A Phase 4 interventional study of Linagliptin and Placebo in Type 2 Diabetes Mellitus, sponsored by Profil Institut für Stoffwechselforschung GmbH. Completed at 2 sites in Germany. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-02-24.
Sponsored by Profil Institut für Stoffwechselforschung GmbH · Phase 4, Interventional, and Basic science
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 89 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Profil Institut für Stoffwechselforschung GmbH is the lead sponsor of 24 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Linagliptin 5mg to be adminstered for 30 days in T2DM patients on stable metformin and Empagliflozin
Drug: Linagliptin · Drug: Empagliflozin
Placebo to be adminstered for 30 days in T2DM patients on stable metformin and Empagliflozin
Other: Placebo · Drug: Empagliflozin
Empagliflozin 25mg will be adminstered for 30 days in T2DM patients
Drug: Empagliflozin
22 subjects will receive Linagliptin for 30 days
Also known as: Trajenta
22 subjects will receive Placebo for 30 days
44 subjects will receive Empagliflozin for 60 days
Also known as: Jardiance
• Change in glucagon release (AUC0-180 min) during Liquid Meal Test (LMT) from V3 to V4 between the two treatment groups (Linagliptin vs. placebo)
Time frame: 30 days
• Change in glucagon release (AUC0-180 min) during LMT from V2 to V3 during treatment with Empagliflozin (V2 vs. V3)
Time frame: 30 days
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Profil Institut für Stoffwechselforschung GmbH