistical analysis

DAPA 5 MG + INS vs PLA + INS · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -15.66 · 95% CI -20.26 to -11.05Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.
DAPA 10 MG + INS vs PLA + INS · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -19.74 · 95% CI -24.34 to -15.14Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.

SecondaryAdjusted Mean Change From Baseline in 24-hour CGM Mean Amplitude of Glycemic Excursion (MAGE) Value at Week 24

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
Reported as:: Least squares mean · mg/dL

Adjusted Mean Change From Baseline in 24-hour CGM Mean Amplitude of Glycemic Excursion (MAGE) Value at Week 24
mg/dL	DAPA 5 MG + INS	DAPA 10 MG + INS	PLA + INS
Adjusted Mean Change From Baseline in 24-hour CGM Mean Amplitude of Glycemic Excursion (MAGE) Value at Week 24	-10.17 (-13.90 to -6.45)	-9.68 (-13.44 to -5.93)	-0.33 (-4.12 to 3.46)

Statistical analysis

DAPA 5 MG + INS vs PLA + INS · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -9.85 · 95% CI -14.66 to -5.03Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.
DAPA 10 MG + INS vs PLA + INS · Mixed Models Analysis · p = 0.0001 · Mean difference (final values): -9.36 · 95% CI -14.16 to -4.55Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.

SecondaryChange 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

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
Reported as:: Least squares mean · % of readings

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
% of readings	DAPA 5 MG + INS	DAPA 10 MG + INS	PLA + INS
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	5.92 (4.32 to 7.52)	7.60 (5.98 to 9.21)	-3.10 (-4.73 to -1.47)

Statistical analysis

DAPA 5 MG + INS vs PLA + INS · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): 9.02 · 95% CI 6.97 to 11.06Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.
DAPA 10 MG + INS vs PLA + INS · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): 10.70 · 95% CI 8.66 to 12.74Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.

SecondaryPercentage 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

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
Reported as:: Count of participants · Participants

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
Participants	DAPA 5 MG + INS	DAPA 10 MG + INS	PLA + INS
Number of Responders	105	111	54

Statistical analysis

DAPA 5 MG + INS vs PLA + INS · Regression, Logistic · p = <0.0001 · Odds ratio (or): 2.71 · 95% CI 1.81 to 4.06Adjusted for baseline HbA1c and randomization strata
DAPA 10 MG + INS vs PLA + INS · Regression, Logistic · p = <0.0001 · Odds ratio (or): 3.07 · 95% CI 2.05 to 4.60Adjusted for baseline HbA1c and randomization strata

Adverse events

Collected over 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).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
DAPA 5 MG + INS	0/271 (0%)	18/271 (6.6%)	79/271 (29.2%)
DAPA 10 MG + INS	0/270 (0%)	7/270 (2.6%)	77/270 (28.5%)
PLA + INS	0/272 (0%)	5/272 (1.8%)	63/272 (23.2%)

Most frequent serious events

Showing 10 of 30

Most frequent serious events
Event	DAPA 5 MG + INS	DAPA 10 MG + INS	PLA + INS
Diabetic ketoacidosisMetabolism and nutrition disorders	7/271	3/270	0/272
HypoglycemiaMetabolism and nutrition disorders	3/271	0/270	1/272
Hypoglycaemic seizureNervous system disorders	2/271	0/270	0/272
Cerebral haemorrhageNervous system disorders	0/271	1/270	0/272
ComaNervous system disorders	0/271	1/270	0/272
Diabetic hyperglycaemic comaNervous system disorders	0/271	1/270	0/272
SeizureNervous system disorders	0/271	1/270	0/272
Femur fractureInjury, poisoning and procedural complications	0/271	1/270	0/272
Subarachnoid haemorrhageInjury, poisoning and procedural complications	0/271	1/270	0/272
Cardiac arrestCardiac disorders	0/271	1/270	0/272

Most frequent other events

Most frequent other events
Event	DAPA 5 MG + INS	DAPA 10 MG + INS	PLA + INS
Viral upper respiratory tract infectionInfections and infestations	39/271	44/270	42/272
PollakiuriaRenal and urinary disorders	22/271	14/270	6/272
Upper respiratory tract infectionInfections and infestations	16/271	12/270	12/272
HeadacheNervous system disorders	10/271	15/270	10/272
ThirstGeneral disorders	6/271	14/270	1/272

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	DAPA 5 MG + INS	DAPA 10 MG + INS	PLA + INS	Total
Mean	42.7 ± 13.35	42.4 ± 12.80	43.0 ± 13.73	42.7 ± 13.29

Sex: Female, Male
Sex: Female, Male(Participants)	DAPA 5 MG + INS	DAPA 10 MG + INS	PLA + INS	Total
Female	153	149	153	455
Male	118	121	119	358

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	DAPA 5 MG + INS	DAPA 10 MG + INS	PLA + INS	Total
White	210	219	208	637
Black or African-American	4	7	1	12
Asian	57	44	59	160
Other	0	0	4	4

Study locations

137 sites

Research Site
Concord, California 94520, United States
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Fresno, California 93720, United States
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Los Angeles, California 90057, United States
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Orange, California 92868, United States
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San Mateo, California 94401, United States
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San Ramon, California 94583, United States
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Walnut Creek, California 94598, United States
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Golden, Colorado 80401, United States
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Newark, Delaware 19713, United States
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Bradenton, Florida 34201, United States
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Clearwater, Florida 33756, United States
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Fort Lauderdale, Florida 33312, United States
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Jacksonville, Florida 32216, United States
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Miami Springs, Florida 33166, United States
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Miami, Florida 33156, United States
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Saint Petersburg, Florida 33709, United States
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Tampa, Florida 33634, United States
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Atlanta, Georgia 30308, United States
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Atlanta, Georgia 30318, United States
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Roswell, Georgia 30076, United States
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Chicago, Illinois 60607, United States
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Chicago, Illinois 60611, United States
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Des Moines, Iowa 50314, United States
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Overland Park, Kansas 66209, United States
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Lexington, Kentucky 40502, United States
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Lexington, Kentucky 40503, United States
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Kalamazoo, Michigan 49008, United States
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Edina, Minnesota 55435, United States
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Jefferson City, Missouri 65109, United States
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Saint Louis, Missouri 63110, United States
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Reno, Nevada 89511, United States
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Albuquerque, New Mexico 87109, United States
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Albany, New York 12208, United States
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Flushing, New York 11355, United States
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Mineola, New York 11501, United States
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New Hyde Park, New York 11042, United States
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New York, New York 10029, United States
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Philadelphia, Pennsylvania 19107-4824, United States
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Amarillo, Texas 79106, United States
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Austin, Texas 78731, United States
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Dallas, Texas 75231, United States
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Edinburg, Texas 78539, United States
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Mesquite, Texas 74194, United States
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San Antonio, Texas 78229, United States
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San Antonio, Texas 78258, United States
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Bennington, Vermont 05201, United States
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Federal Way, Washington 98003, United States
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Buenos Aires, 1180AAX, Argentina
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Buenos Aires, C1405BCH, Argentina
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Caba, 1056, Argentina
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Cordoba, 5000, Argentina
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Cordoba, X5006IKK, Argentina
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Corrientes, 3400, Argentina
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Mar del Plata, B7600FZN, Argentina
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Ramos Mejía, B1704ETD, Argentina
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Brussels (Uccle), 1180, Belgium
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Leuven, 3000, Belgium
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Calgary, Alberta T2V 4J2, Canada
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Edmonton, Alberta T6G 2E1, Canada
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Halifax, Nova Scotia B3H 2Y9, Canada
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Cambridge, Ontario N1R 7L6, Canada
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Hamilton, Ontario L8N 3Z5, Canada
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Ottawa, Ontario K1H 7W9, Canada
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Smiths Falls, Ontario K7A 4W8, Canada
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Sherbrooke, Quebec J1H 5N4, Canada
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Santiago, 7500010, Chile
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Santiago, 8053095, Chile
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Temuco, 4781156, Chile
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Dresden, 1307, Germany
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Essen, 45355, Germany
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Falkensee, 14612, Germany
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Freiburg im Breisgau, 79106, Germany
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Hamburg, 22607, Germany
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Heidelberg, 69115, Germany
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Oldenburg, 23758, Germany
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Pohlheim, 35415, Germany
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Saarlouis, 66740, Germany
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Sulzbach-Rosenberg, 92237, Germany
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Wangen, 88239, Germany
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Aki-gun, 735-0021, Japan
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Amagasaki-shi, 661-0002, Japan
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Chitose-shi, 066-0032, Japan
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Chuo-ku, 103-0002, Japan
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Fukuyama-shi, 721-0927, Japan
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Higashiosaka-shi, 577-0802, Japan
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Ibusuki-shi, 891-0401, Japan
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Kagoshima-shi, 892-0824, Japan
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Kamakura-shi, 247-0056, Japan
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Kashiwara-shi, 582-0005, Japan
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Kitakyushu-shi, 807-0857, Japan
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Koriyama-shi, 963-8851, Japan
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Kumamoto-shi, 862-0976, Japan
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Kurume-shi, 830-8543, Japan
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Miura-shi, 238-0101, Japan
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Nagoya-shi, 455-8530, Japan
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Obihiro-shi, 080-0016, Japan
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Oita-shi, 870-0855, Japan
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Osaka-shi, 530-0001, Japan
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Oyama-shi, 323-0022, Japan
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Sapporo-shi, 060-0001, Japan

Showing the first 100 of 137 sites across 13 countries.

References and documents

Publications

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. PubMed 35403243 ↗
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. PubMed 32946821 ↗
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. PubMed 32691513 ↗
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. PubMed 30756462 ↗
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. PubMed 30026335 ↗

Study documents

Statistical analysis plan · Sep 22, 2017
Study protocol · May 18, 2016

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02460978
Lead sponsor: AstraZeneca
Collaborators: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: Jun 3, 2015
Start date: Jul 8, 2015
Primary completion: Sep 2, 2017
Completion: Apr 18, 2018
Results posted: Nov 6, 2018
Last update: Mar 5, 2019

Study contacts

Anna Maria Langkilde, MD

study director · AstraZeneca

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes

Study summary

Conditions studied

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Keywords

In context

Diabetes Mellitus

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Related links

Study documents

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

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Inclusion criteria

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