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

Phase 1

• Conditions: Type 2 Diabetes mellitus; MedDRA version: 17.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2014-003788-39-DE
• Lead Sponsor: Profil Mainz GmbH & Co KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-27
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

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