EUCTR2014-003788-39-DEActive, not recruitingPhase 1
Effect of Saxagliptin in Addition to Dapagliflozin and Metformin on Insulin Resistance, Islet Cell Dysfunction, and Metabolic Control in Subjects with Type 2 Diabetes Mellitus on Previous Metformin Treatment
Profil Mainz GmbH & Co KG0 sitesStarted: October 27, 2014Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Diabetes mellitus type 2
- •2. HbA1c 7.0%–9.9%, both inclusive
- •3. Treatment with metformin for at least six months (daily dose 1500 – 3000 mg)
- •4. Age 30–75 years, both inclusive
- •5. BMI 25–35 kg/m^2, both inclusive
- •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 21
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
Exclusion Criteria
- •1. Use of any oral antidiabetic treatment except for metformin (i.e., sulphonylureas, DPP-IV inhibitors, thiazolidinediones, SGLT-2 inhibitors) within the last three months prior to Screening
- •2. Use of insulin or GLP-1 analogues within three months prior to Screening
- •3. Treatment with any other investigational drug within three months before screening
- •4. History of diabetes mellitus type 1
Investigators
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