A STUDY ASSESSING THE SAFETY AND EFFICACY OF LIXISENATIDE IN OLDER PATIENTS WITH TYPE 2 DIABETES INADEQUATELY CONTROLLED ON THEIR CURRENT DIABETES TREATMENT REGIME

Not Applicable

• Conditions: -E14 Unspecified diabetes mellitus; Unspecified diabetes mellitus; E14

• Registration Number: PER-029-13
• Lead Sponsor: Sanofi Aventis Recherche & Development,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-23
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 77

Inclusion Criteria

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

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 (see Section 4.1.4)
• 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 anti-diabetic agent other than allowed background therapy.
Allowed therapy includes metformin, sulfonylurea [except glibenclamide >10 mg, glicazide >160 mg], meglitinides [except repaglinide >6 mg], pioglitazone and basal insulin and should follow local product circulars and labeling restrictions for the study population.

Study & Design

• Study Type: Interventional
• Study Design: Not specified