Effects of Metformin Hydrochloride (HCl) in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, in Patients With Type 2 Diabetes Mellitus and the Effects of Colesevelam HCl on Lipids and Glucose on Pre-diabetic Patients.

Inclusion Criteria

• •Age 18 to 79 years, inclusive.
• •HbA1C in the range of greater than or equal to 6.5 percent to small than or equal to 10.0 percent, to be enrolled in the T2DM cohort.
• •2-hour post 75 g OGTT glucose levels in the range of:
• •* greater than or equal to 200 mg/dL to be enrolled in the T2DM cohort, or
• •* greater than or equal to 140 to 200 mg/dL to be enrolled in the pre-diabetes cohort.
• •FPG levels in the range of:
• •* greater than or equal to 126 mg/dL to be enrolled in the T2DM cohort, or
• •* greater than or equal to 110 to smaller than or equal to 125 mg/dL to be enrolled in the pre-diabetes cohort.
• •LDL-C levels greater than or equal to 100 mg/dL.
• •Drug-naïve, defined as having never received treatment for T2DM or not having received antidiabetic drug therapy during the 3 months prior to screening visit.
• •Previous diagnosis of:
• •* T2DM or prediabetes, to be enrolled in the respective cohorts, or
• •* CHD, CVD, and/or primary hypercholesterolemia + BMI greater than or equal to 25 mg/kg2 to be screened for T2DM or pre-diabetes.
• •Understanding of the study procedures and agreement to participate in the study by giving written informed consent at screening visit.
• •Women may be enrolled if all 3 of the following criteria (in addition to the above criteria)are met:
• •* They are not pregnant (women of childbearing potential must have a negative serum pregnancy test \[serum beta human chorionic gonadotropin )\] at screening visit);
• •* They are not breast-feeding; and
• •* They do not plan to become pregnant during the study.
• •In addition to all of the above criteria, women must also meet 1 of the following 3 criteria to be enrolled:
• •* They have been post-menopausal for at least 1 year; or
• •* They are of childbearing potential and will practice 1 of the following methods of birth control throughout the study: oral, injectable, or implantable hormonal contraceptives; intrauterine device; diaphragm plus spermicide; or female condom plus spermicide. Methods of contraception that are not acceptable are partner's use of condoms or partner's vasectomy.