- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03199053
Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus (T2DM) Aged 10 to Below 18 Years Old
A 26 Week, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase 3 Trial With a 26 Week Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 5 and 10 mg, and Saxagliptin 2.5 and 5 mg in Pediatric Patients With Type 2 Diabetes Mellitus Who Are Between 10 and Below 18 Years of Age
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Buenos Aires, Argentina, 6500
- Research Site
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Buenos Aires, Argentina, C1180AAX
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Caba, Argentina, C1119ACN
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Ciudad de Buenos Aires, Argentina, C1405BCH
- Research Site
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San Miguel de Tucuman, Argentina, 4000
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San Miguel de Tucumán, Argentina, 4000
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San Miguel de Tucumán, Argentina, T4000IHE
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Blacktown, Australia, 2148
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Brasilia, Brazil, 71625-009
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Curitiba, Brazil, 80810-040
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Fortaleza, Brazil, 60170-320
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Fortaleza, Brazil, 60430-270
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Passo Fundo, Brazil, 99010-080
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Porto Alegre, Brazil, 90430-001
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Porto Alegre, Brazil, 91350-250
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Ribeirão Preto, Brazil, 14051-104
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Santa Maria, Brazil, 97015-530
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Sao Paulo, Brazil, 05652-900
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Sao Paulo, Brazil, 01223-001
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
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Santiago, Chile, 7500710
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Armenia, Colombia, 630004
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Barranquilla, Colombia, 80020
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Tampere, Finland, 33520
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Ahmedabad, India, 380008
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Aurangabad, India, 431003
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Bangalore, India, 560002
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Bikaner, India, 334003
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Chandigarh, India, 160012
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Coimbatore, India, 641009
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Hyderabad, India, 500012
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Kolkata, India, 700054
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Kozhikode, India, 67300
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Nashik, India, 422002
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Pune, India, 411030
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Visakhapatnam, India, 531011
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Haifa, Israel, 3109601
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Ancona, Italy, 60123
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Napoli, Italy, 80138
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Roma, Italy, 00165
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Daejeon-si, Korea, Republic of, 35233
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Incheon, Korea, Republic of, 22332
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Wonju-si, Korea, Republic of, 26426
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George Town, Malaysia, 10450
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Ipoh, Malaysia, 30990
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Johor Bahru, Malaysia, 80100
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Klang, Malaysia, 41200
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Kota Kinabalu, Malaysia, 88996
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Kuala Lumpur, Malaysia, 50586
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Kuching, Malaysia, 93586
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Melaka, Malaysia, 75400
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Putrajaya, Malaysia, 62250
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Seremban, Malaysia, 70300
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Seri Manjung, Malaysia, 32040
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Taiping, Malaysia, 34000
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Boca del Rio, Mexico, 94290
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Celaya, Mexico, 38000
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Ciudad Madero, Mexico, 89440
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Cuernavaca, Mexico, 62290
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Cuernavaca, Mexico, 62209
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Culiacán, Mexico, 80230
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Durango, Mexico, 34000
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Guadalajara, Mexico, 44150
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Juriquilla, Mexico, 76230
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Merida, Mexico, 97000
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Mexico, Mexico, 06700
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Monterrey, Mexico, 64460
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Monterrey, Mexico, 64620
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México, D.F., Mexico, 11410
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San Juan del Rio, Mexico, 76800
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Veracruz, Mexico, 91900
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Zapopan, Mexico, 45116
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Grafton, New Zealand, 1023
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Tauranga, New Zealand, 3110
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Wellington, New Zealand, 6021
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Quezon City, Philippines, 1112
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Quezon City, Philippines, 1100
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San Fernando City, Philippines, 2000
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Warszawa, Poland, 01-868
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Izhevsk, Russian Federation, 426009
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Moscow, Russian Federation, 125993
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Ufa, Russian Federation, 450000
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Tainan City, Taiwan, 704
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Taipei, Taiwan, 112
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Bangkok, Thailand, 10400
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Hat Yai, Thailand, 90110
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Aydin, Turkey, 9010
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Bursa, Turkey, 16059
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Eskisehir, Turkey, 26480
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Istanbul, Turkey, 34020
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Izmir, Turkey, 35210
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Izmir, Turkey, 35330
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Kocaeli, Turkey, 41380
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Kurupelit, Turkey, 55139
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Manisa, Turkey, 45030
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Dnipro, Ukraine, 49023
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Kyiv, Ukraine, 01021
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Vinnytsia, Ukraine, 21010
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Birmingham, United Kingdom, B4 6NH
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London, United Kingdom, SE5 9RS
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London, United Kingdom, E1 1BB
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Middlesborough, United Kingdom, TS4 3BW
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Nottingham, United Kingdom, NG7 2UH
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California
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Sacramento, California, United States, 95821
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Connecticut
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New Haven, Connecticut, United States, 06519
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Florida
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Hialeah, Florida, United States, 33012
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Hialeah, Florida, United States, 33016
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Hollywood, Florida, United States, 33021
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Miami, Florida, United States, 33165
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Miami, Florida, United States, 33144
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Miami, Florida, United States, 33155
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Miami Springs, Florida, United States, 33166
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Georgia
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Atlanta, Georgia, United States, 30322
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Atlanta, Georgia, United States, 30341
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Idaho
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Idaho Falls, Idaho, United States, 83404
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New Jersey
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Neptune, New Jersey, United States, 07753
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Tennessee
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Memphis, Tennessee, United States, 38119
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Memphis, Tennessee, United States, 38116
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Texas
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Edinburg, Texas, United States, 78539
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Harlingen, Texas, United States, 78550
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McAllen, Texas, United States, 78503
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San Antonio, Texas, United States, 78229
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Virginia
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Charlottesville, Virginia, United States, 22903
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Signed Written Informed Consent
- Target Population
- Previously diagnosed with Type 2 Diabetes Mellitus by World Health Organization/ADA criteria
- HbA1c between 6.5% and 10.5% obtained at screening.
- Currently on diet and exercise and stable dose of at least 1000 mg metformin (IR or XR) for a minimum of 8 weeks, or stable dose of insulin for a minimum of 8 weeks, or a stable combination of at least 1000 mg metformin (IR or XR) and insulin for a minimum of 8 weeks prior to randomization. For those children on insulin, investigators will confirm that attempts at removing insulin from the subject's therapeutic regimen had been previously made but had not been successful.
- Age and Reproductive Status
- Male and female patients eligible if 10 years of age, up to but not including 18 years of age at the time of enrollment/screening. At least 30% of total subjects will be between the ages of 10 and 14 years and at least one third, but no more than two thirds, female subjects.
- Women of childbearing potential must have a negative pregnancy test within 24 hours prior to the start of study drug.
- Women must not be breastfeeding.
- Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs: saxagliptin, and dapagliflozin, plus 5 half-lives of study drugs or 30 days (whichever is longer), plus 30 days (duration of ovulatory cycle) for a total of 60 days post treatment completion.
Exclusion Criteria:
- Target Disease Exceptions
- Presence of Type 1 diabetes, as demonstrated by Preexisting diagnosis of Type 1 diabetes,
- Previous diagnosis of monogenic etiology of Type 2 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, oral or injectable incretins or incretin mimetics, other antidiabetes medications not otherwise specified.
- Sixteen weeks: thiazolidinediones, DPP-4 inhibitors (with no reported medication related AEs related to DPP-4 inhibitors), sodium glucose cotransporter-2 (SGLT-2) inhibitors (with no reported medication related AEs related to SGLT-2 inhibitors)
- 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.
- Medical History and Concurrent Diseases
- 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
- History of or current, acute or chronic pancreatitis
- History of hemoglobinopathy, with the exception of sickle cell trait or thalassemia minor; or chronic or recurrent hemolysis
- Malignancy within 5 years of the screening visit (with the exception of treated basal cell or treated squamous cell carcinoma)
- 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
- Physical and Laboratory Test Findings
- Abnormal renal function,
- An abnormal thyroid-stimulating hormone (TSH) value at enrollment 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.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2× upper limit of normal (ULN), or clinically significant hepatic disease.
- Serum total bilirubin (TB) > 2x ULN unless exclusively caused by Gilbert's syndrome
- Positive serologic evidence of current infectious liver disease including anti hepatitis A virus (HAV) (IgM), hepatitis B surface antigen (HBsAg), or anti hepatitis C virus (HCV). Patients who have isolated positive anti-hepatitis B surface antibodies may be included.
- Anemia of any etiology
- Volume-depleted subjects.
- Allergies and Adverse Drug Reaction
- Known allergy, sensitivity or contraindication to any study drug or its excipient/vehicle
- Other Exclusion Criteria
- Subject is currently abusing alcohol or other drugs or has done so within the last 6 months prior to the screening visit.
- Prisoners or subjects who are involuntarily incarcerated. (Note: under certain specific circumstances a person who has been imprisoned may be included or permitted to continue as a subject. Strict conditions apply and Sponsor/designee approval is required.)
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
- Psychiatric or cognitive disorder that will, in the opinion of investigators, limit the subject's ability to comply with the study medications and monitoring.
- Subjects who have contraindications to therapy as outlined in the saxagliptin and dapagliflozin Investigator Brochure or local package inserts.
- Participation and receiving IP in another clinical study during the prior 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Low dose Dapagliflozin
Oral route.
Start with a low dose of dapagliflozin administered once daily and remain on the low dose regardless of your HbA1c at week 12.
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Tablets, Oral, 5mg , Once daily Tablets, Oral, 10mg, Once daily
Other Names:
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Experimental: Low dose/high dose Dapagliflozin
Oral route.
Start with a low dose of Dapagliflozin administered once daily and up titrate to the high dose Dapagliflozin administered once daily if HbA1c >= 7% at week 12
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Tablets, Oral, 5mg , Once daily Tablets, Oral, 10mg, Once daily
Other Names:
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Experimental: Low dose Saxagliptin
Oral route.
Start with a low dose of saxagliptin administered once daily and remain on the low dose regardless of your HbA1c at week 12
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Tablets, Oral, 2.5mg Once daily Tablets, Oral, 5mg, Once daily
Other Names:
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Experimental: Low dose/high dose Saxagliptin
Oral route.
Start with a low dose of saxagliptin administered once daily and up titrate to the high dose if HbA1c >= 7% at week 12
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Tablets, Oral, 2.5mg Once daily Tablets, Oral, 5mg, Once daily
Other Names:
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Placebo Comparator: Placebo arm
Oral route.
Placebo tablets administered for 52 weeks
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Matching placebo to dapagliflozin 5mg and 10 mg/saxagliptin 2.5 mg and 5 mg, Tablets, oral, Once daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Dapagliflozin Versus Placebo: Adjusted Mean Change From Baseline in HbA1c at Week 26
Time Frame: Baseline and Week 26
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate.
Missing Week 26 data was handled based on multiple imputation washout (MI-WO) within each arm using the data from placebo participants with Week 26 data.
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Baseline and Week 26
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Saxagliptin Versus Placebo: Adjusted Mean Change From Baseline in HbA1c at Week 26
Time Frame: Baseline and Week 26
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate.
Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
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Baseline and Week 26
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Dapagliflozin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26
Time Frame: Baseline and Week 26
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data. Dapagliflozin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1. |
Baseline and Week 26
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Saxagliptin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26
Time Frame: Baseline and Week 26
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data. Saxagliptin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1. |
Baseline and Week 26
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Dapagliflozin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26
Time Frame: Baseline and Week 26
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data. Dapagliflozin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1. |
Baseline and Week 26
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Saxagliptin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26
Time Frame: Baseline and Week 26
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data. Saxagliptin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1. |
Baseline and Week 26
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Dapagliflozin Versus Placebo: Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Time Frame: Baseline and Week 26
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate.
Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
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Baseline and Week 26
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Saxagliptin Versus Placebo: Adjusted Mean Change From Baseline in FPG at Week 26
Time Frame: Baseline and Week 26
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate.
Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
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Baseline and Week 26
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Dapagliflozin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26
Time Frame: Baseline and Week 26
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data. Dapagliflozin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1. |
Baseline and Week 26
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Saxagliptin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26
Time Frame: Baseline and Week 26
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data. Saxagliptin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1. |
Baseline and Week 26
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Dapagliflozin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26
Time Frame: Baseline and Week 26
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data. Dapagliflozin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1. |
Baseline and Week 26
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Saxagliptin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26
Time Frame: Baseline and Week 26
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data. Saxagliptin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1. |
Baseline and Week 26
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Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26
Time Frame: Baseline and Week 26
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A logistic regression model adjusting for sex, age group, background antidiabetes medication and Baseline HbA1c was used.
Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
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Baseline and Week 26
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Low-dose/High-dose Versus Placebo (Weighted): Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26
Time Frame: Baseline and Week 26
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A weighted logistic regression model adjusting for sex, age group, background antidiabetes medication and Baseline HbA1c was used. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data. Participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1. |
Baseline and Week 26
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Low-dose Versus Placebo (Weighted): Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26
Time Frame: Baseline and Week 26
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A weighted logistic regression model adjusting for sex, age group, background antidiabetes medication and Baseline HbA1c was used. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data. Participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1. |
Baseline and Week 26
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Low-dose Versus Uptitration to the High Dose: Adjusted Mean Change From Baseline in HbA1c at Week 26
Time Frame: Baseline and Week 26
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate.
Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
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Baseline and Week 26
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Low-dose Versus Uptitration to the High Dose: Adjusted Mean Change From Baseline in FPG at Week 26
Time Frame: Baseline and Week 26
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Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate.
Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
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Baseline and Week 26
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Dapagliflozin Low-dose Versus Uptitration to the High Dose: Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26
Time Frame: Baseline and Week 26
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A Fisher's exact test was used and unadjusted difference in percentage of participants and Clopper-Pearson CIs presented using imputed data.
Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
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Baseline and Week 26
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Saxagliptin Low-dose Versus Uptitration to the High Dose: Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26
Time Frame: Baseline and Week 26
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A Fisher's exact test was used and unadjusted difference in percentage of participants and Clopper-Pearson CIs presented using imputed data.
Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
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Baseline and Week 26
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of subjects who require glycemic rescue medication or discontinue the study medication due to lack of efficacy during the 26-week treatment period
Time Frame: 26 weeks
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To compare the percentage of subjects requiring glycemic rescue medication or discontinuing study medication due to lack of efficacy with dapagliflozin or saxagliptin against the percentage with placebo during 26 weeks of oral double-blind add-on treatment in pediatric T2DM subjects with HbA1c of 6.5 to 10.5% on diet and exercise and metformin (IR or XR), insulin, or metformin (IR or XR) plus insulin.
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26 weeks
|
Change from baseline in HbA1c at Week 52
Time Frame: 52 weeks
|
To assess the mean change from baseline in HbA1c achieved with dapagliflozin therapy versus placebo, and separately, achieved with saxagliptin therapy versus placebo after 52 weeks of oral blinded add-on treatment in pediatric T2DM subjects with HbA1c of 6.5 to 10.5% on diet and exercise and metformin (IR or XR), insulin, or metformin (IR or XR) plus insulin.
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52 weeks
|
Change from baseline in FPG at Week 52
Time Frame: 52 weeks
|
To assess the mean change from baseline in FPG achieved with dapagliflozin therapy versus placebo, and separately, achieved with saxagliptin therapy versus placebo after 52 weeks of oral blinded add-on treatment in pediatric T2DM subjects with HbA1c of 6.5 to 10.5% on diet and exercise and metformin (IR or XR), insulin, or metformin (IR or XR) plus insulin
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52 weeks
|
Percentage of subjects with baseline HbA1c ≥ 7% who achieve an HbA1c level < 7.0% at Week 52
Time Frame: 52 weeks
|
To assess the percentage of subjects with baseline HbA1c ≥ 7% who achieve an HbA1c level < 7.0% after 52 weeks of oral blinded add-on therapy with dapagliflozin versus placebo, or saxagliptin versus placebo in pediatric T2DM subjects with HbA1c of 6.5 to 10.5% on diet and exercise and metformin (IR or XR), insulin, or metformin (IR or XR) plus insulin.
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52 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Sodium-Glucose Transporter 2 Inhibitors
- Dipeptidyl-Peptidase IV Inhibitors
- Dapagliflozin
- Saxagliptin
Other Study ID Numbers
- D1680C00019
- 2015-005042-66 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD 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.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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