Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008_540 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will assess the safety, tolerability and pharmacokinetics of sitagliptin in 10 to 17 year old diabetic patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin 50 mg | Experimental | Participants were randomized to sitagliptin 50 mg |
|
| Sitagliptin 100 mg | Experimental | Participants were randomized to sitagliptin 100 mg |
|
| Sitagliptin 200 mg | Experimental | Participants were randomized to a single dose of sitagliptin 200 mg |
|
| Placebo to sitagliptin | Placebo Comparator | Participants were randomized to matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin phosphate | Drug | Participants will fast 8 hours prior to dosing. All doses will be given with 240 ml of water. Participants received either a single oral dose of sitagliptin 50 mg tablet, sitagliptin 100 mg tablet, or sitagliptin 200 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced at Least One Adverse Event | Pre-study through 10 to 14 days following administration of study drug | |
| Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity Following a Single Dose of Sitagliptin | Serum samples were used to determine the AUC from time 0 to infinity for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups. | Pre-dose through 72 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax) Following a Single Dose of Sitagliptin | Serum samples were used to determine the Cmax for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups. | Pre-dose through 72 hours post-dose |
| Time of Occurence of Maximum Concentration (Tmax) Following a Single Dose of Sitagliptin |
Not provided
Inclusion Criteria:
Exclusion Criteria:
cardiovascular, hematological, hepatic, immunological, renal, respiratory, or
genitourinary abnormalities or diseases
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30346099 | Derived | Fraser IP, Neufeld ND, Fox LA, Kipnes MS, Miller TL, Zeitler PS, Rodriguez H, Gilmartin JH, Lee SJ, Patterson JK, Li XS, Maganti L, Luo WL, Tatosian DA, Stoch SA. A randomized clinical trial to evaluate the single-dose pharmacokinetics, pharmacodynamics, and safety of sitagliptin in pediatric patients with type 2 diabetes. Pediatr Diabetes. 2019 Feb;20(1):48-56. doi: 10.1111/pedi.12790. Epub 2018 Nov 13. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin 50 mg | Participants who received a single oral dose of sitagliptin 50 mg. |
| FG001 | Sitagliptin 100 mg | Participants who received a single oral dose of sitagliptin 100 mg. |
| FG002 | Sitagliptin 200 mg | Participants who received a single oral dose of sitagliptin 200 mg. |
| FG003 | Placebo | Participants who received a single oral dose of a matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin 50 mg | Participants who received a single oral dose of sitagliptin 50 mg. |
| BG001 | Sitagliptin 100 mg | Participants who received a single oral dose of sitagliptin 100 mg. |
| 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 Who Experienced at Least One Adverse Event | All enrolled participants. | Posted | Number | participants | Pre-study through 10 to 14 days following administration of study drug |
|
Not provided
Not provided
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 50 mg | Participants who received a single oral dose of sitagliptin 50 mg. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharpe & 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Comparator: matching placebo | Drug | Participants will fast 8 hours prior to dosing. All doses will be given with 240 ml of water. Participants received either a single oral dose of matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg. |
|
Serum samples were used to determine the Tmax for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups. |
| Pre-dose through 72 hours post-dose |
| Apparent Terminal Half-life (Apparent t1/2) Following a Single Dose of Sitagliptin | Serum samples were used to determine the apparent t1/2 for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups. | Pre-dose through 72 hours post-dose |
| Plasma Dipeptidyl Peptidase-4 (DPP-4) Activity Following a Single Dose of Sitagliptin or Placebo | Plasma DPP-4 activity was analyzed using the 24-hour weighted average inhibition (WAI) and percent inhibition at 24 hours post-dose. WAI was defined as the AUC of inhibition divided by the length of the post-dose time interval. Positive values of WAI represent a decrease in DPP-4 activity. | Pre-dose through 24 hours post-dose |
| BG002 | Sitagliptin 200 mg | Participants who received a single oral dose of sitagliptin 200 mg. |
| BG003 | Placebo | Participants who received a single oral dose of a matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG003 | Placebo | Participants who received a single oral dose of a matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg. |
|
|
| Primary | Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity Following a Single Dose of Sitagliptin | Serum samples were used to determine the AUC from time 0 to infinity for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups. | All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg. | Posted | Geometric Mean | 95% Confidence Interval | nM*hour | Pre-dose through 72 hours post-dose |
|
|
|
| Secondary | Maximum Concentration (Cmax) Following a Single Dose of Sitagliptin | Serum samples were used to determine the Cmax for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups. | All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg. | Posted | Geometric Mean | 95% Confidence Interval | nM | Pre-dose through 72 hours post-dose |
|
|
|
| Secondary | Time of Occurence of Maximum Concentration (Tmax) Following a Single Dose of Sitagliptin | Serum samples were used to determine the Tmax for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups. | All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg. | Posted | Median | Full Range | hours | Pre-dose through 72 hours post-dose |
|
|
|
| Secondary | Apparent Terminal Half-life (Apparent t1/2) Following a Single Dose of Sitagliptin | Serum samples were used to determine the apparent t1/2 for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups. | All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg. | Posted | Mean | Standard Deviation | hours | Pre-dose through 72 hours post-dose |
|
|
|
| Secondary | Plasma Dipeptidyl Peptidase-4 (DPP-4) Activity Following a Single Dose of Sitagliptin or Placebo | Plasma DPP-4 activity was analyzed using the 24-hour weighted average inhibition (WAI) and percent inhibition at 24 hours post-dose. WAI was defined as the AUC of inhibition divided by the length of the post-dose time interval. Positive values of WAI represent a decrease in DPP-4 activity. | All participants who received a single dose of sitagliptin or placebo. | Posted | Least Squares Mean | 95% Confidence Interval | Percent inhibition | Pre-dose through 24 hours post-dose |
|
|
|
| 0 |
| 9 |
| 3 |
| 9 |
| EG001 | Sitagliptin 100 mg | Participants who received a single oral dose of sitagliptin 100 mg. | 0 | 9 | 1 | 9 |
| EG002 | Sitagliptin 200 mg | Participants who received a single oral dose of sitagliptin 200 mg. | 0 | 8 | 1 | 8 |
| EG003 | Placebo | Participants who received a single oral dose of matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg. | 0 | 9 | 2 | 9 |
| Abdominal pain | Gastrointestinal disorders |
|
| Abdominal pain upper | Gastrointestinal disorders |
|
| Diarrhoea | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Infusion site pain | General disorders |
|
| Infusion site swelling | General disorders |
|
| Pyrexia | General disorders |
|
| Hypoglycaemia | Metabolism and nutrition disorders |
|
| Headache | Nervous system disorders |
|
| Dysmenorrhoea | Reproductive system and breast disorders |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders |
|
| Phlebitis | Vascular disorders |
|
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.
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |
| DDP-4 activity at 24 hours post-dose |
|