Dapagliflozin DPPIV Inhibitor add-on Study

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Dapagliflozin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00984867

D1690C00010

Details and patient eligibility

About

This study aims to investigate how dapagliflozin can control blood sugar in patients with type 2 diabetes when added to existing treatments (sitagliptin alone or in combination with metformin). The effect of dapagliflozin on weight and blood pressure will also be studied.

Enrollment: 833 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with type 2 diabetes
• Patients who are not receiving treatment , or those who currently receive metformin, sitagliptin or vildagliptin or the combination of these
• Patients will be screened by a blood test and only those who need additional therapy can be enrolled

Exclusion criteria

• Patients with type 1 diabetes
• Patients with very poorly controlled diabetes
• Any clinically significant illness, which in the judgement of the investigator would compromise the patient's safety or successful participation in the clinical study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

833 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Dapagliflozin 10 mg tablet

Treatment:

Drug: Dapagliflozin

2

Placebo Comparator group

Description:

Matching placebo tablet

Treatment:

Drug: Placebo