Efficacy of once weekly exenatide long acting release and once daily insulin glargine in patients with Type 2 diabetes treated with metformin alone or in combination with sulphonylurea. - GWBR

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 456

Inclusion Criteria

1. Patients with Type 2 diabetes
2. > or 18 years old at screening
3. Have suboptimal glycemic control as evidenced by an Hba1c between 7.1 and 11.0% inclusive.
4. Body mass index 25 to 45 kg/m2 inclusive.
5. History of stable body weight
6. Have been treated with Met for at least 3 months with stable dose of 1500 mg/day immediate-release Met or extended release Met alone for at least 8 weeks prior to screening, unless lower doses are required for tolerability
or
Have been treated with Met for at least 3 months with stable dose of 1500 mg/day immediate-release Met or extended release Met alone for at least 8 weeks prior to screening, unless lower doses are required for tolerability and have been treated with SU for at least 3 months and have been taking stable dose of at least an optimally effective dose of SU for 8 weeks prior to screening.
7. Females of child bearing potential should not be breast feeding, have a negative pregnancy test, do not intend to become pregnant during the study, practice reliable birth control methods.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Have a clinically significant history of cardiac disease or presence of active CAD within the year prior to inclusion in the study, including MI, clinically significant arrhythmia, unstable angina, moderate to severe CHF (NYHA Class III or IV), coronary artery bypass surgery, or angioplasty, or expected to require coronary artery bypass surgery or angioplasty during the study.
2. Obvious clinical signs of liver disease or hepatitis. ALT or SGPT >than 3 times the upper reference range.
3. Have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine >= 1.5mg/dl for males, >=1.2 mg/dl for females.
4. Have active or untreated malignancy, or have been in remission from clinically significant malignancy for less than 5 years. (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer).
5. Have known hemoglobinopathy or chronic anemia (has Hb <11.5gm/dl for males, <10.5gm/dl females
6. Greater than 3 episodes of major hypoglycaemia within 6 months prior to screening.
7. Contraindication for the OAD which they are using.
8. known allergy or hypersensitivity to exenatide LAR, glargine or excipients
9.Known to have active proliferative retinopathy
10. Treatment within 4 weeks of screening with systemic glucocorticoid therapy or potent inhaled steroids with high systemic absorption
11. Used drugs for weight loss within 3 months of screening.
12. have been treated for longer than two weeks with any of the following with 3 months prior to screening
insulin, Thiazolidinediones, alpha-glucosidase inhibitors, meglitinides, byetta b.id., DPPIV inhibitors, symlin.
13. Have an organ transplant
14. Have donated blood with 30 days of screening
15. have previously been involved in an exenatide LAR study
16. Have received treatment within 30 days of an unlicenced indication
17. Currently involved in another clinical study
18. Have a condition (e.g alcohol abuse) that renders them unable to understand involvement in the study or in the investigator's opinion makes them unsuitable to participate.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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