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Type 1 Diabetes MellitusPhase 3DEPICT 2NCT02460978

Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes

A Phase 3 study testing Dapagliflozin in people with Type 1 Diabetes Mellitus, run by AstraZeneca at 136 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Dapagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
815 participants
Where
136 sitesin 13 countries
Study dates
8 Jul 2015to 18 Apr 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

136 sites in 13 countries.

136 sites in 13 countries

United States47 sites

  • Research Site

    Albany, New York, 12208

  • Research Site

    Albuquerque, New Mexico, 87109

  • Research Site

    Amarillo, Texas, 79106

  • Research Site

    Atlanta, Georgia, 30308

  • Research Site

    Atlanta, Georgia, 30318

  • Research Site

    Austin, Texas, 78731

  • Research Site

    Bennington, Vermont, 05201

  • Research Site

    Bradenton, Florida, 34201

  • Research Site

    Chicago, Illinois, 60607

  • Research Site

    Chicago, Illinois, 60611

  • Research Site

    Clearwater, Florida, 33756

  • Research Site

    Concord, California, 94520

  • Research Site

    Dallas, Texas, 75231

  • Research Site

    Des Moines, Iowa, 50314

  • Research Site

    Edina, Minnesota, 55435

  • Research Site

    Edinburg, Texas, 78539

  • Research Site

    Federal Way, Washington, 98003

  • Research Site

    Flushing, New York, 11355

  • Research Site

    Fort Lauderdale, Florida, 33312

  • Research Site

    Fresno, California, 93720

  • Research Site

    Golden, Colorado, 80401

  • Research Site

    Jacksonville, Florida, 32216

  • Research Site

    Jefferson City, Missouri, 65109

  • Research Site

    Kalamazoo, Michigan, 49008

  • Research Site

    Lexington, Kentucky, 40502

  • Research Site

    Lexington, Kentucky, 40503

  • Research Site

    Los Angeles, California, 90057

  • Research Site

    Mesquite, Texas, 74194

  • Research Site

    Miami, Florida, 33156

  • Research Site

    Miami Springs, Florida, 33166

  • Research Site

    Mineola, New York, 11501

  • Research Site

    New Hyde Park, New York, 11042

  • Research Site

    New York, New York, 10029

  • Research Site

    Newark, Delaware, 19713

  • Research Site

    Orange, California, 92868

  • Research Site

    Overland Park, Kansas, 66209

  • Research Site

    Philadelphia, Pennsylvania, 19107-4824

  • Research Site

    Reno, Nevada, 89511

  • Research Site

    Roswell, Georgia, 30076

  • Research Site

    San Antonio, Texas, 78229

  • Research Site

    San Antonio, Texas, 78258

  • Research Site

    San Mateo, California, 94401

  • Research Site

    San Ramon, California, 94583

  • Research Site

    St Louis, Missouri, 63110

  • Research Site

    St. Petersburg, Florida, 33709

  • Research Site

    Tampa, Florida, 33634

  • Research Site

    Walnut Creek, California, 94598

Other trials in United States

Japan29 sites

  • Research Site

    Aki-gun, 735-0021

  • Research Site

    Amagasaki-shi, 661-0002

  • Research Site

    Chitose-shi, 066-0032

  • Research Site

    Chūōku, 103-0002

  • Research Site

    Fukuyama-shi, 721-0927

  • Research Site

    Higashiosaka-shi, 577-0802

  • Research Site

    Ibusuki-shi, 891-0401

  • Research Site

    Kagoshima, 892-0824

  • Research Site

    Kamakura-shi, 247-0056

  • Research Site

    Kashiwara-shi, 582-0005

  • Research Site

    Kitakyushu-shi, 807-0857

  • Research Site

    Koriyama-shi, 963-8851

  • Research Site

    Kumamoto, 862-0976

  • Research Site

    Kurume-shi, 830-8543

  • Research Site

    Miura-shi, 238-0101

  • Research Site

    Nagoya, 455-8530

  • Research Site

    Obihiro-shi, 080-0016

  • Research Site

    Ōita, 870-0855

  • Research Site

    Osaka, 530-0001

  • Research Site

    Oyama-shi, 323-0022

  • Research Site

    Sapporo, 060-0001

  • Research Site

    Shibuya-ku, 150-0013

  • Research Site

    Shinjuku-ku, 169-0073

  • Research Site

    Shizuoka, 424-0855

  • Research Site

    Tsukuba, 305-0812

  • Research Site

    Ushiku-shi, 300-1207

  • Research Site

    Uwajima-shi, 798-8510

  • Research Site

    Yokohama, 231-8682

  • Research Site

    Yokohama, 235-0045

Other trials in Japan

Germany11 sites

  • Research Site

    Dresden, 1307

  • Research Site

    Essen, 45355

  • Research Site

    Falkensee, 14612

  • Research Site

    Freiburg im Breisgau, 79106

  • Research Site

    Hamburg, 22607

  • Research Site

    Heidelberg, 69115

  • Research Site

    Oldenburg, 23758

  • Research Site

    Pohlheim, 35415

  • Research Site

    Saarlouis, 66740

  • Research Site

    Sulzbach-Rosenberg, 92237

  • Research Site

    Wangen, 88239

Other trials in Germany

Poland9 sites

  • Research Site

    Bialystok, 15-351

  • Research Site

    Bialystok, 15-435

  • Research Site

    Gdansk, 80-546

  • Research Site

    Krakow, 31-156

  • Research Site

    Krakow, 31-261

  • Research Site

    Krakow, 31-501

  • Research Site

    Lublin, 20-044

  • Research Site

    Warsaw, 04736

  • Research Site

    Wroclaw, 51-685

Other trials in Poland

Argentina8 sites

  • Research Site

    Buenos Aires, 1180AAX

  • Research Site

    Buenos Aires, C1405BCH

  • Research Site

    CABA, 1056

  • Research Site

    Córdoba, 5000

  • Research Site

    Córdoba, X5006IKK

  • Research Site

    Corrientes, 3400

  • Research Site

    Mar del Plata, B7600FZN

  • Research Site

    Ramos Mejía, B1704ETD

Other trials in Argentina

Canada8 sites

  • Research Site

    Calgary, Alberta, T2V 4J2

  • Research Site

    Cambridge, Ontario, N1R 7L6

  • Research Site

    Edmonton, Alberta, T6G 2E1

  • Research Site

    Halifax, Nova Scotia, B3H 2Y9

  • Research Site

    Hamilton, Ontario, L8N 3Z5

  • Research Site

    Ottawa, Ontario, K1H 7W9

  • Research Site

    Sherbrooke, Quebec, J1H 5N4

  • Research Site

    Smiths Falls, Ontario, K7A 4W8

Other trials in Canada

United Kingdom5 sites

  • Research Site

    Manchester, M23 9LT

  • Research Site

    Northampton, NN1 5BD

  • Research Site

    Oldham, OL1 2JH

  • Research Site

    Swansea, SA2 8QA

  • Research Site

    Wakefield, WF1 4DG

Other trials in United Kingdom

Russia4 sites

  • Research Site

    Novosibirsk, 630091

  • Research Site

    Saint Petersburg, 191015

  • Research Site

    Saint Petersburg, 194354

  • Research Site

    Saint Petersburg, 199034

Other trials in Russia

Sweden4 sites

  • Research Site

    Gothenburg, 413 45

  • Research Site

    Helsingborg, 25220

  • Research Site

    Linköping, 587 58

  • Research Site

    Uddevalla, 451 80

Other trials in Sweden

Chile3 sites

  • Research Site

    Santiago, 7500010

  • Research Site

    Santiago, 8053095

  • Research Site

    Temuco, 4781156

Other trials in Chile

Netherlands3 sites

  • Research Site

    Hoogeveen, 7909 AA

  • Research Site

    Maastricht, 6020 AZ

  • Research Site

    Utrecht, 3584 CX

Other trials in Netherlands

Switzerland3 sites

  • Research Site

    Olten, 4600

  • Research Site

    Sankt Gallen, 9016

  • Research Site

    Zollikerberg, 8125

Other trials in Switzerland

Belgium2 sites

  • Research Site

    Brussels (Uccle), 1180

  • Research Site

    Leuven, 3000

Other trials in Belgium

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects With Type 1 Diabetes Mellitus - Study Two

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

Being tested
Dapagliflozin, Placebo for dapagliflozin
Keywords
Dapagliflozin, Efficacy, Safety, Add on to insulin, Oral Antidiabetic, Type 1 diabetes
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02460978
Study groupRoleWhat they receive
Dapagliflozin 5 mgExperimentalDapagliflozin 5 mg tablet orally, once daily for 52 weeks
Receives: Drug: Dapagliflozin
Dapagliflozin 10 mgExperimentalDapagliflozin 10 mg tablet orally, once daily for 52 weeks
Receives: Drug: Dapagliflozin
PlaceboPlacebo comparatorPlacebo tablet orally, once daily for 52 weeks
Receives: Other: Placebo for dapagliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline and 24 weeks

Secondary outcomes (6)

  1. 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

    Measured: Baseline and 24 weeks

  2. 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

    Measured: Baseline and 24 weeks

  3. 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

    Measured: Baseline and 24 weeks

  4. 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

    Measured: Baseline and 24 weeks

  5. 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

    Measured: Baseline and 24 weeks

  6. 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

    Measured: Baseline and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2015 (estimated)
  2. Study start8 Jul 2015
  3. Primary completion2 Sep 2017
  4. Study completion18 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
815 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02460978
Sponsor's protocol ID
MB102-230
Other IDs
2014-004599-49, D1695C00007, 2014
Acronym
DEPICT 2
Status last verified
Feb 2019
First submitted
1 Jun 2015
Last updated
5 Mar 2019
Data monitoring committee
Yes

Publications

  • Nardone M, Kugathasan L, Sridhar VS, Dutta P, Campbell DJT, Layton AT, Perkins BA, Barbour S, Lam TKT, Levin A, Lovblom LE, Mucsi I, Rabasa-Lhoret R, Rac VE, Senior P, Sigal RJ, Stanimirovic A, Persson F, Stougaard EB, Doria A, Cherney DZI. Modeling Cardiorenal Protection with Sodium-Glucose Cotransporter 2 Inhibition in Type 1 Diabetes: An Analysis of DEPICT-1 and DEPICT-2. Clin J Am Soc Nephrol. 2025 Apr 1;20(4):529-538. doi: 10.2215/CJN.0000000641. Epub 2025 Feb 7.

    PubMed 39918875

  • Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

    PubMed 38770818

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapagliflozin in people with Type 1 Diabetes Mellitus, run by AstraZeneca at 136 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 136 sites in United States, Japan, Germany, Poland, Argentina and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adjusted Mean Change From Baseline in HbA1c at Week 24 (time frame: Baseline and 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02460978, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.

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