Trial Information

Summary: This study will compare the efficacy and safety of treatment with Novolog 70/30 Insulin plus two oral anti-diabetic medications, to the efficacy and safety of treatment with two oral anti-diabetic medications alone, in patients who have type II diabetes and have never been treated with insulin.

Inclusion Criteria:

• Patient must have type II diabetes diagnosed at least 3 months ago.
• Patient has a Body Mass Index of less than or equal to 42 kg/m².
• Patient, male or female, is at least 18 years of age.
• Patient has an HbA1c value of at least or more than 7.5% but not more than 12% at screening.
• Patient is on 2 oral anti-diabetic medications, with specific dosage requirement for each medication, to enroll into the study.
• Patient is on a stable anti-diabetic regimen for at lest 6 weeks or 3 months, depending on the type of medication he/she is on.
• Patient is able and willing to adhere to the therapeutic regimens and protocol requirements.
• Patient has an average fasting blood sugar level between 120 mg/dL and 220 mg /dL at the entry into this study.

Exclusion Criteria:

• Patient is allergic to the trial drug(s).
• Patient has participated in this study before.
• Patient has used any insulin preparation (greater than 7 consecutive days within the last 6 months).
• Patient has a severe eye complication requiring treatment within 6 months of screening.
• Patient is pregnant, breastfeeding, or intending to become pregnant within the next 12 months, or is judged by the investigator to be using inadequate contraceptive measures.
• Patient has a history of certain heart conditions.
• Patient has a liver disease that has been active for the last 2 years.
• Patient has impaired kidney function.
• Patient has anemia (hemoglobin level less than 10 mg/dL).
• Patient has untreated/inadequately treated high blood pressure (Systolic >180 mmHg and Diastolic >100 mmHg).
• Patient suffers from repeated severe low sugar problem.
• Patient is on any other medication that may affect blood glucose level, or if there is a possibility that these medications may need to be changed/adjusted during the study period.
• Patient has enrolled in any other clinical trial within one month of screening for this study.
• Patient has active substance abuse problem.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.