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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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18 October 2021 |
Main ID: |
EUCTR2007-002957-22-FR |
Date of registration:
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10/03/2008 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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(a)
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Scientific title:
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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(a) |
Date of first enrolment:
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23/04/2008 |
Target sample size:
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456 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002957-22 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: If controlled, specify comparator, Other Medicinial Product: yes Placebo: Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Czech Republic
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Denmark
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France
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Germany
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Greece
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Hungary
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Netherlands
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Spain
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients with Type 2 diabetes 2. >18 years old at screening 3. Suboptimal Hba1c between 7.1 and 11.0% inclusive. 4. Body mass index 25 to 45kg/m2 inclusive. 5. History of stable body weight 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. 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 had a clinically significant history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe CHF (NYHAn Class III or IV), coronary artery bypass surgery, or angioplasty; or is expected to require coronary artery bypass surgery or angioplasty during the course of 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. Have had greater than three episodes of major hypoglycemia 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
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes MedDRA version: 9.1
Level: LLT
Classification code 10045242
Term: Type II diabetes mellitus
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Intervention(s)
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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-
Trade Name: LANTUS Product Name: LANTUS Product Code: A10AE04 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-
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Primary Outcome(s)
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Main Objective: 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 in patients with type 2 diabetes and inadequate glycemic control using Met alone or in combination with SU. Superiority of exenatide LAR with respect to change in HbA1c will be concluded if the upper limit of the 95% confidence interval for the treatment difference (exenatide LAR minus insulin glargine) is less than zero. Non-inferiority will be concluded if the upper limit of the confidence interval is 0.0% and <0.3%.
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Primary end point(s): Change in HbA1c from baseline to week 26.
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Secondary Objective: To compare exenatide LAR and insulin glargine with respect to - proportion of patients achieving HbA1c <=7% and 6.5% -fasting serum glucose -change in body weight -8 point self monitored blood glucose profile -serum lipids, fasting triglycerides, calculated low density lipoprotein cholesterol -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 -long-term maintenance of glycemic control, safety, and tolerability -1,5-anhydroglucitol (1,5-AG) -patient reported health outcomes.
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Secondary ID(s)
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H80-MC-GWBR(a)
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2007-002957-22-NL
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N/A
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 25/02/2008
Contact:
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