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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02725593
Recruitment Status : Completed
First Posted : April 1, 2016
Results First Posted : December 2, 2020
Last Update Posted : February 23, 2022
Sponsor:
Collaborators:
Parexel
Q2 Solutions
PRA Health Sciences
Covance Laboratories, Inc
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Dapagliflozin Drug: Dapagliflozin placebo Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 22, 2016
Actual Primary Completion Date : April 6, 2020
Actual Study Completion Date : April 6, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dapagliflozin Drug: Dapagliflozin
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.
Other Name: FORXIGA

Placebo Comparator: Dapagliflozin placebo Drug: Dapagliflozin placebo
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.




Primary Outcome Measures :
  1. Adjusted Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 24 [ Time Frame: Baseline to Week 24 ]

Secondary Outcome Measures :
  1. Adjusted Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline to Week 24 ]
  2. Percentage of Participants Who Required Glycemic Rescue Medication or Permanently Discontinued Treatment Due to Lack of Glycemic Control [ Time Frame: Baseline to Week 24 ]
  3. Percentage of Participants With Baseline Glycated Haemoglobin (HbA1c) >= 7% Who Achieved HbA1c Level < 7% at Week 24 [ Time Frame: Baseline to Week 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Provision of informed consent prior to any study-specific procedures
  2. Males and Females, ages 10 years of age, up to but not including 25 years of age at the time of randomization
  3. Previously diagnosed as having type 2 diabetes for at least 2 months by WHO/ADA diagnostic criteria
  4. HbA1c >= 6.5% and <= 11% obtained at screening visit
  5. 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
  6. FPG <=255 mg/dL (<= 14.2 mmol/L) obtained at screening visit

Exclusion Criteria:

  1. Previous diagnosis of Type 1 diabetes
  2. Diabetes ketoacidosis (DKA) within 6 months of screening
  3. 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
  4. 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

  5. Pregnant, positive serum pregnancy test, planning to become pregnant during the clinical trials, or breastfeeding
  6. History of unstable or rapidly progressive renal disease
  7. History of unresolved vesico-ureteral reflux
  8. 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

  9. 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)
  10. Presence of either: antibodies to glutamic acid decarboxylase (GAD) or protein tyrosine phosphatase-like protein antibodies (IA-2)
  11. An abnormal TSH value at screening will be further evaluated for free T4. Subjects with abnormal free T4 values will be excluded
  12. Hematuria (confirmed by microscopy at screening) with no explanation as judged by the investigator up to randomization
  13. 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
  14. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02725593


Locations
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United States, Connecticut
Research Site
New Haven, Connecticut, United States, 06514-3434
United States, District of Columbia
Research Site
Washington, District of Columbia, United States, 20010
United States, Florida
Research Site
Gainesville, Florida, United States, 32610
Research Site
Homestead, Florida, United States, 33032
Research Site
Miami, Florida, United States, 33015
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02215
United States, New York
Research Site
Bronx, New York, United States, 10467
Research Site
Buffalo, New York, United States, 14222
United States, Ohio
Research Site
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Research Site
Greenville, South Carolina, United States, 29615
United States, Tennessee
Research Site
Memphis, Tennessee, United States, 38116
Research Site
Memphis, Tennessee, United States, 38119
United States, Texas
Research Site
Lampasas, Texas, United States, 76550
Research Site
McAllen, Texas, United States, 78503
Hungary
Research Site
Budapest, Hungary, 1023
Research Site
Nyíregyháza, Hungary, 4400
Israel
Research Site
Beer Sheva, Israel, 84101
Research Site
Haifa, Israel, 91096
Research Site
Jerusalem, Israel, 91120
Research Site
Ramat Gan, Israel, 5265601
Research Site
Zerifin, Israel, 70300
Mexico
Research Site
Culiacan, Mexico, 80230
Research Site
Guadalajara, Mexico, 44670
Research Site
Merida, Mexico, 97134
Research Site
Monterrey, Mexico, 64460
Research Site
México, D.F., Mexico, 11410
Research Site
Zapopan, Mexico, 45116
Romania
Research Site
Oradea, Romania, 410169
Research Site
Timisoara, Romania, 300011
Russian Federation
Research Site
Izhevsk, Russian Federation, 426009
Research Site
Krasnoyarsk, Russian Federation, 660022
Research Site
Moscow, Russian Federation, 117036
Research Site
Novosibirsk, Russian Federation, 630087
Research Site
Pyatigorsk, Russian Federation, 357500
Research Site
Rostov-on-Don, Russian Federation, 344022
Research Site
Samara, Russian Federation, 443079
Research Site
Saratov, Russian Federation, 410054
Research Site
St. Petersburg, Russian Federation, 194100
Research Site
Tomsk, Russian Federation, 634050
United Kingdom
Research Site
Kent, United Kingdom, CT9 4AN
Research Site
Leicester, United Kingdom, LE15WW
Sponsors and Collaborators
AstraZeneca
Parexel
Q2 Solutions
PRA Health Sciences
Covance Laboratories, Inc
  Study Documents (Full-Text)

Documents provided by AstraZeneca:
Study Protocol  [PDF] September 20, 2017
Statistical Analysis Plan  [PDF] March 11, 2020

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02725593    
Other Study ID Numbers: D1690C00017
2015-005041-31 ( EudraCT Number )
First Posted: April 1, 2016    Key Record Dates
Results First Posted: December 2, 2020
Last Update Posted: February 23, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Keywords provided by AstraZeneca:
Diabetes Mellitus
Dapagliflozin
Placebo
Insulin resistance
Metabolic Diseases
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dapagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs