Study to Evaluate Safety and Efficacy of Dapagliflozin in Patients With Type 2 Diabetes Mellitus Aged 10-24 Years

A Phase 3 study testing Dapagliflozin in people with Type 2 Diabetes, run by AstraZeneca at 42 sites in 7 countries.

Completed

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

Trial summary

A trial of patients aged 10-24 years with type 2 diabetes mellitus to evaluate the comparative efficacy and safety between dapagliflozin and Placebo. Read more about this study

Who is it for?: Ages 10 to 24 years
Conditions the study is for: Type 2 Diabetes
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: 72 participants
Where: 42 sitesin 7 countries
Study dates: 22 Jun 2016to 6 Apr 2020
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 10 to 24 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Provision of informed consent prior to any study-specific procedures
Males and Females, ages 10 years of age, up to but not including 25 years of age at the time of randomization
Previously diagnosed as having type 2 diabetes for at least 2 months by WHO/ADA diagnostic criteria
HbA1c >= 6.5% and <= 11% obtained at screening visit
Currently on diet and exercise and a stable dose of metformin (at least 1000 mg daily) for a minimum of 8 weeks, or stable dose of insulin for a minimum of 8 weeks, or a stable combination of metformin (at least 1000 mg daily) and insulin for a minimum of 8 weeks prior to screening
FPG <=255 mg/dL (<= 14.2 mmol/L) obtained at screening visit

Who cannot join

Previous diagnosis of Type 1 diabetes
Diabetes ketoacidosis (DKA) within 6 months of screening
Current use of the following medications for the treatment of diabetes, or use within the specified timeframe prior to screening for the main study:
Eight weeks: sulfonylureas, alpha glucosidase inhibitors, metiglinide, or injectable incretins or incretin mimetics or other antidiabetes medications not otherwise specified
Sixteen weeks: thiazolidinediones
Any previous history or current use of an SGLT2 inhibitor, including dapagliflozin

Show all 19Show fewer

Initiation or discontinuation of prescription or non-prescription weight loss drugs within 8 weeks of screening.
Use of prescription or non-prescription weight loss drugs must be stable during the study
Pregnant, positive serum pregnancy test, planning to become pregnant during the clinical trials, or breastfeeding
History of unstable or rapidly progressive renal disease
History of unresolved vesico-ureteral reflux
Replacement or chronic systemic corticosteroid therapy, defined as any dose of systemic corticosteroid taken for > 4 weeks within 3 months prior to the Day 1 visit.
Note: Topical, nasal, or inhaled corticosteroids are allowed
Abnormal renal function, which is defined in subjects < 18 years of age as an estimated glomerular filtration rate (eGFR) calculated by the Schwartz Formula < 80 mL/min/1.73 m2 (1.33 mL/s), and in subjects >= 18 years as an estimated glomerular filtration rate (eGFR) calculated by the MDRD Formula < 60 mL/min/1.73 m2 (1.33 mL/s)
Presence of either: antibodies to glutamic acid decarboxylase (GAD) or protein tyrosine phosphatase-like protein antibodies (IA-2)
An abnormal TSH value at screening will be further evaluated for free T4. Subjects with abnormal free T4 values will be excluded
Hematuria (confirmed by microscopy at screening) with no explanation as judged by the investigator up to randomization
Anemia of any etiology defined as hemoglobin <=10.7 g/dL (107 g/L) for females and <= 11.3 g/dL (113 g/L) for males. Subjects who are considered to have anemia according to local guidelines should be excluded
Volume-depleted subjects. Subjects at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics, should carefully monitor their volume status

Trial locations and contacts

42 sites in 7 countries.

Country

City, postcode or hospital

42 sites in 7 countries

United States15 sites

Research Site
Boston, Massachusetts, 02215
Research Site
Buffalo, New York, 14222
Research Site
Columbus, Ohio, 43205
Research Site
Gainesville, Florida, 32610
Research Site
Greenville, South Carolina, 29615
Research Site
Homestead, Florida, 33032
Research Site
Lampasas, Texas, 76550
Research Site
McAllen, Texas, 78503
Research Site
Memphis, Tennessee, 38116
Research Site
Memphis, Tennessee, 38119
Research Site
Miami, Florida, 33015
Research Site
New Haven, Connecticut, 06514-3434
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
The Bronx, New York, 10467
Research Site
Washington D.C., District of Columbia, 20010

Other trials in United States

Russia10 sites

Research Site
Izhevsk, 426009
Research Site
Krasnoyarsk, 660022
Research Site
Moscow, 117036
Research Site
Novosibirsk, 630087
Research Site
Pyatigorsk, 357500
Research Site
Rostov-on-Don, 344022
Research Site
Saint Petersburg, 194100
Research Site
Samara, 443079
Research Site
Saratov, 410054
Research Site
Tomsk, 634050

Other trials in Russia

Mexico6 sites

Research Site
Culiacán, 80230
Research Site
Guadalajara, 44670
Research Site
Mérida, 97134
Research Site
México, D.F., 11410
Research Site
Monterrey, 64460
Research Site
Zapopan, 45116

Other trials in Mexico

Israel5 sites

Research Site
Beersheba, 84101
Research Site
Haifa, 91096
Research Site
Jerusalem, 91120
Research Site
Ramat Gan, 5265601
Research Site
Tsrifin, 70300

Other trials in Israel

Hungary2 sites

Research Site
Budapest, 1023
Research Site
Nyíregyháza, 4400

Other trials in Hungary

Romania2 sites

Research Site
Oradea, 410169
Research Site
Timișoara, 300011

Other trials in Romania

United Kingdom2 sites

Research Site
Kent, CT9 4AN
Research Site
Leicester, LE15WW

Other trials in United Kingdom

About this study

Official title: A 24 Week, Multicenter, Randomized, Double-Blind, Parallel Group, Phase 3 Trial With a 28 Week Long Term Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 10 mg in T2DM Patients Aged 10-24 Years

A trial of patients aged 10-24 years with type 2 diabetes mellitus to evaluate the comparative efficacy and safety between dapagliflozin and Placebo.

Read the detailed description

A 24 Week, Multicenter, Randomized, Double-Blind, Parallel Group, Phase 3 Trial with a 28 Week Long Term Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 10 mg in T2DM Patients aged 10-24 years

Conditions: Type 2 Diabetes
Being tested: Dapagliflozin, Dapagliflozin placebo
Keywords: Diabetes Mellitus, Dapagliflozin, Placebo, Insulin resistance, Metabolic Diseases
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance, Metabolic Diseases

What participants receive

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

DapagliflozinDrug
Also called FORXIGA
Dapagliflozin 10 mg tablets administered orally once daily, for the 24-week blinded treatment period. Dapagliflozin 10mg tablets administered orally once daily, for the 28-week site and subject blinded long term extension.
Dapagliflozin placeboDrug
matching placebo tablets, administered orally once daily, for the 24-week blinded treatment period. Dapagliflozin 10mg tablets administered orally once daily,for the 28-week site and subject blinded long term extension.

Study groups in NCT02725593
Study group	Role	What they receive
Dapagliflozin	Experimental	Not described Receives: Drug: Dapagliflozin
Dapagliflozin placebo	Placebo comparator	Not described Receives: Drug: Dapagliflozin placebo

What is being measured

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

Adjusted Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 24
Measured: Baseline to Week 24

Secondary outcomes (3)

Adjusted Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Measured: Baseline to Week 24
Percentage of Participants Who Required Glycemic Rescue Medication or Permanently Discontinued Treatment Due to Lack of Glycemic Control
Measured: Baseline to Week 24
Percentage of Participants With Baseline Glycated Haemoglobin (HbA1c) >= 7% Who Achieved HbA1c Level < 7% at Week 24
Measured: 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.

22 Jun 20166 Apr 2020

First posted1 Apr 2016 (estimated)
Study start22 Jun 2016
Primary completion6 Apr 2020
Study completion6 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02725593
Sponsor's protocol ID: D1690C00017
Other IDs: 2015-005041-31, 2015
Status last verified: Jan 2022
First submitted: 29 Mar 2016
Last updated: 23 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Publications

Tamborlane WV, Laffel LM, Shehadeh N, Isganaitis E, Van Name M, Ratnayake J, Karlsson C, Norjavaara E. Efficacy and safety of dapagliflozin in children and young adults with type 2 diabetes: a prospective, multicentre, randomised, parallel group, phase 3 study. Lancet Diabetes Endocrinol. 2022 May;10(5):341-350. doi: 10.1016/S2213-8587(22)00052-3. Epub 2022 Apr 1.
PubMed 35378069

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 24 Week, Multicenter, Randomized, Double-Blind, Parallel Group, Phase 3 Trial With a 28 Week Long Term Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 10 mg in T2DM Patients Aged 10-24 Years
ClinicalTrials.gov ID: NCT02725593
Acronym / sponsor ID: D1690C00017
Conditions: Type 2 Diabetes
Keywords: Diabetes Mellitus, Dapagliflozin, Placebo, Insulin resistance, Metabolic Diseases
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Parexel, Q2 Solutions, PRA Health Sciences, Covance
Study start: 22 Jun 2016 (actual)
Primary completion: 6 Apr 2020 (actual)
Study completion: 6 Apr 2020 (actual)
First posted: 1 Apr 2016 (estimated)
Results: Posted 2 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A trial of patients aged 10-24 years with type 2 diabetes mellitus to evaluate the comparative efficacy and safety between dapagliflozin and Placebo.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Dapagliflozin	Experimental	Drug: Dapagliflozin
Dapagliflozin placebo	Placebo comparator	Drug: Dapagliflozin placebo

Who may qualify

Ages: 10 to 24 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

Provision of informed consent prior to any study-specific procedures
Males and Females, ages 10 years of age, up to but not including 25 years of age at the time of randomization
Previously diagnosed as having type 2 diabetes for at least 2 months by WHO/ADA diagnostic criteria
HbA1c >= 6.5% and <= 11% obtained at screening visit
Currently on diet and exercise and a stable dose of metformin (at least 1000 mg daily) for a minimum of 8 weeks, or stable dose of insulin for a minimum of 8 weeks, or a stable combination of metformin (at least 1000 mg daily) and insulin for a minimum of 8 weeks prior to screening

Key exclusion criteria (19 listed)

Previous diagnosis of Type 1 diabetes
Diabetes ketoacidosis (DKA) within 6 months of screening
Current use of the following medications for the treatment of diabetes, or use within the specified timeframe prior to screening for the main study:
Initiation or discontinuation of prescription or non-prescription weight loss drugs within 8 weeks of screening.
Use of prescription or non-prescription weight loss drugs must be stable during the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DapagliflozinAlso: FORXIGADapagliflozin 10 mg tablets administered orally once daily, for the 24-week blinded treatment period. Dapagliflozin 10mg tablets administered orally once daily, for the 28-week site and subject blinded long term extension.	Drug	Dapagliflozin
Dapagliflozin placebomatching placebo tablets, administered orally once daily, for the 24-week blinded treatment period. Dapagliflozin 10mg tablets administered orally once daily,for the 28-week site and subject blinded long term extension.	Drug	Dapagliflozin placebo

Primary outcome

Adjusted Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 24
Time frame: Baseline to Week 24

3 secondary outcomes

Adjusted Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Time frame: Baseline to Week 24
Percentage of Participants Who Required Glycemic Rescue Medication or Permanently Discontinued Treatment Due to Lack of Glycemic Control
Time frame: Baseline to Week 24
Percentage of Participants With Baseline Glycated Haemoglobin (HbA1c) >= 7% Who Achieved HbA1c Level < 7% at Week 24
Time frame: Baseline to Week 24

Results and safety

Results posted to the registry on 2 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dapagliflozin 10mg/ Dapagliflozin 10mg	39	34
Placebo/ Dapagliflozin 10mg	33	27

Primary outcome: Adjusted Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 24

Time frame: Baseline to Week 24. Least squares mean (Standard Error). Unit: Percentage of HbA1c

Measure	Dapagliflozin 10mg/ Dapagliflozin 10mg n = 31	Placebo/ Dapagliflozin 10mg n = 23
Value	-0.25 (0.30)	0.50 (0.34)

Dapagliflozin 10mg/ Dapagliflozin 10mg vs Placebo/ Dapagliflozin 10mg: Mean Difference (Final Values): -0.75 (95% CI -1.65 to 0.15), p = 0.101, Mixed model repeated measures analysis

Population analysed: Full analysis set: All participants who were randomized and assigned to a treatment group, with baseline and at least one-post baseline value, prior to rescue therapy initiation or discontinuation from study treatment.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to a maximum of 56 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dapagliflozin 10mg/ Dapagliflozin 10mg	2 of 39 (5.1%)	24 of 39 (61.5%)	0 of 39
Placebo/ Dapagliflozin 10mg	3 of 33 (9.1%)	19 of 33 (57.6%)	0 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35378069Tamborlane WV, Laffel LM, Shehadeh N, Isganaitis E, Van Name M, Ratnayake J, Karlsson C, Norjavaara E. Efficacy and safety of dapagliflozin in children and young adults with type 2 diabetes: a prospective, multicentre, randomised, parallel group, phase 3 study. Lancet Diabetes Endocrinol. 2022 May;10(5):341-350. doi: 10.1016/S2213-8587(22)00052-3. Epub 2022 Apr 1.
D1690C00017\_CSP\_redactedLink provided by the sponsor.
D1690C00017\_SAP\_redactedLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

42 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapagliflozin in people with Type 2 Diabetes, run by AstraZeneca at 42 sites in 7 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 6 inclusion and 19 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 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Russia, Mexico, Israel, Hungary and 2 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 2 Dec 2020). 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 Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 24 (time frame: 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 NCT02725593, which also lists 1 linked publication.

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 23 Feb 2022.