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This study will test the safety and tolerability of omarigliptin. It is hypothesized that administration of once-weekly omarigliptin in obese but otherwise healthy participants, and in obese participants with Type 2 diabetes (T2D) will be sufficiently safe and well tolerated to permit continued clinical investigation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Omarigliptin | Experimental | Obese healthy participants receive once-weekly omarigliptin 50 mg by mouth for 4 weeks (Panel A). |
|
| Healthy Placebo | Placebo Comparator | Obese healthy participants receive once-weekly placebo by mouth for 4 weeks (Panel A). |
|
| T2D Omarigliptin | Experimental | Obese participants with T2D receive once-weekly omarigliptin 50 mg by mouth for 4 weeks (Panel B). |
|
| T2D Placebo | Placebo Comparator | Obese participants with T2D receive once-weekly placebo by mouth for 4 weeks (Panel B). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omarigliptin | Drug | Once-weekly 50 mg capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing an Adverse Event (AE) | Up to Day 36 | |
| Number of Participants Withdrawing From Study Therapy Due to an AE | Up to Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Inhibition of Dipeptidyl Peptidase-4 (DPP-4) After Day 15 | Percent DPP-4 inhibition at 168 hours after the Day 15 dose (from baseline [pre-dose on Day 1]) was compared in healthy and T2D participants receiving omarigliptin or placebo. | 168 hours post-dose on Day 15 |
| Percent Inhibition of DPP-4 After Day 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26869191 | Result | Addy C, Tatosian D, Glasgow XS, Gendrano IN 3rd, Kauh E, Martucci A, Johnson-Levonas AO, Selverian D, Matthews CZ, Gutierrez M, Wagner JA, Aubrey Stoch S. Pharmacokinetic and Pharmacodynamic Effects of Multiple-dose Administration of Omarigliptin, a Once-weekly Dipeptidyl Peptidase-4 Inhibitor, in Obese Participants With and Without Type 2 Diabetes Mellitus. Clin Ther. 2016 Mar;38(3):516-30. doi: 10.1016/j.clinthera.2015.12.020. Epub 2016 Feb 9. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Participants - Omarigliptin | Obese healthy participants received once-weekly omarigliptin for 4 weeks. |
| FG001 | Healthy - Placebo | Obese healthy participants received once-weekly placebo for 4 weeks. |
| FG002 | T2D - Omarigliptin | Obese T2D participants received once-weekly omarigliptin for 4 weeks. |
| FG003 | T2D - Placebo | Obese T2D participants received once-weekly placebo for 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Participants - Omarigliptin | Obese healthy participants received once-weekly omarigliptin for 4 weeks. |
| BG001 | T2D Participants (Panel B) | Obese participants with T2D received once-weekly omarigliptin or placebo for 4 weeks. |
| 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 | Number of Participants Experiencing an Adverse Event (AE) | AEs were monitored in all obese healthy (Panel A) and Type 2 diabetes (T2D) (Panel B) participants who received omarigliptin 50 mg or placebo. | Posted | Number | Participants | Up to Day 36 |
|
Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
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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 | Omarigliptin 50 mg Healthy (Panel A) | Obese healthy participants received once-weekly omarigliptin 50 mg for 4 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pruritus | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
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| 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 |
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| ID | Term |
|---|---|
| C587539 | 2-(2,5-difluorophenyl)-5-(2-(methylsulfonyl)-2,6-dihydropyrrolo(3,4-c)pyrazol-5(4H)-yl)tetrahydro-2H-pyran-3-amine |
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| Placebo | Drug | Once-weekly placebo capsule |
|
Percent DPP-4 inhibition at 168 hours after the Day 22 dose (from baseline [pre-dose on Day 1]) was compared in healthy and T2D participants receiving omarigliptin or placebo. |
| 168 hours post dose on Day 22 |
| WAA Active Glucagon-like Peptide-1 (GLP-1) Concentration | Weighted average augmentation (WAA) active GLP-1 concentration was based on the 0.25, 0.5, 1, 2, and 4 hour timepoints. WAA was calculated as area under the curve (AUC) for the 4-hr post-dose time period (AUC0-4 hrs); this AUC was then divided by the time interval of 4 hours to obtain WAA. Log scale data were then back-transformed to obtain LS means. | Through 4 hours post dose on Day 21 |
| WAA Total GLP-1 Concentration | WAA total GLP-1 concentration was based on the 0.25, 0.5, 1, 2, and 4 hour timepoints. WAA was calculated as AUC0-4 hrs; this AUC was then divided by the time interval of 4 hours to obtain WAA. Log scale data were then back-transformed to obtain LS means. | Through 4 hours post dose on Day 21 |
| Plasma Glucose Concentration | Post-prandial glucose concentration is presented as a weighted average of the 0.25, 0.5, 1, 2, and 4 hour post-dose time points. Glucose concentration was calculated as area under the curve (AUC) for the 4-hr post-dose time period (AUC0-4 hrs); this AUC was then divided by the time interval of 4 hours to obtain weighted average glucose concentration. Log scale data were then back-transformed to obtain LS means. | Through 4 hours post dose on Day 21 |
| BG002 | T2D - Omarigliptin | Obese T2D participants received once-weekly omarigliptin for 4 weeks. |
| BG003 | T2D - Placebo | Obese T2D participants received once-weekly placebo for 4 weeks. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Obese participants with T2D received once-weekly omarigliptin 50 mg for 4 weeks (Panel B). |
| OG003 | T2D Placebo | Obese participants with T2D received once-weekly placebo for 4 weeks (Panel B). |
|
|
| Primary | Number of Participants Withdrawing From Study Therapy Due to an AE | AEs were monitored in all obese healthy (Panel A) and T2D (Panel B) participants who received omarigliptin 50 mg or placebo. | Posted | Number | Participants | Up to Day 22 |
|
|
|
| Secondary | Percent Inhibition of Dipeptidyl Peptidase-4 (DPP-4) After Day 15 | Percent DPP-4 inhibition at 168 hours after the Day 15 dose (from baseline [pre-dose on Day 1]) was compared in healthy and T2D participants receiving omarigliptin or placebo. | Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 168 hours post-dose on Day 15 were pooled according to treatment. Predose data from Day 1 were missing from 2 participants. | Posted | Geometric Mean | 95% Confidence Interval | Percent DPP-4 inhibition | 168 hours post-dose on Day 15 |
|
|
|
|
| Secondary | Percent Inhibition of DPP-4 After Day 22 | Percent DPP-4 inhibition at 168 hours after the Day 22 dose (from baseline [pre-dose on Day 1]) was compared in healthy and T2D participants receiving omarigliptin or placebo. | No data from obese healthy participants (Panel A) were collected after pre-dose on Day 22. Therefore, data are presented only for obese T2D participants (Panel B) 168 hours post-dose on Day 22. | Posted | Geometric Mean | 95% Confidence Interval | Percent DPP-4 inhibition | 168 hours post dose on Day 22 |
|
|
|
| Secondary | WAA Active Glucagon-like Peptide-1 (GLP-1) Concentration | Weighted average augmentation (WAA) active GLP-1 concentration was based on the 0.25, 0.5, 1, 2, and 4 hour timepoints. WAA was calculated as area under the curve (AUC) for the 4-hr post-dose time period (AUC0-4 hrs); this AUC was then divided by the time interval of 4 hours to obtain WAA. Log scale data were then back-transformed to obtain LS means. | Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 4 hours post dose on Day 21 were pooled according to treatment. All participants who received omarigliptin or placebo are included. | Posted | Least Squares Mean | 95% Confidence Interval | pmol/L | Through 4 hours post dose on Day 21 |
|
|
|
|
| Secondary | WAA Total GLP-1 Concentration | WAA total GLP-1 concentration was based on the 0.25, 0.5, 1, 2, and 4 hour timepoints. WAA was calculated as AUC0-4 hrs; this AUC was then divided by the time interval of 4 hours to obtain WAA. Log scale data were then back-transformed to obtain LS means. | Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 4 hours post dose on Day 21 were pooled according to treatment. All participants who received omarigliptin or placebo are included. | Posted | Least Squares Mean | 95% Confidence Interval | pmol/L | Through 4 hours post dose on Day 21 |
|
|
|
|
| Secondary | Plasma Glucose Concentration | Post-prandial glucose concentration is presented as a weighted average of the 0.25, 0.5, 1, 2, and 4 hour post-dose time points. Glucose concentration was calculated as area under the curve (AUC) for the 4-hr post-dose time period (AUC0-4 hrs); this AUC was then divided by the time interval of 4 hours to obtain weighted average glucose concentration. Log scale data were then back-transformed to obtain LS means. | Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 4 hours post dose on Day 21 were pooled according to treatment. All participants who received omarigliptin or placebo are included. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Through 4 hours post dose on Day 21 |
|
|
|
| 0 |
| 18 |
| 12 |
| 18 |
| EG001 | Placebo Healthy (Panel A) | Obese healthy participants received once-weekly placebo for 4 weeks. | 0 | 6 | 2 | 6 |
| EG002 | Omarigliptin 50 mg T2D (Panel B) | Obese T2D participants received once-weekly omarigliptin 50 mg for 4 weeks. | 0 | 6 | 4 | 6 |
| EG003 | Placebo T2D (Panel B) | Obese T2D participants received once-weekly placebo for 4 weeks. | 0 | 2 | 2 | 2 |
| Eye pruritus | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Foreign body sensation in eyes | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Scintillating scotoma | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
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. SPONSOR review can be expedited to meet publication timelines.
| D004700 | Endocrine System Diseases |