Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Inadequate Glycaemic Control; Type 2 Diabetes Mellitus

Treatments: Drug: Saxagliptin; Drug: Placebo for glimepiride; Drug: Dapagliflozin; Drug: Placebo for saxagliptin; Drug: Placebo for dapagliflozin; Drug: Glimepiride

Study type: Interventional

Funder types: Industry

Identifiers

NCT02471404

D1689C00014

Details and patient eligibility

About

This study is being carried out to see if dapagliflozin and dapagliflozin plus saxagliptin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glimepiride (sulphonylurea) as an addition to metformin treatment.

Enrollment: 939 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Main Inclusion Criteria:

1. Is male or female and ≥18 and <75 years old at time of informed consent.
2. Has a HbA1c of ≥7.5% and ≤10.5% based on central laboratory results from Visit 1, with individual need for therapy escalation.
3. Currently treated with a stable maximum tolarated dose (MTD) (≥1500 mg/day) of metformin therapy for at least 8 weeks prior to Enrolment visit.
4. Has a BMI of ≤45 kg/m2 at Enrolment visit.
5. Has a C-peptide laboratory value of ≥1.0 ng/mL (0.33 nmol/L; 333.3 pmol/L) based on central laboratory results from Visit 1.

Main, Exclusion Criteria:

1. Clinically diagnosed with Type I diabetes, known diagnosis of maturity onset diabetes of the young (MODY), or secondary diabetes mellitus or known presence of glutamate decarboxylase 65 (GAD65) antibodies.
2. Patients who, in the judgment of the Investigator, may be at risk for dehydration or volume depletion that may affect the patient's safety and/or the interpretation of efficacy or safety data.
3. Clinically significant cardiovascular disease or procedure within 3 months prior to Enrolment or expected to require coronary revascularization procedure during the course of the study.
4. Concomitant treatment with loop diuretics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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939 participants in 3 patient groups

Dapagliflozin+metformin

Active Comparator group

Description:

Dapagliflozin + saxagliptin placebo + glimepiride placebo + metformin

Treatment:

Drug: Placebo for saxagliptin

Drug: Placebo for glimepiride

Drug: Dapagliflozin

Dapagliflozin+saxagliptin+metformin

Active Comparator group

Description:

Dapagliflozin + saxagliptin + glimepiride placebo+ metformin

Treatment:

Drug: Placebo for glimepiride

Drug: Dapagliflozin

Drug: Saxagliptin

Glimepiride+metformin

Active Comparator group

Description:

Glimepiride + dapagliflozin placebo + saxagliptin placebo + metformin

Treatment:

Drug: Glimepiride

Drug: Placebo for saxagliptin

Drug: Placebo for dapagliflozin