Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

May 29, 2018 updated by: AstraZeneca

A 26-week International, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3bTrial With a Blinded 26-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

Study will evaluate if a combination of saxagliptin and dapagliflozin added concurrently to metformin in combination with diet and exercise is superior to sitagliptin added to metformin in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

461

Phase

  • 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

  • Hungary
      • Baja, Hungary, 6500
        • Research Site
      • Budapest, Hungary, 1036
        • Research Site
      • Budapest, Hungary, 1097
        • Research Site
      • Debrecen, Hungary, 4032
        • Research Site
      • Gyula, Hungary, 5700
        • Research Site
      • Nyíregyháza, Hungary, 4405
        • Research Site
      • Szekszárd, Hungary, 7100
        • Research Site
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Research Site
      • Chihuahua, Mexico, 31217
        • Research Site
      • Cuautla, Mexico, 62746
        • Research Site
      • Guadalajara, Mexico, 44670
        • Research Site
      • Guadalajara, Mexico, 44130
        • Research Site
      • Guadalajara, Mexico, 44160
        • Research Site
      • Monterrey, Mexico, 64460
        • Research Site
  • Poland
      • Białystok, Poland, 15-879
        • Research Site
      • Gdańsk, Poland, 80-546
        • Research Site
      • Kraków, Poland, 31-156
        • Research Site
      • Kraków, Poland, 31-261
        • Research Site
      • Opole, Poland, 45-367
        • Research Site
      • Poznań, Poland, 61-655
        • Research Site
      • Warszawa, Poland, 02-507
        • Research Site
      • Wroclaw, Poland, 50-349
        • Research Site
      • Wroclaw, Poland, 51-685
        • Research Site
  • Romania
      • Brasov, Romania, 500269
        • Research Site
      • Bucuresti, Romania, 011794
        • Research Site
      • Bucuresti, Romania, 020359
        • Research Site
      • Buzau, Romania, 120203
        • Research Site
      • Craiova, Romania, 200349
        • Research Site
      • Galati, Romania, 800098
        • Research Site
      • Oradea, Romania, 410169
        • Research Site
      • Satu-Mare, Romania, 440055
        • Research Site
      • Timisoara, Romania, 300736
        • Research Site
  • South Africa
      • Boksburg North, South Africa, 1460
        • Research Site
      • Cape Town, South Africa, 7700
        • Research Site
      • Durban, South Africa, 4091
        • Research Site
      • Johannesburg, South Africa, 1818
        • Research Site
      • Lenasia, South Africa, 1829
        • Research Site
      • Moloto, South Africa, 1022
        • Research Site
      • Soweto, South Africa, 2013
        • Research Site
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Research Site
      • Mesa, Arizona, United States, 85213
        • Research Site
      • Phoenix, Arizona, United States, 85020
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Site
    • California
      • Huntington Beach, California, United States, 92648
        • Research Site
      • Huntington Park, California, United States, 90255
        • Research Site
      • Lomita, California, United States, 90717
        • Research Site
      • Los Angeles, California, United States, 90057
        • Research Site
      • Northridge, California, United States, 91325
        • Research Site
      • Norwalk, California, United States, 90650
        • Research Site
      • Paramount, California, United States, 90723
        • Research Site
      • Sacramento, California, United States, 95823
        • Research Site
      • Tarzana, California, United States, 91356
        • Research Site
      • Tustin, California, United States, 92780
        • Research Site
    • Colorado
      • Golden, Colorado, United States, 80401
        • Research Site
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Research Site
      • Kissimmee, Florida, United States, 34744
        • Research Site
      • Miami, Florida, United States, 33135
        • Research Site
      • Miami, Florida, United States, 33015
        • Research Site
      • Miami, Florida, United States, 33174
        • Research Site
      • Miami Beach, Florida, United States, 33140
        • Research Site
      • Palm Harbor, Florida, United States, 34684
        • Research Site
      • Pembroke Pines, Florida, United States, 33026
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60634
        • Research Site
    • Iowa
      • Council Bluffs, Iowa, United States, 51503
        • Research Site
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Research Site
      • Morehead City, North Carolina, United States, 28557
        • Research Site
      • Salisbury, North Carolina, United States, 28144
        • Research Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Research Site
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Research Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Research Site
      • Houston, Texas, United States, 77081
        • Research Site
      • North Richland Hills, Texas, United States, 76180
        • Research Site
      • Pasadena, Texas, United States, 77504
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Research Site
      • Suffolk, Virginia, United States, 23452
        • Research Site
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53142
        • 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

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:

  • Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control, defined as a central laboratory glycosylated hemoglobin (HbA1c) ≥8.0% and ≤ 10.5 % obtained at the screening visit
  • Subjects should have been taking the same daily dose of metformin ≥ 1500 mg for at least 8 weeks prior to the enrollment visit and with no intake of other antihyperglycemic therapy for more than 14 days (consecutive or not) during 12 weeks prior to screening
  • BMI > 20.0 kg/m2 at the enrollment visit
  • Males and Females, age ≥18 years old at time of screening visit
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug
  • Women must not be breastfeeding

Exclusion Criteria:

  • Clinically diagnosed with Type I diabetes, known diagnosis of Maturity Onset Diabetes of Young (MODY), secondary diabetes mellitus or diabetes insipidus
  • History of diabetic ketoacidosis

  • Any of the following cardiovascular (CV)/Vascular Diseases within 3 months of the enrollment visit

    • Myocardial infarction
    • Cardiac surgery or revascularization (coronary artery bypass surgery Coronary Artery Bypass Graft [(CABG)]/percutaneous transluminal coronary angioplasty percutaneous transluminal coronary angioplasty [(PTCA)])
    • Unstable angina
    • Unstable congestive heart failure (CHF)
    • Transient ischemic attack (TIA) or significant cerebrovascular disease
    • Unstable or previously undiagnosed arrhythmia
    • Congestive heart failure, defined as New York Heart Association (NYHA) Class III and IV, unstable or acute congestive heart failure and/or known left ventricular ejection fraction of ≤ 40%
  • Renal Disease
  • Hepatic Diseases
  • Hematological and Oncological Disease/Conditions
  • Hemoglobin ≤ 11.0 g/dL (110 g/L) for men; hemoglobin ≤ 10.0 g/dL (100 g/L) for women
  • Abnormal Free T4

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
Intervention / Treatment
Experimental: A1:Saxagliptin / Placebo + Dapagliflozin / Placebo
Saxagliptin 5 mg and matching placebo 0 mg (once daily) plus Dapagliflozin 10 mg and matching placebo 0 mg (once daily)
Drug: Saxagliptin
administered orally once daily
Drug: Dapagliflozin
administered orally once daily
Drug: Placebo matching with Saxagliptin
administered orally once daily
Drug: Placebo matching with Dapagliflozin
administered orally once daily
Experimental: A2: Sitagliptin / placebo
Sitagliptin 100 mg and matching placebo 0 mg (once daily)
Drug: Sitagliptin
administered orally once daily
Drug: Placebo matching with Sitagliptin
administered orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Change in HbA1c
Time Frame: Baseline (randomization) to Week 26
Baseline (randomization) to Week 26

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%
Time Frame: week 26
week 26
Mean Change in Total Body Weight
Time Frame: Baseline (randomization) to Week 26
Baseline (randomization) to Week 26
Mean Change in Fasting Plasma Glucose (FPG)
Time Frame: Baseline (randomization) to Week 26
Baseline (randomization) to Week 26

Collaborators and Investigators

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

Sponsor

AstraZeneca

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)

September 9, 2014

Primary Completion (Actual)

September 20, 2016

Study Completion (Actual)

September 20, 2016

Study Registration Dates

First Submitted

November 4, 2014

First Submitted That Met QC Criteria

November 4, 2014

First Posted (Estimate)

November 6, 2014

Study Record Updates

Last Update Posted (Actual)

June 1, 2018

Last Update Submitted That Met QC Criteria

May 29, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV181-363
  • 2014-001102-17 (EudraCT Number)

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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