Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Rapid Effects of the DPP-4 Inhibitor Linagliptin on Monocyte Polarization and Endothelial Progenitor Cells in Type 2 Diabetic Patients With and Without Chronic Renal Failure. A Randomized Cross-over Trial Versus Placebo
Brief Summary: Diabetes mellitus is characterized by chronic low grade inflammation, which is worsened by the co-existence of renal failure.

One key aspect of chronic inflammatory diseases is the alteration in the polarization profile of circulating monocyte-macrophage cells.

Namely, monocytes-macrophages can exist in a pro-inflammatory (M1) polarized form or an anti-inflammatory (M2) polarized state. Alterations in the M1/M2 balance is thought to contribute to inflammation within atherosclerotic lesions and visceral adipose tissue which, in turn, can worsen cardiovascular disease and metabolic features in type 2 diabetic patients.

M1 and M2 are regulated by a complex interplay of soluble signaling molecules, many of which are substrate of the enzyme DPP-4 (dipeptidyl peptidase-4). Therefore, inhibition of DPP-4 can affect the M1/M2 polarization balance.

In this clinical trial, the investigators will test whether the DPP-4 inhibitor Linagliptin, compared to placebo, modifies the M1/M2 balance in type 2 diabetic patients with and without chronic renal failure.

In addition, we will test whether DPP-4 inhibition with Linagliptin acutely affects endothelial progenitor cells (EPCs), which are vasculoprotective cells implicated in the pathobiology of diabetic complications.


Options:
A: Arm Label: Sitagliptin; Type: EXPERIMENTAL; Interventions: Drug: Sitagliptin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Sitagliptin; Assigned to Arm(s): Sitagliptin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Linagliptin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Linagliptin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Linagliptin; Assigned to Arm(s): Linagliptin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: Saxagliptin 2.5 mg (A); Type: EXPERIMENTAL; Interventions: Drug: Saxagliptin, Drug: Placebo matching Metformin, Drug: Metformin | Arm Label: Saxagliptin 5 mg (B); Type: EXPERIMENTAL; Interventions: Drug: Saxagliptin, Drug: Placebo matching Metformin, Drug: Metformin | Arm Label: Saxagliptin 10 mg (C); Type: EXPERIMENTAL; Interventions: Drug: Saxagliptin, Drug: Placebo matching Metformin, Drug: Metformin | Arm Label: Placebo (D); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo matching Saxagliptin, Drug: Metformin | Arm Label: Open-Label Treatment Cohort (Direct Enrollees) (E); Type: EXPERIMENTAL; Interventions: Drug: Saxagliptin, Drug: Metformin | Intervention Type: DRUG; Name: Saxagliptin; Assigned to Arm(s): Saxagliptin 2.5 mg (A) | Intervention Type: DRUG; Name: Saxagliptin; Assigned to Arm(s): Saxagliptin 5 mg (B) | Intervention Type: DRUG; Name: Saxagliptin; Assigned to Arm(s): Saxagliptin 10 mg (C) | Intervention Type: DRUG; Name: Placebo matching Saxagliptin; Assigned to Arm(s): Placebo (D) | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Placebo (D) | Intervention Type: DRUG; Name: Placebo matching Metformin; Assigned to Arm(s): Saxagliptin 10 mg (C), Saxagliptin 2.5 mg (A), Saxagliptin 5 mg (B) | Intervention Type: DRUG; Name: Saxagliptin; Assigned to Arm(s): Open-Label Treatment Cohort (Direct Enrollees) (E) | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Open-Label Treatment Cohort (Direct Enrollees) (E), Placebo (D), Saxagliptin 10 mg (C), Saxagliptin 2.5 mg (A), Saxagliptin 5 mg (B)
D: Arm Label: Linagliptin; Type: EXPERIMENTAL; Interventions: Drug: Linagliptin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Linagliptin; Assigned to Arm(s): Linagliptin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: D