Status:
COMPLETED
MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-78 years
Phase:
PHASE3
Brief Summary
A study to evaluate the efficacy and safety of sitagliptin and pioglitazone co-administration in comparison with sitagliptin and pioglitazone monotherapy in patients with type 2 diabetes.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patient is highly unlikely to conceive
- 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 a history of type 1 diabetes mellitus or history of ketoacidosis or has C=peptide value of =\<0.8 ng/mL
- 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
Exclusion
Key Trial Info
Start Date :
September 5 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2011
Estimated Enrollment :
1615 Patients enrolled
Trial Details
Trial ID
NCT00722371
Start Date
September 5 2008
End Date
March 25 2011
Last Update
May 12 2017
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