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Therapeutic Areas: Endocrinology | Family Medicine
 Disease Category: Diabetes Mellitus, Type 2
Location: United States, NJ

Trial Information

6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus both in combination with oral antihyperglycemic drug in Patients with Type 2 Diabetes Mellitus with a 6 month Safety Extension Period.

The purpose of this study is to compare the effctiveness, safety and tolerability of a newly developed formulation of insulin glargine (U300) with that of insulin glargine U100, which has been marketed as Lantus. In addition to the basal insulin Lantus or U300, your oral antidiabetic medications will be continued during the study.

Patient Inclusion Criteria:

  • >= 18 years of age
  • Type 2 Diabetes only
  • Hemoglobin A1c >= 7- <=10
  • >=42U glargine or NPH in the past 4 weeks

Patient Exclusion Criteria:

  • Pre-mixed or other basal insulins (except glargine/NPH) in the last 3 months prior to screening
  • < 10 days of bolus insulin in the last 6 months
  • Insulin pump in the past 6 months
  • New diabetes drugs or weight loss drugs in the past 3 months
  • Significant weight change in the past 3 months
  • Uncontrolled Hypertension

Mary Jo Sites, RN, BSN
Physicians Research Center, LLC
601 Route 37 West Suite 104
Toms River, NJ 08755
Phone: 732-818-7900
Fax: 732-240-4342
Email: Maryjo.sites@verizon.net

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Research Center Information: Physicians Research Center, LLC

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

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