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A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin

NCT02551874 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2018-12-11

Study results available
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Summary

This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM) will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a treatment period of 52 weeks.

Conditions

Interventions

DRUG

Saxagliptin, Onglyza

Tablets, Oral, 5mg , Once daily, 24 weeks

DRUG

Dapagliflozin, Farxiga

Tablets, Oral, 10mg , Once daily, 24 weeks

DRUG

Glargine insulin

100 Units/ml solution for injection in a prefilled SoloStar pen

DRUG

Metformin

Tablets, Oral, ≥ 1500mg/≤ 2500mg, Once daily, 24 weeks

Sponsors & Collaborators

Principal Investigators

  • AstraZeneca · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-10-20
Primary Completion
2017-05-08
Completion
2017-11-10

Countries

  • United States
  • Czechia
  • Denmark
  • Hungary
  • Mexico
  • Poland
  • Romania
  • South Africa
  • Spain
  • Sweden

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 NCT02551874 on ClinicalTrials.gov