An observational study in Type 2 Diabetes Mellitus, sponsored by Merck Sharp & Dohme LLC. Completed. Per ClinicalTrials.gov, last updated 2015-03-06.
Sponsored by Merck Sharp & Dohme LLC · Observational
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of sitagliptin/metformin (JANUMET) through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.
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Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin in usual practice
Exclusion Criteria:
Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
Drug: Sitagliptin/metformin
Sitagliptin/metformin 50/500 mg, 50/850 mg, or 50/1000 mg tablet administered twice daily with meals.
Also known as: JANUMET
Percentage of Participants With Any Adverse Experience
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Time frame: Up to 26 weeks
Change From Baseline to Treatment in Hemoglobin HbA1c (A1C) at Week 12
HbA1C is found when high blood levels of glucose combines with hemoglobin to form glycated hemoglobin. The average amount of glucose in blood over a prolonged periods of time can be determined by measuring a hemoglobin A1c level which is reported as a percentage (%). The change from baseline reflects the Week 12 A1C minus Week 0 A1C.
Time frame: Baseline and Week 12
Change From Baseline to Treatment in Fasting Plasma Glucose (FPG) at Week 12
Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 FPG minus Week 0 FPG.
Time frame: Baseline and Week 12
Change From Baseline in 2-hour Post Prandial Glucose (2hr-PPG) at Week 12
Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 2hr-PPG minus Week 0 2hr-PPG.
Time frame: Baseline and Week 12
Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 12
Overall efficacy analysis was conducted on participants who have used study drug for more than 12 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: "Improved", "Stable" and "Worse" in a Medical History/Physical Examination form.
Time frame: At Week 12
Change From Baseline to Treatment in HbA1c at Week 24
HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Therefore, this change from baseline reflects the Week 24 A1C minus Week 0 A1C.
Time frame: Baseline and Week 24
Change From Baseline to Treatment in FPG at Week 24
Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 FPG minus Week 0 FPG.
Time frame: Baseline and Week 24
Change From Baseline in 2hr-PPG at Week 24
Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 2hr-PPG minus Week 0 2hr-PPG.
Time frame: Baseline and Week 24
Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 24
Overall efficacy analysis was conducted on participants who have used study drug for more than 24 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: "Improved", "Stable" and "Worse" in a Medical History/Physical Examination form.
Time frame: At Week 24
In this post-marketing surveillance study of sitagliptin/metformin (JANUMET®), participants in South Korea treated for \>= 24 weeks were evaluated for long-term safety and efficacy. During the re-examination study period (December 4, 2005 to September 20, 2013), case report forms (CRFs) were collected from 4,065 participants.
| Milestone | All Participants Included in the Safety Evaluation |
|---|---|
| Started | 4065 |
| Completed | 4033 |
| Not completed | 32 |
| Withdrew: Assessed before the contracted date | 1 |
| Withdrew: Contraindication to administration | 6 |
| Withdrew: Violated dosage/administration | 25 |
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
| Percentage of participants | All Participants Included in the Safety Evaluation |
|---|---|
| Percentage of Participants With Any Adverse Experience | 3.74 |
HbA1C is found when high blood levels of glucose combines with hemoglobin to form glycated hemoglobin. The average amount of glucose in blood over a prolonged periods of time can be determined by measuring a hemoglobin A1c level which is reported as a percentage (%). The change from baseline reflects the Week 12 A1C minus Week 0 A1C.
| Percentage of glycosylated hemoglobin | All Participants Included in the Safety Evaluation |
|---|---|
| Change From Baseline to Treatment in Hemoglobin HbA1c (A1C) at Week 12 | -0.93 ± 1.23 |
Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 FPG minus Week 0 FPG.
| mg/dL | All Participants Included in the Safety Evaluation |
|---|---|
| Change From Baseline to Treatment in Fasting Plasma Glucose (FPG) at Week 12 | -28.21 ± 42.21 |
Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 2hr-PPG minus Week 0 2hr-PPG.
| mg/dL | All Participants Included in the Safety Evaluation |
|---|---|
| Change From Baseline in 2-hour Post Prandial Glucose (2hr-PPG) at Week 12 | -58.02 ± 72.96 |
Overall efficacy analysis was conducted on participants who have used study drug for more than 12 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: "Improved", "Stable" and "Worse" in a Medical History/Physical Examination form.
| Percentage of participants | All Participants Included in the Safety Evaluation |
|---|---|
| Improved | 78.68 |
| Stable | 16.38 |
| Worse | 4.94 |
HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Therefore, this change from baseline reflects the Week 24 A1C minus Week 0 A1C.
| Percentage of glycosylated hemoglobin | All Participants Included in the Safety Evaluation |
|---|---|
| Change From Baseline to Treatment in HbA1c at Week 24 | -1.08 ± 1.42 |
Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 FPG minus Week 0 FPG.
| mg/dL | All Participants Included in the Safety Evaluation |
|---|---|
| Change From Baseline to Treatment in FPG at Week 24 | -32.40 ± 44.75 |
Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 2hr-PPG minus Week 0 2hr-PPG.
| mg/dL | All Participants Included in the Safety Evaluation |
|---|---|
| Change From Baseline in 2hr-PPG at Week 24 | -62.13 ± 75.67 |
Overall efficacy analysis was conducted on participants who have used study drug for more than 24 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: "Improved", "Stable" and "Worse" in a Medical History/Physical Examination form.
| Percentage of participants | All Participants Included in the Safety Evaluation |
|---|---|
| Improved | 76.38 |
| Stable | 15.88 |
| Worse | 7.75 |
Collected over Up to 26 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants Included in the Safety Evaluation | — | 17/4,033 (0.4%) | 0/4,033 (0%) |
| Event | All Participants Included in the Safety Evaluation |
|---|---|
| ANGINA UNSTABLECardiac disorders | 2/4033 |
| DYSPNOEARespiratory, thoracic and mediastinal disorders | 2/4033 |
| ACUTE MYOCARDIAL INFARCTIONCardiac disorders | 1/4033 |
| ATRIAL FLUTTERCardiac disorders | 1/4033 |
| CORONARY ARTERY OCCLUSIONCardiac disorders | 1/4033 |
| ABDOMINAL PAINGastrointestinal disorders | 1/4033 |
| INGUINAL HERNIAGastrointestinal disorders | 1/4033 |
| OESOPHAGEAL VARICES HAEMORRHAGEGastrointestinal disorders | 1/4033 |
| VOMITINGGastrointestinal disorders | 1/4033 |
| CHEST PAINGeneral disorders | 1/4033 |
Baseline characteristics were only reported for the Safety Population (4033) who qualified for the study and not for the 4065 participants from whom CRFs were collected.
| Age, Continuous(Years) | All Participants Included in the Safety Evaluation |
|---|---|
| Mean | 58.22 ± 11.55 |
| Sex: Female, Male(Participants) | All Participants Included in the Safety Evaluation |
|---|---|
| Female | 1913 |
| Male | 2120 |
No study locations are listed for this record.
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC