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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004990-34 | EudraCT Number | ||
| MK-0431-845 | Other Identifier | Merck Protocol Number |
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This is a trial of continuing sitagliptin versus withdrawing sitagliptin in participants with Type 2 diabetes mellitus (T2DM) and inadequate glycemic control who initiate and titrate insulin glargine (LANTUS®) based on a treat-to-target algorithm to achieve fasting glucose levels of 72-100 mg/dL (4-5.6 mmol/L). A primary hypothesis of this trial is that after 30 weeks, continuing sitagliptin results in a greater reduction of hemoglobin A1C (A1C) relative to withdrawing sitagliptin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin | Experimental | Sitagliptin 100 mg, oral, once daily for 30 weeks |
|
| Placebo | Placebo Comparator | Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | Sitagliptin 100 mg, oral, once daily for 30 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in A1C at Week 30 | A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 30 A1C minus the Week 0 A1C. | Baseline and Week 30 |
| Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) | Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant. | Up to 30 weeks |
| Percentage of Participants Who Discontinued Study Drug Due to an AE | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | Up to 30 weeks |
| Percentage of Participants Who Experienced One or More Adverse Events (AEs) | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | Up to 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Events of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) | Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The incidence (number of participants with ≥1 event divided by number of participants) of documented symptomatic hypoglycemia was determined. |
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Inclusion Criteria:
Have T2DM based on American Diabetes Association guidelines
Be on one of the following treatment regimens:
Stable dose of sitagliptin (100 mg/day) and metformin IR or XR (metformin) (≥1500 mg/day) either co-administered or as a fixed dose combination (FDC) for ≥12 weeks with A1C between 7.5% and 11.0%, inclusive.
OR
Stable dose of metformin (≥1500 mg/day) and another dipeptidyl peptidase-4 (DPP-4) inhibitor (at maximum labeled dose, other than sitagliptin, either co-administered or as a FDC, for ≥12 weeks with A1C between 7.5% and 11.0%, inclusive.
OR
Stable dose of sitagliptin (100 mg/day) and metformin (≥1500 mg/day) either co administered or as a FDC, and a sulfonylurea for ≥12 weeks OR stable dose of metformin (≥1500 mg/day) and a sulfonylurea administered as a FDC and sitagliptin (100 mg/day) with A1C between 7.0% and 10.0%, inclusive.
OR
Stable dose of metformin (≥1500 mg/day) and another DPP-4 inhibitor (at maximum labeled dose), other than sitagliptin, either co-administered or as a FDC, and a sulfonylurea for ≥12 weeks OR stable dose of metformin (≥1500 mg/day) and a sulfonylurea administered as a FDC and another DPP-4 inhibitor other than sitagliptin with A1C between 7.0% and 10.0%, inclusive OR
Stable dose of metformin (≥1500 mg/day) and a sulfonylurea either co-administered or as a FDC for ≥12 weeks with A1C between 7.5% and 11.0%, inclusive.
Meet one of the following categories:
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 |
|---|---|---|---|
| 30393950 | Derived | Roussel R, Duran-Garcia S, Zhang Y, Shah S, Darmiento C, Shankar RR, Golm GT, Lam RLH, O'Neill EA, Gantz I, Kaufman KD, Engel SS. Double-blind, randomized clinical trial comparing the efficacy and safety of continuing or discontinuing the dipeptidyl peptidase-4 inhibitor sitagliptin when initiating insulin glargine therapy in patients with type 2 diabetes: The CompoSIT-I Study. Diabetes Obes Metab. 2019 Apr;21(4):781-790. doi: 10.1111/dom.13574. Epub 2018 Dec 9. |
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Male and female participants with Type 2 diabetes mellitus (T2DM) ≥18 years of age were enrolled in this trial.
A total of 746 participants were randomized across 149 study sites in 22 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin | Sitagliptin 100 mg, oral, once daily for 30 weeks |
| FG001 | Placebo | Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The overall number of baseline participants included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin | Sitagliptin 100 mg, oral, once daily for 30 weeks |
| BG001 | Placebo | Placebo to sitagliptin 100 mg, oral, once daily for 30 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 | Change From Baseline in A1C at Week 30 | A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 30 A1C minus the Week 0 A1C. | All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline). | Posted | Least Squares Mean | 95% Confidence Interval | Percent A1C | Baseline and Week 30 |
|
Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
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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 | Sitagliptin | Sitagliptin 100 mg, oral, once daily for 30 weeks | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Disclosure | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 14, 2016 | Jan 18, 2019 | Prot_SAP_000.pdf |
| 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 |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D008687 | Metformin |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo to sitagliptin | Drug | Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks |
|
| Metformin | Drug | At least 1500 mg/day, oral, twice daily for participants entering the study on immediate-release metformin + sitagliptin or a fixed dose combination (FDC). |
|
| Metformin XR | Drug | At least 1500 mg/day, oral, once daily for participants entering the study on extended-release metformin + sitagliptin or a FDC. |
|
| Insulin glargine | Drug | Insulin glargine (LANTUS®) initiated at 10 units and titrated based on a treat-to-target algorithm to achieve fasting glucose levels of 72-100 mg/dL (4-5.6 mmol/L); administered once daily subcutaneously. |
|
|
| Up to 30 weeks |
| Change From Baseline in Total Daily Insulin Dose (Units) at Week 30 | Change from baseline reflects the Week 30 total daily insulin dose minus the Week 0 total daily insulin dose. The Week 0 total daily insulin dose was 0, by definition, because insulin was not administered at baseline. | Baseline and Week 30 |
| Event Rate of Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) | Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant. | Up to 30 weeks |
| Event Rate of Documented Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L) | Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration <56 mg/dL (≤3.1 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant. | Up to 30 weeks |
| Percentage of Participants With Documented Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L) | Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration <56 mg/dL (≤3.1 mmol/L). | Up to 30 weeks |
| Percentage of Participants With A1C Goal <7.0% (<53 mmol/Mol) at Week 30 | A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. | Week 30 |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30 | Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 30 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 30 minus FPG at Week 0). | Baseline and Week 30 |
| Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L) | Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration <56 mg/dL (≤3.1 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant. | Up to 30 weeks |
| Percentage of Participants With Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) | Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). | Up to 30 weeks |
| Percentage of Participants With Documented Symptomatic Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L) | Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration <56 mg/dL (≤3.1 mmol/L). | Up to 30 weeks |
| Percentage of Participants With A1C Goal <7.0% (<53 mmol/Mol at Week 30 and No Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) up to Week 30 | A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. | Week 30 |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Physician Decision |
|
| Pregnancy |
|
| Screen Failure |
|
| Site Discontinued Study Participation |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Geographic Region | Count of Participants | Participants |
|
| Hemoglobin A1C (A1C) | Percent A1C= Glycated hemoglobin/total hemoglobin x 100 | All randomized and treated participants | Mean | Standard Deviation | Percent A1C |
|
| Fasting Plasma Glucose (FPG) | Fasting plasma glucose level after a 10-hour overnight fast. | All randomized and treated participants | Mean | Standard Deviation | mg/dL |
|
| Estimated Glomerular Filtration Rate | Estimated Glomerular Filtration Rate (eGFR) is a test of renal function. | All randomized and treated participants | Mean | Standard Deviation | mL/min/1.73 m^2 |
|
| Body Weight | All randomized and treated participants | Mean | Standard Deviation | Kilograms |
|
| Anti-Hyperglycemic Agent | Background Anti-Hyperglycemic Agent (AHA) at Screening metformin = Met) dipeptidyl peptidase 4 inhibitor = DPP-4i | Count of Participants | Participants |
|
Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
|
|
|
| Primary | Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) | Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant. | All randomized participants who received at least one dose of study treatment. Two participants in the sitagliptin group were not included in the primary analysis due to a missing value of a model covariate (race). | Posted | Number | 95% Confidence Interval | Events/Participant-Years | Up to 30 weeks |
|
|
|
|
| Primary | Percentage of Participants Who Discontinued Study Drug Due to an AE | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | All randomized participants who received at least one dose of study treatment. | Posted | Number | Percentage of participants | Up to 30 weeks |
|
|
|
|
| Secondary | Percentage of Participants With Events of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) | Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The incidence (number of participants with ≥1 event divided by number of participants) of documented symptomatic hypoglycemia was determined. | All randomized participants who received at least one dose of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 30 weeks |
|
|
|
|
| Secondary | Change From Baseline in Total Daily Insulin Dose (Units) at Week 30 | Change from baseline reflects the Week 30 total daily insulin dose minus the Week 0 total daily insulin dose. The Week 0 total daily insulin dose was 0, by definition, because insulin was not administered at baseline. | All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline). | Posted | Least Squares Mean | 95% Confidence Interval | Insulin Units | Baseline and Week 30 |
|
|
|
|
| Secondary | Event Rate of Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) | Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant. | All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline). Two participants (both in the sitagliptin group) were not included in the analysis due to a missing value of a model covariate (race). | Posted | Number | 95% Confidence Interval | Events/Participant-Years | Up to 30 weeks |
|
|
|
|
| Secondary | Event Rate of Documented Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L) | Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration <56 mg/dL (≤3.1 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant. | All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline). Two participants (both in the sitagliptin group) were not included in the analysis due to a missing value of a model covariate (race). | Posted | Number | 95% Confidence Interval | Events/Participant-Years | Up to 30 weeks |
|
|
|
|
| Secondary | Percentage of Participants With Documented Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L) | Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration <56 mg/dL (≤3.1 mmol/L). | All randomized participants who received at least one dose of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 30 weeks |
|
|
|
|
| Secondary | Percentage of Participants With A1C Goal <7.0% (<53 mmol/Mol) at Week 30 | A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. | All randomized participants who received at least one dose of study treatment. | Posted | Number | Percentage of participants | Week 30 |
|
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30 | Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 30 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 30 minus FPG at Week 0). | All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline). | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 30 |
|
|
|
|
| Primary | Percentage of Participants Who Experienced One or More Adverse Events (AEs) | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | All randomized participants who received at least one dose of study treatment. | Posted | Number | Percentage of participants | Up to 32 weeks |
|
|
|
|
| Secondary | Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L) | Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration <56 mg/dL (≤3.1 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant. | All randomized participants who received at least one dose of study treatment. Two participants in the sitagliptin group were not included in the primary analysis due to a missing value of a model covariate (race). | Posted | Number | 95% Confidence Interval | Events/Participant-Years | Up to 30 weeks |
|
|
|
|
| Secondary | Percentage of Participants With Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) | Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). | All randomized participants who received at least one dose of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 30 weeks |
|
|
|
|
| Secondary | Percentage of Participants With Documented Symptomatic Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L) | Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration <56 mg/dL (≤3.1 mmol/L). | All randomized participants who received at least one dose of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 30 weeks |
|
|
|
|
| Secondary | Percentage of Participants With A1C Goal <7.0% (<53 mmol/Mol at Week 30 and No Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) up to Week 30 | A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. | All randomized participants who received at least one dose of study treatment. | Posted | Number | Percentage of participants | Week 30 |
|
|
|
|
| 373 |
| 14 |
| 373 |
| 79 |
| 373 |
| EG001 | Placebo | Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks | 2 | 370 | 18 | 370 | 72 | 370 |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Phimosis | Congenital, familial and genetic disorders | MedDRA 20.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Strangulated umbilical hernia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Groin abscess | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Sialoadenitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Tracheitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Heart rate irregular | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Gastrointestinal tract adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Lumbar radiculopathy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Newborns (0-27 days) |
|
| Infants and toddlers (28 days-23 months) |
|
| Children (2-11 years) |
|
| Adolescents (12-17 years) |
|
| Adults (18-64 years) |
|
| From 65-84 years |
|
| 85 years and over |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Latin America |
|
| North America |
|
| Other |
|
| Met + SU |
|