Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea

March 22, 2019 updated by: AstraZeneca

A 52-Week, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Active Controlled, Phase IV Study to Evaluate the Safety and Efficacy of Dapagliflozin or Dapagliflozin Plus Saxagliptin Compared With Sulphonylurea All Given as Add-on Therapy to Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Monotherapy

This study is being carried out to see if dapagliflozin and dapagliflozin plus saxagliptin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glimepiride (sulphonylurea) as an addition to metformin treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

939

Phase

  • Phase 4

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
      • Hodonin, Czechia, 695 01
        • Research Site
      • Hradec Kralove, Czechia, 500 05
        • Research Site
      • Jilove u Prahy, Czechia, 254 01
        • Research Site
      • Ostrava - Belsky les, Czechia, 700 30
        • Research Site
      • Pardubice, Czechia, 530 02
        • Research Site
      • Plzen - Severni Predmesti, Czechia, 301 00
        • Research Site
      • Praha - Klanovice, Czechia, 190 14
        • Research Site
      • Prelouc, Czechia, 535 01
        • Research Site
      • Uherske Hradiste, Czechia, 686 01
        • Research Site
      • Zlin, Czechia, 760 01
        • Research Site
  • Germany
      • Aschaffenburg, Germany, 63739
        • Research Site
      • Bad Homburg, Germany, 61348
        • Research Site
      • Bad Mergentheim, Germany, 97980
        • Research Site
      • Bad Nauheim, Germany, 61231
        • Research Site
      • Bad Neuenahr-Ahrweiler, Germany, 53474
        • Research Site
      • Bad Oeynhausen, Germany, 32545
        • Research Site
      • Bad Reichenhall, Germany, 83435
        • Research Site
      • Berlin, Germany, 13125
        • Research Site
      • Berlin, Germany, 10629
        • Research Site
      • Berlin, Germany, 10787
        • Research Site
      • Berlin, Germany, 10115
        • Research Site
      • Berlin, Germany, 10409
        • Research Site
      • Berlin, Germany, 12627
        • Research Site
      • Berlin, Germany, 13597
        • Research Site
      • Bochum, Germany, 44787
        • Research Site
      • Bochum, Germany, 44869
        • Research Site
      • Bonn, Germany, 53179
        • Research Site
      • Bünde, Germany, 32257
        • Research Site
      • Daaden, Germany, 57567
        • Research Site
      • Darmstadt, Germany, 64295
        • Research Site
      • Datteln, Germany, 45711
        • Research Site
      • Deggingen, Germany, 73326
        • Research Site
      • Dippoldiswalde, Germany, 01744
        • Research Site
      • Dortmund, Germany, 44137
        • Research Site
      • Dresden, Germany, 01309
        • Research Site
      • Duisburg, Germany, 47179
        • Research Site
      • Erfurt, Germany, 99085
        • Research Site
      • Erlangen, Germany, 91052
        • Research Site
      • Eschweiler, Germany, 52249
        • Research Site
      • Essen, Germany, 45136
        • Research Site
      • Essen, Germany, 45355
        • Research Site
      • Essen, Germany, 45359
        • Research Site
      • Frankfurt, Germany, 60596
        • Research Site
      • Frankfurt, Germany, 60594
        • Research Site
      • Frankfurt am Main, Germany, 60594
        • Research Site
      • Freiburg, Germany, 79110
        • Research Site
      • Freiburg im Breisgau, Germany, 79106
        • Research Site
      • Freudenstadt, Germany, 72250
        • Research Site
      • Gelnhausen, Germany, 63571
        • Research Site
      • Giengen, Germany, 89537
        • Research Site
      • Goch, Germany, 47574
        • Research Site
      • Grevesmühlen, Germany, 23936
        • Research Site
      • Grossheirath, Germany, 96269
        • Research Site
      • Göttingen, Germany, 37073
        • Research Site
      • Hamburg, Germany, 20246
        • Research Site
      • Hamburg, Germany, 21073
        • Research Site
      • Hamburg, Germany, 21109
        • Research Site
      • Hamburg, Germany, 22041
        • Research Site
      • Hamburg, Germany, 22391
        • Research Site
      • Hamburg, Germany, 22607
        • Research Site
      • Hameln, Germany, 31785
        • Research Site
      • Hannover, Germany, 30625
        • Research Site
      • Heidelberg, Germany, 69115
        • Research Site
      • Herne, Germany, 44653
        • Research Site
      • Hildesheim, Germany, 31139
        • Research Site
      • Hof, Germany, 95030
        • Research Site
      • Hohenmölsen, Germany, 06679
        • Research Site
      • Höhenkirchen, Germany, 85635
        • Research Site
      • Jerichow, Germany, 39319
        • Research Site
      • Kallstadt, Germany, 67169
        • Research Site
      • Karlsruhe, Germany, 76199
        • Research Site
      • Kassel, Germany, 34117
        • Research Site
      • Kiel-Kronshagen, Germany, 24119
        • Research Site
      • Köln, Germany, 51069
        • Research Site
      • Köthen, Germany, 06366
        • Research Site
      • Leipzig, Germany, 04103
        • Research Site
      • Leipzig, Germany, 04109
        • Research Site
      • Lichtenfels, Germany, 96215
        • Research Site
      • Lingen, Germany, 49808
        • Research Site
      • Ludwigshafen, Germany, 67059
        • Research Site
      • Löhne, Germany, 32584
        • Research Site
      • Magdeburg, Germany, 39120
        • Research Site
      • Mannheim, Germany, 68161
        • Research Site
      • Mannheim, Germany, 68163
        • Research Site
      • Marburg, Germany, 35037
        • Research Site
      • Marl, Germany, 45770
        • Research Site
      • Meine, Germany, 38527
        • Research Site
      • Meißen, Germany, 01662
        • Research Site
      • Mühldorf A. Inn, Germany, 84453
        • Research Site
      • München, Germany, 80339
        • Research Site
      • München, Germany, 80809
        • Research Site
      • München, Germany, 81477
        • Research Site
      • Münster, Germany, 48143
        • Research Site
      • Münster, Germany, 48153
        • Research Site
      • Neumünster, Germany, 24534
        • Research Site
      • Neuwied Am Rhein, Germany, 56564
        • Research Site
      • Oldenburg, Germany, 23758
        • Research Site
      • Papenburg, Germany, 26871
        • Research Site
      • Pirna, Germany, 01796
        • Research Site
      • Rehburg Loccum, Germany, 31547
        • Research Site
      • Rehlingen Siersburg, Germany, 66780
        • Research Site
      • Reinfeld, Germany, 23858
        • Research Site
      • Remagen, Germany, 53424
        • Research Site
      • Rhaunen, Germany, 55624
        • Research Site
      • Rodgau-Dudenhofen, Germany, 63110
        • Research Site
      • Saarlouis, Germany, 66740
        • Research Site
      • Schwabenheim, Germany, 55270
        • Research Site
      • Speyer, Germany, 67346
        • Research Site
      • Stadtbergen, Germany, 86391
        • Research Site
      • Stolberg, Germany, 52222
        • Research Site
      • Straubing, Germany, 94315
        • Research Site
      • Stuttgart, Germany, 70199
        • Research Site
      • Sulzbach, Germany, 92237
        • Research Site
      • Trier, Germany, 54290
        • Research Site
      • Villingen-Schwenningen, Germany, 78048
        • Research Site
      • Wahlstedt, Germany, 23812
        • Research Site
      • Wangen, Germany, 88239
        • Research Site
      • Weinheim, Germany, 69469
        • Research Site
      • Westerkappeln, Germany, 49492
        • Research Site
      • Wetzlar, Germany, 35584
        • Research Site
      • Witten, Germany, 58455
        • Research Site
  • Hungary
      • Budapest, Hungary, 1106
        • Research Site
      • Budapest, Hungary, 1171
        • Research Site
      • Budapest, Hungary, 1213
        • Research Site
      • Csongrád, Hungary, 6640
        • Research Site
      • Debrecen, Hungary, 4025
        • Research Site
      • Esztergom, Hungary, 2500
        • Research Site
      • Hatvan, Hungary, 3000
        • Research Site
      • Kisvárda, Hungary, 4600
        • Research Site
      • Komárom, Hungary, 2921
        • Research Site
      • Miskolc, Hungary, 3529
        • Research Site
      • Mosonmagyaróvár, Hungary, 9200
        • Research Site
      • Nyíregyháza, Hungary, 4405
        • Research Site
      • Orosháza-Szentetornya, Hungary, 5900
        • Research Site
      • Polgár, Hungary, 4090
        • Research Site
      • Pécs, Hungary, 7623
        • Research Site
      • Székesfehérvár, Hungary, 8000
        • Research Site
      • Ács, Hungary, 2941
        • Research Site
  • Poland
      • Bochnia, Poland, 32-700
        • Research Site
      • Bydgoszcz, Poland, 85-231
        • Research Site
      • Chrzanow, Poland, 32-500
        • Research Site
      • Gdańsk, Poland, 80-286
        • Research Site
      • Koluszki, Poland, 95-040
        • Research Site
      • Krakow, Poland, 31-567
        • Research Site
      • Legnica, Poland, 59-220
        • Research Site
      • Mrągowo, Poland, 11-700
        • Research Site
      • Ostrowiec Świętokrzyski, Poland, 27-400
        • Research Site
      • Poznan, Poland, 61655
        • Research Site
      • Sobótka, Poland, 55-050
        • Research Site
      • Wierzchosławice, Poland, 33-122
        • Research Site
      • Wrocław, Poland, 54-144
        • Research Site
      • Łódź, Poland, 90-132
        • Research Site
  • Slovakia
      • Banska Bystrica, Slovakia, 974 01
        • Research Site
      • Bratislava, Slovakia, 81108
        • Research Site
      • Bratislava, Slovakia, 833 01
        • Research Site
      • Kosice, Slovakia
        • Research Site
      • Kosice, Slovakia, 04011
        • Research Site
      • Kosice, Slovakia, 040 01
        • Research Site
      • Levice, Slovakia, 934 01
        • Research Site
      • Levice, Slovakia, 934 05
        • Research Site
      • Lucenec, Slovakia, 984 01
        • Research Site
      • Malacky, Slovakia, 901 01
        • Research Site
      • Namestovo, Slovakia, 029 01
        • Research Site
      • Nove Zamky, Slovakia, 94001
        • Research Site
      • Povazska Bystrica, Slovakia, 017 01
        • Research Site
      • Povazska Bystrica, Slovakia, 017 26
        • Research Site
      • Prievidza, Slovakia, 971 01
        • Research Site
      • Puchov, Slovakia, 020 01
        • Research Site
      • Rimavska Sobota, Slovakia, 979 01
        • Research Site
      • Sabinov, Slovakia, 083 01
        • Research Site
      • Trencin, Slovakia, 911 01
        • Research Site
      • Trnava, Slovakia, 917 01
        • Research Site
      • Vrutky, Slovakia, 038 61
        • 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 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Main Inclusion Criteria:

  1. Is male or female and ≥18 and <75 years old at time of informed consent.
  2. Has a HbA1c of ≥7.5% and ≤10.5% based on central laboratory results from Visit 1, with individual need for therapy escalation.
  3. Currently treated with a stable maximum tolarated dose (MTD) (≥1500 mg/day) of metformin therapy for at least 8 weeks prior to Enrolment visit.
  4. Has a BMI of ≤45 kg/m2 at Enrolment visit.
  5. Has a C-peptide laboratory value of ≥1.0 ng/mL (0.33 nmol/L; 333.3 pmol/L) based on central laboratory results from Visit 1.

Main, Exclusion Criteria:

  1. Clinically diagnosed with Type I diabetes, known diagnosis of maturity onset diabetes of the young (MODY), or secondary diabetes mellitus or known presence of glutamate decarboxylase 65 (GAD65) antibodies.
  2. Patients who, in the judgment of the Investigator, may be at risk for dehydration or volume depletion that may affect the patient's safety and/or the interpretation of efficacy or safety data.
  3. Clinically significant cardiovascular disease or procedure within 3 months prior to Enrolment or expected to require coronary revascularization procedure during the course of the study.
  4. Concomitant treatment with loop diuretics

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
Active Comparator: Dapagliflozin+metformin
Dapagliflozin + saxagliptin placebo + glimepiride placebo + metformin
Drug: Dapagliflozin
10 mg, orally Green, plain, diamond-shaped, film-coated tablet
Other Names:
  • Forxiga
Drug: Placebo for saxagliptin
Does not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet
Drug: Placebo for glimepiride
Does not contain active ingredient, orally. Opaque gray capsule
Active Comparator: Dapagliflozin+saxagliptin+metformin
Dapagliflozin + saxagliptin + glimepiride placebo+ metformin
Drug: Dapagliflozin
10 mg, orally Green, plain, diamond-shaped, film-coated tablet
Other Names:
  • Forxiga
Drug: Placebo for glimepiride
Does not contain active ingredient, orally. Opaque gray capsule
Drug: Saxagliptin
5 mg, orally Plain, yellow, biconvex, round, film-coated tablet
Other Names:
  • Onglyza™
Active Comparator: Glimepiride+metformin
Glimepiride + dapagliflozin placebo + saxagliptin placebo + metformin
Drug: Placebo for saxagliptin
Does not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet
Drug: Glimepiride
1, 2, or 4 mg, orally Opaque gray capsule
Other Names:
  • Amaryl
Drug: Placebo for dapagliflozin
Does not contain active ingredient, orally Green, plain, diamond-shaped, film-coated tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52
Time Frame: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
Change in HbA1c from baseline (week 0) to week 52.
Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients With at Least One Episode of Confirmed Hypoglycaemia
Time Frame: Up to Week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
Percentage of patients reporting at least 1 episode of hypoglycaemia (symptomatic + blood glucose <=50 mg/dL) during the double-blind treatment period
Up to Week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
Change in Total Body Weight From Baseline at Week 52
Time Frame: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
Change in body weight from baseline (week 0) to week 52
Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52
Time Frame: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
Change in FPG from baseline (week 0) to week 52
Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
Time to Rescue
Time Frame: Over the 52 week treatment period
The time to rescue (from first dose date after randomisation to start of rescue medication or discontinuation due to lack of glycaemic control) during the 52 week double blind treatment period
Over the 52 week treatment period
Number of Patients Rescued
Time Frame: Over the 52 week treatment period
Number (%) of patients rescued.
Over the 52 week treatment period

Collaborators and Investigators

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

Sponsor

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)

September 21, 2015

Primary Completion (Actual)

March 13, 2017

Study Completion (Actual)

March 13, 2017

Study Registration Dates

First Submitted

June 11, 2015

First Submitted That Met QC Criteria

June 11, 2015

First Posted (Estimate)

June 15, 2015

Study Record Updates

Last Update Posted (Actual)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 22, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1689C00014

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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