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

November 20, 2018 updated by: AstraZeneca

A 24-week International, Multicenter, Randomized, Open-Label, Active-Controlled, Parallel Group, 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 With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin With or Without Sulfonylurea Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

CV181-369; A 24 Week International, Open-Label Trial With a 28 Week Extension to Evaluate the Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects With Type 2 Diabetes on Metformin With or Without Sulfonylurea Therapy

Study Type

Interventional

Enrollment (Actual)

650

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

  • Czechia
      • Karlovy Vary, Czechia, 360 01
        • Research Site
      • Olomouc, Czechia, 772 00
        • Research Site
  • Denmark
      • Koebenhavn, Denmark, 2400
        • Research Site
  • Hungary
      • Budapest, Hungary, 1171
        • Research Site
      • Budapest, Hungary, 1097
        • Research Site
      • Budapest, Hungary, 1032
        • Research Site
  • Mexico
      • Guadalajara, Mexico, 44670
        • Research Site
      • Mexico, Mexico, 03800
        • Research Site
      • Monterrey, Mexico, 64460
        • Research Site
      • Zapopan, Jalisco, Mexico, 45200
        • Research Site
  • Poland
      • Lodz, Poland, 92-003
        • Research Site
      • Nowy Duninow, Poland, 09-505
        • Research Site
      • Sochaczew, Poland, 96-500
        • Research Site
  • Romania
      • Craiova, Romania, 200349
        • Research Site
      • Ploiesti, Romania, 100018
        • Research Site
      • Timisoara, Romania, 300125
        • Research Site
      • Timișoara, Romania, 300456
        • Research Site
  • South Africa
      • Lenasia, South Africa, 1827
        • Research Site
  • Spain
      • La Coruña, Spain, 15006
        • Research Site
  • Sweden
      • Uddevalla, Sweden, 451 80
        • Research Site
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Research Site
      • Los Angeles, California, United States, 90057
        • Research Site
    • Florida
      • Miami, Florida, United States, 33144
        • Research Site
      • Miami, Florida, United States, 33155
        • Research Site
      • Saint Petersburg, Florida, United States, 33709
        • Research Site
    • Georgia
      • Norcross, Georgia, United States, 30071
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40502
        • Research Site
    • Massachusetts
      • Quincy, Massachusetts, United States, 02169
        • Research Site
    • Ohio
      • Beavercreek, Ohio, United States, 45432
        • Research Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Research Site
    • Pennsylvania
      • Barto, Pennsylvania, United States, 19504
        • Research Site
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Research Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Research Site
      • Kingsport, Tennessee, United States, 37660
        • Research Site
    • Texas
      • Houston, Texas, United States, 77004
        • Research Site
      • Mesquite, Texas, United States, 74194
        • Research Site
      • San Antonio, Texas, United States, 78258
        • Research Site
      • San Antonio, Texas, United States, 78230
        • Research Site
    • Utah
      • Bountiful, Utah, United States, 84010
        • 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:

  • At least 18 years of age at screening
  • HbA1c ≥ 8% and ≤ 12% at screening
  • Fasting plasma glucose (FPG) ≤ 270 mg/dL (15mmol/L)
  • Stable dose metformin ≥ 1500 mg per day with or without a stable dose of sulfonylurea (defined as at least 50% maximal dose per local label) for at least 8 weeks
  • estimated glomerular filtration rate (eGFR) < 60 ml/ml/1.73m2
  • Body Mass Index ≤ 45.0 kg/m2

Exclusion Criteria:

  • Clinical diagnosis of Type 1 diabetes
  • History of ketoacidosis
  • Renal, hepatic or pancreatic disease
  • Impairment of renal function (defined as creatinine clearance [CrCl] < 60 mL/min
  • Cardiovascular or vascular diseases identified within 3 months of participationImpairment of renal function (defined as creatinine clearance [CrCl] < 60 mL/min

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Saxagliptin/Dapagliflozin/Metformin
Oral route. Saxagliptin/Dapa adminsitered once daily for 24 weeks at a dose of 5 mg Saxagliptin and 10 mg Dapagliflozin
Drug: Saxagliptin, Onglyza
Tablets, Oral, 5mg , Once daily, 24 weeks
Other Names:
  • Onglyza
Drug: Dapagliflozin, Farxiga
Tablets, Oral, 10mg , Once daily, 24 weeks
Other Names:
  • BMS-512148
Drug: Metformin
Tablets, Oral, ≥ 1500mg/≤ 2500mg, Once daily, 24 weeks
Other Names:
  • Glucophage
Active Comparator: Insulin Glargine, Lantos/Metformin
Insulin glargine administered once a day with starting dose of 0.2 Unit per kg or 10 units.
Drug: Glargine insulin
100 Units/ml solution for injection in a prefilled SoloStar pen
Other Names:
  • Lantus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in HbA1c at Week 24
Time Frame: Baseline and Week 24
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.
Baseline and Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Total Body Weight at Week 24
Time Frame: Baseline and Week 24
To compare the mean change from baseline in total body weight with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment
Baseline and Week 24
Percentage of Subjects With Confirmed Hypoglycaemia at Week 24
Time Frame: Baseline and Week 24
Hypoglycemia defined as plasma glucose ≤70 mg/dL (3.9 mmol/L)
Baseline and Week 24
Percentage of Subjects Achieving a Therapeutic Glycemic Response, Without Hypoglycaemia, at Week 24
Time Frame: Baseline and Week 24
To compare the percentage of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, without any reported hypoglycemia, with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.
Baseline and Week 24
Percentage of Subjects Achieving a Therapeutic Glycemic Response at Week 24
Time Frame: Baseline and Week 24
To examine whether the percentage of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior (noninferiority margin of 10%) to titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.
Baseline and Week 24
Change From Baseline in the Mean Value of 24-hour Glucose at Week 2
Time Frame: Baseline and Week 2
Change from baseline in the mean value of 24-hour glucose readings measured by Continuous Glucose Monitoring with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior to titrated insulin glargine plus metformin with or without SU after 2 weeks of open-label treatment.
Baseline and Week 2

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca, 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)

October 20, 2015

Primary Completion (Actual)

May 8, 2017

Study Completion (Actual)

November 10, 2017

Study Registration Dates

First Submitted

September 15, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Actual)

December 11, 2018

Last Update Submitted That Met QC Criteria

November 20, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV181-369
  • 2015-001702-33 (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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