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

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2005-006164-59-GB
• Date of registration: 21/04/2006
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company Limited
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 18/05/2006
• Target sample size: 234
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-006164-59
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: Double blind: Parallel group: yes; Cross over: Other: If controlled, specify comparator, Other Medicinial Product: yes; Placebo: Other:
• Phase: Human pharmacology (Phase I): Therapeutic exploratory (Phase II): Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV):

Countries of recruitment

United Kingdom

Key inclusion & exclusion criteria

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:
o Test negative for pregnancy at the time of screening based on a urine test.
o Do not intend to become pregnant during the study.
o Have 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

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 2 Diabetes

Intervention(s)

Product Name: Exenatide
Product Code: AC2993, LY2148568
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Exenatide
CAS Number: 141732-76-5
Current Sponsor code: AC2993 (LY2148568)
Other descriptive name: exendin-4, exenatide
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.25-

Product Name: Insulin Glargine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin Glargine
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Main Objective: The primary objective of this study is to determine whether exenatide given subcutaneously twice daily provides better HbA1c control, with minimal weight gain, than basal insulin given subcutaneously once daily for six months in patients with type 2 diabetes not adequately controlled using a combination of oral anti-diabetic therapy and are a higher risk population (see section 4.1.1) as measured by the proportion of patients who have achieved HbA1c = 7.4% with minimal weight gain (= 1kg).

Secondary Objective: The secondary objectives of the study are to compare exenatide and insulin glargine with respect to:
•Proportion of patients who have achieved HbA1c = 7.4% and = 0.5kg weight gain
•Fasting serum glucose (FSG)
•The proportion of patients achieving:
oHbA1c = 7.4%
oHbA1c < 7%
oHbA1c < 6.5%
•7 point self monitoring blood glucose (SMBG) profile
•Changes in cardiovascular risk parameters:
oBMI (body mass index), waist circumference, waist/hip ratio. Weight change in kg and % plus the proportion of patients achieving 5% and 10% weight change.
oSystolic and diastolic BP (blood pressure).
oLipid profile.
•Hypoglycaemia rate per patient (adjusted for 30 days), incidence and severity
•Noctural hypoglycaemia
•Safety and Tolerability
•Patient reported Quality of Life
•Healthcare Resource Utilisation

Primary end point(s): The primary endpoint will be the proportion of patients achieving HbA1c = 7.4% with minimal weight gain (= 1kg).

Secondary ID(s)

H80-BP-GWBG

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 11/11/2018
• Date Completed: 16/04/2008
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-006164-59/results