Efficacy and Safety of Dapagliflozin, Added to Therapy of Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Dapagliflozin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00673231

D1690C00006

Details and patient eligibility

About

This study is being carried out to see if Dapagliflozin in addition to insulin is effective and safe in treating patients with type 2 diabetes when compared to placebo (identical looking inactive treatment) in addition to insulin

Enrollment: 1,240 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 Diabetes
• Patients with HbA1c ≥7.5% and ≤10.5% and who are on a stable insulin regimen of at least 30 IU of injectable insulin per day either without any other oral antidiabetic drug or with a stable dose of oral antidiabetic drugs

Exclusion criteria

• Type 1 Diabetes
• Treatment with more than two additional oral antidiabetic drugs
• Moderate and severe renal (kidney) failure or dysfunction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,240 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

2.5mg

Treatment:

Drug: Dapagliflozin

Drug: Dapagliflozin

Drug: Dapagliflozin

Drug: Dapagliflozin

Drug: Dapagliflozin

2

Experimental group

Description:

5mg

Treatment:

Drug: Dapagliflozin

Drug: Dapagliflozin

Drug: Dapagliflozin

Drug: Dapagliflozin

Drug: Dapagliflozin

3

Experimental group

Description:

10mg

Treatment:

Drug: Dapagliflozin

Drug: Dapagliflozin

Drug: Dapagliflozin

Drug: Dapagliflozin

Drug: Dapagliflozin

4

Placebo Comparator group

Treatment:

Drug: Placebo