MedTrace Logo

ESR-15-11293 - Saxa/Dapa, Safety and Efficacy Study

NCT02613897 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2019-08-14

Study results available
· View outcomes & findings →

Summary

This is a 16-week, single center, randomized, double-blind, active-controlled, parallel-group, Phase 3b efficacy and safety study of simultaneous administration of saxagliptin 5 mg plus dapagliflozin 10 mg once daily (QD) compared with dapagliflozin plus placebo for saxagliptin, and placebo for saxagliptin plus placebo for dapagliflozin in patients with Type 2 diabetes who have inadequate glycemic control on metformin or metformin/sulfonylurea.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Saxagliptin

Saxagliptin (Onglyza™) is approved by the US FDA as an adjunct to diet and exercise to improve glycemic control in adults with T2DM. The 5 mg dose will be used for this study as it is the dose that is routinely used in the clinic. In addition, this dose is used in the pivotal studies in the saxagliptin/dapagliflozin clinical program.

DRUG

Dapagliflozin

Dapagliflozin (Farxiga) is approved by the FDA as an adjunct to diet and exercise to improve glycemic control in adults with T2DM. Dapagliflozin (Farxiga) is also approved in the EU as an adjunct to diet and exercise to improve glycemic control in patients with T2DM for whom metformin use is considered inappropriate due to intolerance, and in combination with other glucose-lowering medicinal products when these, in combination with diet and exercise do not provide adequate glycemic control. The 10 mg dose was chosen for this study because it has been extensively studied in Phase 3 trials and has demonstrated a favorable benefit-risk profile. In addition, this dose is the most commonly used dose in most countries.

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Eugenio Cersosimo, MD · The University of Texas Health Science Center at San Antonio

  • Ralph A DeFronzo, MD · The University of Texas Health Science Center at San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02613897 on ClinicalTrials.gov