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

June 22, 2020 updated by: AstraZeneca

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
444

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Cheb, Czechia, 350 02
        • Research Site
      • Hradec Kralove, Czechia, 503 41
        • Research Site
      • Krnov, Czechia, 794 01
        • Research Site
      • Kromeriz, Czechia, 767 01
        • Research Site
      • Nachod, Czechia, 54701
        • Research Site
      • Praha 4, Czechia, 140 00
        • Research Site
      • Praha 4, Czechia, 149 00
        • Research Site
  • Germany
      • Dresden, Germany, 01307
        • Research Site
      • Leipzig, Germany, 04249
        • Research Site
  • Hungary
      • Ajka, Hungary, 8400
        • Research Site
      • Balatonfüred, Hungary, 8230
        • Research Site
      • Budapest, Hungary
        • Research Site
      • Budapest, Hungary, 1033
        • Research Site
      • Budapest, Hungary, 1089
        • Research Site
      • Debrecen, Hungary, 4032
        • Research Site
      • Eger, Hungary, 3300
        • Research Site
      • Gyula, Hungary, 5700
        • Research Site
      • Kaposvár, Hungary, 7400
        • Research Site
      • Kecskemét, Hungary, 6000
        • Research Site
      • Nyíregyháza, Hungary, 4405
        • Research Site
      • Zalaegerszeg, Hungary, 8900
        • Research Site
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Research Site
      • Chihuahua, Mexico, 31237
        • Research Site
      • Cuautla, Mexico, 62746
        • Research Site
      • Guadalajara, Mexico, 44600
        • Research Site
      • Guanajuato, Mexico, 38000
        • Research Site
      • Monterrey, Mexico, 64460
        • Research Site
      • Veracruz, Mexico, 91910
        • Research Site
  • Poland
      • Białystok, Poland, 15-351
        • Research Site
      • Katowice, Poland, 40-648
        • Research Site
      • Kraków, Poland, 31-156
        • Research Site
      • Kraków, Poland, 31-261
        • Research Site
      • Opole, Poland, 45-367
        • Research Site
      • Oswiecim, Poland, 32-600
        • Research Site
      • Poznań, Poland, 61-655
        • Research Site
      • Warszawa, Poland, 02-507
        • Research Site
      • Warszawa, Poland, 00-465
        • Research Site
      • Wroclaw, Poland, 50-349
        • Research Site
      • Łódź, Poland, 90-242
        • Research Site
  • Romania
      • Brasov, Romania, 500269
        • Research Site
      • Bucuresti, Romania, 020359
        • Research Site
      • Bucuresti, Romania, 020045
        • Research Site
      • Buzau, Romania, 120203
        • Research Site
      • Galati, Romania, 800291
        • Research Site
      • Oradea, Romania, 410169
        • Research Site
      • Oradea, Romania, 410032
        • Research Site
      • Ploiesti, Romania, 100342
        • Research Site
      • Ploiesti, Romania, 100163
        • Research Site
      • Satu-Mare, Romania, 440055
        • Research Site
      • Targu, Romania, 540142
        • Research Site
      • Timisoara, Romania, 300736
        • Research Site
  • Russian Federation
      • Novosibirsk, Russian Federation, 630087
        • Research Site
      • Saint Petersburg, Russian Federation, 195257
        • Research Site
      • Smolensk, Russian Federation, 214018
        • Research Site
      • St. Petersburg, Russian Federation, 194354
        • Research Site
      • St. Petersburg, Russian Federation, 196084
        • Research Site
      • St. Petersburg, Russian Federation, 190013
        • Research Site
      • St.-Petersburg, Russian Federation, 195176
        • Research Site
  • Sweden
      • Göteborg, Sweden, 413 45
        • Research Site
      • Helsingborg, Sweden, 25220
        • Research Site
      • Rättvik, Sweden, 79530
        • Research Site
  • United Kingdom
      • Dundee, United Kingdom, DD1 9SY
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Research Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Research Site
      • Tempe, Arizona, United States, 85283
        • Research Site
    • California
      • Huntington Park, California, United States, 90255
        • Research Site
      • Los Angeles, California, United States, 90057
        • Research Site
      • Sacramento, California, United States, 95823
        • Research Site
      • Tarzana, California, United States, 91356
        • Research Site
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Research Site
      • Jacksonville, Florida, United States, 32277
        • Research Site
      • Kissimmee, Florida, United States, 34744
        • Research Site
      • Miami, Florida, United States, 33126
        • Research Site
      • Miami, Florida, United States, 33174
        • Research Site
      • New Port Richey, Florida, United States, 34652
        • Research Site
      • Palm Harbor, Florida, United States, 34684
        • Research Site
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Research Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Research Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Research Site
      • Knoxville, Tennessee, United States, 37912
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Subjects must be willing and able to give signed and dated written informed consent
  • Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control
  • Subjects should have been taking the same daily dose of metformin ≥ 1500 mg
  • Fasting Plasma Glucose ≤ 270 mg/dL (≤15 mmol/L)
  • Males and females, aged ≥18 years old at time of screening visit
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test
  • WOCBP and males must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug

Exclusion Criteria:

  • Clinical diagnosis of type I diabetes
  • History of diabetic ketoacidosis
  • Cardiovascular/vascular diseases within 3 months of the enrollment
  • Renal disease
  • Hepatic diseases
  • History of, or currently, acute or chronic pancreatitis
  • Hematological and oncological disease/conditions
  • Patients who have contraindications to therapy being studied
  • Patients on weight loss program(s)
  • Replacement or chronic systemic corticosteroid therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Saxagliptin 5 mg/ dapagliflozin 10mg or Placebo
Saxagliptin 5 mg /dapagliflozin 10 mg Placebo once a day orally
Other: Placebo
Drug: Dapagliflozin
Drug: Saxagliptin
Experimental: Glimepiride or Placebo
Glimepiride or placebo 1mg or 2mg or 3mg or 4mg or 6mg once a day orally
Other: Placebo
Drug: Glimepiride

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52
Time Frame: Baseline and Week 52
To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.
Baseline and Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Total Body Weight at Week 52
Time Frame: Baseline and Week 52
To examine whether the mean change from baseline in total body weight with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.
Baseline and Week 52
Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 52
Time Frame: At Week 52
Therapeutic glycemic response was defined as HbA1c <7.0%. Subjects rescued or discontinued prior to, and subjects with missing measurements at Week 52 were treated as non-responders. The percentage of subjects with a therapeutic glycemic response is based on the logistic regression method with adjustment for baseline HbA1c.
At Week 52
Change From Baseline in Systolic Blood Pressure (SBP) at Week 52
Time Frame: Baseline and Week 52
To examine whether the change from baseline in SBP with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.
Baseline and Week 52
Percentage of Subjects With Treatment Intensification During the 52-week Short-term Treatment Period
Time Frame: Up to Week 52
Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after the 52-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 52 were counted as having an event for the analysis. The values presented are the percentage of subjects requiring the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control during the 52-week short -term treatment period.
Up to Week 52
Percentage of Subjects With Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.
Time Frame: Up to Week 156
Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after 156-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 156 were counted as having an event for the analysis. The values presented are the percentage of subjects requiring the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control during the 156-week treatment period.
Up to Week 156
Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 156
Time Frame: At Week 156
Therapeutic glycemic response was defined as HbA1c <7.0%. Subjects rescued or discontinued prior to, and subjects with missing measurements at Week 156 were treated as non-responders. The percentage of subjects with a therapeutic glycemic response is based on the logistic regression method with adjustment for baseline HbA1c.
At Week 156
Time to Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.
Time Frame: Up to Week 156
Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after 156-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 156 were counted as having an event for the analysis. Time to treatment intensification curves were generated using Kaplan-Meier estimates and compared using a Cox proportional hazards model.
Up to Week 156

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 29, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 18, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CV181-365

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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