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Therapeutic Areas: Endocrinology | Family Medicine
Disease Category: Diabetes Mellitus Types I and II
Location: United States, AZ

Clinical Trial Details

Overview

Research Study Summary

Diabetes treated with Lantus, meal time insulin and metformin

Purpose

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
Phase

3

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Duration

6 Months

Facility Type

N/A

Contact

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

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

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CW ID: 182158

Date Last Changed: July 18, 2013


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