Diabetes Type 2
Conditions
Brief summary
The purpose of this research is to study and determine the effects of Aliskiren on blood vessels and blood flow. The primary hypothesis is that Aliskiren will increase endothelial function by 30% or more in comparison to the placebo group.
Interventions
DRUGPlacebo
0mg tablet, taken orally for 12 weeks daily
DRUGAliskiren
150mg tablet, taken orally for 12 weeks daily
Sponsors
Novartis Pharmaceuticals
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Group 1. Subjects At Risk of Developing Type 2 Diabetes INCLUSION CRITERIA 1. Ages of 21-80 years 2. Subjects at risk of developing type 2 Diabetes Mellitus (First degree relatives history of type 2 Diabetes Mellitus, History of gestational Diabetes, Known impaired glucose tolerance, Impaired fasting plasma glucose 100-126 mg/dl at the time of enrollment)
Exclusion criteria
1. Treatment with Aliskiren (Tekturna) 2. Smokers (use of tobacco products in the previous 3 months) 3. Active or Uncontrolled Cardiovascular Disease * Myocardial infarction, or angina within 12 months of study participation * Arrhythmia (uncontrolled, highly symptomatic, requiring treatment or life-threatening) * CHF (Class III and IV symptoms of heart failure on less than ordinary exertion or at rest) * Stroke or Transient Ischemic Attack (TIA) within 12 months of study participation * Uncontrolled Hypertension (SBP \>180 mmHg or DBP \>105 mmHg; 2 abnormal readings during visit) * History of previous hypotensive episodes 4. Liver Disease (AST, ALT, Alk Phos levels \> 2x UNL) 5. Renal Disease (creatinine \> 1.7 mg/dL for women and \>2.0 mg/dL for men and/or estimated GFR \<30 mL/min, history of dialysis, nephrotic syndrome and known renovascular hypertension) at the time of enrollment 6. Hyperkalemia (serum potassium \>5.0 meq/L) 7. Severe Dyslipidemia (TG \> 600 mg/dL or Cholesterol \>350 mg/dL) 8. Any Other Serious Chronic Disease Requiring Active Treatment 9. Females of Childbearing Potential Not Using an Effective Form of Birth Control as Determined by co-investigators 10. Pregnancy 11. Taking Any of the Following Medications: * Systemic (not inhaled) Glucocorticoids * Antineoplastic Agents * Cyclosporine, Ketoconazole, Furosemide, Warfarin * Bronchodilators (aminophyline, inhaled beta agonists) on a regular basis 12. Patient is known to have a history of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result in the past 13. History of drug or alcohol abuse within the 12months prior to dosing or evidence of such abuse as indicated by laboratory assays conducted during screening or baseline evaluations Group 2. Type 2 Diabetic Patients INCLUSION CRITERIA 1. Ages of 21-80 years 2. Type 2 Diabetes Mellitus stable and not expected to change during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow Mediated Vasodilation | Baseline | Using ultrasound, percent change in brachial artery diameter is measured in response to an increase in shear stress from a tightened blood pressure cuff, which causes endothelium-dependent dilatation. |
| Nitroglycerin Induced Dilation | Baseline | Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG. |
| Nitroglycerine Induced Vasodilation | 12 Weeks post-randomization | Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG. |
| Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside | Baseline | Laser doppler imaging is used to measure microcirculatory changes pre- and post-iontophoresis of acetylcholine and sodium nitroprusside. |
Secondary
| Measure | Time frame |
|---|---|
| Absolute Change in Inflammatory Cytokines and Growth Factors, GM-CSF pg/mL | 12 Weeks post-randomization |
| Absolute Change in Inflammatory Cytokines and Growth Factors, IL-8, pg/mL | 12 Weeks post-randomization |
| Absolute Change in Inflammatory Cytokines and Growth Factors, MCP-1 pg/mL | 12 Weeks post-randomization |
| Absolute Change in Biochemical Markers of Endothelial Function, sICAM-1, ng/mL | 12 Weeks post-randomization |
| Absolute Change in Biochemical Markers of Endothelial Function, sVCAM-1, ng/mL | 12 Weeks post-randomization |
| Absolute Change in Inflammatory Cytokines and Growth Factors, MDC ng/mL | 12 Weeks post-randomization |
| Absolute Change in Biochemical Markers of Endothelial Function, C-reactive Protein, μg/mL | 12 Weeks post-randomization |
| Absolute Change in Biochemical Markers of Endothelial Function, E-Selectin, ng/mL | 12 Weeks post-randomization |
| Absolute Change in Inflammatory Cytokines and Growth Factors, Osteoprotegerin, pg/mL | 12 Weeks post-randomization |
| Absolute Change in Inflammatory Cytokines and Growth Factors, TNFα, pg/mL | 12 Weeks post-randomization |
| Absolute Change in Biochemical Markers of Endothelial Function, t-PAI, pg/mL | 12 Weeks post-randomization |
| Absolute Change in Inflammatory Cytokines and Growth Factors, sCD-40L ng/mL | 12 Weeks post-randomization |
| Absolute Change in Inflammatory Cytokines and Growth Factors, Osteopontin, ng/mL | 12 Weeks post-randomization |
| Absolute Change in Inflammatory Cytokines and Growth Factors, G-CSF, pg/mL | 12 Weeks post-randomization |
Countries
United States
Participant flow
Pre-assignment details
A total of 124 subjects signed the ICF, but after screening procedures, 24 were found ineligible so only 100 were randomized to placebo or Aliskiren.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo: 0mg tablet, taken orally for 12 weeks daily | 51 |
| Aliskiren Aliskiren: 150mg tablet, taken orally for 12 weeks daily | 49 |
| Total | 100 |
Baseline characteristics
| Characteristic | Placebo | Aliskiren | Total |
|---|---|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 11 | 54 years STANDARD_DEVIATION 11 | 54 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 51 participants | 49 participants | 100 participants |
| Sex: Female, Male Female | 20 Participants | 30 Participants | 50 Participants |
| Sex: Female, Male Male | 31 Participants | 19 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 46 | 7 / 42 |
| serious Total, serious adverse events | 0 / 46 | 4 / 42 |
Outcome results
Primary
Flow Mediated Vasodilation
Using ultrasound, percent change in brachial artery diameter is measured in response to an increase in shear stress from a tightened blood pressure cuff, which causes endothelium-dependent dilatation.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects at Risk of DMII | Flow Mediated Vasodilation | 4.8 percentage change over baseline | Standard Deviation 0.7 |
| T2DM Patients | Flow Mediated Vasodilation | 4.4 percentage change over baseline | Standard Deviation 2.6 |
Primary
Flow Mediated Vasodilation
Using ultrasound, percent change in brachial artery diameter is measured in response to an increase in shear stress from a tightened blood pressure cuff, which causes endothelium-dependent dilatation.
Time frame: 12 Weeks post-randomization
Population: Number of subjects that completed the study
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects at Risk of DMII | Flow Mediated Vasodilation | At risk of T2DM, Placebo n=21, Aliskiren n=20 | 0.3 percent change over baseline |
| Subjects at Risk of DMII | Flow Mediated Vasodilation | Diabetic Patients, Placebo n=25, Aliskiren n=22 | 0.4 percent change over baseline |
| T2DM Patients | Flow Mediated Vasodilation | At risk of T2DM, Placebo n=21, Aliskiren n=20 | 0.8 percent change over baseline |
| T2DM Patients | Flow Mediated Vasodilation | Diabetic Patients, Placebo n=25, Aliskiren n=22 | 0.9 percent change over baseline |
Primary
Nitroglycerine Induced Vasodilation
Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG.
Time frame: 12 Weeks post-randomization
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects at Risk of DMII | Nitroglycerine Induced Vasodilation | At risk of T2DM, Placebo n=21, Aliskiren n=20 | 0.4 percent change |
| Subjects at Risk of DMII | Nitroglycerine Induced Vasodilation | Diabetic Patients, Placebo n=25, Aliskiren n=22 | -1.4 percent change |
| T2DM Patients | Nitroglycerine Induced Vasodilation | At risk of T2DM, Placebo n=21, Aliskiren n=20 | -0.8 percent change |
| T2DM Patients | Nitroglycerine Induced Vasodilation | Diabetic Patients, Placebo n=25, Aliskiren n=22 | -0.3 percent change |
Primary
Nitroglycerin Induced Dilation
Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects at Risk of DMII | Nitroglycerin Induced Dilation | 16.5 percent change | Standard Deviation 4.8 |
| T2DM Patients | Nitroglycerin Induced Dilation | 15.2 percent change | Standard Deviation 5 |
Primary
Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside
Laser doppler imaging is used to measure microcirculatory changes pre- and post-iontophoresis of acetylcholine and sodium nitroprusside.
Time frame: Baseline
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects at Risk of DMII | Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside | Acetylcholine induced skin vasodilation | 45 percentage change over baseline |
| Subjects at Risk of DMII | Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside | Sodium nitroprusside skin induced vasodilation | 38 percentage change over baseline |
| T2DM Patients | Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside | Acetylcholine induced skin vasodilation | 38 percentage change over baseline |
| T2DM Patients | Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside | Sodium nitroprusside skin induced vasodilation | 36 percentage change over baseline |
Primary
Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside
Laser doppler imaging is used to measure microcirculatory changes pre- and post-iontophoresis of acetylcholine (Ach) and sodium nitroprusside (NaNP).
Time frame: 12 Weeks post-randomization
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects at Risk of DMII | Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside | At risk of T2DM, Ach, Placebo n=21, Aliskiren n=20 | 6 percent change over baseline |
| Subjects at Risk of DMII | Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside | At risk of T2DM, NaNP, Placebo n=21 Aliskiren n=20 | -1 percent change over baseline |
| Subjects at Risk of DMII | Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside | Diabetic Patient, Ach, Placebo n=25 Aliskiren n=22 | -5 percent change over baseline |
| Subjects at Risk of DMII | Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside | Diabetic Patient, NaNP, Placebo n=25 Ali. n=22 | -9 percent change over baseline |
| T2DM Patients | Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside | Diabetic Patient, NaNP, Placebo n=25 Ali. n=22 | 8 percent change over baseline |
| T2DM Patients | Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside | At risk of T2DM, Ach, Placebo n=21, Aliskiren n=20 | -1 percent change over baseline |
| T2DM Patients | Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside | Diabetic Patient, Ach, Placebo n=25 Aliskiren n=22 | 3 percent change over baseline |
| T2DM Patients | Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside | At risk of T2DM, NaNP, Placebo n=21 Aliskiren n=20 | 13 percent change over baseline |
Secondary
Absolute Change in Biochemical Markers of Endothelial Function, C-reactive Protein, μg/mL
Time frame: 12 Weeks post-randomization
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects at Risk of DMII | Absolute Change in Biochemical Markers of Endothelial Function, C-reactive Protein, μg/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | -1.0 μg/mL |
| Subjects at Risk of DMII | Absolute Change in Biochemical Markers of Endothelial Function, C-reactive Protein, μg/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | -1.7 μg/mL |
| T2DM Patients | Absolute Change in Biochemical Markers of Endothelial Function, C-reactive Protein, μg/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | -0.6 μg/mL |
| T2DM Patients | Absolute Change in Biochemical Markers of Endothelial Function, C-reactive Protein, μg/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | -2.0 μg/mL |
Secondary
Absolute Change in Biochemical Markers of Endothelial Function, E-Selectin, ng/mL
Time frame: 12 Weeks post-randomization
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects at Risk of DMII | Absolute Change in Biochemical Markers of Endothelial Function, E-Selectin, ng/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | 1.9 ng/mL |
| Subjects at Risk of DMII | Absolute Change in Biochemical Markers of Endothelial Function, E-Selectin, ng/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | 0.6 ng/mL |
| T2DM Patients | Absolute Change in Biochemical Markers of Endothelial Function, E-Selectin, ng/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | 0.7 ng/mL |
| T2DM Patients | Absolute Change in Biochemical Markers of Endothelial Function, E-Selectin, ng/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | -0.7 ng/mL |
Secondary
Absolute Change in Biochemical Markers of Endothelial Function, sICAM-1, ng/mL
Time frame: 12 Weeks post-randomization
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects at Risk of DMII | Absolute Change in Biochemical Markers of Endothelial Function, sICAM-1, ng/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | 21 ng/mL |
| Subjects at Risk of DMII | Absolute Change in Biochemical Markers of Endothelial Function, sICAM-1, ng/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | 13 ng/mL |
| T2DM Patients | Absolute Change in Biochemical Markers of Endothelial Function, sICAM-1, ng/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | 30 ng/mL |
| T2DM Patients | Absolute Change in Biochemical Markers of Endothelial Function, sICAM-1, ng/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | 14 ng/mL |
Secondary
Absolute Change in Biochemical Markers of Endothelial Function, sVCAM-1, ng/mL
Time frame: 12 Weeks post-randomization
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects at Risk of DMII | Absolute Change in Biochemical Markers of Endothelial Function, sVCAM-1, ng/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | 335 ng/mL |
| Subjects at Risk of DMII | Absolute Change in Biochemical Markers of Endothelial Function, sVCAM-1, ng/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | 185 ng/mL |
| T2DM Patients | Absolute Change in Biochemical Markers of Endothelial Function, sVCAM-1, ng/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | 236 ng/mL |
| T2DM Patients | Absolute Change in Biochemical Markers of Endothelial Function, sVCAM-1, ng/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | 106 ng/mL |
Secondary
Absolute Change in Biochemical Markers of Endothelial Function, t-PAI, pg/mL
Time frame: 12 Weeks post-randomization
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects at Risk of DMII | Absolute Change in Biochemical Markers of Endothelial Function, t-PAI, pg/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | 45 pg/mL |
| Subjects at Risk of DMII | Absolute Change in Biochemical Markers of Endothelial Function, t-PAI, pg/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | 54 pg/mL |
| T2DM Patients | Absolute Change in Biochemical Markers of Endothelial Function, t-PAI, pg/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | 30 pg/mL |
| T2DM Patients | Absolute Change in Biochemical Markers of Endothelial Function, t-PAI, pg/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | 26 pg/mL |
Secondary
Absolute Change in Inflammatory Cytokines and Growth Factors, G-CSF, pg/mL
Time frame: 12 Weeks post-randomization
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects at Risk of DMII | Absolute Change in Inflammatory Cytokines and Growth Factors, G-CSF, pg/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | 1.1 pg/mL |
| Subjects at Risk of DMII | Absolute Change in Inflammatory Cytokines and Growth Factors, G-CSF, pg/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | 1.9 pg/mL |
| T2DM Patients | Absolute Change in Inflammatory Cytokines and Growth Factors, G-CSF, pg/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | 4.0 pg/mL |
| T2DM Patients | Absolute Change in Inflammatory Cytokines and Growth Factors, G-CSF, pg/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | 4.4 pg/mL |
Secondary
Absolute Change in Inflammatory Cytokines and Growth Factors, GM-CSF pg/mL
Time frame: 12 Weeks post-randomization
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects at Risk of DMII | Absolute Change in Inflammatory Cytokines and Growth Factors, GM-CSF pg/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | 0.4 pg/mL |
| Subjects at Risk of DMII | Absolute Change in Inflammatory Cytokines and Growth Factors, GM-CSF pg/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | -1.6 pg/mL |
| T2DM Patients | Absolute Change in Inflammatory Cytokines and Growth Factors, GM-CSF pg/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | -0.8 pg/mL |
| T2DM Patients | Absolute Change in Inflammatory Cytokines and Growth Factors, GM-CSF pg/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | 0.4 pg/mL |
Secondary
Absolute Change in Inflammatory Cytokines and Growth Factors, IL-8, pg/mL
Time frame: 12 Weeks post-randomization
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects at Risk of DMII | Absolute Change in Inflammatory Cytokines and Growth Factors, IL-8, pg/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | -2.2 pg/mL |
| Subjects at Risk of DMII | Absolute Change in Inflammatory Cytokines and Growth Factors, IL-8, pg/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | -2.4 pg/mL |
| T2DM Patients | Absolute Change in Inflammatory Cytokines and Growth Factors, IL-8, pg/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | -2.0 pg/mL |
| T2DM Patients | Absolute Change in Inflammatory Cytokines and Growth Factors, IL-8, pg/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | 0.6 pg/mL |
Secondary
Absolute Change in Inflammatory Cytokines and Growth Factors, MCP-1 pg/mL
Time frame: 12 Weeks post-randomization
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects at Risk of DMII | Absolute Change in Inflammatory Cytokines and Growth Factors, MCP-1 pg/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | -11 pg/mL |
| Subjects at Risk of DMII | Absolute Change in Inflammatory Cytokines and Growth Factors, MCP-1 pg/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | 36 pg/mL |
| T2DM Patients | Absolute Change in Inflammatory Cytokines and Growth Factors, MCP-1 pg/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | -7 pg/mL |
| T2DM Patients | Absolute Change in Inflammatory Cytokines and Growth Factors, MCP-1 pg/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | 8 pg/mL |
Secondary
Absolute Change in Inflammatory Cytokines and Growth Factors, MDC ng/mL
Time frame: 12 Weeks post-randomization
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects at Risk of DMII | Absolute Change in Inflammatory Cytokines and Growth Factors, MDC ng/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | -0.09 ng/mL |
| Subjects at Risk of DMII | Absolute Change in Inflammatory Cytokines and Growth Factors, MDC ng/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | -0.07 ng/mL |
| T2DM Patients | Absolute Change in Inflammatory Cytokines and Growth Factors, MDC ng/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | -0.07 ng/mL |
| T2DM Patients | Absolute Change in Inflammatory Cytokines and Growth Factors, MDC ng/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | 0.04 ng/mL |
Secondary
Absolute Change in Inflammatory Cytokines and Growth Factors, Osteopontin, ng/mL
Time frame: 12 Weeks post-randomization
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects at Risk of DMII | Absolute Change in Inflammatory Cytokines and Growth Factors, Osteopontin, ng/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | -0.3 ng/mL |
| Subjects at Risk of DMII | Absolute Change in Inflammatory Cytokines and Growth Factors, Osteopontin, ng/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | 1.7 ng/mL |
| T2DM Patients | Absolute Change in Inflammatory Cytokines and Growth Factors, Osteopontin, ng/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | 2.2 ng/mL |
| T2DM Patients | Absolute Change in Inflammatory Cytokines and Growth Factors, Osteopontin, ng/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | 0.2 ng/mL |
Secondary
Absolute Change in Inflammatory Cytokines and Growth Factors, Osteoprotegerin, pg/mL
Time frame: 12 Weeks post-randomization
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects at Risk of DMII | Absolute Change in Inflammatory Cytokines and Growth Factors, Osteoprotegerin, pg/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | -36 pg/mL |
| Subjects at Risk of DMII | Absolute Change in Inflammatory Cytokines and Growth Factors, Osteoprotegerin, pg/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | -24 pg/mL |
| T2DM Patients | Absolute Change in Inflammatory Cytokines and Growth Factors, Osteoprotegerin, pg/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | 97 pg/mL |
| T2DM Patients | Absolute Change in Inflammatory Cytokines and Growth Factors, Osteoprotegerin, pg/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | 48 pg/mL |
Secondary
Absolute Change in Inflammatory Cytokines and Growth Factors, sCD-40L ng/mL
Time frame: 12 Weeks post-randomization
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects at Risk of DMII | Absolute Change in Inflammatory Cytokines and Growth Factors, sCD-40L ng/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | -0.8 ng/mL |
| Subjects at Risk of DMII | Absolute Change in Inflammatory Cytokines and Growth Factors, sCD-40L ng/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | 3.3 ng/mL |
| T2DM Patients | Absolute Change in Inflammatory Cytokines and Growth Factors, sCD-40L ng/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | -3.2 ng/mL |
| T2DM Patients | Absolute Change in Inflammatory Cytokines and Growth Factors, sCD-40L ng/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | -3.6 ng/mL |
Secondary
Absolute Change in Inflammatory Cytokines and Growth Factors, TNFα, pg/mL
Time frame: 12 Weeks post-randomization
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects at Risk of DMII | Absolute Change in Inflammatory Cytokines and Growth Factors, TNFα, pg/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | -0.15 pg/mL |
| Subjects at Risk of DMII | Absolute Change in Inflammatory Cytokines and Growth Factors, TNFα, pg/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | 0.30 pg/mL |
| T2DM Patients | Absolute Change in Inflammatory Cytokines and Growth Factors, TNFα, pg/mL | At risk of T2DM, Placebo n=21, Aliskiren n=20 | -0.21 pg/mL |
| T2DM Patients | Absolute Change in Inflammatory Cytokines and Growth Factors, TNFα, pg/mL | Diabetic Patients, Placebo n=25, Aliskiren n=22 | -0.09 pg/mL |