Trial Outcomes & Findings for Relationship Between Insulin Resistance and Statin Induced Type 2 Diabetes, and Integrative Personal Omics Profiling (NCT NCT02437084)

NCT ID: NCT02437084

Last Updated: 2021-04-06

Results Overview

Insulin sensitivity measured by SSPG concentration (mg/dL) during the insulin suppression test.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 115 participants
• Primary outcome timeframe: baseline, week 9 or 10
• Results posted on: 2021-04-06

Participant Flow

The study was performed between 2015 and 2019 at the Stanford Clinical and Translational Research Unit. Volunteers were recruited from the San Francisco Bay Area through advertisements in newspapers, posted flyers, the social networking site NextDoor and the Preventive Cardiology Clinics at Stanford Health Care.

Of the 115 participants enrolled, 40 declined to participate and 75 started treatment with atorvastatin 40 mg daily. Individuals who were receiving statin therapy at the time of enrollment underwent a 4-week statin washout with approval of their treating physician.

Participant milestones

Measure	Atorvastatin Treatment Participants received treatment with atorvastatin 40 mg daily for 10 weeks.
Overall Study STARTED	75
Overall Study COMPLETED	72
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Atorvastatin Treatment Participants received treatment with atorvastatin 40 mg daily for 10 weeks.
Overall Study Withdrawal by Subject	2
Overall Study Physician Decision	1

Baseline Characteristics

Relationship Between Insulin Resistance and Statin Induced Type 2 Diabetes, and Integrative Personal Omics Profiling

Baseline characteristics by cohort

Measure	Individuals Without Diabetes Eligible to Receive Statin Therapy n=71 Participants Eligible participants will receive 40 mg of atorvastatin Atorvastatin: Study subjects will receive atorvastatin 40 mg for 10 weeks.
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	67 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	17 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	71 participants n=5 Participants
BMI	27.8 kg/m2 n=5 Participants

PRIMARY outcome

Timeframe: baseline, week 9 or 10

Population: Participants who completed both baseline and end-of-study insulin suppression tests and did not receive treatment with a corticosteroid.

Insulin sensitivity measured by SSPG concentration (mg/dL) during the insulin suppression test.

Outcome measures

Measure	Individuals Without Diabetes Eligible to Receive Statin Therapy n=70 Participants Eligible participants will receive 40 mg of atorvastatin Atorvastatin: Study subjects will receive atorvastatin 40 mg for 10 weeks.
Steady-state Plasma Glucose (SSPG) Baseline	130 mg/dL Interval 85.0 to 193.0
Steady-state Plasma Glucose (SSPG) End of Study	139 mg/dL Interval 93.0 to 211.0

PRIMARY outcome

Timeframe: baseline, week 9 or 10

Population: Participants who completed both baseline and end-of-study graded glucose infusion tests and did not receive treatment with a corticosteroid.

Insulin secretion measured by ISR-AUC (pmol/min x 4 h) during the graded glucose infusion test.

Outcome measures

Measure	Individuals Without Diabetes Eligible to Receive Statin Therapy n=64 Participants Eligible participants will receive 40 mg of atorvastatin Atorvastatin: Study subjects will receive atorvastatin 40 mg for 10 weeks.
Insulin Secretion Rate Area Under the Curve (ISR-AUC) Baseline	1824 pmol/min x 4 h Interval 1385.0 to 2549.0
Insulin Secretion Rate Area Under the Curve (ISR-AUC) End of Study	1942 pmol/min x 4 h Interval 1480.0 to 2755.0

SECONDARY outcome

Timeframe: 10 weeks

Population: Participants who completed both baseline and end-of-study tests and did not receive treatment with a corticosteroid.

Baseline and end-of-treatment fasting plasma glucose (mg/dL) values represent average of up to 3 measurements for each value (obtained at baseline weeks -2, -1, and 0 and at the end of study at weeks 8, 9, and 10).

Outcome measures

Measure	Individuals Without Diabetes Eligible to Receive Statin Therapy n=71 Participants Eligible participants will receive 40 mg of atorvastatin Atorvastatin: Study subjects will receive atorvastatin 40 mg for 10 weeks.
Fasting Plasma Glucose End of Study	100 mg/dL Interval 94.0 to 107.0
Fasting Plasma Glucose Baseline	99 mg/dL Interval 92.0 to 108.0

SECONDARY outcome

Timeframe: 10 weeks

Population: Participants who completed both baseline and end-of-study tests, did not receive treatment with a corticosteroid, and underwent fasting insulin measurement.

Baseline and end-of-treatment fasting plasma insulin (mU/L) values represent average of up to 3 measurements for each value (obtained at baseline weeks -2, -1, and 0 and at the end of study at weeks 8, 9, and 10).

Outcome measures

Measure	Individuals Without Diabetes Eligible to Receive Statin Therapy n=69 Participants Eligible participants will receive 40 mg of atorvastatin Atorvastatin: Study subjects will receive atorvastatin 40 mg for 10 weeks.
Fasting Plasma Insulin Baseline	10.1 mU/L Interval 7.3 to 14.8
Fasting Plasma Insulin End of Study	10.6 mU/L Interval 7.6 to 15.1

SECONDARY outcome

Timeframe: baseline, week 8

Population: Participants who completed both baseline and end-of-study oral glucose tolerance tests and did not receive treatment with a corticosteroid.

Glucose area under the curve (AUC) (mg/dL x 2 h) measured during a 75-gram oral glucose tolerance test (OGTT).

Outcome measures

Measure	Individuals Without Diabetes Eligible to Receive Statin Therapy n=71 Participants Eligible participants will receive 40 mg of atorvastatin Atorvastatin: Study subjects will receive atorvastatin 40 mg for 10 weeks.
OGTT Glucose AUC Baseline	295 mg/dL x 2 h Interval 241.0 to 336.0
OGTT Glucose AUC End of Study	299 mg/dL x 2 h Interval 254.0 to 339.0

SECONDARY outcome

Timeframe: baseline, week 8

Population: Participants who completed both baseline and end-of-study oral glucose tolerance tests, did not receive treatment with a corticosteroid, and underwent insulin measurements at all OGTT timepoints.

Insulin area under the curve (AUC) (mU/L x 2h) measured during a 75-gram oral glucose tolerance test (OGTT).

Outcome measures

Measure	Individuals Without Diabetes Eligible to Receive Statin Therapy n=64 Participants Eligible participants will receive 40 mg of atorvastatin Atorvastatin: Study subjects will receive atorvastatin 40 mg for 10 weeks.
OGTT Insulin AUC Baseline	127 mU/L x 2 h Interval 74.0 to 217.0
OGTT Insulin AUC End of Study	133 mU/L x 2 h Interval 88.0 to 218.0

Adverse Events

Individuals Without Diabetes Eligible to Receive Statin Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Joshua W. Knowles, MD, PhD; Assistant Professor, Cardiovascular Medicine

Stanford University School of Medicine

Phone: 650-723-1431

Email: knowlej@stanford.edu

Results disclosure agreements

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