Trial Outcomes & Findings for The Effects of Co-admin of Colesevelam and Sitagliptin on Glucose Metabolism in Subjects With Type 2 Diabetes Mellitus (NCT NCT01092663)

NCT ID: NCT01092663

Last Updated: 2013-01-17

Results Overview

Change from baseline in hemoglobin A1C after 12 weeks of colesevelam or colesevelam plus sitagliptin treatments

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 61 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2013-01-17

Participant Flow

Study period from February 2010 to December 2010. This was a multi-center, randomized, open-label, prospective, parallel-group study consisting of 12 weeks of active treatment.

Subjects treated with acarbose, sulfonylurea or metformin and an A1C ≥6.5% and ≤9% were eligible to enter the study after a 4 (acarbose and sulfonylurea) or 8 (metformin) week wash-out period when meeting all other criteria.

Participant milestones

Measure	Colesevelam Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.	Colesevelam Plus Sitagliptin Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks. Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks.
Overall Study STARTED	31	30
Overall Study COMPLETED	24	26
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Measure	Colesevelam Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.	Colesevelam Plus Sitagliptin Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks. Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks.
Overall Study Withdrawal by Subject	3	2
Overall Study Glucose >300mg/dL	1	0
Overall Study High fasting triglyceride	2	0
Overall Study Adverse Event	1	1
Overall Study Protocol Violation	0	1

Baseline Characteristics

The Effects of Co-admin of Colesevelam and Sitagliptin on Glucose Metabolism in Subjects With Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Measure	Colesevelam n=31 Participants Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.	Colesevelam Plus Sitagliptin n=30 Participants Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks. Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks.	Total n=61 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants	21 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Age Continuous	56 years STANDARD_DEVIATION 9 • n=5 Participants	55 years STANDARD_DEVIATION 13 • n=7 Participants	55.5 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	27 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	30 participants n=7 Participants	61 participants n=5 Participants
Weight	84.6 kilograms STANDARD_DEVIATION 15.3 • n=5 Participants	85.1 kilograms STANDARD_DEVIATION 17.0 • n=7 Participants	84.85 kilograms STANDARD_DEVIATION 16.15 • n=5 Participants
BMI	30.7 kilograms/square meter (kg/m2) STANDARD_DEVIATION 3.7 • n=5 Participants	30.9 kilograms/square meter (kg/m2) STANDARD_DEVIATION 4.7 • n=7 Participants	30.8 kilograms/square meter (kg/m2) STANDARD_DEVIATION 4.2 • n=5 Participants
Fat Free Mass	51.4 kilograms STANDARD_DEVIATION 10.3 • n=5 Participants	54.4 kilograms STANDARD_DEVIATION 11.4 • n=7 Participants	52.9 kilograms STANDARD_DEVIATION 10.85 • n=5 Participants
Hemoglobin A1c	8.0 percentage STANDARD_DEVIATION 0.9 • n=5 Participants	8.0 percentage STANDARD_DEVIATION 1.1 • n=7 Participants	8.0 percentage STANDARD_DEVIATION 1.0 • n=5 Participants
Fasting Glucose	8.9 millimole/liter (mmol/L) STANDARD_DEVIATION 2.5 • n=5 Participants	8.7 millimole/liter (mmol/L) STANDARD_DEVIATION 2.5 • n=7 Participants	8.8 millimole/liter (mmol/L) STANDARD_DEVIATION 2.5 • n=5 Participants
HOMA-IR	5.4 HOMA score STANDARD_DEVIATION 3.0 • n=5 Participants	4.6 HOMA score STANDARD_DEVIATION 2.5 • n=7 Participants	5.0 HOMA score STANDARD_DEVIATION 2.8 • n=5 Participants
HOMA-beta cell	64.9 percentage STANDARD_DEVIATION 44.4 • n=5 Participants	68.8 percentage STANDARD_DEVIATION 63.1 • n=7 Participants	66.9 percentage STANDARD_DEVIATION 53.8 • n=5 Participants
Fasting Insulin	14.1 microunits/milliters (uU/ml) STANDARD_DEVIATION 7.8 • n=5 Participants	12.6 microunits/milliters (uU/ml) STANDARD_DEVIATION 7.6 • n=7 Participants	13.4 microunits/milliters (uU/ml) STANDARD_DEVIATION 7.7 • n=5 Participants
Fasting total-cholesterol	169.3 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 27.7 • n=5 Participants	169.9 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 26.1 • n=7 Participants	169.6 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 26.9 • n=5 Participants
Fasting LDL-cholesterol	97.8 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 22.3 • n=5 Participants	96.2 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 22.1 • n=7 Participants	97.0 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 22.2 • n=5 Participants
Fasting HDL-cholesterol	40.8 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 6.3 • n=5 Participants	44.2 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 11.2 • n=7 Participants	42.5 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 8.8 • n=5 Participants
fasting triglycerides	153.1 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 51.8 • n=5 Participants	147.4 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 59.8 • n=7 Participants	150.3 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 55.8 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Change from baseline in hemoglobin A1C after 12 weeks of colesevelam or colesevelam plus sitagliptin treatments

Outcome measures

Measure	Colesevelam n=24 Participants Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.	Colesevelam Plus Sitagliptin n=26 Participants Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks. Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks.
Hemoglobin A1C	0.3 percentage Standard Deviation 1.2	-0.1 percentage Standard Deviation 1.1

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Change from baseline in fasting plasma glucose concentrations after 12 weeks of colesevelam or colesevelam plus sitagliptin treatments.

Outcome measures

Measure	Colesevelam n=24 Participants Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.	Colesevelam Plus Sitagliptin n=26 Participants Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks. Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks.
Fasting Plasma Glucose	-0.8 millimoles (mmol)/Liter (L) Standard Deviation 2.1	-0.6 millimoles (mmol)/Liter (L) Standard Deviation 2.3

PRIMARY outcome

Timeframe: baseline and 12 weeks

Change from baseline in fasting endogenous glucose production after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment

Outcome measures

Measure	Colesevelam n=24 Participants Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.	Colesevelam Plus Sitagliptin n=26 Participants Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks. Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks.
Fasting Endogenous Glucose Production	1.0 micromoles (umol) per kg FFM per min Standard Deviation 4.4	1.0 micromoles (umol) per kg FFM per min Standard Deviation 3.3

PRIMARY outcome

Timeframe: baseline and 12 weeks

Change from baseline in fasting gluconeogenesis after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment

Outcome measures

Measure	Colesevelam n=24 Participants Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.	Colesevelam Plus Sitagliptin n=26 Participants Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks. Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks.
Fasting Gluconeogenesis	0.2 umol per kilogram (kg) FFM per min Standard Deviation 1.5	-0.3 umol per kilogram (kg) FFM per min Standard Deviation 1.3

PRIMARY outcome

Timeframe: baseline and 12 weeks

Change from baseline in fasting glycogenolysis after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment

Outcome measures

Measure	Colesevelam n=24 Participants Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.	Colesevelam Plus Sitagliptin n=26 Participants Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks. Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks.
Fasting Glycogenolysis	0.8 umol per kg Fat-Free Mass (FFM) per min Standard Deviation 3.6	1.7 umol per kg Fat-Free Mass (FFM) per min Standard Deviation 3.0

PRIMARY outcome

Timeframe: baseline and 12 weeks

Change from baseline in fasting plasma glucose clearance after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments.

Outcome measures

Measure	Colesevelam n=24 Participants Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.	Colesevelam Plus Sitagliptin n=26 Participants Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks. Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks.
Fasting Plasma Glucose Clearance	0.30 ml per kg FFM per minute (min) Standard Deviation 0.35	0.27 ml per kg FFM per minute (min) Standard Deviation 0.41

PRIMARY outcome

Timeframe: baseline and 12 weeks

Change from baseline in appearance rate of oral glucose after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments

Outcome measures

Measure	Colesevelam n=24 Participants Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.	Colesevelam Plus Sitagliptin n=26 Participants Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks. Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks.
Appearance Rate of Oral Glucose	118 umol per kg per min Standard Deviation 613	-244 umol per kg per min Standard Deviation 464

PRIMARY outcome

Timeframe: baseline and 12 weeks

Change from baseline in postprandial endogenous glucose production after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments

Mean value was calculated using all results measured between 10 and 300 min post meal.

Outcome measures

Measure	Colesevelam n=25 Participants Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.	Colesevelam Plus Sitagliptin n=26 Participants Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks. Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks.
Postprandial Endogenous Glucose Production	-0.1 umol per kg per min Standard Deviation 2.0	-0.2 umol per kg per min Standard Deviation 1.5

PRIMARY outcome

Timeframe: baseline and 12 weeks

Change from baseline in postprandial rate of total glucose disposal (AUC) after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments

AUC was calculated by the trapezoid method using all results measured between 0 and 300 min during the meal tolerance test.

Outcome measures

Measure	Colesevelam n=25 Participants Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.	Colesevelam Plus Sitagliptin n=26 Participants Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks. Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks.
Postprandial Rate of Total Glucose Disposal Area Under the Curve (AUC)	-10 umol per kg per min Standard Deviation 914	-256 umol per kg per min Standard Deviation 627

PRIMARY outcome

Timeframe: baseline and 12 weeks

Change in baseline in whole-body glycolytic disposal of oral glucose after 12 weeks of colesevelam alone or colesevelam plus glucose treatments

Outcome measures

Measure	Colesevelam n=25 Participants Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.	Colesevelam Plus Sitagliptin n=26 Participants Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks. Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks.
Whole-body Glycolytic Disposal of Oral Glucose	4 Percent of Load Standard Deviation 6	2 Percent of Load Standard Deviation 6

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Comparison between baseline and 12 weeks values of postrandial glucose (AUC).

Outcome measures

Measure	Colesevelam n=25 Participants Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.	Colesevelam Plus Sitagliptin n=26 Participants Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks. Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks.
Postprandial Glucose (AUC)	-1.1 millimoles (mmol)/l x min Standard Deviation 2.6	-1.5 millimoles (mmol)/l x min Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline and 12 weeks

To evaluate the effect of treatments on plamsa C-peptide concentrations.

Outcome measures

Measure	Colesevelam n=24 Participants Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.	Colesevelam Plus Sitagliptin n=25 Participants Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks. Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks.
Fasting Plasma C-peptide	26 picomoles (pmol)/Liter (L) Standard Deviation 217	103 picomoles (pmol)/Liter (L) Standard Deviation 195

SECONDARY outcome

Timeframe: Baseline and 12 weeks

To evaluate the effect of treatments on plasma glucagon concentrations.

Outcome measures

Measure	Colesevelam n=24 Participants Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.	Colesevelam Plus Sitagliptin n=26 Participants Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks. Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks.
Fasting Plamsa Glucagon	1 picograms (pg)/milliliter (ml) Standard Deviation 22	0 picograms (pg)/milliliter (ml) Standard Deviation 17

SECONDARY outcome

Timeframe: Baseline and 12 weeks

To evaluate the effect of treatments on plasma GLP-1 concentrations.

Outcome measures

Measure	Colesevelam n=24 Participants Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.	Colesevelam Plus Sitagliptin n=26 Participants Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks. Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks.
Fasting Active Plasma Glucagon Like-Peptide 1 (GLP-1)	2.4 pmol/L Standard Deviation 4.2	2.8 pmol/L Standard Deviation 8.4

SECONDARY outcome

Timeframe: Baseline and 12 weeks

To evaluate the effect of treatments on plasma Glucose-dependent Insulinotropic Peptide (GIP) concentrations.

Outcome measures

Measure	Colesevelam n=24 Participants Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.	Colesevelam Plus Sitagliptin n=26 Participants Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks. Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks.
Fasting Plasma Total Glucose-dependent Insulinotropic Peptide (GIP)	1.8 pmol/L Standard Deviation 8.5	-1.3 pmol/L Standard Deviation 3.4

SECONDARY outcome

Timeframe: Baseline and 12 weeks

To evaluate the effect of treatments on fasting insulin concentrations

Outcome measures

Measure	Colesevelam n=24 Participants Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.	Colesevelam Plus Sitagliptin n=26 Participants Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks. Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks.
Fasting Insulin	6 pmol/L Standard Deviation 38	12 pmol/L Standard Deviation 36

SECONDARY outcome

Timeframe: Baseline and 12 weeks

To evaluate the effect of treatments on postprandial insulin (AUC)

Outcome measures

Measure	Colesevelam n=24 Participants Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.	Colesevelam Plus Sitagliptin n=26 Participants Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks. Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks.
Postprandial Insulin (AUC)	-13 pmol/l x min Standard Deviation 118	40 pmol/l x min Standard Deviation 73

SECONDARY outcome

Timeframe: Baseline and 12 weeks

To evaluate the effect of treatments on postprandial C-peptide (AUC)

Outcome measures

Measure	Colesevelam n=24 Participants Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.	Colesevelam Plus Sitagliptin n=26 Participants Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks. Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks.
Postprandial C-peptide (AUC)	30 pmol/l x min Standard Deviation 390	193 pmol/l x min Standard Deviation 367

SECONDARY outcome

Timeframe: Baseline and 12 weeks

To evaluate the effects of treatments on postprandial active GLP-1 (AUC)

Outcome measures

Measure	Colesevelam n=24 Participants Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.	Colesevelam Plus Sitagliptin n=26 Participants Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks. Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks.
Postprandial Active GLP-1 (AUC)	1.8 pmol/l x min Standard Deviation 7.9	6.6 pmol/l x min Standard Deviation 4.9

SECONDARY outcome

Timeframe: Baseline and 12 weeks

To evaluate the effects of treatment on postprandial total GIP (AUC)

Outcome measures

Measure	Colesevelam n=24 Participants Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.	Colesevelam Plus Sitagliptin n=26 Participants Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks. Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks.
Postprandial Total GIP (AUC)	-2 pmol/l x min Standard Deviation 6	-5 pmol/l x min Standard Deviation 7

SECONDARY outcome

Timeframe: Baseline and 12 weeks

To evaluate the effects of treatment on postprandial glucagon (AUC)

Outcome measures

Measure	Colesevelam n=24 Participants Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.	Colesevelam Plus Sitagliptin n=26 Participants Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks. Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks.
Postprandial Glucagon (AUC)	-7 picograms (pg)/milliter (ml) x min Standard Deviation 15	-4.7 picograms (pg)/milliter (ml) x min Standard Deviation 11

Adverse Events

Colesevelam

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Colesevelam Plus Sitagliptin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Colesevelam n=31 participants at risk Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.	Colesevelam Plus Sitagliptin n=30 participants at risk Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks. Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks.
Nervous system disorders Tingling sensation in lower extremities	3.2% 1/31 • Number of events 1	0.00% 0/30
General disorders Non-related Adverse Event	0.00% 0/31	3.3% 1/30 • Number of events 1

Additional Information

Carine Beysen, PhD

KineMed, Inc.

Phone: 510-655-6525

Email: cbeysen@kinemed.com

Results disclosure agreements

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