GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone

Not Applicable

• Conditions: -E118 Non-insulin-dependent diabetes mellitus, with unspecified complications; Non-insulin-dependent diabetes mellitus, with unspecified complications; E118

• Registration Number: PER-090-08
• Lead Sponsor: sanofi-aventis Recherche & Development,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-13
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Patients with type 2 diabetes mellitus, as defined by the QMS (I, Appendix A), diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled with pioglitazone.
• Written informed consent obtained.

Exclusion Criteria

• HbA1c <7.0% or HbA1c> = 10% at screening
• At the time of screening age less than the legal age of majority
• Women with the potential to conceive without an effective contraceptive method (Women with potential to conceive (pre-menopausal, women not surgically sterilized for at least 3 months before the time of screening) should be confirmed negative to the beta-hCG serum of the pregnancy test at the time of screening, they should use a safe contraceptive method through the study, and agree to repeat the beta-HcG serum pregnancy test at the designated visits).
• Diabetes mellitus type 1
• No stable treatment with pioglitazone at a stable dose of at least 30 mg / day at least 3 months before screening.
• If the treatment with metformin: it is not at a stable dose of at least 1.5 g / day for at least 3 months before the screening visit.
• Plasma fasting glucose at screening> 250 mg / dL (> I3.9 mmol / 1)
• Body mass index (BMI) <= 20 kg / m ^
• Weight change of more than 5 kg during the last 3 months preceding the screening visit
• History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach / gastric surgery, inflammatory bowel disease.
• History of metabolic acidosis, including diabetic ketoacidosis within 1 year before screening.
• Hemoglobinopathy or hemolytic anemia, reception of blood or plasma products within 3 months before screening time.
• Within six months before screening: History of myocardial infarction or ischemia.
• Known history of alcohol or drug abuse within 6 months before screening
• Cardiovascular, hepatic, neurological or endocrine disease, active malignant tumor or other major systemic disease or patients with short life expectancy making it difficult to implement the protocol or interpretation of study results, history or clinical presence of significant diabetic retinopathy, history or presence of macular edema that apparently requires laser treatment within the study period.
• Uncontrolled or inadequately controlled hypertension at the time of screening with a systolic or diastolic blood pressure remaining> 180 mmHg or> 95 mmHg respectively.
• Laboratory findings at the time of screening. -AST, ALT or ALP:> 2 times the upper limit of the normal laboratory ranges.
• Any significant clinical abnormality identified in the physical examination, laboratory test, ECG or vital signs at the time of screening that in the opinion of the investigator or any sub-investigator thinks it could impede the safe completion of the study or force the evaluation of efficacy
• Patients considered by the investigator or any sub investigator as inappropriate for the study for any reason (eg, failure to meet protocol requirements, such as visiting schedule, inability to self-inject, likely probability of requiring treatment during the screening phase and phase of treatment with drugs not allowed by the protocol of the clinical study, researcher or any sub investigator, pharmacist, study coordinator, or other staff member or relatives directly involved in the conduct of the protocol, etc.)
• Use of other oral or injectable antidiabetic agents or hypoglycemic agents other than metformin or pioglitazone (eg sulfonylurea, alpha glucosidase inhibitor, other thiazolidinediones, rimonabant, exenatide, DPP-IV inhibitor, insulin, etc.) within 3 months before the time of screening.
• Use of systemic glucocorticoids (excluding topical appli

Study & Design

• Study Type: Interventional
• Study Design: Not specified