Phase 3
Completed N=1,615
MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)
Source: ClinicalTrials.gov NCT00722371 ↗Enrolled (actual)
1,615
Serious AEs
4.6%
Results posted
Oct 2011
Primary outcomePrimary: Change From Baseline in Hemoglobin A1C (A1C) at Week 24 — -1.09; -0.88; -1.21; -1.20 Percentage of glycosylated hemoglobin
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1C (A1C) at Week 24 |
-1.09; -0.88; -1.21; -1.20; -1.53; -1.63 | — |
| PRIMARY Change From Baseline in A1C at Week 54 |
-0.93; -0.74; -1.16; -1.23; -1.45; -1.49 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 |
-24.3; -19.5; -29.9; -37.4; -41.0; -46.9 | — |
| SECONDARY Change From Baseline in 2-Hour Post-meal Glucose (PMG) at Week 24 |
-51.1; -30.6; -52.5; -66.6; -69.2; -85.5 | — |
| SECONDARY Change From Baseline in FPG at Week 54 |
-13.1; -10.5; -24.0; -33.3; -33.9; -37.1 | — |
| SECONDARY Change From Baseline in 2-Hour PMG at Week 54 |
-37.0; -26.7; -46.8; -58.2; -64.7; -69.7 | — |
Eligibility Criteria
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 = =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
Data sourced from ClinicalTrials.gov (NCT00722371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.