Diabetes Mellitus, Type 2
Conditions
Keywords
Colesevelam, type 2 diabetes, sitagliptin, glucose metabolism
Brief summary
This study will assess the effects of colesevelam, alone or in combination with sitagliptin, on glucose metabolism in subjects with T2DM inadequately controlled by diet and exercise
Detailed description
The hypothesis is that co-administrationof colesevelam plus sitagliptin results in a greater reduction in HbA1c compared to colesevelam HCl treatment by 1. improving the effects of colesevelam on fasting glucose metabolism 2. improving the effects of colsevelam on postprandial glucose metabolism
Interventions
DRUGColesevelam HCl
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.
DRUGSitagliptin
Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks.
Sponsors
KineMed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or Female * Females of childbearing potential are on approved birth control method * Negative pregnancy testing for females of childbearing potential * Previously diagnosed or newly diagnosed with T2DM drug naïve subjects * HbA1c: 6.7-10% * Age 18 - 80 years * BMI ≥ 18.5 kg/m2 and ≤ 40 kg/m2 * Fasting serum glucose \< 300 mg/dL * Normal liver function, normal thyroid function, no history of liver, biliary or intestinal disease * Normal TSH * On stable diet and exercise routine for at least 4 weeks prior to screening * Has had a stable weight (+/-5%) for ≥3 months before screening
Exclusion criteria
* A history of type 1 diabetes mellitus or history of diabetic ketoacidosis * History of chronic (required daily for \> 2 months) use of insulin therapy * Treatment with blood pressure lowering therapy that has not been stable for three months before screening * Treatment with lipid lowering medication other than statins * Treatment with statins that has not been stable for three months before screening * Treatment with a DPP-4 inhibitor or and GLP1 agonists at any time * Treatment with a thiazolidinedione (TZD) within the last 6 months of screening * History of an allergic or toxic reaction to sitagliptin or colesevelam * History of dysphagia, swallowing disorders, bowel obstruction, intestinal motility disorder, and gastrointestinal disorders * History of major gastrointestinal surgery * History of kidney problems * Fasting plasma triglycerides \> 300 mg/dL * Serum LDL-C \<60 mg/dL * Positive toxicology test * Known hypersensitivity to colesevelam HCl or sitagliptin. * Any contraindications to a study medication (colesevelam HCl or sitagliptin).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial Glucose (AUC) | Baseline and 12 weeks | Comparison between baseline and 12 weeks values of postrandial glucose (AUC). |
| Hemoglobin A1C | Baseline and 12 weeks | Change from baseline in hemoglobin A1C after 12 weeks of colesevelam or colesevelam plus sitagliptin treatments |
| Fasting Plasma Glucose | Baseline and 12 weeks | Change from baseline in fasting plasma glucose concentrations after 12 weeks of colesevelam or colesevelam plus sitagliptin treatments. |
| Fasting Endogenous Glucose Production | baseline and 12 weeks | Change from baseline in fasting endogenous glucose production after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment |
| Fasting Gluconeogenesis | baseline and 12 weeks | Change from baseline in fasting gluconeogenesis after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment |
| Fasting Glycogenolysis | baseline and 12 weeks | Change from baseline in fasting glycogenolysis after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment |
| Fasting Plasma Glucose Clearance | baseline and 12 weeks | Change from baseline in fasting plasma glucose clearance after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments. |
| Appearance Rate of Oral Glucose | baseline and 12 weeks | Change from baseline in appearance rate of oral glucose after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments |
| Postprandial Endogenous Glucose Production | 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. |
| Postprandial Rate of Total Glucose Disposal Area Under the Curve (AUC) | 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. |
| Whole-body Glycolytic Disposal of Oral Glucose | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Plamsa Glucagon | Baseline and 12 weeks | To evaluate the effect of treatments on plasma glucagon concentrations. |
| Fasting Active Plasma Glucagon Like-Peptide 1 (GLP-1) | Baseline and 12 weeks | To evaluate the effect of treatments on plasma GLP-1 concentrations. |
| Fasting Plasma Total Glucose-dependent Insulinotropic Peptide (GIP) | Baseline and 12 weeks | To evaluate the effect of treatments on plasma Glucose-dependent Insulinotropic Peptide (GIP) concentrations. |
| Fasting Insulin | Baseline and 12 weeks | To evaluate the effect of treatments on fasting insulin concentrations |
| Postprandial Insulin (AUC) | Baseline and 12 weeks | To evaluate the effect of treatments on postprandial insulin (AUC) |
| Postprandial C-peptide (AUC) | Baseline and 12 weeks | To evaluate the effect of treatments on postprandial C-peptide (AUC) |
| Postprandial Active GLP-1 (AUC) | Baseline and 12 weeks | To evaluate the effects of treatments on postprandial active GLP-1 (AUC) |
| Postprandial Total GIP (AUC) | Baseline and 12 weeks | To evaluate the effects of treatment on postprandial total GIP (AUC) |
| Postprandial Glucagon (AUC) | Baseline and 12 weeks | To evaluate the effects of treatment on postprandial glucagon (AUC) |
| Fasting Plasma C-peptide | Baseline and 12 weeks | To evaluate the effect of treatments on plamsa C-peptide concentrations. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 31 |
| Colesevelam Plus Sitagliptin 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. | 30 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Glucose >300mg/dL | 1 | 0 |
| Overall Study | High fasting triglyceride | 2 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Colesevelam | Colesevelam Plus Sitagliptin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 9 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 21 Participants | 45 Participants |
| Age Continuous | 56 years STANDARD_DEVIATION 9 | 55 years STANDARD_DEVIATION 13 | 55.5 years STANDARD_DEVIATION 11 |
| BMI | 30.7 kilograms/square meter (kg/m2) STANDARD_DEVIATION 3.7 | 30.9 kilograms/square meter (kg/m2) STANDARD_DEVIATION 4.7 | 30.8 kilograms/square meter (kg/m2) STANDARD_DEVIATION 4.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants | 29 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fasting Glucose | 8.9 millimole/liter (mmol/L) STANDARD_DEVIATION 2.5 | 8.7 millimole/liter (mmol/L) STANDARD_DEVIATION 2.5 | 8.8 millimole/liter (mmol/L) STANDARD_DEVIATION 2.5 |
| Fasting HDL-cholesterol | 40.8 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 6.3 | 44.2 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 11.2 | 42.5 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 8.8 |
| Fasting Insulin | 14.1 microunits/milliters (uU/ml) STANDARD_DEVIATION 7.8 | 12.6 microunits/milliters (uU/ml) STANDARD_DEVIATION 7.6 | 13.4 microunits/milliters (uU/ml) STANDARD_DEVIATION 7.7 |
| Fasting LDL-cholesterol | 97.8 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 22.3 | 96.2 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 22.1 | 97.0 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 22.2 |
| Fasting total-cholesterol | 169.3 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 27.7 | 169.9 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 26.1 | 169.6 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 26.9 |
| fasting triglycerides | 153.1 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 51.8 | 147.4 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 59.8 | 150.3 micrograms/deciliter (mg/dL) STANDARD_DEVIATION 55.8 |
| Fat Free Mass | 51.4 kilograms STANDARD_DEVIATION 10.3 | 54.4 kilograms STANDARD_DEVIATION 11.4 | 52.9 kilograms STANDARD_DEVIATION 10.85 |
| Hemoglobin A1c | 8.0 percentage STANDARD_DEVIATION 0.9 | 8.0 percentage STANDARD_DEVIATION 1.1 | 8.0 percentage STANDARD_DEVIATION 1 |
| HOMA-beta cell | 64.9 percentage STANDARD_DEVIATION 44.4 | 68.8 percentage STANDARD_DEVIATION 63.1 | 66.9 percentage STANDARD_DEVIATION 53.8 |
| HOMA-IR | 5.4 HOMA score STANDARD_DEVIATION 3 | 4.6 HOMA score STANDARD_DEVIATION 2.5 | 5.0 HOMA score STANDARD_DEVIATION 2.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 26 Participants | 27 Participants | 53 Participants |
| Region of Enrollment United States | 31 participants | 30 participants | 61 participants |
| Sex: Female, Male Female | 12 Participants | 14 Participants | 26 Participants |
| Sex: Female, Male Male | 19 Participants | 16 Participants | 35 Participants |
| Weight | 84.6 kilograms STANDARD_DEVIATION 15.3 | 85.1 kilograms STANDARD_DEVIATION 17 | 84.85 kilograms STANDARD_DEVIATION 16.15 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 31 | 1 / 30 |
| serious Total, serious adverse events | 0 / 31 | 0 / 30 |
Outcome results
Primary
Appearance Rate of Oral Glucose
Change from baseline in appearance rate of oral glucose after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments
Time frame: baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Appearance Rate of Oral Glucose | 118 umol per kg per min | Standard Deviation 613 |
| Colesevelam Plus Sitagliptin | Appearance Rate of Oral Glucose | -244 umol per kg per min | Standard Deviation 464 |
Comparison: Difference in treatment effect between the 2 groupsp-value: =0.01t-test, 2 sided
Primary
Fasting Endogenous Glucose Production
Change from baseline in fasting endogenous glucose production after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment
Time frame: baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Fasting Endogenous Glucose Production | 1.0 micromoles (umol) per kg FFM per min | Standard Deviation 4.4 |
| Colesevelam Plus Sitagliptin | Fasting Endogenous Glucose Production | 1.0 micromoles (umol) per kg FFM per min | Standard Deviation 3.3 |
Comparison: Treament difference in fasting EGP between the 2 groups were compared.p-value: >0.05t-test, 2 sided
Primary
Fasting Gluconeogenesis
Change from baseline in fasting gluconeogenesis after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment
Time frame: baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Fasting Gluconeogenesis | 0.2 umol per kilogram (kg) FFM per min | Standard Deviation 1.5 |
| Colesevelam Plus Sitagliptin | Fasting Gluconeogenesis | -0.3 umol per kilogram (kg) FFM per min | Standard Deviation 1.3 |
Comparison: Difference in treatment effect between groups was evaluatedp-value: >0.05t-test, 2 sided
Primary
Fasting Glycogenolysis
Change from baseline in fasting glycogenolysis after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment
Time frame: baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Fasting Glycogenolysis | 0.8 umol per kg Fat-Free Mass (FFM) per min | Standard Deviation 3.6 |
| Colesevelam Plus Sitagliptin | Fasting Glycogenolysis | 1.7 umol per kg Fat-Free Mass (FFM) per min | Standard Deviation 3 |
Comparison: Difference in treatment effect between groups was evaluatedp-value: >0.05t-test, 2 sided
Primary
Fasting Plasma Glucose
Change from baseline in fasting plasma glucose concentrations after 12 weeks of colesevelam or colesevelam plus sitagliptin treatments.
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Fasting Plasma Glucose | -0.8 millimoles (mmol)/Liter (L) | Standard Deviation 2.1 |
| Colesevelam Plus Sitagliptin | Fasting Plasma Glucose | -0.6 millimoles (mmol)/Liter (L) | Standard Deviation 2.3 |
Comparison: Difference in treatment effects between the 2 groupsp-value: >0.05t-test, 2 sided
Primary
Fasting Plasma Glucose Clearance
Change from baseline in fasting plasma glucose clearance after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments.
Time frame: baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Fasting Plasma Glucose Clearance | 0.30 ml per kg FFM per minute (min) | Standard Deviation 0.35 |
| Colesevelam Plus Sitagliptin | Fasting Plasma Glucose Clearance | 0.27 ml per kg FFM per minute (min) | Standard Deviation 0.41 |
Comparison: Difference in treatment effect between the 2 groupsp-value: >0.05t-test, 2 sided
Primary
Hemoglobin A1C
Change from baseline in hemoglobin A1C after 12 weeks of colesevelam or colesevelam plus sitagliptin treatments
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Hemoglobin A1C | 0.3 percentage | Standard Deviation 1.2 |
| Colesevelam Plus Sitagliptin | Hemoglobin A1C | -0.1 percentage | Standard Deviation 1.1 |
Comparison: Difference in treatment effect between the 2 groupsp-value: >0.05t-test, 2 sided
Primary
Postprandial Endogenous Glucose Production
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.
Time frame: baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Postprandial Endogenous Glucose Production | -0.1 umol per kg per min | Standard Deviation 2 |
| Colesevelam Plus Sitagliptin | Postprandial Endogenous Glucose Production | -0.2 umol per kg per min | Standard Deviation 1.5 |
Comparison: differerences in treatment effect between the 2 groupsp-value: >0.05t-test, 2 sided
Primary
Postprandial Glucose (AUC)
Comparison between baseline and 12 weeks values of postrandial glucose (AUC).
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Postprandial Glucose (AUC) | -1.1 millimoles (mmol)/l x min | Standard Deviation 2.6 |
| Colesevelam Plus Sitagliptin | Postprandial Glucose (AUC) | -1.5 millimoles (mmol)/l x min | Standard Deviation 2.8 |
Comparison: Difference in treatment effect between the 2 groupsp-value: >0.05t-test, 2 sided
Primary
Postprandial Rate of Total Glucose Disposal Area Under the Curve (AUC)
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.
Time frame: baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Postprandial Rate of Total Glucose Disposal Area Under the Curve (AUC) | -10 umol per kg per min | Standard Deviation 914 |
| Colesevelam Plus Sitagliptin | Postprandial Rate of Total Glucose Disposal Area Under the Curve (AUC) | -256 umol per kg per min | Standard Deviation 627 |
Comparison: Difference in treatment effect between the 2 groupsp-value: >0.05t-test, 2 sided
Primary
Whole-body Glycolytic Disposal of Oral Glucose
Change in baseline in whole-body glycolytic disposal of oral glucose after 12 weeks of colesevelam alone or colesevelam plus glucose treatments
Time frame: baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Whole-body Glycolytic Disposal of Oral Glucose | 4 Percent of Load | Standard Deviation 6 |
| Colesevelam Plus Sitagliptin | Whole-body Glycolytic Disposal of Oral Glucose | 2 Percent of Load | Standard Deviation 6 |
Comparison: Difference in treatment effect between the 2 groupsp-value: >0.05t-test, 2 sided
Secondary
Fasting Active Plasma Glucagon Like-Peptide 1 (GLP-1)
To evaluate the effect of treatments on plasma GLP-1 concentrations.
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Fasting Active Plasma Glucagon Like-Peptide 1 (GLP-1) | 2.4 pmol/L | Standard Deviation 4.2 |
| Colesevelam Plus Sitagliptin | Fasting Active Plasma Glucagon Like-Peptide 1 (GLP-1) | 2.8 pmol/L | Standard Deviation 8.4 |
Comparison: Difference in treatment effect between the 2 groupsp-value: >0.05t-test, 2 sided
Secondary
Fasting Insulin
To evaluate the effect of treatments on fasting insulin concentrations
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Fasting Insulin | 6 pmol/L | Standard Deviation 38 |
| Colesevelam Plus Sitagliptin | Fasting Insulin | 12 pmol/L | Standard Deviation 36 |
Comparison: Difference in treatment effect between the 2 groupsp-value: >0.05t-test, 2 sided
Secondary
Fasting Plamsa Glucagon
To evaluate the effect of treatments on plasma glucagon concentrations.
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Fasting Plamsa Glucagon | 1 picograms (pg)/milliliter (ml) | Standard Deviation 22 |
| Colesevelam Plus Sitagliptin | Fasting Plamsa Glucagon | 0 picograms (pg)/milliliter (ml) | Standard Deviation 17 |
Comparison: Difference in treatment effect between the 2 groupsp-value: >0.05t-test, 2 sided
Secondary
Fasting Plasma C-peptide
To evaluate the effect of treatments on plamsa C-peptide concentrations.
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Fasting Plasma C-peptide | 26 picomoles (pmol)/Liter (L) | Standard Deviation 217 |
| Colesevelam Plus Sitagliptin | Fasting Plasma C-peptide | 103 picomoles (pmol)/Liter (L) | Standard Deviation 195 |
Comparison: Difference in treatment effect between the 2 groupsp-value: >0.05t-test, 2 sided
Secondary
Fasting Plasma Total Glucose-dependent Insulinotropic Peptide (GIP)
To evaluate the effect of treatments on plasma Glucose-dependent Insulinotropic Peptide (GIP) concentrations.
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Fasting Plasma Total Glucose-dependent Insulinotropic Peptide (GIP) | 1.8 pmol/L | Standard Deviation 8.5 |
| Colesevelam Plus Sitagliptin | Fasting Plasma Total Glucose-dependent Insulinotropic Peptide (GIP) | -1.3 pmol/L | Standard Deviation 3.4 |
Comparison: Difference in treatment effect between the 2 groupsp-value: <0.05t-test, 2 sided
Secondary
Postprandial Active GLP-1 (AUC)
To evaluate the effects of treatments on postprandial active GLP-1 (AUC)
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Postprandial Active GLP-1 (AUC) | 1.8 pmol/l x min | Standard Deviation 7.9 |
| Colesevelam Plus Sitagliptin | Postprandial Active GLP-1 (AUC) | 6.6 pmol/l x min | Standard Deviation 4.9 |
Comparison: Difference in treatment effect between the 2 groupsp-value: <0.01t-test, 2 sided
Secondary
Postprandial C-peptide (AUC)
To evaluate the effect of treatments on postprandial C-peptide (AUC)
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Postprandial C-peptide (AUC) | 30 pmol/l x min | Standard Deviation 390 |
| Colesevelam Plus Sitagliptin | Postprandial C-peptide (AUC) | 193 pmol/l x min | Standard Deviation 367 |
Comparison: Difference in treatment effect between the 2 groupsp-value: <0.05t-test, 2 sided
Secondary
Postprandial Glucagon (AUC)
To evaluate the effects of treatment on postprandial glucagon (AUC)
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Postprandial Glucagon (AUC) | -7 picograms (pg)/milliter (ml) x min | Standard Deviation 15 |
| Colesevelam Plus Sitagliptin | Postprandial Glucagon (AUC) | -4.7 picograms (pg)/milliter (ml) x min | Standard Deviation 11 |
Comparison: Difference in treatment effect between the 2 groupsp-value: >0.05t-test, 2 sided
Secondary
Postprandial Insulin (AUC)
To evaluate the effect of treatments on postprandial insulin (AUC)
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Postprandial Insulin (AUC) | -13 pmol/l x min | Standard Deviation 118 |
| Colesevelam Plus Sitagliptin | Postprandial Insulin (AUC) | 40 pmol/l x min | Standard Deviation 73 |
Comparison: Difference in treatment effect between the 2 groupsp-value: <0.05t-test, 2 sided
Secondary
Postprandial Total GIP (AUC)
To evaluate the effects of treatment on postprandial total GIP (AUC)
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Postprandial Total GIP (AUC) | -2 pmol/l x min | Standard Deviation 6 |
| Colesevelam Plus Sitagliptin | Postprandial Total GIP (AUC) | -5 pmol/l x min | Standard Deviation 7 |
Comparison: Difference in treatment effect between the 2 groupsp-value: <0.01t-test, 2 sided