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CompletedNCT02268214DEPICT 1Updated Sep 13, 2018Results 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 131 sites in 17 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-09-13.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
833
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

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

02

Conditions studied

  • Type 1 Diabetes Mellitus

Keywords

  • Dapagliflozin
  • Efficacy
  • Safety
  • Add on to insulin
  • Oral Antidiabetic
  • Type 1 diabetes
03

In context

Diabetes Mellitus

10,926 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 833 is above the median of 80 across 8,368 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 358 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Browse AstraZeneca studies →

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

04

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 metformin and/or thiazolidinediones within 2 months prior to screening

  • Taking any antidiabetic medication (other than insulin), 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
  • 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
05

Study design

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

Study arms

  • Experimental
    Arm A: Dapagliflozin

    Dapagliflozin 5 mg tablet orally, once daily for 52 weeks

    Drug: Dapagliflozin

  • Experimental
    Arm B: Dapagliflozin

    Dapagliflozin 10 mg tablet orally, once daily for 52 weeks

    Drug: Dapagliflozin

  • Placebo comparator
    Arm C: Placebo for Dapagliflozin

    Placebo tablet orally, once daily for 52 weeks

    Drug: Placebo for dapagliflozin

Interventions

  • DrugDapagliflozin

    Tablets

  • DrugPlacebo for dapagliflozin

    Tablets

06

What researchers measure

Primary outcomes

  1. Adjusted Mean Change in HbA1c From Baseline at Week 24

    Adjusted mean change from baseline in HbA1c at Week 24 (Repeated Measures Model\[RMM\]).

    Time frame: From Baseline to Week 24

Secondary outcomes

  1. Adjusted Mean Percent Change in Total Daily Insulin Dose From Baseline at Week 24

    Adjusted mean change from baseline in Total Daily Insulin Dose at Week 24 (Repeated Measures Model\[RMM\])

    Time frame: From Baseline to Week 24

  2. Adjusted Mean Percent Change in Body Weight From Baseline at Week 24

    Adjusted mean percent change from baseline in body weight at Week 24 (Repeated Measures Model\[RMM\])

    Time frame: From Baseline to Week 24

  3. Adjusted Mean Change in 24-hour Mean Continuous Glucose Monitoring Glucose From Baseline at Week 24

    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

  4. Adjusted Mean Change in 24-hour Continuous Glucose Monitoring MAGE From Baseline at Week 24

    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

  5. Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) From Baseline at Week 24

    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

  6. Subjects With HbA1c Reduction From Baseline to Week 24 (LOCF) >= 0.5% and Without Severe Hypoglycemia Events

    Subjects with HbA1c reduction from baseline to week 24 (LOCF) \>= 0.5% and without severe hypoglycemia events

    Time frame: From Baseline to Week 24

07

Results

Posted Mar 29, 2018

Participant flow

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.

Participant flow — Overall Study
MilestoneDapagliflozin 5 mg + InsulinDapagliflozin 10 mg + InsulinPlacebo + Insulin
Started277296260
Completed 24 week period252273232
Completed235255218
Not completed424142
Withdrew: Subject no longer meets study criteria020
Withdrew: Pregnancy221
Withdrew: Lost to follow-up334
Withdrew: Lack of efficacy102
Withdrew: Adverse event11149
Withdrew: Withdrawal by subject4510
Withdrew: Subject request to discontinue treatment1086
Withdrew: Poor/non-compliance212
Withdrew: Other reasons733
Withdrew: Not entering long-term period235

Outcome measures

PrimaryAdjusted Mean Change in HbA1c From Baseline at Week 24

Adjusted mean change from baseline in HbA1c at Week 24 (Repeated Measures Model\[RMM\]).

Time frame:
From Baseline to Week 24
Reported as:
Least squares mean · Percentage of hemoglobin
Adjusted Mean Change in HbA1c From Baseline at Week 24
Percentage of hemoglobinDapagliflozin 5 mg + InsulinDapagliflozin 10 mg + InsulinPlacebo + Insulin
Adjusted Mean Change in HbA1c From Baseline at Week 24-0.45 ± 0.0537-0.47 ± 0.0538-0.03 ± 0.0540
Statistical analysis
  • Dapagliflozin 5 mg + Insulin vs Placebo + Insulin · RMM · p = <0.0001 · Mean difference (final values): -0.42 · 95% CI -0.56 to -0.28Repeated Measures Model
  • Dapagliflozin 10 mg + Insulin vs Placebo + Insulin · RMM · p = <0.0001 · Median difference (final values): -0.45 · 95% CI -0.58 to -0.31Repeated Measures Model
SecondaryAdjusted Mean Percent Change in Total Daily Insulin Dose From Baseline at Week 24

Adjusted mean change from baseline in Total Daily Insulin Dose at Week 24 (Repeated Measures Model\[RMM\])

Time frame:
From Baseline to Week 24
Reported as:
Least squares mean · IU
Adjusted Mean Percent Change in Total Daily Insulin Dose From Baseline at Week 24
IUDapagliflozin 5 mg + InsulinDapagliflozin 10 mg + InsulinPlacebo + Insulin
Adjusted Mean Percent Change in Total Daily Insulin Dose From Baseline at Week 24-7.74 ± 1.4881-12.16 ± 1.43261.16 ± 1.6593
Statistical analysis
  • Dapagliflozin 5 mg + Insulin vs Placebo + Insulin · RMM · p = <0.0001 · Mean difference (final values): -8.80 · 95% CI -12.56 to -4.88Repeated Measures Model
  • Dapagliflozin 10 mg + Insulin vs Placebo + Insulin · RMM · p = <0.0001 · Mean difference (final values): -13.17 · 95% CI -16.75 to -9.43Repeated Measures Model
SecondaryAdjusted Mean Percent Change in Body Weight From Baseline at Week 24

Adjusted mean percent change from baseline in body weight at Week 24 (Repeated Measures Model\[RMM\])

Time frame:
From Baseline to Week 24
Reported as:
Least squares mean · Kg
Adjusted Mean Percent Change in Body Weight From Baseline at Week 24
KgDapagliflozin 5 mg + InsulinDapagliflozin 10 mg + InsulinPlacebo + Insulin
Adjusted Mean Percent Change in Body Weight From Baseline at Week 24-3.00 ± 0.2330-3.67 ± 0.22990.05 ± 0.2407
Statistical analysis
  • Dapagliflozin 5 mg + Insulin vs Placebo + Insulin · RMM · p = <0.0001 · Mean difference (final values): -3.05 · 95% CI -3.68 to -2.41Repeated Measures Model
  • Dapagliflozin 10 mg + Insulin vs Placebo + Insulin · RMM · p = <0.0001 · Mean difference (final values): -3.72 · 95% CI -4.34 to -3.08Repeated Measures Model
SecondaryAdjusted Mean Change in 24-hour Mean Continuous Glucose Monitoring Glucose From Baseline at Week 24

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
Reported as:
Least squares mean · mg/dL
Adjusted Mean Change in 24-hour Mean Continuous Glucose Monitoring Glucose From Baseline at Week 24
mg/dLDapagliflozin 5 mg + InsulinDapagliflozin 10 mg + InsulinPlacebo + Insulin
Adjusted Mean Change in 24-hour Mean Continuous Glucose Monitoring Glucose From Baseline at Week 24-10.28 ± 1.8862-12.97 ± 1.92315.06 ± 1.9320
Statistical analysis
  • Dapagliflozin 5 mg + Insulin vs Placebo + Insulin · RMM · p = <0.0001 · Mean difference (final values): -15.34 · 95% CI -20.22 to -10.46Repeated Measures Model
  • Dapagliflozin 10 mg + Insulin vs Placebo + Insulin · RMM · p = <0.0001 · Mean difference (final values): -18.03 · 95% CI -22.95 to -13.11Repeated Measures Model
SecondaryAdjusted Mean Change in 24-hour Continuous Glucose Monitoring MAGE From Baseline at Week 24

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
Reported as:
Least squares mean · mg/dL
Adjusted Mean Change in 24-hour Continuous Glucose Monitoring MAGE From Baseline at Week 24
mg/dLDapagliflozin 5 mg + InsulinDapagliflozin 10 mg + InsulinPlacebo + Insulin
Adjusted Mean Change in 24-hour Continuous Glucose Monitoring MAGE From Baseline at Week 24-14.92 ± 1.9915-16.55 ± 2.04192.38 ± 2.0477
Statistical analysis
  • Dapagliflozin 5 mg + Insulin vs Placebo + Insulin · RMM · p = <0.0001 · Mean difference (final values): -17.30 · 95% CI -22.46 to -12.14Repeated Measures Model
  • Dapagliflozin 10 mg + Insulin vs Placebo + Insulin · RMM · p = <0.0001 · Mean difference (final values): -18.93 · 95% CI -24.13 to -13.73Repeated Measures Model
SecondaryAdjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) From Baseline at Week 24

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
Reported as:
Least squares mean · Percentage
Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) From Baseline at Week 24
PercentageDapagliflozin 5 mg + InsulinDapagliflozin 10 mg + InsulinPlacebo + Insulin
Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) From Baseline at Week 246.98 ± 0.88248.52 ± 0.9000-2.13 ± 0.9032
Statistical analysis
  • Dapagliflozin 5 mg + Insulin vs Placebo + Insulin · RMM · p = <0.0001 · Mean difference (final values): 9.11 · 95% CI 6.83 to 11.39Repeated Measures Model
  • Dapagliflozin 10 mg + Insulin vs Placebo + Insulin · RMM · p = <0.0001 · Mean difference (final values): 10.65 · 95% CI 8.35 to 12.94Repeated Measures Model
SecondarySubjects With HbA1c Reduction From Baseline to Week 24 (LOCF) >= 0.5% and Without Severe Hypoglycemia Events

Subjects with HbA1c reduction from baseline to week 24 (LOCF) \>= 0.5% and without severe hypoglycemia events

Time frame:
From Baseline to Week 24
Reported as:
Count of participants · Participants
Subjects With HbA1c Reduction From Baseline to Week 24 (LOCF) >= 0.5% and Without Severe Hypoglycemia Events
ParticipantsDapagliflozin 5 mg + InsulinDapagliflozin 10 mg + InsulinPlacebo + Insulin
Responders12712965
Statistical analysis
  • Dapagliflozin 5 mg + Insulin vs Placebo + Insulin · Regression, Logistic · p = <0.0001 · Odds ratio (or): 3.09 · 95% CI 2.10 to 4.56
  • Dapagliflozin 10 mg + Insulin vs Placebo + Insulin · Regression, Logistic · p = <0.0001 · Odds ratio (or): 3.29 · 95% CI 2.23 to 4.85

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Dapagliflozin 5 mg + Insulin0/277 (0%)37/277 (13.4%)123/277 (44.4%)
Dapagliflozin 10 mg + Insulin0/296 (0%)40/296 (13.5%)118/296 (39.9%)
Placebo + Insulin1/260 (0.4%)30/260 (11.5%)99/260 (38.1%)
Most frequent serious events
Showing 10 of 80
Most frequent serious events
EventDapagliflozin 5 mg + InsulinDapagliflozin 10 mg + InsulinPlacebo + Insulin
Diabetic ketoacidosisMetabolism and nutrition disorders10/2777/2963/260
HypoglycaemiaMetabolism and nutrition disorders2/2774/2963/260
KetoacidosisMetabolism and nutrition disorders2/2774/2960/260
Ankle fractureInjury, poisoning and procedural complications0/2771/2962/260
Vitreous haemorrhageEye disorders2/2770/2960/260
KetosisMetabolism and nutrition disorders2/2772/2960/260
Chest painGeneral disorders1/2772/2961/260
Angina pectorisCardiac disorders1/2770/2961/260
Hyperparathyroidism primaryEndocrine disorders0/2770/2961/260
OphthalmoplegiaEye disorders0/2770/2961/260
Most frequent other events
Most frequent other events
EventDapagliflozin 5 mg + InsulinDapagliflozin 10 mg + InsulinPlacebo + Insulin
Viral upper respiratory tract infectionInfections and infestations51/27746/29648/260
Urinary tract infectionInfections and infestations27/27710/29619/260
Upper respiratory tract infectionInfections and infestations19/27728/29615/260
DiarrhoeaGastrointestinal disorders11/27721/2969/260
HeadacheNervous system disorders14/27720/29613/260
InfluenzaInfections and infestations15/27715/29617/260
GastroenteritisInfections and infestations15/27710/2968/260
NauseaGastrointestinal disorders14/27715/2967/260

Baseline characteristics

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
Age, Continuous(Years)Dapagliflozin 5 mg + InsulinDapagliflozin 10 mg + InsulinPlacebo + InsulinTotal
Mean42.1 ± 13.9443.4 ± 13.8942.7 ± 13.5742.7 ± 13.80
Age, Customized
Age, Customized(Participants)Dapagliflozin 5 mg + InsulinDapagliflozin 10 mg + InsulinPlacebo + InsulinTotal
< 65 years262279246787
Between 65 and 75 years15161445
>= 75 years0101
Sex: Female, Male
Sex: Female, Male(Participants)Dapagliflozin 5 mg + InsulinDapagliflozin 10 mg + InsulinPlacebo + InsulinTotal
Female158144128430
Male119152132403
08

Study locations

131 sites
  • Research Site
    Little Rock, Arkansas 72205, United States
  • Research Site
    Encino, California 91436, United States
  • Research Site
    La Mesa, California 91942, United States
  • Research Site
    San Diego, California 92161, United States
  • Research Site
    Tarzana, California 91356, United States
  • Research Site
    Torrance, California 90502, United States
  • Research Site
    Aurora, Colorado 80045, United States
  • Research Site
    Denver, Colorado 80220, United States
  • Research Site
    Cooper City, Florida 33024, United States
  • Research Site
    Jacksonville, Florida 32258, United States
  • Research Site
    Miami, Florida 33136, United States
  • Research Site
    Port Orange, Florida 32127, United States
  • Research Site
    Idaho Falls, Idaho 83404-7596, United States
  • Research Site
    Des Moines, Iowa 50314, United States
  • Research Site
    Louisville, Kentucky 40213, United States
  • Research Site
    Portland, Maine 04101, United States
  • Research Site
    Hyattsville, Maryland 20782, United States
  • Research Site
    Rockville, Maryland 20852, United States
  • Research Site
    Kalamazoo, Michigan 49008, United States
  • Research Site
    Minneapolis, Minnesota 55416, United States
  • Research Site
    Chesterfield, Missouri 63017, United States
  • Research Site
    Las Vegas, Nevada 89148, United States
  • Research Site
    Albany, New York 12206, United States
  • Research Site
    Buffalo, New York 14215, United States
  • Research Site
    Asheville, North Carolina 28803, United States
  • Research Site
    Chapel Hill, North Carolina 27517, United States
  • Research Site
    Greenville, North Carolina 27834, United States
  • Research Site
    Morehead City, North Carolina 28557, United States
  • Research Site
    Langhorne, Pennsylvania 19047, United States
  • Research Site
    Kingsport, Tennessee 37660, United States
  • Research Site
    Nashville, Tennessee 37212, United States
  • Research Site
    Amarillo, Texas 79106, United States
  • Research Site
    Dallas, Texas 75230, United States
  • Research Site
    Houston, Texas 77090, United States
  • Research Site
    Salt Lake City, Utah 84108, United States
  • Research Site
    Olympia, Washington 98502, United States
  • Research Site
    Concord, 2139, Australia
  • Research Site
    Daw Park, 5041, Australia
  • Research Site
    Fitzroy, 3065, Australia
  • Research Site
    Heidelberg West, 3081, Australia
  • Research Site
    Newcastle, 2291, Australia
  • Research Site
    Southport, 4215, Australia
  • Research Site
    Wollongong, 2500, Australia
  • Research Site
    Innsbruck, 6020, Austria
  • Research Site
    Saint Stefan/Stainz, 8511, Austria
  • Research Site
    Wien, 1060, Austria
  • Research Site
    Wien, 1090, Austria
  • Research Site
    Wien, 1130, Austria
  • Research Site
    Bonheiden, 2820, Belgium
  • Research Site
    Leuven, 3000, Belgium
  • Research Site
    Liege, B-4000, Belgium
  • Research Site
    Vancouver, British Columbia V5Y 3W2, Canada
  • Research Site
    Winnipeg, Manitoba R3E 3P4, Canada
  • Research Site
    London, Ontario N6A 4V2, Canada
  • Research Site
    Laval, Quebec H7T 2P5, Canada
  • Research Site
    Arhus C, 8000, Denmark
  • Research Site
    Esbjerg, 6700, Denmark
  • Research Site
    Odense, 5000, Denmark
  • Research Site
    Randers NØ, 8930, Denmark
  • Research Site
    Helsinki, 00014, Finland
  • Research Site
    Jyvaskyla, 40100, Finland
  • Research Site
    Kuopio, 70100, Finland
  • Research Site
    Oulu, 90100, Finland
  • Research Site
    Tampere, 33520, Finland
  • Research Site
    Besançon Cedex, 25000, France
  • Research Site
    Corbeil-Essonnes, 91106, France
  • Research Site
    Dijon, 21000, France
  • Research Site
    SAINT HERBLAIN Cedex, 44805, France
  • Research Site
    Vandoeuvre les Nancy, 54500, France
  • Research Site
    Aschaffenburg, 63739, Germany
  • Research Site
    Aßlar, 35614, Germany
  • Research Site
    Bad Oeynhausen, 32545, Germany
  • Research Site
    Falkensee, 14612, Germany
  • Research Site
    Munich, 80939, Germany
  • Research Site
    Munster, 48145, Germany
  • Research Site
    Neuwied, 56564, Germany
  • Research Site
    Oldenburg, 23758, Germany
  • Research Site
    Pohlheim, 35415, Germany
  • Research Site
    Schweinfurt, 97421, Germany
  • Research Site
    Sulzbach, 92237, Germany
  • Research Site
    Witten, 58455, Germany
  • Research Site
    Baja, 6500, Hungary
  • Research Site
    Balatonfured, 8230, Hungary
  • Research Site
    Budapest, 1213, Hungary
  • Research Site
    Létavértes, 4281, Hungary
  • Research Site
    Szeged, 6726, Hungary
  • Research Site
    Zalaegerszeg, 8900, Hungary
  • Research Site
    Haifa, 31096, Israel
  • Research Site
    Jerusalem, 91120, Israel
  • Research Site
    Safed, 13100, Israel
  • Research Site
    Tel-Aviv, 61480, Israel
  • Research Site
    Tikva, 49202, Israel
  • Research Site
    Firenze, 50141, Italy
  • Research Site
    Milano, 20132, Italy
  • Research Site
    Padowa, 35100, Italy
  • Research Site
    Palermo, 90127, Italy
  • Research Site
    Ravenna, 48100, Italy
  • Research Site
    Sesto San Giovanni, 20099, Italy
  • Research Site
    Siena, 53100, Italy
  • Research Site
    Aguascalientes, 20230, Mexico

Showing the first 100 of 131 sites across 17 countries.

09

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 ↗
  • Dandona P, Mathieu C, Phillip M, Hansen L, Tschope D, Thoren F, Xu J, Langkilde AM; DEPICT-1 Investigators. Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes: The DEPICT-1 52-Week Study. Diabetes Care. 2018 Dec;41(12):2552-2559. doi: 10.2337/dc18-1087. Epub 2018 Oct 23. PubMed 30352894 ↗
  • Dandona P, Mathieu C, Phillip M, Hansen L, Griffen SC, Tschope D, Thoren F, Xu J, Langkilde AM; DEPICT-1 Investigators. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol. 2017 Nov;5(11):864-876. doi: 10.1016/S2213-8587(17)30308-X. Epub 2017 Sep 14. Erratum In: Lancet Diabetes Endocrinol. 2017 Dec;5(12):e8. doi: 10.1016/S2213-8587(17)30375-3. PubMed 28919061 ↗

Related links

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02268214
Lead sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Oct 20, 2014
Start date
Nov 11, 2014
Primary completion
Jan 4, 2017
Completion
Aug 25, 2017
Results posted
Mar 29, 2018
Last update
Sep 13, 2018

Study contacts

Anna Maria Langkilde
study director · AstraZeneca

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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