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NCT02551874 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Type 2 Diabetes Mellitus, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
650
Enrollment target
20
Study locations

NCT02551874: Completed Phase 3 study of Type 2 Diabetes Mellitus, sponsored by AstraZeneca.

NCT02551874 is a Phase 3 study of Type 2 Diabetes Mellitus that has completed, run by AstraZeneca. The registered enrollment target is 650 participants, below the 2,955-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02551874, a Phase 3 study of Type 2 Diabetes Mellitus, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
650 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior (noninferiority margin of 0.3%) to titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.

Conditions Studied

Interventions

  • DRUG Metformin
  • DRUG Glargine insulin
  • DRUG Saxagliptin, Onglyza
  • DRUG Dapagliflozin, Farxiga

Study Locations (20)

Texas

  • Research Site - Houston
  • Research Site - Mesquite
  • Research Site - San Antonio
  • Research Site - San Antonio

Florida

  • Research Site - Miami
  • Research Site - Miami
  • Research Site - St. Petersburg

California

  • Research Site - Anaheim
  • Research Site - Los Angeles

Tennessee

  • Research Site - Bristol
  • Research Site - Kingsport

Georgia

  • Research Site - Norcross

Illinois

  • Research Site - Chicago

Kentucky

  • Research Site - Lexington

Massachusetts

  • Research Site - Quincy

Trial Details

FieldValue
Enrollment Target 650 participants
Start Date 2015-10-20
Est. Completion 2017-11-10
Phase Phase 3
AstraZeneca

1,285 total trials

What the finished NCT02551874 record still lists

NCT02551874 is an interventional study that assigns participants to a tested intervention. The registered 650 participants enrollment target is mid-sized for trials with a published cap, below the 2,955-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (78% lower).

The record links to 1 condition, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 4 interventions - of which Metformin is the first listed.

NCT02551874 names 20 study sites across 13 states, led by Texas, Florida, California.

Frequently Asked Questions

What is clinical trial NCT02551874 about?

NCT02551874 is a clinical study titled "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". 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,...

What is the current status of trial NCT02551874?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 650 participants. The study started on 2015-10-20. Estimated completion is 2017-11-10.

What conditions does trial NCT02551874 study?

This clinical trial studies the following conditions: Type 2 Diabetes Mellitus.

What interventions are being tested in trial NCT02551874?

The interventions under investigation include: Metformin (DRUG), Glargine insulin (DRUG), Saxagliptin, Onglyza (DRUG), Dapagliflozin, Farxiga (DRUG).

Who is sponsoring clinical trial NCT02551874?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02551874 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Type 2 Diabetes Mellitus

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02551874's enrollment target sits among peer trials

650 17th of 130 higher than 114 of 130 other Type 2 Diabetes Mellitus trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02551874, the US trial registry maintained by the National Library of Medicine. NCT02551874 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.