Trial Outcomes & Findings for The Effect of Aliskiren on Endothelial Function in Pre-Diabetes and Diabetes (NCT NCT01165983)

NCT ID: NCT01165983

Last Updated: 2017-03-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 124 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2017-03-28

Participant Flow

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.

Participant milestones

Measure	Placebo Placebo: 0mg tablet, taken orally for 12 weeks daily	Aliskiren Aliskiren: 150mg tablet, taken orally for 12 weeks daily
Overall Study STARTED	51	49
Overall Study COMPLETED	46	42
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Aliskiren on Endothelial Function in Pre-Diabetes and Diabetes

Baseline characteristics by cohort

Measure	Placebo n=51 Participants Placebo: 0mg tablet, taken orally for 12 weeks daily	Aliskiren n=49 Participants Aliskiren: 150mg tablet, taken orally for 12 weeks daily	Total n=100 Participants Total of all reporting groups
Age, Continuous	54 years STANDARD_DEVIATION 11 • n=5 Participants	54 years STANDARD_DEVIATION 11 • n=7 Participants	54 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	30 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	19 Participants n=7 Participants	50 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants	49 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Subjects at Risk of DMII n=48 Participants	T2DM Patients n=52 Participants
Flow Mediated Vasodilation	4.8 percentage change over baseline Standard Deviation 0.7	4.4 percentage change over baseline Standard Deviation 2.6

PRIMARY outcome

Timeframe: 12 Weeks post-randomization

Population: Number of subjects that completed the study

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.

Outcome measures

Measure	Subjects at Risk of DMII n=46 Participants	T2DM Patients n=42 Participants
Flow Mediated Vasodilation At risk of T2DM, Placebo n=21, Aliskiren n=20	0.3 percent change over baseline Interval -0.3 to 1.8	0.8 percent change over baseline Interval 0.3 to 2.1
Flow Mediated Vasodilation Diabetic Patients, Placebo n=25, Aliskiren n=22	0.4 percent change over baseline Interval 0.0 to 1.0	0.9 percent change over baseline Interval 0.0 to 1.4

PRIMARY outcome

Timeframe: Baseline

Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG.

Outcome measures

Measure	Subjects at Risk of DMII n=48 Participants	T2DM Patients n=52 Participants
Nitroglycerin Induced Dilation	16.5 percent change Standard Deviation 4.8	15.2 percent change Standard Deviation 5.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Subjects at Risk of DMII n=46 Participants	T2DM Patients n=42 Participants
Nitroglycerine Induced Vasodilation At risk of T2DM, Placebo n=21, Aliskiren n=20	0.4 percent change Interval -2.4 to 3.7	-0.8 percent change Interval -1.8 to 2.5
Nitroglycerine Induced Vasodilation Diabetic Patients, Placebo n=25, Aliskiren n=22	-1.4 percent change Interval -3.9 to 0.4	-0.3 percent change Interval -3.4 to 1.5

PRIMARY outcome

Timeframe: Baseline

Laser doppler imaging is used to measure microcirculatory changes pre- and post-iontophoresis of acetylcholine and sodium nitroprusside.

Outcome measures

Measure	Subjects at Risk of DMII n=48 Participants	T2DM Patients n=52 Participants
Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside Acetylcholine induced skin vasodilation	45 percentage change over baseline Interval 19.0 to 62.0	38 percentage change over baseline Interval 22.0 to 75.0
Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside Sodium nitroprusside skin induced vasodilation	38 percentage change over baseline Interval 23.0 to 61.0	36 percentage change over baseline Interval 20.0 to 64.0

PRIMARY outcome

Timeframe: 12 Weeks post-randomization

Laser doppler imaging is used to measure microcirculatory changes pre- and post-iontophoresis of acetylcholine (Ach) and sodium nitroprusside (NaNP).

Outcome measures

Measure	Subjects at Risk of DMII n=46 Participants	T2DM Patients n=42 Participants
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 Interval -31.0 to 37.0	-1 percent change over baseline Interval -43.0 to 15.0
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 Interval -23.0 to 30.0	13 percent change over baseline Interval -34.0 to 40.0
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 Interval -34.0 to 11.0	3 percent change over baseline Interval -48.0 to 20.0
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 Interval -21.0 to 5.0	8 percent change over baseline Interval -5.0 to 31.0

SECONDARY outcome

Timeframe: 12 Weeks post-randomization

Outcome measures

Measure	Subjects at Risk of DMII n=46 Participants	T2DM Patients n=42 Participants
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 Interval -8.0 to 59.0	30 ng/mL Interval -7.0 to 44.0
Absolute Change in Biochemical Markers of Endothelial Function, sICAM-1, ng/mL Diabetic Patients, Placebo n=25, Aliskiren n=22	13 ng/mL Interval -25.0 to 45.0	14 ng/mL Interval -13.0 to 40.0

SECONDARY outcome

Timeframe: 12 Weeks post-randomization

Outcome measures

Measure	Subjects at Risk of DMII n=46 Participants	T2DM Patients n=42 Participants
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 Interval -263.0 to 629.0	236 ng/mL Interval -216.0 to 636.0
Absolute Change in Biochemical Markers of Endothelial Function, sVCAM-1, ng/mL Diabetic Patients, Placebo n=25, Aliskiren n=22	185 ng/mL Interval -91.0 to 651.0	106 ng/mL Interval -124.0 to 498.0

SECONDARY outcome

Timeframe: 12 Weeks post-randomization

Outcome measures

Measure	Subjects at Risk of DMII n=46 Participants	T2DM Patients n=42 Participants
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 Interval -29.0 to 66.0	30 pg/mL Interval -15.0 to 73.0
Absolute Change in Biochemical Markers of Endothelial Function, t-PAI, pg/mL Diabetic Patients, Placebo n=25, Aliskiren n=22	54 pg/mL Interval -59.0 to 93.0	26 pg/mL Interval -42.0 to 76.0

SECONDARY outcome

Timeframe: 12 Weeks post-randomization

Outcome measures

Measure	Subjects at Risk of DMII n=46 Participants	T2DM Patients n=42 Participants
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 Interval -2.6 to 10.9	-0.6 μg/mL Interval -15.0 to 4.8
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 Interval -17.5 to 5.5	-2.0 μg/mL Interval -6.0 to 0.8

SECONDARY outcome

Timeframe: 12 Weeks post-randomization

Outcome measures

Measure	Subjects at Risk of DMII n=46 Participants	T2DM Patients n=42 Participants
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 Interval -1.7 to 7.1	0.7 ng/mL Interval -2.1 to 11.0
Absolute Change in Biochemical Markers of Endothelial Function, E-Selectin, ng/mL Diabetic Patients, Placebo n=25, Aliskiren n=22	0.6 ng/mL Interval -18.5 to 4.9	-0.7 ng/mL Interval -48.1 to 4.9

SECONDARY outcome

Timeframe: 12 Weeks post-randomization

Outcome measures

Measure	Subjects at Risk of DMII n=46 Participants	T2DM Patients n=42 Participants
Absolute Change in Inflammatory Cytokines and Growth Factors, Osteoprotegerin, pg/mL At risk of T2DM, Placebo n=21, Aliskiren n=20	-36 pg/mL Interval -78.0 to 80.0	97 pg/mL Interval 15.0 to 158.0
Absolute Change in Inflammatory Cytokines and Growth Factors, Osteoprotegerin, pg/mL Diabetic Patients, Placebo n=25, Aliskiren n=22	-24 pg/mL Interval -86.0 to 75.0	48 pg/mL Interval -24.0 to 127.0

SECONDARY outcome

Timeframe: 12 Weeks post-randomization

Outcome measures

Measure	Subjects at Risk of DMII n=46 Participants	T2DM Patients n=42 Participants
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 Interval -5.9 to 2.1	2.2 ng/mL Interval -0.8 to 4.5
Absolute Change in Inflammatory Cytokines and Growth Factors, Osteopontin, ng/mL Diabetic Patients, Placebo n=25, Aliskiren n=22	1.7 ng/mL Interval -1.3 to 7.3	0.2 ng/mL Interval -6.1 to 4.6

SECONDARY outcome

Timeframe: 12 Weeks post-randomization

Outcome measures

Measure	Subjects at Risk of DMII n=46 Participants	T2DM Patients n=42 Participants
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 Interval -8.5 to 13.0	4.0 pg/mL Interval -0.8 to 12.8
Absolute Change in Inflammatory Cytokines and Growth Factors, G-CSF, pg/mL Diabetic Patients, Placebo n=25, Aliskiren n=22	1.9 pg/mL Interval -11.4 to 10.6	4.4 pg/mL Interval -7.8 to 12.8

SECONDARY outcome

Timeframe: 12 Weeks post-randomization

Outcome measures

Measure	Subjects at Risk of DMII n=46 Participants	T2DM Patients n=42 Participants
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 Interval -1.3 to 3.7	-0.8 pg/mL Interval -1.4 to 4.7
Absolute Change in Inflammatory Cytokines and Growth Factors, GM-CSF pg/mL Diabetic Patients, Placebo n=25, Aliskiren n=22	-1.6 pg/mL Interval -6.3 to 1.0	0.4 pg/mL Interval -1.2 to 3.1

SECONDARY outcome

Timeframe: 12 Weeks post-randomization

Outcome measures

Measure	Subjects at Risk of DMII n=46 Participants	T2DM Patients n=42 Participants
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 Interval -5.8 to 0.8	-2.0 pg/mL Interval -5.0 to 0.2
Absolute Change in Inflammatory Cytokines and Growth Factors, IL-8, pg/mL Diabetic Patients, Placebo n=25, Aliskiren n=22	-2.4 pg/mL Interval -5.9 to 1.6	0.6 pg/mL Interval -2.6 to 4.0

SECONDARY outcome

Timeframe: 12 Weeks post-randomization

Outcome measures

Measure	Subjects at Risk of DMII n=46 Participants	T2DM Patients n=42 Participants
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 Interval -125.0 to 23.0	-7 pg/mL Interval -112.0 to 75.0
Absolute Change in Inflammatory Cytokines and Growth Factors, MCP-1 pg/mL Diabetic Patients, Placebo n=25, Aliskiren n=22	36 pg/mL Interval -76.0 to 110.0	8 pg/mL Interval -154.0 to 66.0

SECONDARY outcome

Timeframe: 12 Weeks post-randomization

Outcome measures

Measure	Subjects at Risk of DMII n=46 Participants	T2DM Patients n=42 Participants
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 Interval -0.32 to 0.11	-0.07 ng/mL Interval -0.32 to 0.08
Absolute Change in Inflammatory Cytokines and Growth Factors, MDC ng/mL Diabetic Patients, Placebo n=25, Aliskiren n=22	-0.07 ng/mL Interval -0.46 to 0.19	0.04 ng/mL Interval -0.36 to 0.16

SECONDARY outcome

Timeframe: 12 Weeks post-randomization

Outcome measures

Measure	Subjects at Risk of DMII n=46 Participants	T2DM Patients n=42 Participants
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 Interval -3.8 to 2.7	-3.2 ng/mL Interval -9.6 to 4.1
Absolute Change in Inflammatory Cytokines and Growth Factors, sCD-40L ng/mL Diabetic Patients, Placebo n=25, Aliskiren n=22	3.3 ng/mL Interval -1.5 to 12.8	-3.6 ng/mL Interval -7.9 to 1.8

SECONDARY outcome

Timeframe: 12 Weeks post-randomization

Outcome measures

Measure	Subjects at Risk of DMII n=46 Participants	T2DM Patients n=42 Participants
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 Interval -0.78 to 1.8	-0.21 pg/mL Interval -1.65 to 2.3
Absolute Change in Inflammatory Cytokines and Growth Factors, TNFα, pg/mL Diabetic Patients, Placebo n=25, Aliskiren n=22	0.30 pg/mL Interval -3.26 to 1.67	-0.09 pg/mL Interval -3.2 to 1.13

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Aliskiren

Serious events: 4 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=46 participants at risk Placebo: 0mg tablet, taken orally for 12 weeks daily	Aliskiren n=42 participants at risk Aliskiren: 150mg tablet, taken orally for 12 weeks daily
Cardiac disorders Cardiac event	0.00% 0/46 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.	4.8% 2/42 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.
Endocrine disorders Diabetic Ketoacidosis	0.00% 0/27 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.	4.8% 1/21 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.
Skin and subcutaneous tissue disorders Cellulitis	0.00% 0/46 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.	2.4% 1/42 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.

Other adverse events

Measure	Placebo n=46 participants at risk Placebo: 0mg tablet, taken orally for 12 weeks daily	Aliskiren n=42 participants at risk Aliskiren: 150mg tablet, taken orally for 12 weeks daily
Gastrointestinal disorders Constipation	2.2% 1/46 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.	0.00% 0/42 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.
Ear and labyrinth disorders Tinnitus	0.00% 0/46 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.	2.4% 1/42 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.
General disorders Mild increase in Serum Calcium Level	4.3% 2/46 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.	2.4% 1/42 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.
Endocrine disorders Decrease in Blood Glucose	2.2% 1/46 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.	0.00% 0/42 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.
General disorders Increase in serum creatinine levels	0.00% 0/46 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.	2.4% 1/42 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.
Musculoskeletal and connective tissue disorders Numbness and cramping	2.2% 1/46 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.	2.4% 1/42 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.
Gastrointestinal disorders GI virus	2.2% 1/46 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.	0.00% 0/42 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.
Blood and lymphatic system disorders Decreased hematocrit	2.2% 1/46 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.	0.00% 0/42 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.
Gastrointestinal disorders Bloating and gas	0.00% 0/46 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.	2.4% 1/42 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.
Renal and urinary disorders Increased urination	0.00% 0/46 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.	2.4% 1/42 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.
Blood and lymphatic system disorders Increase in eosinophil levels	0.00% 0/46 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.	2.4% 1/42 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.
General disorders Decrease in serum calcium	0.00% 0/46 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.	2.4% 1/42 Number for "at risk" of Diabetic Ketoacidosis reduced to reflect number of subjects enrolled who were diagnosed with T2DM. Diabetic ketoacidosis is primarily a concern in patients with T1DM, however the patient who experienced ketoacidosis was later shown to have undiagnosed T1DM, improperly diagnosed as T2DM.

Additional Information

Aristidis Veves, Research Director

Beth Israel Deaconess Medical Center

Phone: 617-632-7075

Email: aveves@bidmc.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60