Pragmatic Randomised 104 Week Multicentre Trial to Evaluate the Comparative Effectiveness of dapagliflozin and Standard of Care in Type 2 Diabetes. The DECIDE Study.

INTERVENTION: Trade Name: FORXIGA Product Name: Forxiga Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: dapagliflozin propanediol monohydrate CAS Number: 960404‐48‐2 Other descriptive name: DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Pharmaceutical Form: Pharmaceutical Form: Tablet INN or Proposed INN: repaglinide CAS Number: 135062‐02‐1 Other descriptive name: REPAGLINIDE Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: nateglinide CAS Number: 105816‐04‐4 Other descriptive name: NATEGLINIDE Pharmaceutical Form: Pharmaceutical Form: Tablet INN or Proposed INN: pioglitazone Other descriptive name: PIOGLITAZONE HYDROCHLORIDE Trade Name: XIGDUO Product Name: Xigduo Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: dapagliflozin propanediol monohydrate CAS Number: 960404‐48‐2 Other descriptive name: DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ INN or Proposed INN: metformin Other descriptive name: METFORMIN HYDROCHLORIDE Pharmaceutical Form: INN or Proposed INN: metformin Other descriptive name: METFORMIN HYDROCHLORIDE Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: pioglitazone Other descriptive name: PIOGLITAZONE HYDROCHLORIDE INN or Proposed INN: metformin Other descriptive name: METFORMIN HYDROCHLORIDE Pharmaceutical Form: Tablet INN or Proposed INN: acarbose CAS Number: 56180‐94‐0 Other descriptive name: ACARBOSE CONDITION: Therapeutic area: Diseases [C] ‐ Nutritional and Metabolic Diseases [C18] Type 2 diabetes mellitus ; MedDRA version: 20.0 Level: LLT Classification code 10012613 Term: Diabetes mellitus non‐insulin‐dependent System Organ Class: 100000004861 PRIMARY OUTCOME: Main Objective: To assess differences between dapagliflozin and SOC (subsequent to at least 3 months post‐randomization) in the achievement of clinical success in the treatment of Type II diabetes mellitus using a 4‐item composite endpoint, at the clinical evaluation that occurs closest to 52 weeks of follow‐up (allowing a window of 12 weeks). Primary end point(s): HbA1c reduction vs. baseline (= 0.5%), weight loss vs. baseline (= 2 Kg), no severe or documented; hypoglycaemic events since the last (most recent) clinical assessment, and no switching from; or adding to the treatment to which the patient was randomized (e.g., dapagliflozin or SOC).; Secondary Objective: To assess differences between dapagliflozin and SOC (subsequent to at least 3 months postrandomization) in the achievement of clinical success in the treatment of Type II diabetes mellitus using a 4‐item composite endpoint at any clinical evaluation that occurs within the first 52 weeks of follow‐up.; To assess differences between dapagliflozin and SOC (subsequent to 52 weeks of followup) in the achievement of clinical success in the treatment of Type II diabetes mellitus using a 4‐item composite endpoint at the clinical evaluation that occurs:; ‐ closest to 104 weeks of follow‐up (allowing a window of 12 weeks); ; ‐ and separately, within the second 52 weeks of follow‐up (Week 53 through Week 104).; Other objectives include evaluation of each separate item of the composite; change from baseline in HbA1c and in total body weight; the patient’s worry related to the risk of hypoglycaemic episodes; the patient’s satisfaction with treatment; and the need for antyhpertensive escalation.; Timepoint(s) of evaluation of this end point: At the clinical evaluation that occurs closest to 52 weeks of follow‐up (allowing a window of 12 weeks). ; Timepoint(s) of evaluation of this end point: • At any clinical evaluation that occurs within the first 52 weeks of follow‐up. ; • At the clinical evaluation that occurs closest to 104 weeks of follow‐up (allowing a window of 12 weeks). SECONDARY OUTCOME: Secondary end point(s): HbA1c reduction vs. baseline (= 0.5%); weight loss vs. baseline (= 2 Kg); no severe or documented hypoglycaemic events since the last (most recent) clinical assessment; no switching from or adding to the treatment to which the patient was randomized (e.g., dapagliflozin or SOC); HFS‐II Worry scale score; DTSQ score; proportion of patients needing antyhypertensive escalation. ; • At any clinical evaluation within the second 52 weeks of follow‐up (Week 53 through Week 104). INCLUSION CRITERIA: For inclusion in the study patients should fulfil the following criteria at the time of screening: 1. Provision of informed consent prior to any study specific procedures 2. Females and males aged =18 years 3. Diagnosed with Type 2 Diabetes Mellitus. 4. Uncontrolled on first‐line metformin treatment, defined as =8 weeks on maximum tolerated dose of metformin and HbA1c > 6.5%. 5. Ability to read and write as judged by the investigator. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 676 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 196