EUCTR2014-003788-39-DE
Active, Not Recruiting
Phase 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 sitesOctober 27, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Profil Mainz GmbH & Co KG
- Status
- Active, Not Recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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