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

Part of paid clinical trials in Sacramento, California.

Sponsor
AstraZeneca
Study ID
NCT03199053
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Tablets, Oral, 5mg , Once daily Tablets, Oral, 10mg, Once daily
  • Saxagliptin — DRUG
    Tablets, Oral, 2.5mg Once daily Tablets, Oral, 5mg, Once daily
  • Placebo — DRUG
    Matching placebo to dapagliflozin 5mg and 10 mg/saxagliptin 2.5 mg and 5 mg, Tablets, oral, Once daily

Study Details

The primary objective of this study is to determine if there will be a greater mean reduction from baseline in glycated hemoglobin (HbA1c) achieved after 26 weeks of oral double-blind add-on therapy of dapagliflozin or saxagliptin compared to placebo in paediatric T2DM patients with HbA1c levels of 6.5 to 10.5% on diet and exercise and metformin, insulin, or metformin plus insulin.

Key Dates

Start date
Oct 11, 2017
Status verified
May 2024
Primary completion
Feb 1, 2023
Completion
Jan 3, 2024

Study Design

Enrollment
256 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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
  • 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
  • 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
  • Placebo Comparator: Placebo arm
    Oral route. Placebo tablets administered for 52 weeks

Primary Outcome Measure

Dapagliflozin Versus Placebo: Adjusted Mean Change From Baseline in HbA1c at Week 26 [ Time Frame: Baseline and Week 26 ]

Locations (20)

FacilityCityStateZIPSite coordinators
Research SiteSacramentoCalifornia95821-
Research SiteNew HavenConnecticut06519-
Research SiteHialeahFlorida33012-
Research SiteHialeahFlorida33016-
Research SiteHollywoodFlorida33021-
Research SiteMiamiFlorida33144-
Research SiteMiamiFlorida33155-
Research SiteMiamiFlorida33165-
Research SiteMiami SpringsFlorida33166-
Research SiteAtlantaGeorgia30322-
Research SiteAtlantaGeorgia30341-
Research SiteIdaho FallsIdaho83404-
Research SiteNeptune CityNew Jersey07753-
Research SiteMemphisTennessee38116-
Research SiteMemphisTennessee38119-
Research SiteEdinburgTexas78539-
Research SiteHarlingenTexas78550-
Research SiteMcAllenTexas78503-
Research SiteSan AntonioTexas78229-
Research SiteCharlottesvilleVirginia22903-

Find similar trials in Sacramento, CA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Research Site· Sacramento, CAResearch Site· New Haven, CTResearch Site· Hialeah, FLResearch Site· Hollywood, FLResearch Site· Miami, FLResearch Site· Miami Springs, FL

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