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Therapeutic Areas: Endocrinology | Family Medicine
Disease Category: Diabetes Mellitus Types I and II
Location: United States, AZ
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
Both Male and Female
Date Last Changed:
July 18, 2013
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