clinical Trials - General Medicine

Diabetes still controllable by oral medication:

This trial is for people with Type II Diabetes, which can still be controlled by oral medication. The trial looks at a fixed dose combination of Repaglinide and Metformin in a three times/day dosing as compared to dosing twice daily and compares this to twice daily dosing of Avandamet. These are all oral agents for treating Type II diabetes. This trial is potentially appropriate for patients who do not yet need insulin for the treatment of their diabetes. After reading the criteria if you are interested in this trial and/or you have additional questions, please call us at (702) 384-9101.

The following criteria are necessary for inclusion into this trial:

Willing to sign informed consent and HIPPA form before initiating any trial related procedures.
Male and female volunteers> 18 years of age.
Diagnosis of type 2 diabetes > 3 months.
HbA1c > 7.5% and < 11.0% on monotherapy or > 7.0 and 10.0% on dual therapy.
BMI of < 45.o kg/m2.
Currently on a stable therapeutic regimen of OAD monotherapy > months. Drugs other than Metformin should be at one half or less of maximum daily dose.
At randomization, a mean fasting blood glucose meter reading measured two consecutive times should be < 260 mg/dL.

The following criteria would exclude a patient from this trial:

Any clinically significant disease history, in the opinion of the Investigator, of systemic or organ disease.
Subject has clinically significant or active (over the past 12 months) cardiovascular history (including a history of recent MI, arrhythmia or conduction delays, unstable angina, or decompensated heart failure NYHA class III and IV).
ALT or AST > 2.5 x ULN.
History of active proliferative retinopathy or macular edema.
Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening.
Known positive results for Hepatitis B surface antigen, Hepatitis C antibody.
Acute or chronic metabolic acidosis or any planned radiographic procedure requiring iodinated contrast media.
Treatment with a thiazolidinedione < 2 months prior to screening.
Treatment with systemic corticosteroids within the past 2 months prior to screening.
History of hypoglycemic unawareness or recurrent severe hypoglycemia.
Current addiction to alcohol or substances of abuse as determined by the Investigator.
Pregnant or positive pregnancy test as screening, nursing mother, or unwillingness to use adequate contraception.
Known or suspected allergy to trial product or any of the excipients or a history of multiple and/or severe allergies to drugs or foods or of severe anaphylactic reactions.
Subject has taken an investigational drug in another clinical trial within the last 4 weeks.
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation in the study.
Previous randomization in this trial.
For subjects selected for meal test study: unwillingness to ingest any component(s) of the test meal.