Sitagliptin/Metformin (JANUMET) Re-examination Study (0431A-182)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of JANUMET in Usual Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065766
• Other study ID #: 0431A-182
• Secondary ID: 2010_006
• Status: Completed
• Phase: N/A
• First received: February 8, 2010
• Last updated: February 18, 2015
• Start date: March 2009
• Est. completion date: May 2013

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4065
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Sitagliptin/metformin
Sitagliptin/metformin 50/500 mg, 50/850 mg, or 50/1000 mg tablet administered twice daily with meals.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 26 weeks	Yes
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.	Baseline and Week 12	No
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.	Baseline and Week 12	No
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.	Baseline and Week 12	No
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.	At Week 12	No
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.	Baseline and Week 24	No
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.	Baseline and Week 24	No
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.	Baseline and Week 24	No
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.	At Week 24	No