Clinical trial NCT00094770: An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024)
Official title: A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK0431 Compared With Sulfonylurea Therapy in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-10-25
Enrollment: 1172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this investigational study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes).

Detailed description: The duration of treatment is 104 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients who are at least 18 years of age and not older than 78 with type 2 diabetes mellitus

Primary outcomes:
measure: Change From Baseline in HbA1c at Week 52
timeFrame: Baseline and Week 52
Secondary outcomes:
measure: Change From Baseline in HbA1c at Week 104
timeFrame: Baseline and Week 104
measure: Change From Baseline in Body Weight at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in Body Weight at Week 104
timeFrame: Baseline and Week 104
measure: Hypoglycemic Events at Week 52
timeFrame: Baseline to Week 52
measure: Hypoglycemic Events at Week 104
timeFrame: Baseline to Week 104
measure: Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104
timeFrame: Baseline to Week 104
measure: Number of Participants With Serious CAEs at Week 104
timeFrame: Baseline to Week 104
measure: Number of Participants With Drug-related CAEs at Week 104
timeFrame: Baseline to Week 104
measure: Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104
timeFrame: Baseline to Week 104
measure: Number of Participants With Serious LAEs at Week 104
timeFrame: Baseline to Week 104
measure: Number of Participants With Drug-related LAEs at Week 104
timeFrame: Baseline to Week 104
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Nauck MA, Meininger G, Sheng D, Terranella L, Stein PP; Sitagliptin Study 024 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2007 Mar;9(2):194-205. doi: 10.1111/j.1463-1326.2006.00704.x.
citation: Ommen ES, Xu L, O'Neill EA, Goldstein BJ, Kaufman KD, Engel SS. Comparison of treatment with sitagliptin or sulfonylurea in patients with type 2 diabetes mellitus and mild renal impairment: a post hoc analysis of clinical trials. Diabetes Ther. 2015 Mar;6(1):29-40. doi: 10.1007/s13300-015-0098-y. Epub 2015 Jan 30.
citation: Seck TL, Engel SS, Williams-Herman DE, Sisk CM, Golm GT, Wang H, Kaufman KD, Goldstein BJ. Sitagliptin more effectively achieves a composite endpoint for A1C reduction, lack of hypoglycemia and no body weight gain compared with glipizide. Diabetes Res Clin Pract. 2011 Jul;93(1):e15-7. doi: 10.1016/j.diabres.2011.03.006. Epub 2011 Apr 8.
citation: Seck T, Nauck M, Sheng D, Sunga S, Davies MJ, Stein PP, Kaufman KD, Amatruda JM; Sitagliptin Study 024 Group. Safety and efficacy of treatment with sitagliptin or glipizide in patients with type 2 diabetes inadequately controlled on metformin: a 2-year study. Int J Clin Pract. 2010 Apr;64(5):562-76. doi: 10.1111/j.1742-1241.2010.02353.x.