Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

Primary objective: \- To evaluate the effect of lixisenatide versus placebo over a period of 24 weeks on glycemic control, as evaluated by glycosylated hemoglobin (HbA1c) reduction, in older type 2 diabetes participants (T2DM) who are inadequately controlled with their current anti-diabetic treatment regimen. Main secondary objective: \- To assess the safety and tolerability of lixisenatide compared to placebo in older T2DM participants (including occurrence of documented (Plasma Glucose PG \< 60 mg/dL) symptomatic hypoglycemia and gastrointestinal side effects). Other secondary objectives: * To assess the effect of lixisenatide compared to placebo after 24-week treatment on: * Fasting plasma glucose (FPG); * During liquid standardized breakfast meal challenge test : 2 hour- Postprandial Plasma Glucose (PPG) and Plasma Glucose Excursion; * 7-point Self-monitored plasma glucose (SMPG) profile; * Body weight; * Change in total daily dose of basal insulin (if taken); * Percentage of participants requiring rescue therapy * Safety and tolerability; * To assess lixisenatide pharmacokinetic profile; * To assess anti-lixisenatide antibody development.

Key facts

Study ID

NCT01798706

Run by

Sanofi

People needed

350

Starts

2013-06-01

Expected to finish

2015-02-01

Last updated by the study team

2017-04-18

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• At screening HbA1c ≤7.0% or >10% (Acknowledging that the threshold of 7% may not be appropriate for all older participants and that this was the responsibility of the investigator to include the participant based on an individual evaluation of the expected benefits of better glycemic control versus risk of hypoglycemia).
• At screening participants 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 anti-diabetic agent than allowed background therapy. Allowed therapy includes metformin, sulfonylurea (except glibenclamide >10mg, gliclazide >160mg), meglitinides (except repaglinide >6mg), pioglitazone and basal insulin and should follow local product circulars and labeling restrictions for the study population.
• Participants who had been on an approved or an investigational Glucagon-like peptide 1 (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/m\^2.
• Malnutrition assessed clinically by the investigator or any sub-investigator and by Mini-Nutritional Assessment-Short Form (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 Mini Mental State Examination (MMSE) score <24 (the judgment of the investigator prevails on questionnaires scores), or any neurologic disorder that affected the participant's ability to participate in the study.
• Participant who had a glomerular filtration rate (eGFR) (using the Modification of Diet in Renal Disease (MDRD) formula <30ml/min/1.73m\^2).
• Participant 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
• Alanine aminotransferase (ALT) or aspartate aminotransferase (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 (i.e. worsening) and not controlled (i.e. 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 predisposed to medullary thyroid cancer (e.g., multiple endocrine neoplasia syndromes).
• The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 840015 — Norwalk, California, United States
• Investigational Site Number 840003 — Miami, Florida, United States
• Investigational Site Number 840012 — Miami, Florida, United States
• Investigational Site Number 840002 — Des Moines, Iowa, United States
• Investigational Site Number 840008 — Oxon Hill, Maryland, United States
• Investigational Site Number 840004 — Rockville, Maryland, United States
• Investigational Site Number 840017 — Biloxi, Mississippi, United States
• Investigational Site Number 840009 — Omaha, Nebraska, United States
• Investigational Site Number 840016 — Salisbury, North Carolina, United States
• Investigational Site Number 840006 — Fargo, North Dakota, United States
• Investigational Site Number 840014 — Canal Fulton, Ohio, United States
• Investigational Site Number 840011 — St. George, Utah, United States
• Investigational Site Number 840007 — Milwaukee, Wisconsin, United States
• Investigational Site Number 036002 — Box Hill, Australia
• Investigational Site Number 036006 — Brookvale, Australia
• Investigational Site Number 036004 — Camperdown, Australia
• Investigational Site Number 036005 — Gosford, Australia
• Investigational Site Number 036001 — Heidelberg, Australia
• Investigational Site Number 036003 — Parkville, Australia
• Investigational Site Number 100002 — Plovdiv, Bulgaria
• Investigational Site Number 100005 — Plovdiv, Bulgaria
• Investigational Site Number 100003 — Sofia, Bulgaria
• Investigational Site Number 100004 — Stara Zagora, Bulgaria
• Investigational Site Number 100001 — Varna, Bulgaria
• Investigational Site Number 840010 — La Jolla, California, United States

Full record on ClinicalTrials.gov

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