Trial Outcomes & Findings for Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes) (NCT NCT00990184)

NCT ID: NCT00990184

Last Updated: 2012-11-21

Results Overview

Increase in insulin following glucose injection. AIRg is measured as the magnitude of the insulin response to an intravenous glucose injection calculated over the 10 minutes following glucose administration.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 21 participants
• Primary outcome timeframe: Baseline and 8 weeks
• Results posted on: 2012-11-21

Participant Flow

Participant milestones

Measure	Colesevelam Hydrochloride People with IGT will take 2 weeks of placebo and then 8 weeks of study drug
Overall Study STARTED	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Colesevelam Hydrochloride People with IGT will take 2 weeks of placebo and then 8 weeks of study drug
Overall Study Physician Decision	1

Baseline Characteristics

Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes)

Baseline characteristics by cohort

Measure	Colesevelam Hydrochloride n=21 Participants People with IGT will take 2 weeks of placebo and then 8 weeks of study drug
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age Continuous	60.7 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Population: Subjects who completed the study

Increase in insulin following glucose injection. AIRg is measured as the magnitude of the insulin response to an intravenous glucose injection calculated over the 10 minutes following glucose administration.

Outcome measures

Measure	Colesevelam n=20 Participants Effect of colesevelam treatment compared to baseline
Acute Insulin Response (AIRg) to Intravenous Glucose 8 Weeks	1866 pmol/1*min Interval 678.0 to 2670.0
Acute Insulin Response (AIRg) to Intravenous Glucose Baseline	1752 pmol/1*min Interval 564.0 to 3306.0

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Tissue response to circulating insulin in the blood. Insulin sensitivity is measured using a mathematical model that quantifies the fractional rate of change in glucose concentrations per unit of insulin. Low values are insulin resistant and high values are insulin sensitive. *Please note: the "-1" in the Unit of Measure should be a superscripted value.

Outcome measures

Measure	Colesevelam n=20 Participants Effect of colesevelam treatment compared to baseline
Insulin Sensitivity 8 weeks	4.6 min-1 per pmol/L Standard Error 0.6
Insulin Sensitivity Baseline	4.8 min-1 per pmol/L Standard Error 0.5

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Rate of fall of glucose in the blood

Outcome measures

Measure	Colesevelam n=20 Participants Effect of colesevelam treatment compared to baseline
Glucose Disappearance Rate 8 weeks	1.32 percentage of glucose/min Standard Error 0.10
Glucose Disappearance Rate Baseline	1.26 percentage of glucose/min Standard Error 0.08

Adverse Events

Colesevelam Hydrochloride

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Colesevelam Hydrochloride n=21 participants at risk People with IGT will take 2 weeks of placebo and then 8 weeks of study drug
Nervous system disorders TIA	4.8% 1/21 • Number of events 1

Other adverse events

Measure	Colesevelam Hydrochloride n=21 participants at risk People with IGT will take 2 weeks of placebo and then 8 weeks of study drug
Gastrointestinal disorders Constipation	35.0% 7/20 • Number of events 7
Hepatobiliary disorders Cholelithiasis	5.0% 1/20 • Number of events 1

Additional Information

Steven E. Kahn

SIBCR

Phone: 206-277-5515

Email: skahn@u.washington.edu

Results disclosure agreements

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