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

Phase 1

• Conditions: Type 2 diabetes mellitus, inadequate glycaemic control; MedDRA version: 19.1Level: HLTClassification code 10012602Term: Diabetes mellitus (incl subtypes)System Organ Class: 100000004860; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-002376-24-HU
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-17
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 930

Inclusion Criteria

Main Inclusion Criteria:
1. Is male or female and =18 and <75 years old at time of informed consent.
2. Has a HbA1c of =7.5% and =10.5% based on central laboratory results from Visit 1, with individual need for therapy escalation.
3. Currently treated with a stable maximum tolarated dose (MTD) (=1500 mg/day) of metformin therapy for at least 8 weeks prior to Enrolment visit.
4. Has a BMI of =45 kg/m2 at Enrolment visit.
5. Has a C-peptide laboratory value of =1.0 ng/mL (0.33 nmol/L; 331 pmol/L) based on central laboratory results from Visit 1.

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 700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 230

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

Study & Design

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