A 52-week International, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3bTrial With a Blinded 104-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin ≥1500 mg in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
Overview
- Phase
- Phase 3
- Intervention
- Saxagliptin
- Conditions
- Diabetes
- Sponsor
- AstraZeneca
- Enrollment
- 444
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin, in addition to metformin, results in better glycemic control, as measured by HbA1c, over a treatment period of 52 weeks, compared to the addition of glimepiride to metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on Metformin Alone. We will compare the change from baseline in HbA1c achieved with saxagliptin, in co-administration with dapagliflozin, added to current background therapy with metformin compared to glimepiride added to current background therapy with metformin ≥1500 mg at Week 52.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must be willing and able to give signed and dated written informed consent
- •Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control
- •Subjects should have been taking the same daily dose of metformin ≥ 1500 mg
- •Fasting Plasma Glucose ≤ 270 mg/dL (≤15 mmol/L)
- •Males and females, aged ≥18 years old at time of screening visit
- •Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test
- •WOCBP and males must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug
Exclusion Criteria
- •Clinical diagnosis of type I diabetes
- •History of diabetic ketoacidosis
- •Cardiovascular/vascular diseases within 3 months of the enrollment
- •Renal disease
- •Hepatic diseases
- •History of, or currently, acute or chronic pancreatitis
- •Hematological and oncological disease/conditions
- •Patients who have contraindications to therapy being studied
- •Patients on weight loss program(s)
- •Replacement or chronic systemic corticosteroid therapy
Arms & Interventions
Saxagliptin 5 mg/ dapagliflozin 10mg or Placebo
Saxagliptin 5 mg /dapagliflozin 10 mg Placebo once a day orally
Intervention: Saxagliptin
Saxagliptin 5 mg/ dapagliflozin 10mg or Placebo
Saxagliptin 5 mg /dapagliflozin 10 mg Placebo once a day orally
Intervention: Dapagliflozin
Saxagliptin 5 mg/ dapagliflozin 10mg or Placebo
Saxagliptin 5 mg /dapagliflozin 10 mg Placebo once a day orally
Intervention: Placebo
Glimepiride or Placebo
Glimepiride or placebo 1mg or 2mg or 3mg or 4mg or 6mg once a day orally
Intervention: Glimepiride
Glimepiride or Placebo
Glimepiride or placebo 1mg or 2mg or 3mg or 4mg or 6mg once a day orally
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52
Time Frame: Baseline and Week 52
To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.
Secondary Outcomes
- Change From Baseline in Total Body Weight at Week 52(Baseline and Week 52)
- Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 52(At Week 52)
- Change From Baseline in Systolic Blood Pressure (SBP) at Week 52(Baseline and Week 52)
- Percentage of Subjects With Treatment Intensification During the 52-week Short-term Treatment Period(Up to Week 52)
- Percentage of Subjects With Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.(Up to Week 156)
- Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 156(At Week 156)
- Time to Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.(Up to Week 156)