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

• Register: EUCTR
• Last refreshed on: 15 April 2013
• Main ID: EUCTR2008-001002-16-DE
• Date of registration: 09/06/2008
• Prospective Registration: Yes
• Primary sponsor: Sanofi-Aventis Recherche & Développement
• Public title: 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
• Scientific title: 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: 29/09/2008
• Target sample size: 450
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001002-16
• Study type: Interventional clinical trial of medicinal product
• Study design: 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

Countries of recruitment

Estonia, Germany, Italy, Lithuania, Slovakia

Key inclusion & exclusion criteria

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:
• Related to study methodo:
- HbA1c < 7% or HbA1c > 10% at screening
- At the time of screening age < legal age of majority
- Women of childbearing potential with no effective contraceptive method (women of
childbearing potential (pre-menopausal, not surgically sterile for at least 3 months prior to the time of screening) must have a confirmed negative serum ß-hCG pregnancy test at screening Visit. They must use an effective contraceptive method throughout the study, and agree to repeat serum ß-hCG pregnancy tests at designated visits)
- 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 pancreatitis, 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 myocardial infarction, 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 the normal laboratory range, Amylase and/or lipase > 3 times the upper limit of the normal laboratory range, Total bilirubin: > 1.5 times the upper limit of the normal laboratory range (except in case of Gilbert’s syndrome), Hemoglobin < 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 (e.g. impossibility to meet specific protocol requirements, such as scheduled visits, being able to do self-injections, etc), 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 (e.g., sulfonylurea, alpha gl

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

Health Condition(s) or Problem(s) studied

Type II Diabetes
MedDRA version: 10.1 Level: LLT Classification code 10067585 Term:

Intervention(s)

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: 0.1-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): Absolute change of HbA1c from baseline to week 24.

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.

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.

Secondary ID(s)

EFC10743