NCT00069784

Who might be able to join this trial:

• You have been found to have higher-than-normal blood sugar levels (either mildly high fasting sugar, mildly high sugar after eating, or early type 2 diabetes) based on a specific blood sugar test.
• If you have early type 2 diabetes, you must either be taking no diabetes medication, or be taking just one type of oral diabetes pill at a stable dose for at least 10 weeks, with your blood sugar levels not too high (confirm with trial site for exact numbers).
• You are a man or woman aged 50 years or older.
• You have at least one heart or blood vessel risk factor, such as a previous heart attack, stroke, heart procedure, chest pain with confirmed reduced blood flow to the heart, kidney protein leakage, an enlarged heart muscle, significant narrowing of arteries, or a low ankle-to-arm blood pressure ratio.
• You have signed and dated a consent form before any study procedures begin.
• You are able and willing to fill out study diaries and questionnaires.
• You have shown that you can use a blood sugar monitoring device and give yourself an injection before the study starts.
• If you are a woman who could become pregnant, you must have a negative pregnancy test and agree to use reliable birth control for the whole study.
• You are willing to stop taking omega-3 fish oil supplements for the duration of the study.

Who may not be able to join:

• You have type 1 diabetes.
• You currently need insulin injections for your diabetes, or your blood sugar is so uncontrolled that you are likely to need insulin or a new diabetes medication very soon.
• You have previously tested positive for a specific antibody linked to type 1 diabetes (anti-GAD antibody).
• Your blood sugar (HbA1c) level is too high at the screening visit (confirm with trial site for exact threshold).
• You are unwilling to give yourself injections or check your own blood sugar levels.
• You did not complete a required practice period of injecting a dummy (placebo) insulin and checking blood sugar for at least 4 days before the study start.
• You have had or are planning to have coronary bypass heart surgery (CABG) within the past 4 years (with some exceptions — confirm with trial site).
• Your kidneys are not working well enough, based on a blood test at screening.
• You have active liver disease or abnormal liver test results at screening.
• You regularly use steroid medications (taken by mouth or injection) or take niacin for high cholesterol.
• You have severe heart failure (classified as Class III or IV — confirm with trial site).
• You are not expected to survive more than 3 years due to a non-heart condition, such as cancer.
• There is any other reason that makes it unlikely you could follow the study rules or report side effects properly.
• You are unwilling or unable to stop taking a type of diabetes pill called a thiazolidinedione (TZD).
• You are currently taking part in another clinical trial involving an active medication.
• You are unwilling to allow the study site to contact your own doctor to share information about the study and your treatment.
• You have had an allergic reaction to any of the study medications in the past.
• You have already taken part in this study before.
• You have had a heart transplant or are currently waiting for one.
• You are known to be infected with HIV.

Important: Always verify eligibility with the trial site directly before applying.