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Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

NCT02284893 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 461

Last updated 2018-06-01

Study results available
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Summary

Study will evaluate if a combination of saxagliptin and dapagliflozin added concurrently to metformin in combination with diet and exercise is superior to sitagliptin added to metformin in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26 weeks.

Conditions

Interventions

DRUG

Saxagliptin

administered orally once daily

DRUG

Dapagliflozin

administered orally once daily

DRUG

Sitagliptin

administered orally once daily

DRUG

Placebo matching with Saxagliptin

administered orally once daily

DRUG

Placebo matching with Dapagliflozin

administered orally once daily

DRUG

Placebo matching with Sitagliptin

administered orally once daily

Sponsors & Collaborators

Principal Investigators

  • Astra Zeneca · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-09-09
Primary Completion
2016-09-20
Completion
2016-09-20

Countries

  • United States
  • Hungary
  • Mexico
  • Poland
  • Romania
  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT02284893 on ClinicalTrials.gov