Type 2 Diabetes Mellitus
Conditions
Brief summary
The primary aim of this exploratory mechanistic study is to investigate the effects of Empagliflozin and Linagliptin on alpha- and beta cell physiology in T2DM patients. This study aims to evaluate the effect of the DPP-IV inhibitor linagliptin (as compared to placebo) in addition to the SGLT-2 inhibitor empagliflozin on pancreatic alpha and beta cell function, as well as several markers of metabolic control.
Detailed description
This study will be performed as a multi-center study which includes 2 centres. 44 subjects with T2DM are to be included according to the defined in- and exclusion criteria. Subjects has to be on a stable metformin therapy and will receive in a first step empagliflozin for 30 days. Both therapies (metformin and empagliflozin) will be continued for another 30 days and subjects will be randomized to receive in addition Linagliptin or Placebo for 30 days. Subjects will come for two inhouse periods to their corresponding study center and will undergo an hyperglycaemic clamp test as well as a Meal test in each of the periods.
Interventions
DRUGLinagliptin
22 subjects will receive Linagliptin for 30 days
OTHERPlacebo
22 subjects will receive Placebo for 30 days
DRUGEmpagliflozin
44 subjects will receive Empagliflozin for 60 days
Sponsors
Profil Institut für Stoffwechselforschung GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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)
Exclusion criteria
1. History of diabetes mellitus type 1 2. GFR (as calculated by the Cockcroft-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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Change in glucagon release (AUC0-180 min) during Liquid Meal Test (LMT) from V3 to V4 between the two treatment groups (Linagliptin vs. placebo) | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| • Change in glucagon release (AUC0-180 min) during LMT from V2 to V3 during treatment with Empagliflozin (V2 vs. V3) | 30 days |
Countries
Germany
Outcome results
None listed