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| ID | Type | Description | Link |
|---|---|---|---|
| R03DK084089 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is to determine the pharmacogenetics, pharmacokinetics, and drug-drug interactions of sitagliptin therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABCB1 Group 1 | Experimental | ABCB1 CGC/CGC genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses |
|
| ABCB1 Group 2 | Experimental | ABCB1 CGC/TTT genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses |
|
| ABCB1 Group 3 | Experimental | ABCB1 TTT/TTT genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | sitagliptin 100 mg x 1 dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sitagliptin Monotherapy: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose | |
| Sitagliptin Monotherapy: Sitagliptin Maximum Plasma Concentration (Cmax) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose | |
| Sitagliptin Monotherapy: Sitagliptin Renal Clearance (CLr) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Sitagliptin + Atorvastatin: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose | |
| Sitagliptin + Atorvastatin: Sitagliptin Maximum Plasma Concentration (Cmax) |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Change in Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity | AUC of sitagliptin when administered with atorvastatin divided by AUC of sitagliptin when administered alone | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose |
| Relative Change in Sitagliptin Maximum Plasma Concentration (Cmax) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina L Aquilante, PharmD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
Participants (n=145) were genetically pre-screened for ABCB1 1236/2677/3435 diplotypes. Those who possessed the needed ABCB1 genetic diplotypes, along with requisite clinical inclusion criteria, were started in the study (n=33).
Healthy volunteers were recruited from the Denver metro area between November 2009 and December 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | ABCB1 Group 1 | ABCB1 CGC/CGC genetic make-up. Sitagliptin to Sitagliptin+Atorvastatin. 8 participants started. 7 participants completed. |
| FG001 | ABCB1 Group 1* | ABCB1 CGC/CGC genetic make-up. Sitagliptin+Atorvastatin to Sitagliptin. 3 participants started. 3 participants completed. |
| FG002 | ABCB1 Group 2 | ABCB1 CGC/TTT genetic make-up. Sitagliptin to Sitagliptin+Atorvastatin. 7 participants started. 6 participants completed. |
| FG003 | ABCB1 Group 2* | ABCB1 CGC/TTT genetic make-up. Sitagliptin+Atorvastatin to Sitagiptin. 4 participants started. 4 participants completed. |
| FG004 | ABCB1 Group 3 | ABCB1 TTT/TTT genetic make-up. Sitagliptin to Sitagliptin+Atorvastatin. 6 participants started. 5 participants completed. |
| FG005 | ABCB1 Group 3* | ABCB1 TTT/TTT genetic make-up. Sitagliptin+Atorvastatin to Sitagliptin. 5 participants started. 5 participants completed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sitagliptin to Sitagliptin+Atorvastatin |
| |||||||||||||
| Sitagliptin+Atorvastatin to Sitagliptin |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population | All participants who participated in at least one period of the study (n=33) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sitagliptin Monotherapy: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity | The population analyzed included participants who completed both periods of the pharmacokinetic crossover study. | Posted | Mean | Standard Deviation | ng*hr/ml | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose |
|
Pharmacokinetic study periods
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall Study Population | All participants who started the study (n=33) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Systematic Assessment |
Findings are only applicable to individuals with ABCB1 CGC/CGC, CGC/TTT, or TTT/TTT diplotypes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christina Aquilante, Pharm.D. | University of Colorado | 303-724-6126 | christina.aquilante@ucdenver.edu |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| atorvastatin | Drug | atorvastatin 40 mg x 5 doses |
|
|
| 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose |
| Sitagliptin + Atorvastatin: Sitagliptin Renal Clearance (CLr) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose |
Cmax of sitagliptin when administered with atorvastatin divided by Cmax of sitagliptin when administered alone |
| 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose |
| Relative Change in Sitagliptin Renal Clearance (CLr) | CLr of sitagliptin when administered with atorvastatin divided by CLr of sitagliptin when administered alone | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours |
| Atorvastatin Area Under the Plasma Concentration Time Curve (AUC) Over the Dosing Interval (0-24 Hours) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose |
| Atorvastatin Maximum Plasma Concentration (Cmax) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose |
| COMPLETED |
|
| NOT COMPLETED |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
ABCB1 TTT/TTT genetic make-up
|
|
|
| Primary | Sitagliptin Monotherapy: Sitagliptin Maximum Plasma Concentration (Cmax) | The population analyzed included participants who completed both periods of the pharmacokinetic crossover study. | Posted | Mean | Standard Deviation | ng/ml | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose |
|
|
|
|
| Secondary | Sitagliptin + Atorvastatin: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity | The population analyzed included participants who completed both periods of the pharmacokinetic crossover study. | Posted | Mean | Standard Deviation | ng*h/ml | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose |
|
|
|
|
| Secondary | Sitagliptin + Atorvastatin: Sitagliptin Maximum Plasma Concentration (Cmax) | The population analyzed included participants who completed both periods of the pharmacokinetic crossover study. | Posted | Mean | Standard Deviation | ng/ml | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose |
|
|
|
|
| Other Pre-specified | Relative Change in Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity | AUC of sitagliptin when administered with atorvastatin divided by AUC of sitagliptin when administered alone | The population analyzed included participants who completed both periods of the pharmacokinetic crossover study. | Posted | Mean | 95% Confidence Interval | ratio | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose |
|
|
|
|
| Other Pre-specified | Relative Change in Sitagliptin Maximum Plasma Concentration (Cmax) | Cmax of sitagliptin when administered with atorvastatin divided by Cmax of sitagliptin when administered alone | The population analyzed included participants who completed both periods of the pharmacokinetic crossover study. | Posted | Mean | 95% Confidence Interval | ratio | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose |
|
|
|
|
| Primary | Sitagliptin Monotherapy: Sitagliptin Renal Clearance (CLr) | The population analyzed included participants who completed both periods of the pharmacokinetic crossover study and who had complete urine data. | Posted | Mean | Standard Deviation | ml/min | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose |
|
|
|
|
| Secondary | Sitagliptin + Atorvastatin: Sitagliptin Renal Clearance (CLr) | The population analyzed included participants who completed both periods of the pharmacokinetic crossover study and who had complete urine data. | Posted | Mean | Standard Deviation | ml/min | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose |
|
|
|
|
| Other Pre-specified | Relative Change in Sitagliptin Renal Clearance (CLr) | CLr of sitagliptin when administered with atorvastatin divided by CLr of sitagliptin when administered alone | The population analyzed included participants who completed both periods of the pharmacokinetic crossover study and who had complete urine data. | Posted | Mean | 95% Confidence Interval | ratio | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours |
|
|
|
|
| Other Pre-specified | Atorvastatin Area Under the Plasma Concentration Time Curve (AUC) Over the Dosing Interval (0-24 Hours) | The population analyzed included participants who completed both periods of the pharmacokinetic crossover study. | Posted | Mean | Standard Deviation | ng*h/ml | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose |
|
|
|
|
| Other Pre-specified | Atorvastatin Maximum Plasma Concentration (Cmax) | The population analyzed included participants who completed both periods of the pharmacokinetic crossover study. | Posted | Mean | Standard Deviation | ng/ml | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose |
|
|
|
|
| 0 |
| 33 |
| 24 |
| 33 |
| Lightheadedness | General disorders | Systematic Assessment |
|
| Muscle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Nasal congestion | General disorders | Systematic Assessment |
|
| Increased liver function tests | Hepatobiliary disorders | Systematic Assessment |
|
| Hypoalbuminemia | General disorders | Systematic Assessment |
|
| Pain at IV site | General disorders | Systematic Assessment |
|
| Dry mouth | General disorders | Systematic Assessment |
|
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| D011719 |
| Pyrazines |
| D011758 | Pyrroles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |