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

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-ARM PARALLEL-GROUP, MULTICENTER, 24-WEEK STUDY ASSESSING THE SAFETY AND EFFICACY OF LIXISENATIDE IN OLDER PATIENTS WITH TYPE 2 DIABETES INADEQUATELY CONTROLLED ON THEIR CURRENT DIABETES TREATMENT REGIMEN.

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-029-13
Enrollment
34
Registered
2013-10-23
Start date
2013-09-16
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Lixisenatide is supplied as a disposable pre-filled pen (lixisenatide pen). Route(s) of administration: Deep subcutaneous (s.c.) injection. Route of administration: • Basal insulin: Subcutaneous
g once daily (QD) of lixisenatide (or matching placebo) for 2 weeks then followed by the maintenance dose of 20 &#956
g QD lixisenatide (or matching placebo) from Visit 9 (Week 2) up to the end of the treatment period. • Each patient self-administers one injection of lixisenatide or matching placebo QD in the morn

Sponsors

Sanofi Aventis Recherche & Development,
Lead Sponsor

Eligibility

Sex/Gender
All
Age
70 Years to 100 Years

Inclusion criteria

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

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.

Countries

Australia, Bulgaria, Canada, Denmark, Germany, Poland, Russian Federation, South Africa, Spain, Switzerland, United States

Contacts

Public ContactKatia Lourdes Meza

SANOFI AVENTIS DEL PERU S.A.

Katia.Meza-ext@sanofi.com987214888

Outcome results

None listed

Source: REPEC (via WHO ICTRP)