Trial Outcomes & Findings for A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs (NCT NCT00831129)

NCT ID: NCT00831129

Last Updated: 2017-02-10

Results Overview

change in high-sensitivity C-reactive between baseline and 6 month

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 53 participants
• Primary outcome timeframe: Baseline and 6 months
• Results posted on: 2017-02-10

Participant Flow

Participant milestones

Measure	Placebo simvastatin 40 mg/day plus placebo	Rosiglitazone simvastatin 40 mg/day plus rosiglitazone 4 mg/day
Overall Study STARTED	20	33
Overall Study COMPLETED	20	23
Overall Study NOT COMPLETED	0	10

Reasons for withdrawal

Measure	Placebo simvastatin 40 mg/day plus placebo	Rosiglitazone simvastatin 40 mg/day plus rosiglitazone 4 mg/day
Overall Study Adverse Event	0	1
Overall Study 9 lost to follow-up reasons uknown	0	9

Baseline Characteristics

A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs

Baseline characteristics by cohort

Measure	Placebo n=20 Participants simvastatin 40 mg/day plus placebo	Rosiglitazone n=23 Participants simvastatin 40 mg/day plus rosiglitazone 4 mg/day	Total n=43 Participants Total of all reporting groups
Age, Continuous	55.1 years STANDARD_DEVIATION 9.3 • n=5 Participants	58.7 years STANDARD_DEVIATION 12.1 • n=7 Participants	57.03 years STANDARD_DEVIATION 10.7 • n=5 Participants
Gender Female	6 Participants n=5 Participants	14 Participants n=7 Participants	20 Participants n=5 Participants
Gender Male	14 Participants n=5 Participants	9 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

change in high-sensitivity C-reactive between baseline and 6 month

Outcome measures

Measure	Placebo n=20 Participants simvastatin 40 mg/day plus placebo	Rosiglitazone n=23 Participants simvastatin 40 mg/day plus rosiglitazone 4 mg/day
Change in High-sensitivity C-reactive Protein	0.72 mg/dl Standard Deviation 2.49	-0.61 mg/dl Standard Deviation 1.36

SECONDARY outcome

Timeframe: Baseline and 6 months

change in urinary isoprostane between baseline and 6 month

Outcome measures

Measure	Placebo n=20 Participants simvastatin 40 mg/day plus placebo	Rosiglitazone n=23 Participants simvastatin 40 mg/day plus rosiglitazone 4 mg/day
Change in Urinary Isoprostane	-0.79 ng/ml Standard Deviation 2.1	-1.09 ng/ml Standard Deviation 1.9

SECONDARY outcome

Timeframe: Baseline and 6 months

change in Malondialdehyde between baseline and 6 month

Outcome measures

Measure	Placebo n=20 Participants simvastatin 40 mg/day plus placebo	Rosiglitazone n=23 Participants simvastatin 40 mg/day plus rosiglitazone 4 mg/day
Change in Malondialdehyde	-1.27 nM Standard Deviation 2.4	-1.52 nM Standard Deviation 3.0

SECONDARY outcome

Timeframe: Baseline and 6 months

change in office systolic blood pressure between baseline and 6 month

Outcome measures

Measure	Placebo n=20 Participants simvastatin 40 mg/day plus placebo	Rosiglitazone n=23 Participants simvastatin 40 mg/day plus rosiglitazone 4 mg/day
Change in Office Systolic Blood Pressure	-18.24 mm Hg Standard Deviation 12.5	-16.77 mm Hg Standard Deviation 15.2

SECONDARY outcome

Timeframe: Baseline and 6 months

change in office diastolic blood pressure between baseline and 6 month

Outcome measures

Measure	Placebo n=20 Participants simvastatin 40 mg/day plus placebo	Rosiglitazone n=23 Participants simvastatin 40 mg/day plus rosiglitazone 4 mg/day
Change in Office Diastolic Blood Pressure	-9.59 mm Hg Standard Deviation 9.9	-9.46 mm Hg Standard Deviation 8.4

SECONDARY outcome

Timeframe: Baseline and 6 months

change in (ambulatory blood pressure monitoring) systolic blood pressure between baseline and 6 month

Outcome measures

Measure	Placebo n=20 Participants simvastatin 40 mg/day plus placebo	Rosiglitazone n=23 Participants simvastatin 40 mg/day plus rosiglitazone 4 mg/day
Change in (Ambulatory Blood Pressure Monitoring) Systolic Blood Pressure	3.41 mm Hg Standard Deviation 3.7	-1.08 mm Hg Standard Deviation 1.2

SECONDARY outcome

Timeframe: Baseline and 6 months

change in (ambulatory blood pressure monitoring) diastolic blood pressure between baseline and 6 month

Outcome measures

Measure	Placebo n=20 Participants simvastatin 40 mg/day plus placebo	Rosiglitazone n=23 Participants simvastatin 40 mg/day plus rosiglitazone 4 mg/day
Change in (Ambulatory Blood Pressure Monitoring) Diastolic Blood Pressure	-0.88 mm Hg Standard Deviation 0.9	-0.69 mm Hg Standard Deviation 0.6

SECONDARY outcome

Timeframe: Baseline and 6 months

change in low-density lipoprotein between baseline and 6 month

Outcome measures

Measure	Placebo n=20 Participants simvastatin 40 mg/day plus placebo	Rosiglitazone n=23 Participants simvastatin 40 mg/day plus rosiglitazone 4 mg/day
Change in Low-density Lipoprotein	-38.88 mg/dl Standard Deviation 41.2	-28.77 mg/dl Standard Deviation 31.7

SECONDARY outcome

Timeframe: Baseline and 6 months

change in Triglycerides between baseline and 6 month

Outcome measures

Measure	Placebo n=20 Participants simvastatin 40 mg/day plus placebo	Rosiglitazone n=23 Participants simvastatin 40 mg/day plus rosiglitazone 4 mg/day
Change in Triglycerides	-34.32 mg/dl Standard Deviation 22.1	-42.47 mg/dl Standard Deviation 27.3

SECONDARY outcome

Timeframe: Baseline and 6 months

change in high-density lipoprotein between baseline and 6 month

Outcome measures

Measure	Placebo n=20 Participants simvastatin 40 mg/day plus placebo	Rosiglitazone n=23 Participants simvastatin 40 mg/day plus rosiglitazone 4 mg/day
Change in High-density Lipoprotein	0.71 mg/dl Standard Deviation 7.9	2.77 mg/dl Standard Deviation 6.7

SECONDARY outcome

Timeframe: Baseline and 6 months

change in glycosylated haemoglobin between baseline and 6 month

Outcome measures

Measure	Placebo n=20 Participants simvastatin 40 mg/day plus placebo	Rosiglitazone n=23 Participants simvastatin 40 mg/day plus rosiglitazone 4 mg/day
Change in Glycosylated Haemoglobin	0.12 percentage of glycosylated haemoglobin Standard Deviation 0.11	-0.22 percentage of glycosylated haemoglobin Standard Deviation 0.07

SECONDARY outcome

Timeframe: Baseline and 6 months

change in fasting blood glucose between baseline and 6 month

Outcome measures

Measure	Placebo n=20 Participants simvastatin 40 mg/day plus placebo	Rosiglitazone n=23 Participants simvastatin 40 mg/day plus rosiglitazone 4 mg/day
Change in Fasting Blood Glucose	5.94 mg/dl Standard Deviation 10.9	-4.85 mg/dl Standard Deviation 11.3

SECONDARY outcome

Timeframe: Baseline and 6 months

change in Insulin between baseline and 6 month

Outcome measures

Measure	Placebo n=20 Participants simvastatin 40 mg/day plus placebo	Rosiglitazone n=23 Participants simvastatin 40 mg/day plus rosiglitazone 4 mg/day
Change in Insulin	0.59 IU/ml Standard Deviation 1.1	-3.47 IU/ml Standard Deviation 1.8

SECONDARY outcome

Timeframe: Baseline and 6 months

change in homeostatic model assessment for insulin resistance between baseline and 6 month

Outcome measures

Measure	Placebo n=20 Participants simvastatin 40 mg/day plus placebo	Rosiglitazone n=23 Participants simvastatin 40 mg/day plus rosiglitazone 4 mg/day
Change in Homeostatic Model Assessment for Insulin Resistance	0.31 HOMA units Standard Deviation 1.4	-2.08 HOMA units Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline and 6 months

change in Adiponectin between baseline and 6 month

Outcome measures

Measure	Placebo n=20 Participants simvastatin 40 mg/day plus placebo	Rosiglitazone n=23 Participants simvastatin 40 mg/day plus rosiglitazone 4 mg/day
Change in Adiponectin	-0.24 μg/ml Standard Deviation 1.3	4.15 μg/ml Standard Deviation 3.9

SECONDARY outcome

Timeframe: Baseline and 6 months

change in body mass index between baseline and 6 month

Outcome measures

Measure	Placebo n=20 Participants simvastatin 40 mg/day plus placebo	Rosiglitazone n=23 Participants simvastatin 40 mg/day plus rosiglitazone 4 mg/day
Change in Body Mass Index	-0.21 kg/m2 Standard Deviation 2.18	0.68 kg/m2 Standard Deviation 1.1

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Rosiglitazone

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=20 participants at risk simvastatin 40 mg/day plus placebo	Rosiglitazone n=23 participants at risk simvastatin 40 mg/day plus rosiglitazone 4 mg/day
Musculoskeletal and connective tissue disorders Nonspecific muscle aches in lower extremities	20.0% 4/20 • Number of events 4	4.3% 1/23 • Number of events 1
Gastrointestinal disorders Nausea Vomiting	0.00% 0/20	4.3% 1/23 • Number of events 1
Respiratory, thoracic and mediastinal disorders Upper respiratory symptoms	0.00% 0/20	8.7% 2/23 • Number of events 2
Nervous system disorders Headaches	5.0% 1/20 • Number of events 1	0.00% 0/23
Skin and subcutaneous tissue disorders Rash	0.00% 0/20	4.3% 1/23 • Number of events 1
Gastrointestinal disorders Constipation	5.0% 1/20 • Number of events 1	0.00% 0/23
Musculoskeletal and connective tissue disorders Joint aches	0.00% 0/20	17.4% 4/23 • Number of events 4

Additional Information

Dr. George Bakris

University of Chicago

Phone: 773-702-7936

Email: bbrisky@medicine.bsd.uchicago.edu

Results disclosure agreements

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