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Main
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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. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2009-010830-23-GB |
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Date of registration:
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06/07/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy of Once-Weekly Exenatide versus Once or Twice Daily Insulin Detemir in Patients with Type 2 Diabetes Treated with Metformin Alone or in Combination with Sulphonylurea - D3
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Scientific title:
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Efficacy of Once-Weekly Exenatide versus Once or Twice Daily Insulin Detemir in Patients with Type 2 Diabetes Treated with Metformin Alone or in Combination with Sulphonylurea - D3 |
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Date of first enrolment:
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21/08/2009 |
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Target sample size:
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257 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-010830-23 |
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Study type:
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Interventional clinical trial of medicinal product |
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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: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
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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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Ireland
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United Kingdom
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Contacts
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Name:
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Clinical Trial Information
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Address:
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Telephone:
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Email:
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EU_Lilly_Clinical_Trials@lilly.com |
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Affiliation:
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Eli Lilly |
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Name:
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Clinical Trial Information
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Address:
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Telephone:
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Email:
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EU_Lilly_Clinical_Trials@lilly.com |
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Affiliation:
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Eli Lilly |
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Key inclusion & exclusion criteria
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Inclusion criteria:
[1]Present with type 2 diabetes based on the disease diagnostic criteria as described by the World Health Organization (WHO) (refer to Attachment GWDL.3).
[2]Are at least 18 years of age at screening.
[3]Have suboptimal glycaemic control as evidenced by an HbA1c 7.1% to 10.0%, inclusive.
[4]Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).
[5]Have a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive.
[6]Are receiving metformin at a stable dose (consistent with country specific requirements) of a minimum of 1000mg for at least 3 months prior to visit 3
Or
Are receiving metformin at a minimum dose (consistent with country specific requirements) of 1000mg and sulphonylurea (as separate medications not as a fixed dose combination) at stable doses for 3 months prior to visit 3.
[7]For females of child-bearing potential (not surgically sterilised and between menarche and 1-year postmenopause) only:
•Are not breastfeeding
•Test negative for pregnancy at the time of screening based on a urine pregnancy test
•Intend not to become pregnant during the study
•Have practiced a reliable method of birth control (e.g. use of oral contraceptives or Norplant®; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy for at least 6 weeks prior to screening)
•Agree to continue to use a reliable method of birth control (as above) during the study, as determined by the investigator.
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:
[8] Are Lilly, Amylin, or Alkermes employees.
[9] Are investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
[10] 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 congestive heart failure (New York Heart Association Class III or IV), coronary artery bypass surgery or angioplasty; or are expected to require coronary artery bypass surgery or angioplasty during the course of the study.
[11] Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, alanine aminotransaminase (ALT), or serum glutamic pyruvic transaminase (SGPT), greater than three times the upper limit of the reference range.
[12] Have a history of renal transplantation or are currently receiving renal dialysis or have a creatinine clearance of <30 mL/min (using the Cockcroft-Gault formula).
[13] Have 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.
[14] Have known haemoglobinopathy or chronic anaemia (haemoglobin concentration <11.5 g/dL [115 g/L] for males, <10.5 g/dL [105 g/L] for females).
[15] Patients with a history of severe gastrointestinal disorder (e.g. gastroparesis)
[16] Have had greater than three episodes of major hypoglycaemia within 6 months prior to screening (refer to Section 9.5.1.1 for more information on hypoglycaemia).
[17] Have any contraindication for the OAD that they have been using.
[18] Have a known allergy or hypersensitivity to insulin detemir, exenatide or excipients contained in these agents.
[19] Are known to have active proliferative retinopathy.
[20] Have fasting triglycerides levels > 500mg/dL (>5.64mmol/L)
[21] Have been treated within 4 weeks of screening with systemic glucocorticoid therapy by oral, intravenous (IV) or intramuscular (IM) route, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption. Exceptions to this criterion include patients who are receiving glucocorticoid therapy for corticotropic hypopituitary deficiency (e.g. Addison disease).
[22] Have been treated with drugs that promote weight loss, within 3 months of screening.
[23] Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening:
• insulin
• alpha-glucosidase
• meglitinides
• Byetta® (exenatide BID formulation)
• thiazolidinediones (TZD)
• dipeptidyl peptidase (DPP)-4 inhibitors.
[24] Have had an organ transplant.
[25] Have donated blood within 30 days of screening.
[26] Have previously completed or withdrawn from this s
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Diabetes
MedDRA version: 14.0
Level: LLT
Classification code 10012594
Term: Diabetes
System Organ Class: 10027433 - Metabolism and nutrition disorders
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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-
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Primary Outcome(s)
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Primary end point(s): The primary efficacy measure will be assessed by the proportion of patients on each therapy who have achieved HbA1c concentration =7.0% with weight loss (=1.0 kg) at endpoint.
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Secondary Objective: The secondary efficacy measure of the study are to compare exenatide QW with insulin detemir over 26 weeks with respect to:
•the proportion of patients who have achieved HbA1c =7.0% with weight loss (=1.0 kg) at 12 weeks.
•the proportion of patients who have achieved HbA1c =7.4% with weight loss (=1.0 kg) at endpoint
•the proportion of patients who have achieved HbA1c =7.0% and =7.4%, with minimal weight gain (=1 kg) at endpoint
•HbA1c change from baseline
•change in body weight
•the proportion of patients achieving HbA1c =7.4%, =7.0% and =6.5%
•change in fasting serum glucose
•7-point self-monitored blood glucose (SMBG) profile (blood glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)
•changes in cardiovascular risk parameters:
•incidence and rate of hypoglycaemic events
•resource utilisation
•safety and tolerability
•health outcomes.
safety and tolerability (including anti exenatide antibodies)
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Main Objective: The primary objective of this study is to test the hypothesis that exenatide QW given once weekly for 26 weeks is superior to a titration of insulin detemir, given once or twice daily (titrated to reach a target of pre-breakfast and pre-dinner glucose concentrations of <5.5 mmol/L) when given for 26 weeks in the treatment of patients with type 2 diabetes not adequately controlled using OAD therapy. The primary efficacy measure will be assessed by the proportion of patients on each therapy who have achieved HbA1c concentration =7.0% with weight loss (=1.0 kg) at endpoint.
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Timepoint(s) of evaluation of this end point: 26 Weeks
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Secondary Outcome(s)
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Secondary end point(s): The secondary efficacy measure of the study are to compare exenatide QW with insulin detemir over 26 weeks with respect to:
•the proportion of patients who have achieved HbA1c =7.0% with weight loss (=1.0 kg) at 12 weeks.
•the proportion of patients who have achieved HbA1c =7.4% with weight loss (=1.0 kg) at endpoint
•the proportion of patients who have achieved HbA1c =7.0% and =7.4%, with minimal weight gain (=1 kg) at endpoint
•HbA1c change from baseline
•change in body weight
•the proportion of patients achieving HbA1c =7.4%, =7.0% and =6.5%
•change in fasting serum glucose
•7-point self-monitored blood glucose (SMBG) profile (blood glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)
•changes in cardiovascular risk parameters:
oBMI (body mass index)
owaist circumference
osystolic and diastolic blood pressure (SBP and DBP)
olipid profile
ochanges in plasminogen activator inhibitor (PAI1)
ochanges in high sensitivity C reactive protein (hsCRP) concentrations
ochanges in adiponectin levels
•incidence and rate of hypoglycaemic events
•resource utilisation
•safety and tolerability
•health outcomes.
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Timepoint(s) of evaluation of this end point: 26 Weeks
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Secondary ID(s)
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H8O-EW-GWDL
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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