Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)
NCT ID: NCT00086515
Last Updated: 2017-05-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
701 participants
INTERVENTIONAL
2004-06-30
2007-02-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sitagliptin 100 mg
The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
Sitagliptin (MK0431)
Sitagliptin 100 mg once daily, from Visit 4 through Final Visit, week 104
Metformin
Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104)
Pioglitazone
Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period \[Phase A\], from Visit 5 (Week 6) to Visit 8 (Week 24)
Placebo / Glipizide 5 mg
The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated, in a blinded fashion, to a maximum dose of 15 mg/day.
Placebo/Glipizide 5 mg
Placebo (to match Sitagliptin 100 mg) from Visit 4 through Visit 8; Glipizide 5 mg from Visit 8, week 24 to Final Visit (Week 104)
Metformin
Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104)
Pioglitazone
Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period \[Phase A\], from Visit 5 (Week 6) to Visit 8 (Week 24)
Interventions
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Sitagliptin (MK0431)
Sitagliptin 100 mg once daily, from Visit 4 through Final Visit, week 104
Placebo/Glipizide 5 mg
Placebo (to match Sitagliptin 100 mg) from Visit 4 through Visit 8; Glipizide 5 mg from Visit 8, week 24 to Final Visit (Week 104)
Metformin
Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104)
Pioglitazone
Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period \[Phase A\], from Visit 5 (Week 6) to Visit 8 (Week 24)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
18 Years
78 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Charbonnel B, Karasik A, Liu J, Wu M, Meininger G; Sitagliptin Study 020 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone. Diabetes Care. 2006 Dec;29(12):2638-43. doi: 10.2337/dc06-0706.
Xu L, Man CD, Charbonnel B, Meninger G, Davies MJ, Williams-Herman D, Cobelli C, Stein PP. Effect of sitagliptin, a dipeptidyl peptidase-4 inhibitor, on beta-cell function in patients with type 2 diabetes: a model-based approach. Diabetes Obes Metab. 2008 Dec;10(12):1212-20. doi: 10.1111/j.1463-1326.2008.00887.x. Epub 2008 May 12.
Study Documents
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Document Type: CSR Synopsis
View DocumentOther Identifiers
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Formally-B0604T2DMT
Identifier Type: -
Identifier Source: secondary_id
2006_411
Identifier Type: -
Identifier Source: secondary_id
0431-020
Identifier Type: -
Identifier Source: org_study_id
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