A comparison of treatment with Saxagliptin and Dapagliflozin against Insulin Glargine in Type 2 Diabetes patients whose current treatment of Metformin with or without Sulfonylurea Therapy is not adequate.

Phase 1

• Conditions: Type 2 diabetes mellitus and inadequate glycemic control on a stable dose of metformin; MedDRA version: 20.0Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitusSystem Organ Class: 100000064343; MedDRA version: 20.0Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlSystem Organ Class: 100000019249; MedDRA version: 20.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000072461; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-001702-33-CZ
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-29
• Last Update Posted: 3 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 598

Inclusion Criteria

• Males and females aged = 18 years old at the time of screening visit.
• Subjects with T2DM with inadequate glycemic control, defined as a central laboratory HbA1c = 8 % and = 12 % obtained at the screening visit.
• Subjects must be taking a stable dose of metformin = 1500 mg/day for at least 8 weeks prior to screening visit with or without a stable dose of SU of at least 50% maximal dose per local label for at least 8 weeks prior to screening visit. Subjects must not take any other antidiabetic therapy for more than 14 days (consecutive or not) during 12 weeks prior to screening.
• BMI = 45.0 kg/m2 at the screening visit.
• Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of hCG) at screening and within 24 hours prior to the start of study drug.

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 478
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

• Clinical diagnosis of Type 1 Diabetes.
• History of diabetic ketoacidosis
• Any of the following cardiovascular/vascular diseases within 3 months of enrollment visit: myocardial infarction (MI), coronary arterial bypass graft (CABG), percutaneous coronary intervention (PCI), valvular disease or repair, unstable angina or unstable congestive heart failure (CHF), transient ischemic attack (TIA), Class III or IV heart failure, known left ventricular ejection fraction of < 40%, or significant cerebrovascular disease.
• Impairment of renal function (defined as creatinine clearance [CrCl] < 60 mL/min [estimated by Cockcroft-Gault] or serum creatinine [SCr] = 1.5 mg/dL in male subjects or = 1.4 mg/dL in female subjects).
• Bladder cancer
• Hematuria (confirmed by microscopy at screening) with no explanation as judged by the investigator up to randomization.
• Other hematological or oncological diseases or conditions.
• Participation in a commercial weight loss program or history of bariatric surgery.
• Replacement or chronic systemic corticosteroid therapy.
• Administration of any other investigational drug or participation in any interventional clinical study within (30) days prior to screening for this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified