Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes: The DEPICT-1 52-Week Study

@article{Dandona2018EfficacyAS,
  title={Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes: The DEPICT-1 52-Week Study},
  author={Paresh Dandona and Chantal Mathieu and Moshe Phillip and Lars Hansen and Diethelm Tsch{\"o}pe and Fredrik A. Thoren and John Xu and Anna Maria Langkilde},
  journal={Diabetes Care},
  year={2018},
  volume={41},
  pages={2552 - 2559}
}
OBJECTIVE This study evaluated the long-term safety and efficacy of dapagliflozin as an adjunct to adjustable insulin in patients with type 1 diabetes and inadequate glycemic control. [...] Key MethodRESULTS Of the 833 patients randomized into the study, 708 (85%) completed the 52-week study.Expand

Paper Mentions

Interventional Clinical Trial
Mexico has one of the highest prevalence of obesity, reported on 32.4 percent of people over 20 years old, with a prevalence of obesity class III of 1.8 percent on males and 4.1 percent… Expand
ConditionsDiabetes Mellitus, Type 2, Obesity, Morbid, PreDiabetes
InterventionDrug
Interventional Clinical Trial
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.  
ConditionsType 1 Diabetes Mellitus
InterventionDrug
Long‐term efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (the DEPICT‐2 study): 52‐week results from a randomized controlled trial
TLDR
Dapagliflozin led to long‐term reductions in HbA1c and body weight in adults with T1D, but increased DKA risk compared with placebo, as well as exploratory endpoints in this extension to DEPICT‐2. Expand
Glucose Variables in Type 1 Diabetes Studies With Dapagliflozin: Pooled Analysis of Continuous Glucose Monitoring Data From DEPICT-1 and -2
TLDR
In patients with type 1 diabetes, treatment with dapagliflozin over 24 weeks improved time in range, mean glucose, and glycemic variability without increasing the time spent in the range indicating hypoglycemia. Expand
The efficacy of dapagliflozin for type 1 diabetes: a meta-analysis of randomized controlled studies
TLDR
Dapagliflozin treatment benefits to reduce HbA1c and FPG for type 1 diabetes and the incidence of ketone-related events is higher than those in control group. Expand
Effect of dapagliflozin as an adjunct to insulin over 52 weeks in individuals with type 1 diabetes: post-hoc renal analysis of the DEPICT randomised controlled trials.
TLDR
Treatment with dapagliflozin resulted in UACR reduction, which might provide renoprotective benefits in individuals with type 1 diabetes and albuminuria, and two dedicated prospective studies are needed to confirm these findings as prespecified endpoints. Expand
A systematic review and dose-response meta-analysis on the efficacy of dapagliflozin in patients with type 1 diabetes mellitus.
Formulation of insulin analogs and its delivery are developed in over recent years but glycemic control in most patients with type-1 diabetes mellitus (DM) is not adequate yet. The aim of thisExpand
Dapagliflozin: A Review in Type 1 Diabetes
TLDR
Dapagliflozin is the first SGLT2 inhibitor to be approved for use in T1D and it provides a promising adjunctive treatment option for adults with type 1 diabetes and a BMI of ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy. Expand
An up-to-date evaluation of sotagliflozin for the treatment of type 1 diabetes
TLDR
Based on the existing evidence, sotagliflozin should be considered only in patients who have failed to achieve adequate glycemic control despite optimal insulin therapy, are at low risk for diabetic ketoacidosis, have been adequately trained to recognize this complication and are able to be in close contact with their physician. Expand
Sodium–glucose cotransporter 2 inhibitors as an add-on therapy to insulin for type 1 diabetes mellitus: Meta-analysis of randomized controlled trials
TLDR
SGLT2i as an add-on therapy to insulin improved glycemic control and body weight and decreased the required dose of insulin without increasing the risk of hypoglycemia, however, after 6 months the benefits of S GLT2is on glycemic Control may weaken and the risks of GTIs and DKA increased. Expand
SGLT2 inhibitors as adjunctive therapy for type 1 diabetes: balancing benefits and risks.
TLDR
HbA1c-lowering efficacy was greatest at 8-12 weeks of therapy, but the magnitude of HbA 1c lowering waned with longer duration of treatment, which raises important questions about the risk-to-benefit profile of SGLT2 inhibitors when used as adjunctive therapy in patients with type 1 diabetes. Expand
Efficacy and safety of dapagliflozin in Japanese patients with inadequately controlled type 1 diabetes (DEPICT‐5): 52‐week results from a randomized, open‐label, phase III clinical trial
To investigate the safety and tolerability of 5 and 10 mg dapagliflozin added to insulin therapy over 52 weeks in Japanese patients with inadequately controlled type 1 diabetes mellitus (T1DM).
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Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes (the DEPICT-2 Study): 24-Week Results From a Randomized Controlled Trial
TLDR
Dapagliflozin as adjunct therapy to adjustable insulin in patients with type 1 diabetes was well tolerated and improved glycemic control with no increase in hypoglycemia versus placebo but with more DKA events. Expand
Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial.
TLDR
The primary efficacy outcome was the change from baseline in HbA1c after 24 weeks of treatment in the full analysis set, which consisted of all randomly assigned patients who received at least one dose of study drug. Expand
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This exploratory study of dapagliflozin in adults with type 1 diabetes demonstrated acceptable short-term tolerability and expected pharmacokinetic profiles and increases in urinary glucose excretion, which provide hope that SGLT2 inhibition may prove in larger randomized controlled trials to be efficacious in reducing hyperglycemia in type 2 diabetes. Expand
Efficacy and Safety of Canagliflozin, a Sodium–Glucose Cotransporter 2 Inhibitor, as Add-on to Insulin in Patients With Type 1 Diabetes
TLDR
Canagliflozin provided reductions in HbA1c, body weight, and insulin dose with no increase in hypoglycemia, but increased rates of ketone-related AEs, including DKA, in adults with type 1 diabetes inadequately controlled with insulin. Expand
Effects of Sotagliflozin Added to Insulin in Patients with Type 1 Diabetes
TLDR
Among patients with type 1 diabetes who were receiving insulin, the proportion of patients who achieved a glycated hemoglobin level lower than 7.0% with no severe hypoglycemia or diabetic ketoacidosis was larger in the group that received sotagliflozin than in the placebo group. Expand
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TLDR
This double-blind, placebo-controlled, phase 3 study aimed to compare blood pressure and glycaemic effects of the SGLT2 inhibitor dapagliflozin with placebo in patients with inadequately controlled type 2 diabetes mellitus and hypertension. Expand
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TLDR
Clinical trials published to date show that dapagliflozin is safe and effective as monotherapy or as an add-on to insulin or oral antidiabetic agents in patients with T2DM. Expand
Sodium-Glucose Cotransporter 2 Inhibition and Glycemic Control in Type 1 Diabetes: Results of an 8-Week Open-Label Proof-of-Concept Trial
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This proof-of-concept study strongly supports a randomized clinical trial of adjunctive-to-insulin empagliflozin in patients with T1D. Expand
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The meta-analysis showed that dapagliflozin as an add-on drug to conventional antidiabetic drugs improved the glycaemic control in T2DM participants without significant body weight gain. Expand
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TLDR
After a mean of 27 years' follow-up of patients with type 1 diabetes, 6.5 years of initial intensive diabetes therapy was associated with a modestly lower all-cause mortality rate when compared with conventional therapy. Expand
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