A randomized, placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week double-blind treatment period assessing the efficacy and safety of lixisenatide in patients with Type 2 diabetes insufficiently controlled with insulin glargine and metformin - GETGOAL DUO 1

Conditions: Type II Diabetes
MedDRA version: 11.1Level: LLTClassification code 10045242Term: <Manually entered code. Term in E.1.1>

Registration Number: EUCTR2008-007335-40-PL

Lead Sponsor: Sanofi-Aventis Recherche & Développement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 950

Inclusion Criteria

Patients meeting all of the following inclusion criteria will be screened:

I 01. Patients with type 2 diabetes mellitus, as defined by WHO, 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 the screening visit. In addition to metformin, patients may receive sulfonylureas or glinides (both must
be discontinued at the run-in visit (V2, week-12)) and/or thiazolidinediones (that can be continued).

I 02. Written informed consent obtained

At the end of the screening period (screening phase + run-in phase), patients with insufficient glycemic control (see E 27 and E 28) will enter the double-blind randomized treatment period
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. At screening age < legal age of majority
2. At screening: HbA1c < 7.0 or HbA1c >10%
3. Pregnancy or lactation
4. Women of childbearing potential with no effective contraceptive method.
Women of childbearing potential (pre-menopausal, not surgically sterile women for at least 3 months prior to the time of screening) must have a confirmed negative serum pregnancy test at screening visit. They must use an effective contraceptive method throughout the study, and agree to repeat pregnancy tests at designated visits. The applied methods of contraception have to meet the criteria for a highly effective method of birth control according to the Note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals (CPMP/ICH/286/95, modification)”
5. Type 1 diabetes mellitus
6. Metformin not at a stable dose of at least 1.5 g/day for at least 3 months prior to the screening visit.
7. Use of oral or injectable antidiabetic or hypoglycemic agents other than metformin, sulfonylurea, glinides and thiazolidinediones (e.g., alpha glucosidase inhibitor, other GPL-1 receptor agonists, DPP-IV inhibitors, insulin etc.) within 3 months prior to the time of screening
8. History of hypoglycemia unawareness.
9. Body Mass Index (BMI) =20 kg/m²
10. History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease, personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g multiple endocrine neoplasia syndromes),
11. History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
12. Hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within 3 months prior to the time of screening
13. Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization
14. Known history of drug or alcohol abuse within 6 months prior to the time of screening
15. 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 such as active malignant tumor or other major systemic diseases, presence of clinically significant diabetic retinopathy or presence of macular edema likely to require laser treatment within the study period.
16. Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic or diastolic blood pressure > 180 mmHg or > 110 mmHg, respectively
17. Laboratory findings at the time of screening:
• Amylase and/or lipase > 3 times the upper limit of the normal laboratory range
• ALT > 3 ULN
• 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
• Calcitonin = 20 pg/mL (5.9 pmol/L)
19. Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 3 months prior to the time of screening
20. Use of any investigational drug within 3 months prior to screening
21. Renal impairment defined with serum creatinine > 1.4 mg/d

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to assess the effects on glycemic control of lixisenatide in comparison to placebo as an add-on treatment to insulin glargine and metformin in terms of HbA1c change over a period of 24 weeks.;Secondary Objective: • To assess the effects of lixisenatide on<br>- the percentage of patients reaching HbA1c <7 % and =6.5 %<br>- plasma glucose (fasting, post-prandial during a standardized meal challenge test, 7-point self monitored profiles)<br>- body weight<br>- insulin glargine doses<br><br>• To evaluate lixisenatide safety and tolerability (including anti-lixisenatide antibody assessment) as add on treatment to insulin glargine and metformin<br><br>• To assess the impact of lixisenatide on treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the participating countries where it is validated;Primary end point(s): Change of HbA1c from baseline to week 24

Secondary Outcome Measures

Name	Time	Method

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