Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure

Completed · Phase 4

Conditions studied: Diabetes Mellitus, Type 2

In brief

Primary objective: To demonstrate the superiority of insulin glargine over liraglutide in terms of percentage of patients reaching a Glycosylated Haemoglobin (HbA1c) \< 7% at the end of the comparative period (24 weeks) in Type 2 diabetic patients failing lifestyle management and oral agents Secondary objectives of the comparative period (24 weeks): \>To assess the effect of insulin glargine in comparison with liraglutide on: * HbA1c level * Percentage of patients whose HbA1c has decreased but remains \>= 7% at the end of the comparative period * Percentage of patients whose HbA1c has increased at the end of the comparative period * Fasting Plasma Glucose (FPG) * 7-point Plasma Glucose (PG) profiles * Hypoglycemia occurrence * Body weight * Adverse events Objectives of the extension period (24 weeks): \>To assess the effect of insulin glargine in patients not adequately controlled with liraglutide on: * HbA1c level * FPG * 7-point PG profiles * Hypoglycemia occurrence * Body weight * Adverse events

Key facts

Study ID: NCT01117350
Run by: Sanofi
People needed: 978
Starts: 2010-07-01
Expected to finish: 2013-03-01
Last updated by the study team: 2014-04-11

Who can join

Age: 35 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Previous treatment with Glucagon Like Peptide-1 analogues or insulin in the past year (except in case of temporary treatment for gestational diabetes, surgery, hospitalization...),
Treatment with thiazolidinediones or α-Glucosidases inhibitors within 3 months prior to study entry,
Diabetes other than Type 2 diabetes (e.g. secondary to pancreatic disorders, drug or chemical agents intake),
Pregnant women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method),
Lactating women,
Hospitalized patients (except hospitalization for routine diabetes check-up),
Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by a retina examination within 2 years prior to study entry,
Impaired renal function (creatinine clearance < 60 mL/mn),
Impaired hepatic function (Alanine Aminotransferase, Aspartate Aminotransferase 2.5 times the upper limit of normal range),
Personal or family history of medullary thyroid carcinoma,
Multiple endocrine neoplasia syndrome type 2,
Severe gastro-intestinal disease (including inflammatory bowel disease or diabetic gastroparesis),
Congestive heart failure,
History of acute pancreatitis,
Treatment with corticosteroids with potential systemic action for more than 10 days within 3 months prior to study entry,
Alcohol or drug abuse in the past 5 years,
History of sensitivity to the study drugs or to drugs with a similar chemical structure.
Night shift worker,
Presence of any condition (medical, psychological, social or geographical), current or anticipated that would compromise the patients safety or limit the patient successful participation in the study,
Participation in a clinical trial (drug or device) within 3 months prior to study entry,
Refusal or inability to give informed consent to participate in the study,
Patient is the Investigator or any sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
Additional exclusion criteria for the extension period:
Treatment with oral antidiabetic drugs other than metformin and patient's usual sulfonylurea if any, or with insulin during the comparative period (except in case of an emergency, for a period of time less than 7 days),
Treatment with corticosteroids with potential systemic action within the last 3 months of the comparative period.

Where it is running

Investigational Site Number 840002 — Goodyear, Arizona, United States
Investigational Site Number 840047 — Phoenix, Arizona, United States
Investigational Site Number 840017 — La Jolla, California, United States
Investigational Site Number 840036 — La Mesa, California, United States
Investigational Site Number 840037 — Loma Linda, California, United States
Investigational Site Number 840045 — Long Beach, California, United States
Investigational Site Number 840048 — Mission Hills, California, United States
Investigational Site Number 840033 — Mission Viejo, California, United States
Investigational Site Number 840019 — Palm Springs, California, United States
Investigational Site Number 840039 — San Diego, California, United States
Investigational Site Number 840042 — San Diego, California, United States
Investigational Site Number 840043 — Tustin, California, United States
Investigational Site Number 840028 — Denver, Colorado, United States
Investigational Site Number 840034 — Grand Junction, Colorado, United States
Investigational Site Number 840026 — Longmont, Colorado, United States
Investigational Site Number 840022 — Lawrenceville, Georgia, United States
Investigational Site Number 840029 — Roswell, Georgia, United States
Investigational Site Number 840009 — Arlington Heights, Illinois, United States
Investigational Site Number 840051 — Springfield, Illinois, United States
Investigational Site Number 840050 — Indianapolis, Indiana, United States
Investigational Site Number 840031 — Kansas City, Kansas, United States
Investigational Site Number 840004 — Paducah, Kentucky, United States
Investigational Site Number 840010 — Rockville, Maryland, United States
Investigational Site Number 840038 — Eagan, Minnesota, United States
Investigational Site Number 840023 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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