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Sitagliptin/Metformin (JANUMET) Re-examination Study (0431A-182 AM4)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01065766
First received: February 8, 2010
Last updated: February 28, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Non-Insulin-Dependent
 Drug: Sitagliptin/metformin

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of JANUMET in Usual Practice

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Percentage of participants with any adverse experience which occurs during treatment or within 14 days following cessation of treatment [ Time Frame: up to 14 days following cessation of treatment ] [ Designated as safety issue: Yes ]
  • Change from baseline to treatment in HbA1c [ Time Frame: At 12 weeks +/- 2 weeks and 24 weeks +/- 2 weeks after first treatment ] [ Designated as safety issue: No ]
  • Change from baseline to treatment in fasting plasma glucose (FPG) [ Time Frame: At 12 weeks +/- 2 weeks and 24 weeks +/- 2 weeks after first treatment ] [ Designated as safety issue: No ]
  • Change from baseline to treatment in 2-hour post prandial glucose (2hr-PPG) [ Time Frame: At 12 weeks +/- 2 weeks and 24 weeks +/- 2 weeks after first treatment ] [ Designated as safety issue: No ]
  • Overall efficacy evaluation by the investigator (improved, stable, worse) [ Time Frame: At 12 weeks +/- 2 weeks and 24 weeks +/- 2 weeks after first treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: March 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All participants
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.
Other Name: JANUMET

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin in usual practice

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065766

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01065766     History of Changes
Other Study ID Numbers: 0431A-182, 2010_006
Study First Received: February 8, 2010
Last Updated: February 28, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Merck:
Diabetes Mellitus, Non-Insulin-Dependent

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Metformin
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013