Back to resultsEfficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea
Primary Purpose
Type 2 Diabetes Mellitus, Inadequate Glycaemic Control
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Dapagliflozin
Saxagliptin
Glimepiride
Placebo for dapagliflozin
Placebo for saxagliptin
Placebo for glimepiride
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Diabetes Mellitus Type 2,, metformin,, saxagliptin,, dapagliflozin,, glimepiride,, inadequate glycaemic control
Eligibility Criteria
Inclusion Criteria: Main Inclusion Criteria:
- Is male or female and ≥18 and <75 years old at time of informed consent.
- Has a HbA1c of ≥7.5% and ≤10.5% based on central laboratory results from Visit 1, with individual need for therapy escalation.
- Currently treated with a stable maximum tolarated dose (MTD) (≥1500 mg/day) of metformin therapy for at least 8 weeks prior to Enrolment visit.
- Has a BMI of ≤45 kg/m2 at Enrolment visit.
- 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:
- 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.
- 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.
- 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.
- Concomitant treatment with loop diuretics
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Dapagliflozin+metformin
Dapagliflozin+saxagliptin+metformin
Glimepiride+metformin
Arm Description
Dapagliflozin + saxagliptin placebo + glimepiride placebo + metformin
Dapagliflozin + saxagliptin + glimepiride placebo+ metformin
Glimepiride + dapagliflozin placebo + saxagliptin placebo + metformin
Outcomes
Primary Outcome Measures
Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52
Change in HbA1c from baseline (week 0) to week 52.
Secondary Outcome Measures
Patients With at Least One Episode of Confirmed Hypoglycaemia
Percentage of patients reporting at least 1 episode of hypoglycaemia (symptomatic + blood glucose <=50 mg/dL) during the double-blind treatment period
Change in Total Body Weight From Baseline at Week 52
Change in body weight from baseline (week 0) to week 52
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52
Change in FPG from baseline (week 0) to week 52
Time to Rescue
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
Number of Patients Rescued
Number (%) of patients rescued.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02471404
Brief Title
Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 21, 2015 (Actual)
Primary Completion Date
March 13, 2017 (Actual)
Study Completion Date
March 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Inadequate Glycaemic Control
Keywords
Diabetes Mellitus Type 2,, metformin,, saxagliptin,, dapagliflozin,, glimepiride,, inadequate glycaemic control
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
939 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dapagliflozin+metformin
Arm Type
Active Comparator
Arm Description
Dapagliflozin + saxagliptin placebo + glimepiride placebo + metformin
Arm Title
Dapagliflozin+saxagliptin+metformin
Arm Type
Active Comparator
Arm Description
Dapagliflozin + saxagliptin + glimepiride placebo+ metformin
Arm Title
Glimepiride+metformin
Arm Type
Active Comparator
Arm Description
Glimepiride + dapagliflozin placebo + saxagliptin placebo + metformin
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Other Intervention Name(s)
Forxiga
Intervention Description
10 mg, orally Green, plain, diamond-shaped, film-coated tablet
Intervention Type
Drug
Intervention Name(s)
Saxagliptin
Other Intervention Name(s)
Onglyza™
Intervention Description
5 mg, orally Plain, yellow, biconvex, round, film-coated tablet
Intervention Type
Drug
Intervention Name(s)
Glimepiride
Other Intervention Name(s)
Amaryl
Intervention Description
1, 2, or 4 mg, orally Opaque gray capsule
Intervention Type
Drug
Intervention Name(s)
Placebo for dapagliflozin
Intervention Description
Does not contain active ingredient, orally Green, plain, diamond-shaped, film-coated tablet
Intervention Type
Drug
Intervention Name(s)
Placebo for saxagliptin
Intervention Description
Does not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet
Intervention Type
Drug
Intervention Name(s)
Placebo for glimepiride
Intervention Description
Does not contain active ingredient, orally. Opaque gray capsule
Primary Outcome Measure Information:
Title
Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52
Description
Change in HbA1c from baseline (week 0) 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
Secondary Outcome Measure Information:
Title
Patients With at Least One Episode of Confirmed Hypoglycaemia
Description
Percentage of patients reporting at least 1 episode of hypoglycaemia (symptomatic + blood glucose <=50 mg/dL) during the double-blind treatment period
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
Title
Change in Total Body Weight From Baseline at Week 52
Description
Change in body weight from baseline (week 0) 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
Title
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52
Description
Change in FPG from baseline (week 0) 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
Title
Time to Rescue
Description
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
Time Frame
Over the 52 week treatment period
Title
Number of Patients Rescued
Description
Number (%) of patients rescued.
Time Frame
Over the 52 week treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Main Inclusion Criteria:
Is male or female and ≥18 and <75 years old at time of informed consent.
Has a HbA1c of ≥7.5% and ≤10.5% based on central laboratory results from Visit 1, with individual need for therapy escalation.
Currently treated with a stable maximum tolarated dose (MTD) (≥1500 mg/day) of metformin therapy for at least 8 weeks prior to Enrolment visit.
Has a BMI of ≤45 kg/m2 at Enrolment visit.
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:
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.
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.
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.
Concomitant treatment with loop diuretics
Facility Information:
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City
Hodonin
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695 01
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Czechia
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Hradec Kralove
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500 05
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Czechia
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Jilove u Prahy
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254 01
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Czechia
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City
Ostrava - Belsky les
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700 30
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Czechia
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Pardubice
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530 02
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Czechia
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Plzen - Severni Predmesti
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301 00
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Czechia
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Praha - Klanovice
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190 14
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Czechia
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City
Prelouc
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535 01
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Czechia
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Uherske Hradiste
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686 01
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Czechia
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Zlin
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760 01
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Czechia
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Aschaffenburg
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63739
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Germany
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Bad Homburg
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61348
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Germany
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Bad Mergentheim
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97980
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Germany
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Bad Nauheim
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61231
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Germany
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Bad Neuenahr-Ahrweiler
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53474
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Germany
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Bad Oeynhausen
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32545
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Germany
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Bad Reichenhall
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83435
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Germany
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Berlin
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10115
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Germany
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Berlin
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10409
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Germany
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Berlin
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10629
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Germany
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Berlin
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10787
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Germany
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Berlin
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12627
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Germany
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Berlin
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13125
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Germany
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Berlin
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Bochum
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Bochum
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Bonn
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Bünde
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32257
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Darmstadt
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Datteln
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45711
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Germany
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Deggingen
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Germany
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Dippoldiswalde
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Dortmund
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99085
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91052
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Essen
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45136
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Essen
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45355
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Essen
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Frankfurt am Main
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60594
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Germany
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Frankfurt
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60594
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Germany
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Frankfurt
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60596
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Germany
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Freiburg im Breisgau
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79106
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Germany
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Freiburg
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79110
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Germany
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Freudenstadt
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72250
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Germany
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Gelnhausen
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63571
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Germany
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Giengen
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89537
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Germany
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Goch
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47574
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Germany
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Grevesmühlen
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23936
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Germany
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Grossheirath
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96269
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Germany
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Göttingen
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37073
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Hamburg
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20246
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Hamburg
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21073
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Hamburg
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21109
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Hamburg
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22041
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Hamburg
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22391
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Hamburg
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22607
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Hameln
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31785
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Hannover
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30625
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Heidelberg
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69115
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Herne
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44653
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Hildesheim
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31139
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Hof
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95030
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Germany
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Hohenmölsen
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06679
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Germany
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Höhenkirchen
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85635
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Germany
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Jerichow
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39319
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Germany
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Kallstadt
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67169
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Germany
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Karlsruhe
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76199
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Germany
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Kassel
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34117
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Germany
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Kiel-Kronshagen
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24119
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Germany
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Köln
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51069
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Germany
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Köthen
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06366
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Leipzig
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04103
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Germany
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Leipzig
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04109
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Lichtenfels
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96215
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Germany
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Lingen
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49808
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Germany
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Ludwigshafen
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67059
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Germany
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Löhne
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32584
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Germany
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Magdeburg
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39120
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Germany
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Mannheim
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68161
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Germany
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Mannheim
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68163
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Germany
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Marburg
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35037
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Germany
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Marl
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45770
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Germany
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Meine
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38527
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Germany
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Meißen
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01662
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Germany
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Mühldorf A. Inn
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84453
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Germany
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München
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80339
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Germany
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München
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80809
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Germany
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München
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81477
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Germany
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Münster
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48143
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Germany
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Münster
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48153
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Germany
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Neumünster
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24534
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Neuwied Am Rhein
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56564
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Germany
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Oldenburg
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23758
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Germany
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Papenburg
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26871
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Germany
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Pirna
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01796
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Germany
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Rehburg Loccum
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31547
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Germany
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Rehlingen Siersburg
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66780
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Germany
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Reinfeld
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23858
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Germany
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Remagen
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53424
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Germany
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Rhaunen
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55624
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Germany
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Rodgau-Dudenhofen
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63110
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Germany
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Saarlouis
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66740
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Germany
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Schwabenheim
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55270
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Germany
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Speyer
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67346
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Germany
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Stadtbergen
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86391
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Germany
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Stolberg
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52222
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Germany
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Straubing
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94315
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Germany
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Stuttgart
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70199
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Germany
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Sulzbach
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92237
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Germany
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Trier
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54290
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Germany
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Villingen-Schwenningen
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78048
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Germany
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Wahlstedt
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23812
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Germany
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Wangen
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88239
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Germany
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Weinheim
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69469
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Germany
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Westerkappeln
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49492
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Germany
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Wetzlar
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35584
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Germany
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Witten
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58455
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Germany
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Budapest
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1106
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Hungary
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Budapest
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1171
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Hungary
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Budapest
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1213
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Hungary
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Csongrád
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6640
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Hungary
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Debrecen
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4025
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Hungary
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Esztergom
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2500
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Hungary
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Hatvan
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3000
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Hungary
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Kisvárda
ZIP/Postal Code
4600
Country
Hungary
Facility Name
Research Site
City
Komárom
ZIP/Postal Code
2921
Country
Hungary
Facility Name
Research Site
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Research Site
City
Mosonmagyaróvár
ZIP/Postal Code
9200
Country
Hungary
Facility Name
Research Site
City
Nyíregyháza
ZIP/Postal Code
4405
Country
Hungary
Facility Name
Research Site
City
Orosháza-Szentetornya
ZIP/Postal Code
5900
Country
Hungary
Facility Name
Research Site
City
Polgár
ZIP/Postal Code
4090
Country
Hungary
Facility Name
Research Site
City
Pécs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Research Site
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Research Site
City
Ács
ZIP/Postal Code
2941
Country
Hungary
Facility Name
Research Site
City
Bochnia
ZIP/Postal Code
32-700
Country
Poland
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85-231
Country
Poland
Facility Name
Research Site
City
Chrzanow
ZIP/Postal Code
32-500
Country
Poland
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-286
Country
Poland
Facility Name
Research Site
City
Koluszki
ZIP/Postal Code
95-040
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31-567
Country
Poland
Facility Name
Research Site
City
Legnica
ZIP/Postal Code
59-220
Country
Poland
Facility Name
Research Site
City
Mrągowo
ZIP/Postal Code
11-700
Country
Poland
Facility Name
Research Site
City
Ostrowiec Świętokrzyski
ZIP/Postal Code
27-400
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
61655
Country
Poland
Facility Name
Research Site
City
Sobótka
ZIP/Postal Code
55-050
Country
Poland
Facility Name
Research Site
City
Wierzchosławice
ZIP/Postal Code
33-122
Country
Poland
Facility Name
Research Site
City
Wrocław
ZIP/Postal Code
54-144
Country
Poland
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
90-132
Country
Poland
Facility Name
Research Site
City
Banska Bystrica
ZIP/Postal Code
974 01
Country
Slovakia
Facility Name
Research Site
City
Bratislava
ZIP/Postal Code
81108
Country
Slovakia
Facility Name
Research Site
City
Bratislava
ZIP/Postal Code
833 01
Country
Slovakia
Facility Name
Research Site
City
Kosice
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
Research Site
City
Kosice
ZIP/Postal Code
04011
Country
Slovakia
Facility Name
Research Site
City
Kosice
Country
Slovakia
Facility Name
Research Site
City
Levice
ZIP/Postal Code
934 01
Country
Slovakia
Facility Name
Research Site
City
Levice
ZIP/Postal Code
934 05
Country
Slovakia
Facility Name
Research Site
City
Lucenec
ZIP/Postal Code
984 01
Country
Slovakia
Facility Name
Research Site
City
Malacky
ZIP/Postal Code
901 01
Country
Slovakia
Facility Name
Research Site
City
Namestovo
ZIP/Postal Code
029 01
Country
Slovakia
Facility Name
Research Site
City
Nove Zamky
ZIP/Postal Code
94001
Country
Slovakia
Facility Name
Research Site
City
Povazska Bystrica
ZIP/Postal Code
017 01
Country
Slovakia
Facility Name
Research Site
City
Povazska Bystrica
ZIP/Postal Code
017 26
Country
Slovakia
Facility Name
Research Site
City
Prievidza
ZIP/Postal Code
971 01
Country
Slovakia
Facility Name
Research Site
City
Puchov
ZIP/Postal Code
020 01
Country
Slovakia
Facility Name
Research Site
City
Rimavska Sobota
ZIP/Postal Code
979 01
Country
Slovakia
Facility Name
Research Site
City
Sabinov
ZIP/Postal Code
083 01
Country
Slovakia
Facility Name
Research Site
City
Trencin
ZIP/Postal Code
911 01
Country
Slovakia
Facility Name
Research Site
City
Trnava
ZIP/Postal Code
917 01
Country
Slovakia
Facility Name
Research Site
City
Vrutky
ZIP/Postal Code
038 61
Country
Slovakia
12. IPD Sharing Statement
Citations:
PubMed Identifier
29947099
Citation
Muller-Wieland D, Kellerer M, Cypryk K, Skripova D, Rohwedder K, Johnsson E, Garcia-Sanchez R, Kurlyandskaya R, Sjostrom CD, Jacob S, Seufert J, Dronamraju N, Csomos K. Efficacy and safety of dapagliflozin or dapagliflozin plus saxagliptin versus glimepiride as add-on to metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Nov;20(11):2598-2607. doi: 10.1111/dom.13437. Epub 2018 Jul 16.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3910&filename=d1689c00014_SAP_Redacted.pdf
Description
d1689c00014_SAP_Redacted
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3910&filename=d1689c00014_CSP_redacted.pdf
Description
d1689c00014_CSP_Redacted
Learn more about this trial
Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea
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