Please select the eligibility criteria that correspond to the clinical trial below.
Title: The ADDITION Study. Anglo-Danish-Dutch Study of Intensive Treatment In PeOple With screeN Detected Diabetes in Primary Care
Brief Summary: The ADDITION study comprise 2 parts: screening for Type 2 diabetes and intensive treatment compared to standard treatment.

1. In the screening study, the feasibility and results of country specific models to identify undiagnosed individuals with Type 2 diabetes will be evaluated.
2. In the treatment study the effects of routine care in general practice according to local and national guidelines will be compared with an intensive ADDITION protocol, including structured lifestyle education (dietary modification, increased physical activity and smoking cessation) and intensive treatment of blood glucose, blood pressure and lipids, and prophylactic aspirin with or without motivational interviewing, on mortality, macrovascular and microvascular disease. Furthermore the impact of treatment on health status, treatment satisfaction and health service costs will also be assessed.


Options:
A: Inclusion Criteria

* Type 2 diabetes mellitus
* Glycosylated hemoglobin above the upper limit of normal (ie, the local equivalent of 6.5% for)
* Established history of macrovascular disease, defined as 1 or more of:

  * Myocardial infarction at least 6 months before entry into the study.
  * Stroke at least 6 months before entry into the study
  * Percutaneous coronary intervention or coronary artery bypass graft at least 6 months before entry into the study.
  * Acute coronary syndrome at least 3 months before entry into the study.
  * Objective evidence of coronary artery disease.
  * Peripheral arterial obstructive disease

Exclusion Criteria

* Signs of type 1 diabetes.
* Patients prescribed insulin as sole therapy for glycemic control of diabetes for 2 weeks or more at any time in the previous 3 months.
* Myocardial infarction, stroke, coronary artery bypass graft, or percutaneous cardiac intervention in the 6 months prior to enrolment.
* Acute coronary syndrome in the 3 months prior to enrolment.
* Heart failure at entry defined as patient having a New York Heart Association functional score of II or above.
* Had an appointment for a coronary angiogram or endovascular or surgical intervention.
* Leg ulcers, gangrene, or ischemic rest pain.
* Had an appointment for an angiogram or endovascular or surgical intervention for leg ischemia.
* Had undergone a major operation (defined as a surgical procedure lasting for more than 30 minutes) at any time in the previous 4 weeks.
* Significantly impaired hepatic function, defined as alanine aminotransferase greater than 2.5 times the upper limit of normal.
* Familial polyposis coli.
* Required dialysis.
* History of alcohol or drug abuse.
* Any other intercurrent disease believed to be likely to have a significant impact on the patient's life expectancy during the course of the study (eg, cancer).
* Patient was undergoing follow-up as part of another clinical trial or less than 3 months had elapsed since the last dose of an investigational drug or procedure.
* Hypersensitivity to pioglitazone or other TZD.
* Current use of pioglitazone or other TZD.
* Patient was known to be infected with human immunodeficiency virus or was known to have viral hepatitis.
* Women who were any of the following: pregnant, breast feeding, wished to become pregnant during the course of the study or of childbearing potential and not planning to use a reliable method of contraception throughout the study.
B: Participants originally enrolled in the Diabetes Control and Complications Trial (DCCT) (N01-DK-6-2204-A).
C: Inclusion Criteria:

* Clinical diagnosis of Type 2 diabetes mellitus
* HgbA1c between 6,8 - 10,0%
* With or without one or more micro- and macrovascular or neurological complications.

Exclusion Criteria:

* HgbA1c \< 6,8 and \> 10,0 %
* Patients who have attended lifestyle intervention in the past year
* Patients who is planned to start treatment with insulin during intervention period
* Lack of motivation
* Patients with severe heart-, liver or kidney disease or incurable cancer
D: Inclusion Criteria:

Screening study: Every one aged 40-69 years (UK and DK) or 50-69 years(NL). Treatment study: All with screen detected type 2 diabetes.

Exclusion Criteria:

Participants are excluded if they already have diabetes at time of screening, are pregnant or lactating or have a severe psychotic illness, are house bound or have an illness with a likely survival of less than one year.

Answer: D