Back to resultsMK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
sitagliptin phosphate
Comparator: placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria: Patients have Type 2 Diabetes Mellitus and have laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) >=7.5% and <=11% and a Fasting Plasma Glucose (FPG) >=130 mg/dL and <=280 mg/dL Exclusion Criteria : Patients have Type 1 Diabetes Mellitus or required insulin therapy within the past 12 months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
sitagliptin 100 mg
placebo
Outcomes
Primary Outcome Measures
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18
A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
Secondary Outcome Measures
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18
Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.
Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18
Change from baseline at Week 18 is defined as Week 18 minus Week 0.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00289848
Brief Title
MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040)
Official Title
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
530 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
sitagliptin 100 mg
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
sitagliptin phosphate
Other Intervention Name(s)
Januvia
Intervention Description
Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks.
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo
Intervention Description
placebo to match Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18
Description
A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
Time Frame
Baseline and Week 18
Secondary Outcome Measure Information:
Title
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18
Description
Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.
Time Frame
Baseline and Week 18
Title
Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18
Description
Change from baseline at Week 18 is defined as Week 18 minus Week 0.
Time Frame
Baseline and Week 18
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients have Type 2 Diabetes Mellitus and have laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) >=7.5% and <=11% and a Fasting Plasma Glucose (FPG) >=130 mg/dL and <=280 mg/dL
Exclusion Criteria :
Patients have Type 1 Diabetes Mellitus or required insulin therapy within the past 12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19097665
Citation
Mohan V, Yang W, Son HY, Xu L, Noble L, Langdon RB, Amatruda JM, Stein PP, Kaufman KD. Efficacy and safety of sitagliptin in the treatment of patients with type 2 diabetes in China, India, and Korea. Diabetes Res Clin Pract. 2009 Jan;83(1):106-16. doi: 10.1016/j.diabres.2008.10.009. Epub 2008 Dec 20.
Results Reference
background
PubMed Identifier
33914296
Citation
Singh B, Sims H, Trueheart I, Simpson K, Wang KC, Patzkowsky K, Wegman T, Soma JM, Dixon R, Jayes F, Voegltine K, Yenokyan G, Su SC, Leppert P, Segars JH. A Phase I Clinical Trial to Assess Safety and Tolerability of Injectable Collagenase in Women with Symptomatic Uterine Fibroids. Reprod Sci. 2021 Sep;28(9):2699-2709. doi: 10.1007/s43032-021-00573-8. Epub 2021 Apr 29.
Results Reference
derived
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MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040)
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