An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)
NCT ID: NCT00094757
Last Updated: 2019-05-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
521 participants
INTERVENTIONAL
2004-10-06
2006-04-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024)
NCT00094770
MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036)
NCT00103857
MK0431 (Sitagliptin) Pioglitazone Add-on Study for Patients With Type 2 Diabetes Mellitus (0431-055)(COMPLETED)
NCT00372060
Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)
NCT00087516
MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040)
NCT00289848
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sitagliptin 100 mg
Sitagliptin 100 mg
Comparator: sitagliptin 100 mg
sitagliptin 100 mg oral tablet once daily for 54 weeks
Sitagliptin 200 mg
Sitagliptin 200 mg
Comparator: sitagliptin 200 mg
sitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks
Placebo/Pioglitazone
Placebo/Pioglitazone
Comparator: placebo
placebo oral tablet once daily during Phase A (Weeks 0-18)
Comparator: pioglitazone
pioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Comparator: sitagliptin 100 mg
sitagliptin 100 mg oral tablet once daily for 54 weeks
Comparator: sitagliptin 200 mg
sitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks
Comparator: placebo
placebo oral tablet once daily during Phase A (Weeks 0-18)
Comparator: pioglitazone
pioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Any condition, which in the opinion of the investigator, may not be in the patient's best interest to participate
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
Explore related publications, articles, or registry entries linked to this study.
Raz I, Hanefeld M, Xu L, Caria C, Williams-Herman D, Khatami H; Sitagliptin Study 023 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus. Diabetologia. 2006 Nov;49(11):2564-71. doi: 10.1007/s00125-006-0416-z. Epub 2006 Sep 26.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2004_045
Identifier Type: -
Identifier Source: secondary_id
0431-023
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.