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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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10 July 2012 |
Main ID: |
EUCTR2008-001002-16-IT |
Date of registration:
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26/09/2008 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A randomized, double-blind, placebo-controlled, parallel-group, multicenter, 24-week study followed by an extension assessing the efficacy and safety of AVE0010 in two titration regimens on top of metformin in patients with type 2 diabetes not adequately controlled with metformin - GETGOAL-F1
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Scientific title:
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A randomized, double-blind, placebo-controlled, parallel-group, multicenter, 24-week study followed by an extension assessing the efficacy and safety of AVE0010 in two titration regimens on top of metformin in patients with type 2 diabetes not adequately controlled with metformin - GETGOAL-F1 |
Date of first enrolment:
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10/07/2008 |
Target sample size:
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450 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001002-16 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Estonia
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Germany
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Italy
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Lithuania
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Slovakia
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients meeting all the following inclusion criteria will be screened: - Patients with type 2 diabetes mellitus, as defined by WHO (Fasting plasma glucose ≥ 7 mmol/L (126 mg/dL) or 2 hours postprandial plasma glucose ≥ 11.1 mmol/L (200 mg/dL)), diagnosed for at least 1 year at the time of screening visit, insufficiently controlled with metformin at a stable dose of at least 1.5 g/day for at least 3 months prior to screening visit. - Written informed consent obtained. 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: - HbA1c < 7% or HbA1c > 10% at screening - At screening age < legal age of majority - Women of childbearing potential with no effective contraceptive method (see protocol) Type 1 diabetes mellitus - Treatment with an antidiabetic pharmacological agent other than metformin within the 3 months preceding the screening - Fasting Plasma Glucose at screening > 250 mg/dL (> 13.9 mmol/L) - Body Mass Index ≤20 kg/m2 - Weight change of more than 5 kg during the 3 months preceding the screening visit - History of unexplained or chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease - History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening - Hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within 3 months prior to the time of screening - Within the last 6 months prior to screening: history of M.I., stroke, or heart failure requiring hospitalization - Known history of drug or alcohol abuse within 6 months prior to the time of screening - Cardiovascular, hepatic, neurological, endocrine disease, active malignant tumor or other major systemic disease or patients with short life expectancy making implementation of the protocol or interpretation of the study results difficult, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period - Uncontrolled or inadequately controlled hypertension at the time of screening with a resting supine systolic or diastolic blood pressure > 180 mmHg or > 95 mmHg, respectively - Laboratory findings at the time of screening: AST, ALT or ALP: > 2 times the upper limit of NR, Amylase and/or lipase > 3 times the upper limit of NR, Total bilirubin: > 1.5 times the upper limit of NR (except in case of Gilbert?s syndrome), Hb < 11 g/dL and/or neutrophils < 1,500/mm3 and/or platelets < 100,000/mm3, Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody, Positive serum pregnancy test in females of childbearing potential - Any clinically significant abnormality identified on physical examination, laboratory tests, ECG or vital signs at the time of screening that in the judgment of the investigator or any sub investigator would preclude safe completion of the study or constrains efficacy assessment - Patients considered by the investigator or any sub-investigator as inappropriatefor this study for any reason likelihood of requiring treatment during the screening phase and treatment phase with drugs not permitted by the clinical study protocol; investigator or any sub-investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol, etc.) - Use of oral or injectable antidiabetic or hypoglycemic agents other than metformin within 3 months prior to the time of screening - Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to the time of screening - Use of any investigational drug within 3 months prior to screening - Pregnancy, lactation. - Any previous treatment with AVE0010. Related to the background therapy (i.e. metformin): - Renal impairment defined with serum Creatinine > 1.4 mg/dL in women and serum Creatinine > 1.5 mg/dL in men. Related to AVE0010: - Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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patients with type 2 diabetes not adequately controlled with metformin 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 Code: AVE0010 Pharmaceutical Form: Solution for injection CAS Number: 320367-13-3 Current Sponsor code: AVE0010 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: .1- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Main Objective: The primary objective of this study is to assess the effects of AVE0010 as an add-on treatment to metformin on glycemic control using a two-step dose titration regimen in comparison to placebo in terms of HbA1c reduction (absolute change) over a period of 24 weeks in patients with type 2 diabetes.
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Primary end point(s): Absolute change of HbA1c from baseline to week 24
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Secondary Objective: The secondary objectives of this study are: To assess the effects of AVE0010 on: − Glycemic control in comparison to placebo in terms of HbA1c reduction when it is used in a one-step dose titration regimen, − Percentage of patients reaching HbA1c <7% or HbA1c<6.5%, − Body weight, − Fasting plasma glucose, To assess AVE0010 safety and tolerability, To assess AVE0010 PK and anti-AVE0010 antibody development
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Secondary ID(s)
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EFC10743 - GETGOAL-F1
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2008-001002-16-DE
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Source(s) of Monetary Support
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Results
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Results available:
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