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
Overview
- Phase
- Phase 4
- Intervention
- Dapagliflozin
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- AstraZeneca
- Enrollment
- 939
- Locations
- 1
- Primary Endpoint
- Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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
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
Arms & Interventions
Dapagliflozin+metformin
Dapagliflozin + saxagliptin placebo + glimepiride placebo + metformin
Intervention: Dapagliflozin
Dapagliflozin+metformin
Dapagliflozin + saxagliptin placebo + glimepiride placebo + metformin
Intervention: Placebo for saxagliptin
Dapagliflozin+metformin
Dapagliflozin + saxagliptin placebo + glimepiride placebo + metformin
Intervention: Placebo for glimepiride
Dapagliflozin+saxagliptin+metformin
Dapagliflozin + saxagliptin + glimepiride placebo+ metformin
Intervention: Dapagliflozin
Dapagliflozin+saxagliptin+metformin
Dapagliflozin + saxagliptin + glimepiride placebo+ metformin
Intervention: Saxagliptin
Dapagliflozin+saxagliptin+metformin
Dapagliflozin + saxagliptin + glimepiride placebo+ metformin
Intervention: Placebo for glimepiride
Glimepiride+metformin
Glimepiride + dapagliflozin placebo + saxagliptin placebo + metformin
Intervention: Glimepiride
Glimepiride+metformin
Glimepiride + dapagliflozin placebo + saxagliptin placebo + metformin
Intervention: Placebo for dapagliflozin
Glimepiride+metformin
Glimepiride + dapagliflozin placebo + saxagliptin placebo + metformin
Intervention: Placebo for saxagliptin
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Patients With at Least One Episode of Confirmed Hypoglycaemia(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 Fasting Plasma Glucose (FPG) From Baseline 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(Over the 52 week treatment period)
- Change in Total Body Weight From Baseline at 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)
- Number of Patients Rescued(Over the 52 week treatment period)