An Open Label Study Comparing Exenatide with Basal Insulin in Achieving an HbA1c of <_7.4% with Minimum Weight Gain, in Type 2 Diabetes Patients who are not Achieving Adequate HbA1c Control on Oral Anti Diabetic Therapies Alone

Phase 1

• Conditions: Type 2 Diabetes

• Registration Number: EUCTR2005-006164-59-GB
• Lead Sponsor: Eli Lilly and Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-04-21
• Study Completion: 2008-04-16
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 234

Inclusion Criteria

Patients are eligible to be included in the study only if they meet all of the following criteria:
[1] Present with type 2 diabetes based on the disease diagnostic criteria, and are currently being treated with the following:
Dual or triple oral therapy – on a stable combination and dose for at least 3 months. Patients will continue on their oral therapy.
[2] HbA1c between 7.5% and 9.5%.
[3] Present with any one of the cardiovascular risk factors as defined in Section 4.1.1. Disease Diagnostic Criteria.
[4] BMI >27.
[5] Are at least 30 years of age and less than 75 years of age.
[6] Negative pregnancy test for women of childbearing potential (see exclusion criteria).

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

Patients will be excluded from the study if they meet any of the following criteria:
[7] Investigators, site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
[8] Are employed by Lilly or Amylin (that is, employees, temporary contract workers, or designees responsible for conducting the study). Immediate family of Lilly or Amylin employees may participate in Lilly-sponsored clinical trials, but are not permitted to participate at a Lilly facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
[9] Patients who have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
[10] Have cardiac disease that is Class III or IV (see attachment GWBG.7).
[11] Uncontrolled hypertension (systolic = 180mmHg, diastolic = 105mmHg).
[12] Have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine greater than or equal to 135 µmol/L for males and greater than or equal to 110 µmol/L for females.
[13] Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or ALT/SGPT greater than three times the upper limit of the reference range as defined by the local laboratory.
[14] Have known haemoglobinopathy or chronic anaemia.
[15] Have known proliferative retinopathy.
[16] Have known metabolic acidosis.
[17] Patients who would be otherwise excluded due to the label of the concomitant oral therapy.
[18] Female patients who are breastfeeding.
AND
Female patients of childbearing potential (not surgically sterilised and between menarche and 1-year postmenopausal) who must fulfill all of the following criteria:
oTest negative for pregnancy at the time of screening based on a urine test.
oDo not intend to become pregnant during the study.
oHave practiced a reliable method of birth control (oral contraceptives or Norplant®; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy) for 3 months prior to screening.
o Agree to continue to use a reliable method of birth control (oral contraceptives or Norplant®; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy) during the study, as determined by the investigator.
[19] Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to Visit 1.
[20] Have had more than one episode of severe hypoglycaemia (defined as requiring assistance of a third party due to disabling hypoglycaemia) within 6 months prior to entry into the study.
[21] Have participated in an interventional medical, surgical, or pharmaceutical

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified