Efficacy of Pioglitazone and Fortamet Combination Therapy in Subjects With Type 2 Diabetes

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy of pioglitazone and metformin combination therapy, once daily (QD), on glycosylated hemoglobin in adults with type 2 diabetes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Metformin; Pioglitazone

Criteria

Inclusion Criteria

• Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study

• Diagnosed with type 2 diabetes and must have received appropriate counseling on lifestyle modification for type 2 diabetes including diet and exercise.

• If taking metformin monotherapy or metformin and sulfonylurea combination therapy, has a glycosylated hemoglobin greater than or equal to 7.5% and less than or equal to 9.0% at screening and randomization.

• If naïve or taking sulfonylurea monotherapy has an glycosylated hemoglobin greater than or equal to 8.5% and less than or equal to 10.0% at screening and greater than or equal to 7.5% and less than or equal to 9.0% at randomization.

Exclusion Criteria

• Has type 1 diabetes mellitus

• Currently taking any thiazolidinedione or have taken any thiazolidinedione within 12 weeks prior to screening

• Has congestive heart failure; has a triglyceride level greater than 500 mg per dL

• Diastolic blood pressure greater than 100 mmHg or a systolic pressure greater than 160 mmHg

• Body mass index greater than or equal to 42 kg/m2 (weight /height2)

• Alanine transaminase level greater than or equal to 2.5 times the upper limit of normal, active liver disease, or jaundice.

• Male subjects who have a serum creatinine level greater than or equal to 1.5 mg per dL; female subjects who have a serum creatinine level greater than or equal to 1.4 mg per dL at the screening visit and at randomization.

• Currently using insulin or has used insulin 3 months prior to Screening

• Acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma.

• Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:

• Chronically used oral or parenteral glucocorticoids (eg, prednisone, cortisone, hydrocortisone, dexamethasone)

• Niacin greater than 200 mg per day, including niacin-containing products such as Advicor - 3 months prior to screening and during the study

• Chronically used steroid-joint injections - 3 months prior to screening and during the study

• Thiazolidinediones - 3 months prior to screening and during the study

• Insulin - 3 months prior to screening

• Other oral antidiabetic medications (eg, nateglinide [Starlix], acarbose [Precose]) with the exception of sulfonylurea - 3 months prior to screening and during the study

• Metformin - Fortamet Stabilization and during the study