Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes (DEPICT 2)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Dapagliflozin; Other: Placebo for dapagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02460978

D1695C00007 (Other Identifier)

2014-004599-49 (EudraCT Number)

MB102-230

Details and patient eligibility

About

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.

Full description

Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics

Enrollment: 815 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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815 participants in 3 patient groups, including a placebo group

Dapagliflozin 5 mg

Experimental group

Description:

Dapagliflozin 5 mg tablet orally, once daily for 52 weeks

Treatment:

Drug: Dapagliflozin

Dapagliflozin 10 mg

Experimental group

Description:

Dapagliflozin 10 mg tablet orally, once daily for 52 weeks

Treatment:

Drug: Dapagliflozin

Placebo

Placebo Comparator group

Description:

Placebo tablet orally, once daily for 52 weeks

Treatment:

Other: Placebo for dapagliflozin