Efficacy and safety of lixisenatide versus placebo on top of basal insulin and/or oral antidiabetic treatment in older type 2 diabetic patients

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 340

Inclusion Criteria

• Older patients, aged 70 years and above, with T2DM inadequately controlled on their current anti-diabetic regimen
• Signed written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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 340

Exclusion Criteria

• At screening HbA1c =7.0% or >10% (Acknowledging that the threshold of 7% may not be appropriate for all older patients and that this is the responsibility of the investigator to include the patient based on an individual evaluation of the expected benefits of better glycemic control versus risk of hypoglycemia)
• At screening patients on both basal insulin and sulfonylurea or basal insulin and meglitinides
• At screening FPG >250 mg/dL (>13.9 mmol/L)
• Type 1 diabetes mellitus or history of ketoacidosis within one year prior to the screening visit.
• Type 2 diabetes mellitus diagnosed less than 1 year prior to screening
• Anti-diabetic treatment not at a stable regimen or initiated within the last 3 months prior to screening
• Treatment within the 3 months preceding the screening with other antidiabetic agent than allowed background therapy. Allowed therapy includes metformin, sulfonylurea [except glibenclamide >10mg, glicazide >160mg], meglitinides [except repaglinide >6mg], pioglitazone and basal insulin and should follow local product circulars and labeling restrictions for the study population. .
• Patients who have been on an approved or an investigational GLP-1 medication (exenatide, liraglutide, lixisenatide or others)
• History of severe hypoglycemia associated with symptoms unawareness or results in unconsciousness/coma/seizure in the 6 months prior to screening
• BMI <22 or >40 kg/m²
• Malnutrition assessed clinically by the investigator or any sub-investigator and by MNA-SF score <12 in countries (the judgment of the investigator prevails on questionnaires scores)
• Cognitive disorder and dementia assessed clinically by the investigator or any sub investigator and by MMSE score <24 (the judgment of the investigator prevails on questionnaires scores), or any neurologic disorder that will affect the patient’s ability to participate in the study
• Patient who have an eGFR (using the Modification of Diet in Renal Disease {MDRD} formula <30ml/min/1.73m2
• Patients with severe or uncontrolled disease, or any clinically significant abnormality identified on physical examination or investigational clinical procedure that, in the judgment of the investigator or any sub-investigator, would preclude safe completion of the study or constrains efficacy assessment
• Laboratory findings at the time of screening:
- Amylase and/or lipase: >3 times the upper limit of the normal (ULN) laboratory range
- ALT or AST >3 times ULN
- Calcitonin >20 pg/mL (5.9 pmol/L)
• Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (ie, worsening) and not controlled (ie, prolonged nausea and vomiting) gastroesophageal reflux disease within 6 months prior to screening
• History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease
• Personal or immediate family history of medullary thyroid cancer or genetic conditions that predisposes to medullary thyroid cancer (eg, multiple endocrine neoplasia syndromes)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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Updated 4/15/2024