NCT02725593

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at below P25 for phase_3 type-2-diabetes

Timeline
Completed

Started Jun 2016

Longer than P75 for phase_3 type-2-diabetes

Geographic Reach
7 countries

42 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

June 22, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2020

Completed
8 months until next milestone

Results Posted

Study results publicly available

December 2, 2020

Completed
Last Updated

February 23, 2022

Status Verified

January 1, 2022

Enrollment Period

3.8 years

First QC Date

March 29, 2016

Results QC Date

October 2, 2020

Last Update Submit

January 28, 2022

Conditions

Type 2 Diabetes

Keywords

Diabetes MellitusDapagliflozinPlaceboInsulin resistanceMetabolic Diseases

Outcome Measures

Primary Outcomes (1)

  • Adjusted Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 24

    Baseline to Week 24

Secondary Outcomes (3)

  • Adjusted Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

    Baseline to Week 24

  • Percentage of Participants Who Required Glycemic Rescue Medication or Permanently Discontinued Treatment Due to Lack of Glycemic Control

    Baseline to Week 24

  • Percentage of Participants With Baseline Glycated Haemoglobin (HbA1c) >= 7% Who Achieved HbA1c Level < 7% at Week 24

    Baseline to Week 24

Study Arms (2)

Dapagliflozin

EXPERIMENTAL
Drug: Dapagliflozin

Dapagliflozin placebo

PLACEBO COMPARATOR
Drug: Dapagliflozin placebo

Interventions

DapagliflozinDRUG

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.

Also known as: FORXIGA
Dapagliflozin
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.

Dapagliflozin placebo

Eligibility Criteria

Age10 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (42)

Research Site

New Haven, Connecticut, 06514-3434, United States

Location

Research Site

Washington D.C., District of Columbia, 20010, United States

Location

Research Site

Gainesville, Florida, 32610, United States

Location

Research Site

Homestead, Florida, 33032, United States

Location

Research Site

Miami, Florida, 33015, United States

Location

Research Site

Boston, Massachusetts, 02215, United States

Location

Research Site

Buffalo, New York, 14222, United States

Location

Research Site

The Bronx, New York, 10467, United States

Location

Research Site

Columbus, Ohio, 43205, United States

Location

Research Site

Philadelphia, Pennsylvania, 19104, United States

Location

Research Site

Greenville, South Carolina, 29615, United States

Location

Research Site

Memphis, Tennessee, 38116, United States

Location

Research Site

Memphis, Tennessee, 38119, United States

Location

Research Site

Lampasas, Texas, 76550, United States

Location

Research Site

McAllen, Texas, 78503, United States

Location

Research Site

Budapest, 1023, Hungary

Location

Research Site

Nyíregyháza, 4400, Hungary

Location

Research Site

Beersheba, 84101, Israel

Location

Research Site

Haifa, 91096, Israel

Location

Research Site

Jerusalem, 91120, Israel

Location

Research Site

Ramat Gan, 5265601, Israel

Location

Research Site

Ẕerifin, 70300, Israel

Location

Research Site

Culiacán, 80230, Mexico

Location

Research Site

Guadalajara, 44670, Mexico

Location

Research Site

Mérida, 97134, Mexico

Location

Research Site

México, D.F., 11410, Mexico

Location

Research Site

Monterrey, 64460, Mexico

Location

Research Site

Zapopan, 45116, Mexico

Location

Research Site

Oradea, 410169, Romania

Location

Research Site

Timișoara, 300011, Romania

Location

Research Site

Izhevsk, 426009, Russia

Location

Research Site

Krasnoyarsk, 660022, Russia

Location

Research Site

Moscow, 117036, Russia

Location

Research Site

Novosibirsk, 630087, Russia

Location

Research Site

Pyatigorsk, 357500, Russia

Location

Research Site

Rostov-on-Don, 344022, Russia

Location

Research Site

Saint Petersburg, 194100, Russia

Location

Research Site

Samara, 443079, Russia

Location

Research Site

Saratov, 410054, Russia

Location

Research Site

Tomsk, 634050, Russia

Location

Research Site

Kent, CT9 4AN, United Kingdom

Location

Research Site

Leicester, LE15WW, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 35378069DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusInsulin ResistanceMetabolic Diseases

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Results Point of Contact

Title
Global Clinical Lead
Organization
Study Information Center
information.center@astrazeneca.com
+1-887-240-9479

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 1, 2016

Study Start

June 22, 2016

Primary Completion

April 6, 2020

Study Completion

April 6, 2020

Last Updated

February 23, 2022

Results First Posted

December 2, 2020

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
More information

Locations

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