Clinical Trial Details


Research Study Summary

Diabetes treated with Lantus, meal time insulin and metformin


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

Patient Inclusion Criteria:

  • Are you 18 years old, or older?
  • Have you been diagnosed with Type 2 Diabetes?
  • What medications have you been taking to treat your Type 2 Diabetes? To qualify, they must be taking Lantus or NPH (Humulin, Novolin) insulin, and a fast or intermediate acting insulin (Novolog, Apidra, Humalog), with or without Metformin. Those taking mixed insulins (Novolin 70/30, Humulin 70/30 etc.) are excluded.
  • Are you taking at least 42 total units of Lantus per day, or at least 50.4 total units of Humulin or Novolin per day?
  • How long have you been taking long acting and short/intermediate acting insulin together to treat your diabetes?
  • To qualify, they must have been taking both for 1 year or greater?
  • Do you know what your last A1c reading was? If yes, then was it between 7% and 10%? If unknown, then they should be scheduled for a screening visit to determine eligibility.
  • If female, then are you capable of becoming pregnant?
    • If yes, then are you abstinent or using birth control (hormonal pills, hormonal injections, condoms with spermicide gel, diaphragm with spermicide gel, intrauterine device, male partner with a vasectomy)?
    • If no, then have you had a hysterectomy, tubal ligation or are you post menopausal (at least 3 months since last menstrual cycle)?

Patient Exclusion Criteria:

  • Have you participated in any investigational drug studies within the last 3 months?
  • Have you taken any diabetic medications, other than insulin with or without Metformin, within the last 3 months?
  • If taking Novolog, Apidra, or Humalog, have you been taking it with meals?
  • Have you used an insulin pump within the last 6 months?
  • Have you lost more than 11 pounds (5 kg) in the last 3 months?
  • Have you ever been diagnosed with ketoacidosis (increased acidity of the blood due to poor blood sugar control)? Those with a history of ketoacidosis within the last 6 months are excluded.
  • Have you been to an ophthalmologist or optometrist within the last 12 months? Those who have not are excluded.
  • Have you ever been diagnosed with retinopathy? Those who have had laser or surgical treatment within the last 3 months are excluded.
  • Have you received blood products (plazma, platelets or whole blood) in the last 3 months?
  • Have you had any cardiovascular conditions in the last 3 months, such as a heart attack, stroke, mini stroke, or hospitalization for heart failure?
  • Have you started taking any weight loss medications (sibutramine (Meridia), orlistat (alli, Xenical)) in the last 3 months? Those who have been on the same dosage of weight loss medications for 3 months or more may participate in the study if they plan on remaining on the medication throughout the study.
  • Are you taking any immune system altering medications (Prednisone, Hydrocortisone, Methylprednisolone, Cortisone)? Those who have taken steroids for one week or more within the last 3 months are excluded.
  • If female, then are you pregnant or nursing?
  • Do you have any known liver (hepatitis b or c) diseases? Subjects who have known liver disease may still be able to participate if their screening labs are within reference range.
  • Do you work night sifts?
  • Have you had any alcohol or drug abuse within the last 6 months?

To Learn more

CW ID:182158
Date Last Changed: July 18, 2013

Clinical Trial Snapshot

Both Male and Female
18 and up
Overall Status
6 Months
Facility Type


Brian Latham, Recruitment Specialist
Clinical Research Advantage, Inc.
East Valley Family Physicians
1455 W. Chandler Blvd, Building A Suite 1
Chandler, AZ 85224
Phone: 480-305-5701
Fax: 480-820-5656

View Map

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

DISCLAIMER: CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties. This information is designed to help patients find clinical trials of interest and contact the research centers conducting the trials.