MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Metformin; Drug: Pioglitazone hydrochloride; Drug: Matching placebo to pioglitazone; Drug: Matching placebo to sitagliptin; Drug: Sitagliptin phosphate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00722371

0431-102

2008_522 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,615 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 =<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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,615 participants in 7 patient groups

Sitagliptin 100 mg

Experimental group

Treatment:

Drug: Metformin

Drug: Sitagliptin phosphate

Drug: Matching placebo to pioglitazone

Pioglitazone 15 mg

Experimental group

Treatment:

Drug: Metformin

Drug: Pioglitazone hydrochloride

Drug: Matching placebo to sitagliptin

Pioglitazone 30 mg

Experimental group

Treatment:

Drug: Metformin

Drug: Pioglitazone hydrochloride

Drug: Matching placebo to sitagliptin

Pioglitazone 45 mg

Experimental group

Treatment:

Drug: Metformin

Drug: Pioglitazone hydrochloride

Drug: Matching placebo to sitagliptin

Sitagliptin 100 mg/ Pioglitazone 15 mg

Experimental group

Treatment:

Drug: Metformin

Drug: Sitagliptin phosphate

Drug: Pioglitazone hydrochloride

Sitagliptin 100 mg/ Pioglitazone 30 mg

Experimental group

Treatment:

Drug: Metformin

Drug: Sitagliptin phosphate

Drug: Pioglitazone hydrochloride

Sitagliptin 100 mg/ Pioglitazone 45 mg

Experimental group

Treatment:

Drug: Metformin

Drug: Sitagliptin phosphate

Drug: Pioglitazone hydrochloride