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PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, and pharmacodynamics, of multiple oral doses of PF-04620110 in T2DM patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04620110 | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04620110 | Drug | 5 mg of PF-04620110 given once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Post-Prandial Glucose Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 | Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. | Baseline (Day -1); 2 to 6 hours post-dose on Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 24-Hour Average Plasma Glucose (APG) Post-Dose at Day 28 | APG= AUC (0-24)/24. AUC (0-24) was computed using Linear trapezoidal method. | Baseline (Day -1); 24 hours post-dose on Day 28 |
| Change From Baseline in Post-Prandial Insulin Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Chula Vista | California | 91911 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID | PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4. |
| FG001 | PF-04620110 5 mg QD | PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks. |
| FG002 | Placebo | Matching placebo orally twice daily (BID) for 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID | PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4. |
| BG001 | PF-04620110 5 mg QD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 Post-Prandial Glucose Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 | Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. | Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT glucose area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group. | Posted | Mean | Standard Deviation | mg*hr/dL | Baseline (Day -1); 2 to 6 hours post-dose on Day 28 |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID | PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| C582730 | PF-04620110 |
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| PF-04620110 |
| Drug |
2.5 mg of PF-04620110 given twice daily |
|
| Placebo | Drug | Matching placebo giving for 4 weeks |
|
Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. |
| Baseline (Day -1); 2 to 6 hours post-dose on Day 28 |
| Change From Baseline in Post-Prandial C-Peptide Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 | Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. | Baseline (Day -1); 2 to 6 hours post-dose on Day 28 |
| Change From Baseline in Post-Prandial Net Triglyceride Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 | Change from baseline in post-prandial area under the plasma net triglyceride concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. | Baseline (Day -1); 2 to 6 hours post-dose on Day 28 |
| Change From Baseline in Total Amide Glucagon Like Peptide-1 (GLP-1) and Active Glucagon Like Peptide-1 (GLP-1) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28 | Change from baseline in total amide GLP-1 and active GLP-1 area under the plasma concentration time curve was computed by Linear trapezoidal method. | Baseline (Day -1); 2 to 6 hours post-dose on Day 28 |
| Change From Baseline in Gastric Inhibitory Peptide (GIP) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28 | Change from baseline in GIP area under the plasma concentration time curve was computed by Linear trapezoidal method. | Baseline (Day -1); 2 to 6 hours post-dose on Day 28 |
| Change From Baseline in Peptide YY (PYY) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28 | Change from baseline in PYY area under the plasma concentration time curve was computed by Linear trapezoidal method. | Baseline (Day -1); 2 to 6 hours post-dose on Day 28 |
| Change From Baseline in Fasting Glucose at Day 28 | 0 hour (pre-dose) on Day -1, Day 28 |
| Change From Baseline in Fasting Insulin at Day 28 | 0 hour (pre-dose) on Day -1, Day 28 |
| Change From Baseline in Fasting Net Triglycerides at Day 28 | 0 hour (pre-dose) on Day -1, Day 28 |
| Change From Baseline in Post-Lunch Glucose Excursions Area Under the Concentration-Time Curve From Time 6 to 10 Hours (AUC 6-10) Post-dose at Day 28 | Change from baseline in post-lunch glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method. | Baseline (Day -1); 6 to 10 hours post-dose on Day 28 |
| Change From Baseline in Post-Dinner Glucose Excursions Area Under the Concentration-Time Curve From Time 12 to 16 Hours (AUC 12-16) Post-dose at Day 28 | Change from baseline in post-dinner glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method. | Baseline (Day -1); 12 to 16 hours post-dose on Day 28 |
| Maximum Observed Plasma Concentration (Cmax) of PF-04620110 | 24 hours post-morning dose on Day 28 |
| Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110 | 24 hours post-morning dose on Day 28 |
| Time to Cmax (Tmax) of PF-04620110 | 24 hours post-morning dose on Day 28 |
| Area Under the Concentration-Time Curve AUC (0-24) of PF-04620110 | Area under the plasma concentration-time curve from time 0 (pre-dose) to 24 hours. AUC (0-24) was computed using the linear trapezoidal method. | 24 hours post-morning dose on Day 28 |
| DeLand |
| Florida |
| 32720 |
| United States |
| Pfizer Investigational Site | Miami Gardens | Florida | 33169 | United States |
PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks. |
| BG002 | Placebo | Matching placebo orally twice daily (BID) for 4 weeks. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | PF-04620110 5 mg QD | PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks. |
| OG002 | Placebo | Matching placebo orally twice daily (BID) for 4 weeks. |
|
|
| Secondary | Change From Baseline in 24-Hour Average Plasma Glucose (APG) Post-Dose at Day 28 | APG= AUC (0-24)/24. AUC (0-24) was computed using Linear trapezoidal method. | Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 APG value. Here, 'n' is participants evaluable at specified time points for each group. | Posted | Mean | Standard Deviation | mg/dL | Baseline (Day -1); 24 hours post-dose on Day 28 |
|
|
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| Secondary | Change From Baseline in Post-Prandial Insulin Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 | Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. | Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT insulin area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group. | Posted | Mean | Standard Deviation | micro-IU*hr/mL | Baseline (Day -1); 2 to 6 hours post-dose on Day 28 |
|
|
|
| Secondary | Change From Baseline in Post-Prandial C-Peptide Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 | Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. | Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT C-peptide area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group. | Posted | Mean | Standard Deviation | ng*hr/mL | Baseline (Day -1); 2 to 6 hours post-dose on Day 28 |
|
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|
| Secondary | Change From Baseline in Post-Prandial Net Triglyceride Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 | Change from baseline in post-prandial area under the plasma net triglyceride concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. | Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT net triglyceride area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group. | Posted | Mean | Standard Deviation | mg*hr/dL | Baseline (Day -1); 2 to 6 hours post-dose on Day 28 |
|
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| Secondary | Change From Baseline in Total Amide Glucagon Like Peptide-1 (GLP-1) and Active Glucagon Like Peptide-1 (GLP-1) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28 | Change from baseline in total amide GLP-1 and active GLP-1 area under the plasma concentration time curve was computed by Linear trapezoidal method. | Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 total amide GLP-1 and active GLP-1 area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group. | Posted | Mean | Standard Deviation | pmol*hr/L | Baseline (Day -1); 2 to 6 hours post-dose on Day 28 |
|
|
|
| Secondary | Change From Baseline in Gastric Inhibitory Peptide (GIP) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28 | Change from baseline in GIP area under the plasma concentration time curve was computed by Linear trapezoidal method. | Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 GIP area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group. | Posted | Mean | Standard Deviation | pg*hr/mL | Baseline (Day -1); 2 to 6 hours post-dose on Day 28 |
|
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|
| Secondary | Change From Baseline in Peptide YY (PYY) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28 | Change from baseline in PYY area under the plasma concentration time curve was computed by Linear trapezoidal method. | Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PYY area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group. | Posted | Mean | Standard Deviation | pg*hr/mL | Baseline (Day -1); 2 to 6 hours post-dose on Day 28 |
|
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| Secondary | Change From Baseline in Fasting Glucose at Day 28 | Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 fasting glucose value. Here, 'n' is participants evaluable at specified time points for each group. | Posted | Mean | Standard Deviation | mg/dL | 0 hour (pre-dose) on Day -1, Day 28 |
|
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|
| Secondary | Change From Baseline in Fasting Insulin at Day 28 | Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 fasting insulin value. Here, 'n' is participants evaluable at specified time points for each group. | Posted | Mean | Standard Deviation | micro-IU/mL | 0 hour (pre-dose) on Day -1, Day 28 |
|
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|
| Secondary | Change From Baseline in Fasting Net Triglycerides at Day 28 | Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 fasting net triglycerides value. Here, 'n' is participants evaluable at specified time points for each group. | Posted | Mean | Standard Deviation | mg/dL | 0 hour (pre-dose) on Day -1, Day 28 |
|
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| Secondary | Change From Baseline in Post-Lunch Glucose Excursions Area Under the Concentration-Time Curve From Time 6 to 10 Hours (AUC 6-10) Post-dose at Day 28 | Change from baseline in post-lunch glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method. | Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-lunch glucose excursion area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group. | Posted | Mean | Standard Deviation | mg*hr/dL | Baseline (Day -1); 6 to 10 hours post-dose on Day 28 |
|
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| Secondary | Change From Baseline in Post-Dinner Glucose Excursions Area Under the Concentration-Time Curve From Time 12 to 16 Hours (AUC 12-16) Post-dose at Day 28 | Change from baseline in post-dinner glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method. | Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-dinner glucose excursion area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group. | Posted | Mean | Standard Deviation | mg*hr/dL | Baseline (Day -1); 12 to 16 hours post-dose on Day 28 |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of PF-04620110 | Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 Cmax value. | Posted | Geometric Mean | Standard Deviation | ng/mL | 24 hours post-morning dose on Day 28 |
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| Secondary | Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110 | Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 Cmin value. | Posted | Geometric Mean | Standard Deviation | ng/mL | 24 hours post-morning dose on Day 28 |
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| Secondary | Time to Cmax (Tmax) of PF-04620110 | Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 Tmax value. | Posted | Median | Full Range | hr | 24 hours post-morning dose on Day 28 |
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| Secondary | Area Under the Concentration-Time Curve AUC (0-24) of PF-04620110 | Area under the plasma concentration-time curve from time 0 (pre-dose) to 24 hours. AUC (0-24) was computed using the linear trapezoidal method. | Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 AUC(0-24) value. | Posted | Geometric Mean | Standard Deviation | ng*hr/mL | 24 hours post-morning dose on Day 28 |
|
|
|
| 0 |
| 16 |
| 12 |
| 16 |
| EG001 | PF-04620110 5 mg QD | PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks. | 0 | 16 | 15 | 16 |
| EG002 | Placebo | Matching placebo orally twice daily (BID) for 4 weeks. | 0 | 16 | 10 | 16 |
| Dry eye | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Proctalgia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Chills | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Thirst | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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| Active GLP-1: Baseline (n=15, 16, 15) |
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| Active GLP-1: Change at Day 28 (n=14, 14, 14) |
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