Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, Non-Insulin-Dependent
Brief summary
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.
Interventions
Sitagliptin/metformin 50/500 mg, 50/850 mg, or 50/1000 mg tablet administered twice daily with meals.
Sponsors
Merck Sharp & Dohme LLC
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Has type 2 diabetes mellitus * Is treated with sitagliptin/metformin within local label for the first time
Exclusion criteria
* Has a contraindication to sitagliptin/metformin according to the local label * Is treated with sitagliptin/metformin before contract and out of enrollment period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Treatment in FPG at Week 24 | Baseline and 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. |
| Change From Baseline in 2hr-PPG at Week 24 | Baseline and 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. |
| Percentage of Participants With Any Adverse Experience | Up to 26 weeks | 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. |
| Change From Baseline to Treatment in Hemoglobin HbA1c (A1C) at Week 12 | Baseline and 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. |
| Change From Baseline to Treatment in Fasting Plasma Glucose (FPG) at Week 12 | Baseline and 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. |
| Change From Baseline in 2-hour Post Prandial Glucose (2hr-PPG) at Week 12 | Baseline and 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. |
| Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 12 | 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. |
| Change From Baseline to Treatment in HbA1c at Week 24 | Baseline and 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. |
| Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 24 | 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. |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Included in the Safety Evaluation Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin | 4,033 |
| Total | 4,033 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Assessed before the contracted date | 1 |
| Overall Study | Contraindication to administration | 6 |
| Overall Study | Violated dosage/administration | 25 |
Baseline characteristics
| Characteristic | All Participants Included in the Safety Evaluation |
|---|---|
| Age, Continuous | 58.22 Years STANDARD_DEVIATION 11.55 |
| Sex: Female, Male Female | 1913 Participants |
| Sex: Female, Male Male | 2120 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 4,033 |
| serious Total, serious adverse events | 17 / 4,033 |
Outcome results
Primary
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
Population: Participants with a pre-treatment and a 12-week post-treatment measurement of 2hr-PPG.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants Included in the Safety Evaluation | Change From Baseline in 2-hour Post Prandial Glucose (2hr-PPG) at Week 12 | -58.02 mg/dL | Standard Deviation 72.96 |
Primary
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
Population: Participants with a pre-treatment and a 24-week post-treatment measurement of 2hr-PPG.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants Included in the Safety Evaluation | Change From Baseline in 2hr-PPG at Week 24 | -62.13 mg/dL | Standard Deviation 75.67 |
Primary
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
Population: Participants with a pre-treatment and a 12-week post-treatment measurement of FPG.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants Included in the Safety Evaluation | Change From Baseline to Treatment in Fasting Plasma Glucose (FPG) at Week 12 | -28.21 mg/dL | Standard Deviation 42.21 |
Primary
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
Population: Participants with a pre-treatment and a 24-week post-treatment measurement of FPG.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants Included in the Safety Evaluation | Change From Baseline to Treatment in FPG at Week 24 | -32.40 mg/dL | Standard Deviation 44.75 |
Primary
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
Population: All participants with a pre-treatment and a 24-week post-treatment HbA1c value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants Included in the Safety Evaluation | Change From Baseline to Treatment in HbA1c at Week 24 | -1.08 Percentage of glycosylated hemoglobin | Standard Deviation 1.42 |
Primary
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
Population: All participants with a pre-treatment and a 12-week post-treatment HbA1c value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants Included in the Safety Evaluation | Change From Baseline to Treatment in Hemoglobin HbA1c (A1C) at Week 12 | -0.93 Percentage of glycosylated hemoglobin | Standard Deviation 1.23 |
Primary
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
Population: Participants who have used study drug for more than 12 weeks and whose improvement of the disease has been assessed by Principal investigator.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants Included in the Safety Evaluation | Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 12 | Improved | 78.68 Percentage of participants |
| All Participants Included in the Safety Evaluation | Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 12 | Stable | 16.38 Percentage of participants |
| All Participants Included in the Safety Evaluation | Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 12 | Worse | 4.94 Percentage of participants |
Primary
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
Population: Participants who have used study drug for more than 24 weeks and whose improvement of the disease has been assessed by Principal investigator.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants Included in the Safety Evaluation | Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 24 | Improved | 76.38 Percentage of participants |
| All Participants Included in the Safety Evaluation | Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 24 | Stable | 15.88 Percentage of participants |
| All Participants Included in the Safety Evaluation | Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 24 | Worse | 7.75 Percentage of participants |
Primary
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
Population: All participants who were included in the safety evaluation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants Included in the Safety Evaluation | Percentage of Participants With Any Adverse Experience | 3.74 Percentage of participants |