Efficacy and Safety of Dapagliflozin and Dapagliflozin plus Saxagliptinin in Combination with Metformin in Type 2 Diabetes Patients compared with Sulphonylurea.

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002376-24-DE

Enrollment

930

Registered

2015-07-02

Start date

2015-10-06

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus, inadequate glycaemic control MedDRA version: 19.1 Level: HLT Classification code 10012602 Term: Diabetes mellitus (incl subtypes) System Organ Class: 100000004860

Interventions

Trade Name: Forxiga Product Name: Dapagliflozin Pharmaceutical Form: Film-coated tablet INN or Proposed INN: DAPAGLIFLOZIN PROPANEDIOL CAS Number: 960404-48-2 Other descriptive name: DAPAGLIFLOZIN PRO

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Main Inclusion Criteria: 1. Is male or female and =18 and =65 years) yes F.1.3.1 Number of subjects for this age range 230

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the absolute change from baseline in HbA1c at Week 52 between dapagliflozin plus metformin and dapagliflozin plus saxagliptin plus metformin with glimepiride plus metformin;Primary end point(s): Change in HbA1c from baseline to Week 52.;Timepoint(s) of evaluation of this end point: at 52 week;Secondary Objective: - To compare the proportion of patients reporting hypoglycaemia episodes during the 52-week treatment period between dapagliflozin plus metformin and dapagliflozin plus saxagliptin plus metformin with glimepiride plus metformin - To compare the change from baseline in total body weight at Week 52 between dapagliflozin plus metformin and dapagliflozin plus saxagliptin plus metformin with glimepiride plus metformin - To compare the change from baseline in FPG at Week 52 between dapagliflozin plus metformin and dapagliflozin plus saxagliptin plus metformin with glimepiride plus metformin - To compare the time to rescue among the treatment groups during the 52 week treatment period between dapagliflozin plus metformin and dapagliflozin plus saxagliptin plus metformin with glimepiride plus metformin	—

Measure

Time frame

Main Objective: To compare the absolute change from baseline in HbA1c at Week 52 between dapagliflozin plus metformin and dapagliflozin plus saxagliptin plus metformin with glimepiride plus metformin;Primary end point(s): Change in HbA1c from baseline to Week 52.;Timepoint(s) of evaluation of this end point: at 52 week;Secondary Objective: - To compare the proportion of patients reporting hypoglycaemia episodes during the 52-week treatment period between dapagliflozin plus metformin and dapagliflozin plus saxagliptin plus metformin with glimepiride plus metformin - To compare the change from baseline in total body weight at Week 52 between dapagliflozin plus metformin and dapagliflozin plus saxagliptin plus metformin with glimepiride plus metformin - To compare the change from baseline in FPG at Week 52 between dapagliflozin plus metformin and dapagliflozin plus saxagliptin plus metformin with glimepiride plus metformin - To compare the time to rescue among the treatment groups during the 52 week treatment period between dapagliflozin plus metformin and dapagliflozin plus saxagliptin plus metformin with glimepiride plus metformin

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Secondary

Measure	Time frame
Secondary end point(s): • Proportion of patients reporting at least 1 episode of hypoglycaemia during the double-blind treatment period. •Change in total body weight from baseline at Week 52. •Change in FPG from baseline at Week 52. •Time to rescue (start of insulin or discontinuation due to lack of glycaemic control) during the 52-week double-blind treatment period. ;Timepoint(s) of evaluation of this end point: at 52 week	—

Measure

Time frame

Secondary end point(s): • Proportion of patients reporting at least 1 episode of hypoglycaemia during the double-blind treatment period. •Change in total body weight from baseline at Week 52. •Change in FPG from baseline at Week 52. •Time to rescue (start of insulin or discontinuation due to lack of glycaemic control) during the 52-week double-blind treatment period. ;Timepoint(s) of evaluation of this end point: at 52 week

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Countries

Czech Republic, Germany, Hungary, Poland, Slovakia

Contacts

Public ContactClinical Trial Transparency

AstraZeneca AB

clinicaltrialtransparency@astrazeneca.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026