NCT02460978CompletedPhase 3
A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects With Type 1 Diabetes Mellitus - Study Two
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 815
- Locations
- 1
- Primary Endpoint
- Adjusted Mean Change From Baseline in HbA1c at Week 24
Study Overview
Brief Summary
The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.
Detailed Description
Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of Type 1 Diabetes mellitus (T1DM)
- •Central laboratory C-peptide < 0.7 ng/ml (0.23 nmol/L)
- •Insulin use for at least 12 months per patient reported or medical records
- •Method of insulin administration (MDI or CSII) must have been unchanged for at least 3 months prior to screening
- •Subjects must be on a total insulin dose of ≥ 0.3 U/kg/day for at least 3 months prior to screening
- •If on MDI insulin administration, subject must be on ≥ 3x injections per day
- •Screening Visit: Central laboratory HbA1c ≥ 7.7% and ≤ 11.0%
- •Body mass index (BMI) ≥ 18.5 kg/m2
Exclusion Criteria
- •History of Type 2 Diabetes mellitus (T2DM) or maturity onset diabetes of the young (MODY), pancreatic surgery, or chronic pancreatitis that could result in decreased beta cell capacity
- •Taking any non-insulin antihyperglicemic agent within 1 month prior to screening
- •Taking GLP-1 receptor agonist within 2 months prior to screening for once weekly administration and within 1 month prior to screening for once or twice daily administration
- •Taking metformin and/or thiazolidinediones within 2 months prior to screening
- •History of diabetes ketoacidosis requiring medical intervention within 1 month prior to screening
- •History of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 1 month prior to screening
- •Frequent episodes of severe hypoglycemia (more than one episode requiring medical assistance, emergency care), and/or glucagon therapy administered by a third-party individual within 1 month prior to screening
- •History of Addison's disease
Arms & Interventions
Dapagliflozin 5 mg
Experimental
Dapagliflozin 5 mg tablet orally, once daily for 52 weeks
Intervention: Dapagliflozin (Drug)
Dapagliflozin 10 mg
Experimental
Dapagliflozin 10 mg tablet orally, once daily for 52 weeks
Intervention: Dapagliflozin (Drug)
Placebo
Placebo Comparator
Placebo tablet orally, once daily for 52 weeks
Intervention: Placebo for dapagliflozin (Other)
Outcomes
Primary Outcomes
Adjusted Mean Change From Baseline in HbA1c at Week 24
Time Frame: Baseline and 24 weeks
To compare the change from baseline in HbA1c between dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment
Secondary Outcomes
- Adjusted Mean Percentage Change From Baseline in Total Daily Insulin Dose at Week 24(Baseline and 24 weeks)
- Adjusted Mean Percentage Change From Baseline in Body Weight at Week 24(Baseline and 24 weeks)
- Adjusted Mean Change From Baseline in 24-hour Continuous Glucose Monitoring (CGM) Mean Value at Week 24(Baseline and 24 weeks)
- Adjusted Mean Change From Baseline in 24-hour CGM Mean Amplitude of Glycemic Excursion (MAGE) Value at Week 24(Baseline and 24 weeks)
- Change From Baseline in the Percent of 24-hour Glucose Readings Obtained From CGM That Falls Within the Target Range of > 70 mg/dL and <= 180 mg/dL (%) at Week 24(Baseline and 24 weeks)
- Percentage of Subjects With HbA1c Reduction From Baseline to Week 24 Last Observation Carried Forward (LOCF) >= 0.5% and Without Severe Hypoglycemia Events at Week 24(Baseline and 24 weeks)
Investigators
Study Sites (1)
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