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

CompletadoFase 3ClinicalTrials.gov

ID: NCT02460978Tipo: INTERVENTIONALInicio: 8 de jul de 2015Fin estimado: 18 de abr de 2018

Traducción no disponible, mostrando original

Resumen

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.

Descripción detallada

Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Dapagliflozin

Tablets

other

Placebo for dapagliflozin

Tablets

Ubicaciones

Research Site

Buenos Aires, Argentina

Research Site

Buenos Aires, Argentina

Research Site

CABA, Argentina

Research Site

Corrientes, Argentina

Research Site

Córdoba, Argentina

Research Site

Córdoba, Argentina

Research Site

Mar del Plata, Argentina

Research Site

Ramos Mejía, Argentina

Patrocinadores

PrincipalAstraZeneca

ColaboradorBristol-Myers Squibb

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