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

• Register: EUCTR
• Last refreshed on: 1 May 2012
• Main ID: EUCTR2007-002957-22-GR
• Date of registration: 05/03/2008
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 16/07/2008
• Target sample size: 456
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002957-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Belgium, Czech Republic, France, Germany, Greece, Hungary, Netherlands, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patients with Type 2 diabetes
2. At least 18 years old at screening
3.Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11.0%, inclusive.
4.Have a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive.
5.Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).
6.Have been treated with Met for at least 3 months and have been taking a 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 due to tolerability concerns.
OR
Have been treated with Met for at least 3 months and have been taking a 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 due to tolerability concerns and have been treated with SU for at least 3 months and have been taking a stable dose of at least an optimally effective dose of brand of SU for 8 weeks prior to screening.
If combined Met plus SU OAD preparations are used, the total daily dose of each component needs to meet the criteria as outlined above.
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.



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

Health Condition(s) or Problem(s) studied

Type 2 Diabetes
MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus

Intervention(s)

Product Name: Exenatide
Product Code: LY2148568, AC2993
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Exenatide
CAS Number: 141732-76-5
Current Sponsor code: AC2993, LY2148568
Other descriptive name: exendin-4,exendin 4, exenatide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.0-

Primary Outcome(s)

Primary end point(s): Change in HbA1c from baseline to week 26.

Secondary Objective: To compare exenatide LAR and insulin glargine with respect to

•the proportion of patients achieving HbA1c <=7% and <=6.5%.
•fasting serum glucose
•change in body weight
•1,5-anhydroglucitol (1,5-AG)
•8-point self-monitored blood glucose (SMBG) profile (blood glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, at bedtime, and at the 0300 hour)
•serum lipids (total cholesterol [TC], high-density lipoprotein cholesterol [HDL C], fasting triglycerides, calculated low-density lipoprotein cholesterol [LDL C])
•frequency and rate of hypoglycemic events (overall, daytime, and nocturnal) in the set of patients using Met alone or in combination with SU
•safety and tolerability
•patient-reported health outcomes
•long-term maintenance of glycemic control, safety, and tolerability.

Main Objective: The primary objective is to estimate the difference in change in HbA1c from baseline to treatment endpoint (26 weeks) between 2.0 mg exenatide LAR once weekly and insulin glargine QD (using the algorithm described by Yki- Järvinen et al. 2007) in patients with type 2 diabetes and inadequate glycemic control using Met alone or in combination with SU.

Secondary ID(s)

2007-002957-22-NL

H80-MC-GWBR(a)

N/A