A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

ClinicalTrials.gov ID: NCT02419612

Public ClinicalTrials.gov record NCT02419612. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A 52-week International, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3bTrial With a Blinded 104-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin ≥1500 mg in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin, in addition to metformin, results in better glycemic control, as measured by HbA1c, over a treatment period of 52 weeks, compared to the addition of glimepiride to metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on Metformin Alone. We will compare the change from baseline in HbA1c achieved with saxagliptin, in co-administration with dapagliflozin, added to current background therapy with metformin compared to glimepiride added to current background therapy with metformin ≥1500 mg at Week 52.

Study identification

NCT ID: NCT02419612
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: AstraZeneca; Industry
Enrollment: 444 participants

Conditions and interventions

Conditions

Diabetes

Interventions

Drug · Other

Eligibility (public fields only)

Age range: 18 Years to 120 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 13, 2015
Primary completion: Aug 28, 2017
Completion: Sep 17, 2019
Last update posted: Jun 22, 2020

2015 – 2019

United States locations

U.S. sites: 22
U.S. states: 10
U.S. cities: 20

Facility	City	State	ZIP	Site status
Research Site	Birmingham	Alabama	35211	—
Research Site	Chandler	Arizona	85224	—
Research Site	Tempe	Arizona	85283	—
Research Site	Huntington Park	California	90255	—
Research Site	Los Angeles	California	90057	—
Research Site	Sacramento	California	95823	—
Research Site	Tarzana	California	91356	—
Research Site	Waterbury	Connecticut	06708	—
Research Site	Jacksonville	Florida	32207	—
Research Site	Jacksonville	Florida	32277	—
Research Site	Kissimmee	Florida	34744	—
Research Site	Miami	Florida	33126	—
Research Site	Miami	Florida	33174	—
Research Site	New Port Richey	Florida	34652	—
Research Site	Palm Harbor	Florida	34684	—
Research Site	Edina	Minnesota	55435	—
Research Site	Las Vegas	Nevada	89128	—
Research Site	Greer	South Carolina	29651	—
Research Site	Bristol	Tennessee	37620	—
Research Site	Knoxville	Tennessee	37912	—
Research Site	Dallas	Texas	75230	—
Research Site	San Antonio	Texas	78229	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 62 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02419612, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 22, 2020 · Synced Sep 1, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02419612 live on ClinicalTrials.gov.

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