Treating To Target in Type 2 diabetes

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 700

Inclusion Criteria

Current inclusion criteria as of 06/07/2007:
1. Informed consent
2. People with type 2 diabetes for at least 12 months who are insulin naive
3. On maximally tolerated metformin and sulphonylurea therapy for at least four months
4. Males and females, aged 18 years or more
5. Body mass index of 40.0 kg/m^2 or less
6. HbA1c in the range 7.0 to 10.0% inclusive
7. Able and willing to use insulin injections and perform self-monitoring of plasma glucose for the entire trial period

Previous inclusion criteria:
1. 700 subjects with type 2 diabetes
2. Males and females
3. Aged 18 years or over
4. Body mass index (BMI) less than or equal to 40kg/m^2 currently treated with oral antidiabetic drugs (OADs) (metformin and/or a sulphonylurea) and with an HbA1c in the range 7.0% to 10.0% inclusive

Exclusion Criteria

Current exclusion criteria as of 06/07/2007:
1. Current or previous treatment with thiazolidinediones within the last six months
2. Current or previous treatment with an alpha-glucosidase inhibitor, repaglinide or nateglinide within the past 30 days
3. Oral Antidiabetic (OAD) treatment with three or more OADs within the last six months
4. Diabetes other than type 2 diabetes mellitus
5. Known sight-threatening retinopathy as judged by the investigator
6. Plasma creatinine 130 micromoles/l or more
7. Cardiac disease defined as:
7.1. Unstable angina pectoris within the last six months
7.2. Myocardial infarction (MI) within last six months
7.3. Congestive heart failure New York Heart Association (NYHA) class III and IV
8. Evidence of hepatic disease as determined by alanine aminotransferase (ALT) values of twice the upper limit of normal or more
9. Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator
10. Anticipated change in dose of concomitant medication, which may interfere with glucose regulation, such as monoamine oxidase inhibitors (MAOI), beta-adrenergic agents, anabolic steroids or systemic glucocorticoids
11. Uncontrolled hypertension with systolic blood pressure repeatedly 180 mmHg or more, or diastolic blood pressure 105 mmHg or more
12. Known or suspected allergy to trial products or related products
13. Any condition that the Investigator and/or the Sponsor feel would interfere with trial participation or the evaluation of results
14. Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation
15. Pregnant or planning to become pregnant within the next 36 months, breastfeeding, or judged to be using inadequate contraceptive methods. Adequate contraceptive methods are sterilisation, intrauterine device (IUD), oral contraceptives or consistent use of barrier methods.
16. Receipt of any investigational trial drug within three months prior to participation in this trial
17. Subjects previously screened for participation or having already participated in this trial