Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003600-20 | EudraCT Number |
Not provided
Not provided
Not provided
The study was terminated early by the Sponsor for business reasons.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This two-phase study was to examine if 16 weeks of treatment with sitagliptin in combination with atorvastatin reduces hemoglobin A1C (A1C) and low density lipoprotein cholesterol (LDL-C) from baseline more than atorvastatin alone and sitagliptin alone, respectively. Following a single-blind placebo run-in period, participants were to be randomized to one of three treatment arms (sitagliptin monotherapy, atorvastatin monotherapy, or sitagliptin plus atorvastatin) for 16 weeks (Phase A). During Phase B of the study (Weeks 16 through 54), participants were to receive either sitagliptin plus atorvastatin or glimepiride plus atorvastatin. The primary hypotheses were that after 16 weeks of treatment, sitagliptin in combination with atorvastatin reduces A1C from baseline more than atorvastatin alone, and that atorvastatin in combination with sitagliptin lowers LDL-C from baseline more than sitagliptin alone.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin/Sitagliptin + Atorvastatin | Experimental | In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks. |
|
| Atorvastatin/Atorvastatin + Glimepiride | Active Comparator | In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks. |
|
| Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin | Experimental | In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | Sitagliptin 100 mg tablet orally daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1C (A1C) at Week 16 | A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. | Baseline and Week 16 |
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 | Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%. | Baseline and Week 16 |
| Number of Participants Who Experienced at Least One Adverse Event | An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an adverse event. Data presented exclude data following the initiation of glycemic rescue therapy. | Up to 56 weeks (including 2-week follow-up) |
| Number of Participants Who Discontinued Study Drug Due to an Adverse Event | An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an adverse event. Data presented exclude data following the initiation of glycemic rescue therapy. | Up to 54 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16 | Change from baseline reflects the Week 16 value minus the Week 0 value. | Baseline and Week 16 |
| Percent Change From Baseline in Total Cholesterol at Week 16 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
Not provided
Not provided
Not provided
| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
Not provided
Note: 10 participants were enrolled in the study more than once (at more than 1 study site). Nine participants were enrolled twice and one participant was randomized at 3 different sites. Therefore, data of 10 actual participants (counted as 21 participants due to multiple screening/randomization) were removed from the efficacy analyses.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin/Sitagliptin + Atorvastatin | In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase A |
|
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Atorvastatin | Drug | Atorvastatin 80 mg tablet orally daily |
|
|
| Placebo to sitagliptin | Other | Placebo to sitagliptin tablet orally daily |
|
| Placebo to atorvastatin | Other | Placebo to atorvastatin tablet orally daily. |
|
| Metformin (open-label) | Drug | Participant will remain on prestudy dose of metformin tablets (at least 1500 mg daily) throughout entire study. |
|
|
| Glimepiride (open-label) | Drug | Phase A: Glimepiride 1 or 2 mg tablet once daily with breakfast or the first main meal of the day (titrated up to 6 mg/day) for 16 weeks as rescue therapy for randomized participants not meeting specific glycemic goals. |
|
|
| Glimepiride (double-blind) | Drug | Phase B: glimepiride up to 6 mg daily for participants not rescued with open-label glimepiride during Phase A. |
|
| Placebo to glimepiride | Drug | Phase B: placebo to glimepiride tablet orally daily. |
|
Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
| Baseline and Week 16 |
| Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 | Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%. | Baseline and Week 16 |
| Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16 | Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%. | Baseline and Week 16 |
| Percent Change From Baseline in Triglycerides at Week 16 | Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%. | Baseline and Week 16 |
| Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16 | Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%. | Baseline and Week 16 |
| Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 16 | Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%. | Baseline and Week 16 |
| Atorvastatin/Atorvastatin + Glimepiride |
In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks. |
| FG002 | Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin | In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Phase B |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin/Sitagliptin + Atorvastatin | In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks. |
| BG001 | Atorvastatin/Atorvastatin + Glimepiride | In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks. |
| BG002 | Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin | In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Change From Baseline in Hemoglobin A1C (A1C) at Week 16 | A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. | Full analysis set (FAS) population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint. | Posted | Mean | Standard Error | Percent | Baseline and Week 16 |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 | Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%. | FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint. | Posted | Mean | Standard Deviation | Percent change | Baseline and Week 16 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16 | Change from baseline reflects the Week 16 value minus the Week 0 value. | FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint. | Posted | Mean | Standard Error | mg/dL | Baseline and Week 16 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Total Cholesterol at Week 16 | Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%. | FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint. | Posted | Mean | Standard Error | Percent change | Baseline and Week 16 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 | Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%. | FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint. | Posted | Mean | Standard Error | Percent change | Baseline and Week 16 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16 | Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%. | FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint. | Posted | Mean | Standard Error | Percent change | Baseline and Week 16 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Triglycerides at Week 16 | Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%. | FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint. | Posted | Mean | Standard Error | Percent change | Baseline and Week 16 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16 | Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%. | FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint. | Posted | Mean | Standard Error | Percent change | Baseline and Week 16 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 16 | Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%. | FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint. | Posted | Mean | Standard Error | Percent change | Baseline and Week 16 |
| |||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Experienced at Least One Adverse Event | An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an adverse event. Data presented exclude data following the initiation of glycemic rescue therapy. | All participants as treated population included all randomized participants who received at least 1 dose of study treatment. | Posted | Number | Participants | Up to 56 weeks (including 2-week follow-up) |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Discontinued Study Drug Due to an Adverse Event | An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an adverse event. Data presented exclude data following the initiation of glycemic rescue therapy. | All participants as treated population included all randomized participants who received at least 1 dose of study treatment. | Posted | Number | Participants | Up to 54 weeks |
|
Up to 56 weeks including 2-week follow-up (up to 56 weeks for serious adverse events, up to 54 weeks for non-serious adverse events)
All participants as treated population included all randomized participants who received at least 1 dose of study treatment. Serious adverse events include data after the initiation of rescue therapy and non-serious adverse events exclude data after the initiation of rescue therapy.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sitagliptin/Sitagliptin + Atorvastatin | In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks. | 0 | 55 | 3 | 55 | ||
| EG001 | Atorvastatin/Atorvastatin + Glimepiride | In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks. | 0 | 56 | 3 | 56 | ||
| EG002 | Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin | In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks. | 1 | 55 | 5 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
The study was terminated early by the Sponsor for business reasons. Due to the small number of participants included in the FAS, the results for Phase A and for the overall study should be interpreted with caution.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D000069059 | Atorvastatin |
| D008687 | Metformin |
| C057619 | glimepiride |
| D004311 | Double-Blind Method |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D011758 | Pyrroles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Not provided
Not provided
| Male |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| OG002 | Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin | In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks. |
|
|
| OG002 | Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin | In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks. |
|
|