Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Type 2 Diabetics With Inadequate Glycemic Control on Sulfonylurea Monotherapy or Sulfonylurea Therapy in Combination With Other Oral Anti-Diabetic Agents
Brief Summary: The purpose of the study is to see how safe and effective and tolerable the use of colesevelam hydrochloride is for type 2 diabetes when added to sulfonylurea alone or in combination with other anti-diabetic drugs.


Options:
A: Inclusion Criteria:

* Diagnosed with type 2 diabetes mellitus, as determined by the new American Diabetes Association guidelines, which include a fasting plasma glucose level greater than 126 mg/dl (7.0 mmol/l), or a 2-hour postload value in the oral glucose tolerance test of greater than 200 mg/dl, with confirmation by a retest
* For participants aged 40 years or older, history of CVD (heart attack, stroke, history of coronary revascularization, history of peripheral or carotid revascularization, or demonstrated angina)
* For participants aged 55 years or older, a history of CVD is not required, but participant must be considered to be at high risk for experiencing a CVD event due to existing CVD, subclinical disease, or 2+ CVD risk factors
* HbA1c 7.5%-9% (if on more drugs) or 7.5%-11% (if on fewer drugs)
B: Inclusion Criteria:

* Age 18-75 years, inclusive
* Diagnosed with type 2 diabetes
* Stable dose of sulfonylurea alone or in combination with other anti-diabetic medications for 90 days
* Hemoglobin A1c value 7.5% to 9.5%, inclusive
* C peptide \> 0.5 ng/mL
* Prescribed ADA diet

Exclusion Criteria:

* History of type 1 diabetes or ketoacidosis
* History of pancreatitis
* Uncontrolled hypertension
* Allergy or toxic response to colesevelam or any of its components
* Serum LDL-C \< 60 mg/dL
* Serum TG \> 500 mg/dL
* Body mass index (BMI) \> 45 kg/m2
C: Inclusion Criteria:

1. A diagnosis of type 2 diabetes mellitus first made at age 30 years or older
2. Age 55 years or older at entry
3. Ability to provide informed consent
4. A substantially elevated risk of cardiovascular disease, indicated by:

   * A history of major macrovascular disease defined as any one of: stroke, myocardial infarction, hospital admission for transient ischaemic attack, hospital admission for unstable angina, coronary artery bypass graft, percutaneous transluminal coronary angioplasty (with or without stenting), peripheral revascularisation (angioplasty or surgery) or amputation secondary to vascular disease or
   * A history of major microvascular disease defined as any one of nephropathy (albumin:creatinine ratio \>300ug/mg), retinal photocoagulation therapy, proliferative retinopathy (new blood vessels on the disc or elsewhere, vitreous haemorrhage, pre-retinal haemorrhage, or fibrous proliferations on the disc or elsewhere), macular oedema (retinal thickening within one disc diameter of the macular centre) or blindness in either eye (corrected visual acuity 6/60 or worse, persisting for three months or more) not known to be due to non-diabetic causes or
   * A first diagnosis of type 2 diabetes made 10 or more years prior to entry or
   * Another major risk factor for vascular disease defined as any one of: current daily cigarette smoking, total cholesterol greater than 6.0 mmol/l (with or without cholesterol lowering treatment), HDL cholesterol \<1.0 mmol/l, microalbuminuria (albumin:creatinine ratio 30-300ug/mg) or
   * Age 65 years or over

Exclusion Criteria:

1. A definite contraindication to treatment with an ACE inhibitor or a thiazide-like diuretic
2. A specific indication for treatment with an ACE inhibitor other than perindopril 2-4 mg daily (see also section 5.2.3) or a thiazide-like diuretic
3. A definite and specific indication for treatment with gliclazide or a haemoglobin A1c control target of 6.5% or less
4. A definite contra-indication to treatment with gliclazide or a haemoglobin A1c control target of 6.5% or less
5. A definite indication for long-term full-dose or bed-time insulin therapy
6. Participation in a trial within the month prior to the Registration Visit or current participation in another trial

Other potential reasons for ineligibility include:

* High probability of non-adherence to study treatment or follow-up
* Current clinical instability (e.g. a major cerebral or coronary event or sight-threatening retinopathy or macular oedema within the previous few weeks)
* Life threatening non-vascular disease other than diabetes and its complications
* Moderate or severe dementia
* Major disability that is likely to prevent regular attendance at study clinics

Final decisions about eligibility were made at the discretion of the study investigator and the potential study participant, in the light of any requirements or guidance from local ethics committees and other regulatory bodies.
D: Inclusion Criteria:

* Ages 18 - 75 years, inclusive
* Diagnosed with type 2 diabetes
* Stable insulin therapy for 6 weeks
* Stable dose of any other antidiabetic medications for 90 days
* Hemoglobin A1c value between 7.5% to 9.5%
* C peptide greater than 0.5 ng/mL
* Prescribed ADA diet

Exclusion Criteria:

* History of type 1 diabetes or ketoacidosis
* History of pancreatitis
* Uncontrolled hypertension
* Allergy or toxic response to colesevelam or any of its components
* Serum LDL-C less than 60 mg/dL
* Serum TG greater than 500 mg/dL
* Body mass index (BMI) greater than 45 kg/m2-

Answer: B