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

AstraZeneca1 site in 1 country833 target enrollmentNovember 11, 2014

ConditionsType 1 Diabetes Mellitus

InterventionsDapagliflozin Placebo for dapagliflozin

DrugsDapagliflozin Placebo for dapagliflozin

Overview

Phase: Phase 3
Intervention: Dapagliflozin
Conditions: Type 1 Diabetes Mellitus
Sponsor: AstraZeneca
Enrollment: 833
Locations: 1
Primary Endpoint: Adjusted Mean Change in HbA1c From Baseline at Week 24
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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

Registry

clinicaltrials.gov

Start Date

November 11, 2014

End Date

August 25, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

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 metformin and/or thiazolidinediones within 2 months prior to screening
•Taking any antidiabetic medication (other than insulin), 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
•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

Arm A: Dapagliflozin

Dapagliflozin 5 mg tablet orally, once daily for 52 weeks

Intervention: Dapagliflozin

Arm B: Dapagliflozin

Dapagliflozin 10 mg tablet orally, once daily for 52 weeks

Intervention: Dapagliflozin

Arm C: Placebo for Dapagliflozin

Placebo tablet orally, once daily for 52 weeks

Intervention: Placebo for dapagliflozin

Outcomes

Primary Outcomes

Adjusted Mean Change in HbA1c From Baseline at Week 24

Time Frame: From Baseline to Week 24

Adjusted mean change from baseline in HbA1c at Week 24 (Repeated Measures Model\[RMM\]).

Secondary Outcomes

Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) From Baseline at Week 24(From Baseline to Week 24)
Adjusted Mean Percent Change in Body Weight From Baseline at Week 24(From Baseline to Week 24)
Adjusted Mean Percent Change in Total Daily Insulin Dose From Baseline at Week 24(From Baseline to Week 24)
Adjusted Mean Change in 24-hour Mean Continuous Glucose Monitoring Glucose From Baseline at Week 24(From Baseline to Week 24)
Adjusted Mean Change in 24-hour Continuous Glucose Monitoring MAGE From Baseline at Week 24(From Baseline to Week 24)
Subjects With HbA1c Reduction From Baseline to Week 24 (LOCF) >= 0.5% and Without Severe Hypoglycemia Events(From Baseline to Week 24)