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Type 1 Diabetes MellitusPhase 3DEPICT 1NCT02268214

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 131 sites in 17 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
833 participants
Where
131 sitesin 17 countries
Study dates
11 Nov 2014to 25 Aug 2017
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 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

Trial locations and contacts

131 sites in 17 countries.

131 sites in 17 countries

United States36 sites

  • Research Site

    Albany, New York, 12206

  • Research Site

    Amarillo, Texas, 79106

  • Research Site

    Asheville, North Carolina, 28803

  • Research Site

    Aurora, Colorado, 80045

  • Research Site

    Buffalo, New York, 14215

  • Research Site

    Chapel Hill, North Carolina, 27517

  • Research Site

    Chesterfield, Missouri, 63017

  • Research Site

    Cooper City, Florida, 33024

  • Research Site

    Dallas, Texas, 75230

  • Research Site

    Denver, Colorado, 80220

  • Research Site

    Des Moines, Iowa, 50314

  • Research Site

    Encino, California, 91436

  • Research Site

    Greenville, North Carolina, 27834

  • Research Site

    Houston, Texas, 77090

  • Research Site

    Hyattsville, Maryland, 20782

  • Research Site

    Idaho Falls, Idaho, 83404-7596

  • Research Site

    Jacksonville, Florida, 32258

  • Research Site

    Kalamazoo, Michigan, 49008

  • Research Site

    Kingsport, Tennessee, 37660

  • Research Site

    La Mesa, California, 91942

  • Research Site

    Langhorne, Pennsylvania, 19047

  • Research Site

    Las Vegas, Nevada, 89148

  • Research Site

    Little Rock, Arkansas, 72205

  • Research Site

    Louisville, Kentucky, 40213

  • Research Site

    Miami, Florida, 33136

  • Research Site

    Minneapolis, Minnesota, 55416

  • Research Site

    Morehead City, North Carolina, 28557

  • Research Site

    Nashville, Tennessee, 37212

  • Research Site

    Olympia, Washington, 98502

  • Research Site

    Port Orange, Florida, 32127

  • Research Site

    Portland, Maine, 04101

  • Research Site

    Rockville, Maryland, 20852

  • Research Site

    Salt Lake City, Utah, 84108

  • Research Site

    San Diego, California, 92161

  • Research Site

    Tarzana, California, 91356

  • Research Site

    Torrance, California, 90502

Other trials in United States

Germany12 sites

  • Research Site

    Aschaffenburg, 63739

  • Research Site

    Aßlar, 35614

  • Research Site

    Bad Oeynhausen, 32545

  • Research Site

    Falkensee, 14612

  • Research Site

    Munich, 80939

  • Research Site

    Münster, 48145

  • Research Site

    Neuwied, 56564

  • Research Site

    Oldenburg, 23758

  • Research Site

    Pohlheim, 35415

  • Research Site

    Schweinfurt, 97421

  • Research Site

    Sulzbach, 92237

  • Research Site

    Witten, 58455

Other trials in Germany

Mexico11 sites

  • Research Site

    Aguascalientes, 20230

  • Research Site

    Chihuahua City, 31237

  • Research Site

    Cuernavaca, 62250

  • Research Site

    Guadalajara, 44150

  • Research Site

    Mérida, 97070

  • Research Site

    México, 6090

  • Research Site

    Monterrey, 64020

  • Research Site

    Monterrey, 64460

  • Research Site

    Torreón, 27000

  • Research Site

    Zapopan, 45116

  • Research Site

    Zapopan, Jalisco, 45200

Other trials in Mexico

Australia7 sites

  • Research Site

    Concord, 2139

  • Research Site

    Daw Park, 5041

  • Research Site

    Fitzroy, 3065

  • Research Site

    Heidelberg West, 3081

  • Research Site

    Newcastle, 2291

  • Research Site

    Southport, 4215

  • Research Site

    Wollongong, 2500

Other trials in Australia

Italy7 sites

  • Research Site

    Florence, 50141

  • Research Site

    Milan, 20132

  • Research Site

    Padowa, 35100

  • Research Site

    Palermo, 90127

  • Research Site

    Ravenna, 48100

  • Research Site

    Sesto San Giovanni, 20099

  • Research Site

    Siena, 53100

Other trials in Italy

Hungary6 sites

  • Research Site

    Baja, 6500

  • Research Site

    Balatonfüred, 8230

  • Research Site

    Budapest, 1213

  • Research Site

    Létavértes, 4281

  • Research Site

    Szeged, 6726

  • Research Site

    Zalaegerszeg, 8900

Other trials in Hungary

Romania6 sites

  • Research Site

    Bucharest, 010825

  • Research Site

    Bucharest, 020045

  • Research Site

    Dolj, 200134

  • Research Site

    Galati, 800098

  • Research Site

    Iași, 700515

  • Research Site

    Timișoara, 300736

Other trials in Romania

United Kingdom6 sites

  • Research Site

    Belfast, BT12 6BA

  • Research Site

    Chesterfield, S40 4AA

  • Research Site

    Dundee, DD1 9SY

  • Research Site

    Nottingham, NG7 2UH

  • Research Site

    Sheffield, S5 7AU

  • Research Site

    Welwyn Garden City, AL7 4HQ

Other trials in United Kingdom

Austria5 sites

  • Research Site

    Innsbruck, 6020

  • Research Site

    Saint Stefan/Stainz, 8511

  • Research Site

    Vienna, 1060

  • Research Site

    Vienna, 1090

  • Research Site

    Vienna, 1130

Other trials in Austria

Finland5 sites

  • Research Site

    Helsinki, 00014

  • Research Site

    Jyväskylä, 40100

  • Research Site

    Kuopio, 70100

  • Research Site

    Oulu, 90100

  • Research Site

    Tampere, 33520

Other trials in Finland

France5 sites

  • Research Site

    Besançon, 25000

  • Research Site

    Corbeil-Essonnes, 91106

  • Research Site

    Dijon, 21000

  • Research Site

    Saint-Herblain, 44805

  • Research Site

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Israel5 sites

  • Research Site

    Haifa, 31096

  • Research Site

    Jerusalem, 91120

  • Research Site

    Safed, 13100

  • Research Site

    Tel Aviv, 61480

  • Research Site

    Tikva, 49202

Other trials in Israel

Spain5 sites

  • Research Site

    A Coruña, 15006

  • Research Site

    Almería, 04001

  • Research Site

    Barcelona, 08036

  • Research Site

    Seville, 41071

  • Research Site

    Valencia, 46009

Other trials in Spain

Canada4 sites

  • Research Site

    Laval, Quebec, H7T 2P5

  • Research Site

    London, Ontario, N6A 4V2

  • Research Site

    Vancouver, British Columbia, V5Y 3W2

  • Research Site

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Denmark4 sites

  • Research Site

    Arhus C, 8000

  • Research Site

    Esbjerg, 6700

  • Research Site

    Odense, 5000

  • Research Site

    Randers NØ, 8930

Other trials in Denmark

Sweden4 sites

  • Research Site

    Gothenburg, 413 45

  • Research Site

    Karlstad, 651 85

  • Research Site

    Lund, 22185

  • Research Site

    Uppsala, 75185

Other trials in Sweden

Belgium3 sites

  • Research Site

    Bonheiden, 2820

  • Research Site

    Leuven, 3000

  • Research Site

    Liège, B-4000

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

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 NCT02268214
Study groupRoleWhat they receive
Arm A: DapagliflozinExperimentalDapagliflozin 5 mg tablet orally, once daily for 52 weeks
Receives: Drug: Dapagliflozin
Arm B: DapagliflozinExperimentalDapagliflozin 10 mg tablet orally, once daily for 52 weeks
Receives: Drug: Dapagliflozin
Arm C: Placebo for DapagliflozinPlacebo comparatorPlacebo tablet orally, once daily for 52 weeks
Receives: Drug: Placebo for dapagliflozin

What is being measured

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

  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]).

    Measured: From Baseline to Week 24

Secondary outcomes (6)

  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])

    Measured: 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])

    Measured: 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])

    Measured: 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])

    Measured: 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])

    Measured: 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

    Measured: From Baseline to Week 24

Timeline

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

  1. First posted20 Oct 2014 (estimated)
  2. Study start11 Nov 2014
  3. Primary completion4 Jan 2017
  4. Study completion25 Aug 2017

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
833 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02268214
Sponsor's protocol ID
MB102-229
Other IDs
2013-004674-97, D1695C00006
Acronym
DEPICT 1
Status last verified
Aug 2018
First submitted
15 Oct 2014
Last updated
13 Sep 2018
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

  • 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.

    PubMed 28919061

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 131 sites in 17 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 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 131 sites in United States, Germany, Mexico, Australia, Italy and 12 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 29 Mar 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 in HbA1c From Baseline at Week 24 (time frame: From Baseline to Week 24). 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 NCT02268214, which also lists 8 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 13 Sep 2018.

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