Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology and Metabolic Control in Patients with Type 2 Diabetes Mellitus on Stable Metformin Treatment
Phase 1
Active, not recruiting
- Conditions
- Type 2 Diabetes MellitusMedDRA version: 17.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2014-004895-48-DE
- Lead Sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1. Male or female subject with diabetes mellitus type 2
2. Diabetes mellitus type 2 on stable treatment with metformin (daily dose at least 1000 mg) for at least 6 months
3. HbA1c 7.0%–9.9%, both inclusive
4. Diabetes duration of at least 24 months)
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 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12
Exclusion Criteria
1. History of diabetes mellitus type 1
2. GFR (as calculated by the Cockroft-Gault equation) < 60 ml/min at Screening
3. Systolic blood pressure outside the range of 100–160 mmHg or diastolic blood pressure above 95 mmHg at Screening
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method