Trial Information

Summary: We are looking for men and women at least 18 years old with Type 2 Diabetes that is not adequately controlled while taking one or two drugs to treat diabetes to participate in an approximately 26 week research study, This study will assess the safety and effectiveness of an investigational medication (repaglinide with metformin) compared to Avandame ® on controlling blood sugar.

You are being asked to participate in a research study to investigate whether an experimental combination tablet (NN4440) containing two commonly used diabetes drugs (metformin and repaglinide) will control glucose as well as when given twice a day (breakfast and dinner) as opposed to three times a day (breakfast, lunch and dinner dosing). "Experimental" means that it has not been approved by the Food and Drug Administration (FDA) for sale in the United States. A comparitor group in the study is Avandamet ® (rosiglitazone and metformin) which is given twice a day. This study will include subjects who are currently taking only one drug or two drugs for the diabetes and are not adequately controlled. Adequate control is to have glycosylated hemoglobin (HbA1c) of less than 7%.

During the study, you will receive one of three study drugs: NN4440 twice a day (BID), NN4440 three times a day (TID), or Aavandment ® The study drug you receive will be assigned randomly (by chance or like the roll of dice).

Repaglinide is an FDA approved drug (marketed as Prandin ® ) for the treatment of type 2 diabetes which works by increasing insulin secretion. Repaglinide may lower your blood sugar and is often used with metformin (as a separate tablet) to treat type 2 diabetes. Metformin (marketed as Glucophage ® and other trade names) is a drug which has been used for many years to improve glucose blood levels in subjects with type 2 diabetes and works by assisting the body in using glucose more efficiently. Avandamet ® is a combination of a drug known as rosiglitazone (Avandia ®) and metformin and is approved by the FDA for the treatment of diabetes. Rosiglitazone improves insulin resistance and makes insulin use by the body more efficient.

The study will require10 visits spaced over approximately 28 weeks including 7 office visits and 3 telephone contacts. If you agree to take part in this study, you will first sign an informed consent before any study-related procedures..

Patients may be included in the study if all of the following criteria are met:

• Male and female volunteers at least 18 years of age.
• Diagnosis of type 2 diabetes at least 3 months ago.
• Body Mass Index (BMI) of at least 45.0 kg/m².
• Currently on 1 or 2 drugs for your diabetes.
• At time of receiving study drug, you have a fasting blood glucose reading measured two times that when combined are no more than 260 mg/dL

Patients are excluded from participating in this study if 1 or more of the following criteria are met.

• History of active proliferative retinopathy or macular edema.
• Treatment with a thiazolidinedione or systemic corticosteroids within the past 2 months.
• History of hypoglycemic unawareness or recurrent sever hypoglycemia.
• Pregnant or positive pregnancy test at screening, nursing mother, or unwillingness to use adequate contraception, adequate contraception.
• Known or suspected allergy to repaglinide, metformin, or Avandamet ® or any of the components.
• History of multiple and/or severe allergies to drugs or foods or of severe anaphylactic reactions.
• You have taken an investigational drug in another clinical trial within the past 4 weeks.
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation in the study.

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Trial listings updated: June 1, 2008 at 5:46:30 AM