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

NCT02471404 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 939

Last updated 2019-03-26

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Dapagliflozin

10 mg, orally Green, plain, diamond-shaped, film-coated tablet

DRUG

Saxagliptin

5 mg, orally Plain, yellow, biconvex, round, film-coated tablet

DRUG

Glimepiride

1, 2, or 4 mg, orally Opaque gray capsule

DRUG

Placebo for dapagliflozin

Does not contain active ingredient, orally Green, plain, diamond-shaped, film-coated tablet

DRUG

Placebo for saxagliptin

Does not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet

DRUG

Placebo for glimepiride

Does not contain active ingredient, orally. Opaque gray capsule

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-09-21
Primary Completion
2017-03-13
Completion
2017-03-13

Countries

  • Czechia
  • Germany
  • Hungary
  • Poland
  • Slovakia

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 NCT02471404 on ClinicalTrials.gov