MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)
NCT ID: NCT00722371
Last Updated: 2017-05-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1615 participants
INTERVENTIONAL
2008-09-05
2011-03-25
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
Sitagliptin phosphate
Sitagliptin 100 mg tablet (blinded) orally once daily for 54 weeks.
Matching placebo to pioglitazone
Matching placebo to pioglitazone tablets or capsules orally once daily for 54 weeks.
Metformin
Metformin 500 mg (open-label) was to be initiated as rescue therapy to participants not meeting specific glycemic goals. The dose of metformin may have been uptitrated and adjusted, at the discretion of the investigator, up to the maximum approved dose in the country of origin.
Pioglitazone 15 mg
Pioglitazone hydrochloride
Pioglitazone 15 mg, 30 mg, or 45 mg tablets or capsules (blinded) orally once daily for 54 weeks. Participants randomized to receive pioglitazone 45 mg as monotherapy or in combination with sitagliptin were to start on pioglitazone 30 mg at Week 1 and undergo uptitration to pioglitazone 45 mg at Week 4.
Matching placebo to sitagliptin
Matching placebo to sitagliptin orally once daily for 54 weeks.
Metformin
Metformin 500 mg (open-label) was to be initiated as rescue therapy to participants not meeting specific glycemic goals. The dose of metformin may have been uptitrated and adjusted, at the discretion of the investigator, up to the maximum approved dose in the country of origin.
Pioglitazone 30 mg
Pioglitazone hydrochloride
Pioglitazone 15 mg, 30 mg, or 45 mg tablets or capsules (blinded) orally once daily for 54 weeks. Participants randomized to receive pioglitazone 45 mg as monotherapy or in combination with sitagliptin were to start on pioglitazone 30 mg at Week 1 and undergo uptitration to pioglitazone 45 mg at Week 4.
Matching placebo to sitagliptin
Matching placebo to sitagliptin orally once daily for 54 weeks.
Metformin
Metformin 500 mg (open-label) was to be initiated as rescue therapy to participants not meeting specific glycemic goals. The dose of metformin may have been uptitrated and adjusted, at the discretion of the investigator, up to the maximum approved dose in the country of origin.
Pioglitazone 45 mg
Pioglitazone hydrochloride
Pioglitazone 15 mg, 30 mg, or 45 mg tablets or capsules (blinded) orally once daily for 54 weeks. Participants randomized to receive pioglitazone 45 mg as monotherapy or in combination with sitagliptin were to start on pioglitazone 30 mg at Week 1 and undergo uptitration to pioglitazone 45 mg at Week 4.
Matching placebo to sitagliptin
Matching placebo to sitagliptin orally once daily for 54 weeks.
Metformin
Metformin 500 mg (open-label) was to be initiated as rescue therapy to participants not meeting specific glycemic goals. The dose of metformin may have been uptitrated and adjusted, at the discretion of the investigator, up to the maximum approved dose in the country of origin.
Sitagliptin 100 mg/ Pioglitazone 15 mg
Sitagliptin phosphate
Sitagliptin 100 mg tablet (blinded) orally once daily for 54 weeks.
Pioglitazone hydrochloride
Pioglitazone 15 mg, 30 mg, or 45 mg tablets or capsules (blinded) orally once daily for 54 weeks. Participants randomized to receive pioglitazone 45 mg as monotherapy or in combination with sitagliptin were to start on pioglitazone 30 mg at Week 1 and undergo uptitration to pioglitazone 45 mg at Week 4.
Metformin
Metformin 500 mg (open-label) was to be initiated as rescue therapy to participants not meeting specific glycemic goals. The dose of metformin may have been uptitrated and adjusted, at the discretion of the investigator, up to the maximum approved dose in the country of origin.
Sitagliptin 100 mg/ Pioglitazone 30 mg
Sitagliptin phosphate
Sitagliptin 100 mg tablet (blinded) orally once daily for 54 weeks.
Pioglitazone hydrochloride
Pioglitazone 15 mg, 30 mg, or 45 mg tablets or capsules (blinded) orally once daily for 54 weeks. Participants randomized to receive pioglitazone 45 mg as monotherapy or in combination with sitagliptin were to start on pioglitazone 30 mg at Week 1 and undergo uptitration to pioglitazone 45 mg at Week 4.
Metformin
Metformin 500 mg (open-label) was to be initiated as rescue therapy to participants not meeting specific glycemic goals. The dose of metformin may have been uptitrated and adjusted, at the discretion of the investigator, up to the maximum approved dose in the country of origin.
Sitagliptin 100 mg/ Pioglitazone 45 mg
Sitagliptin phosphate
Sitagliptin 100 mg tablet (blinded) orally once daily for 54 weeks.
Pioglitazone hydrochloride
Pioglitazone 15 mg, 30 mg, or 45 mg tablets or capsules (blinded) orally once daily for 54 weeks. Participants randomized to receive pioglitazone 45 mg as monotherapy or in combination with sitagliptin were to start on pioglitazone 30 mg at Week 1 and undergo uptitration to pioglitazone 45 mg at Week 4.
Metformin
Metformin 500 mg (open-label) was to be initiated as rescue therapy to participants not meeting specific glycemic goals. The dose of metformin may have been uptitrated and adjusted, at the discretion of the investigator, up to the maximum approved dose in the country of origin.
Interventions
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Sitagliptin phosphate
Sitagliptin 100 mg tablet (blinded) orally once daily for 54 weeks.
Pioglitazone hydrochloride
Pioglitazone 15 mg, 30 mg, or 45 mg tablets or capsules (blinded) orally once daily for 54 weeks. Participants randomized to receive pioglitazone 45 mg as monotherapy or in combination with sitagliptin were to start on pioglitazone 30 mg at Week 1 and undergo uptitration to pioglitazone 45 mg at Week 4.
Matching placebo to sitagliptin
Matching placebo to sitagliptin orally once daily for 54 weeks.
Matching placebo to pioglitazone
Matching placebo to pioglitazone tablets or capsules orally once daily for 54 weeks.
Metformin
Metformin 500 mg (open-label) was to be initiated as rescue therapy to participants not meeting specific glycemic goals. The dose of metformin may have been uptitrated and adjusted, at the discretion of the investigator, up to the maximum approved dose in the country of origin.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient meets one of the 3 categories is naïve to all antihyperglycemic agent (AHA) therapies, or is non-naïve based upon the patient's current diet, medical regimen and screening A1c patient is currently not on AHA with a screening A1c \>=7.5 % and =\<11.0 % patient is currently on either metformin pr sulfonylurea monotherapy with a screening A1c \>=7.0 % and =\<9.0 %
Exclusion Criteria
* Patient has previously been treated with insulin, thiazolidinedione (TZD) (rosiglitazone or pioglitazone), any Dipeptidyl peptidase-4 (DPP-4) inhibitor (sitagliptin, vildagliptin, or alogliptin), exenatide or has previously been in a clinical study with any DPP-4 inhibitor or incretin mimetic
* Patient is on a weight loss program and is not in the maintenance phase or has started a weight loss medication (e.g. orlistat or sibutramine) within the prior 8 weeks
* Patient has undergone surgery within the prior 30 days or has major surgery planned during the study
* Patient has a medical history of active liver disease including chronic active hepatitis B or C or symptomatic gallbladder disease including primary biliary cirrhosis
* Patient has received treatment with an investigational product within 12 weeks prior to Visit 1
18 Years
78 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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References
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Henry RR, Staels B, Fonseca VA, Chou MZ, Teng R, Golm GT, Langdon RB, Kaufman KD, Steinberg H, Goldstein BJ. Efficacy and safety of initial combination treatment with sitagliptin and pioglitazone--a factorial study. Diabetes Obes Metab. 2014 Mar;16(3):223-30. doi: 10.1111/dom.12194. Epub 2013 Aug 29.
Other Identifiers
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2008_522
Identifier Type: OTHER
Identifier Source: secondary_id
0431-102
Identifier Type: -
Identifier Source: org_study_id
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