Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc; Liraglutide; Metformin

Criteria

Inclusion criteria (comparative period):

• Patients With Type 2 Diabetes diagnosed for at least 1 year,

• Treated with lifestyle interventions and metformin at the maximum tolerated dosage (with a minimum daily dosage of 1g), either alone or in combination with an oral insulin secretagogue (sulfonylurea, glinide or DiPeptidyl Peptidase IV inhibitor), for more than 3 months,

• 7.5% < HbA1c <= 12%,

• Body Mass Index (BMI) between 25 and 40 kg/m2 inclusively,

• Ability and willingness to perform PG (Plasma Glucose) self monitoring using the sponsor-provided glucose meter and to complete the patient diary,

• Willingness and ability to comply with the study protocol,

• Signed informed consent obtained prior to any study procedure.

Inclusion criteria (extension period):

• Patients treated with liraglutide (at the maximal tolerated dosage), having a mean FPG ≥ 250 mg/dL at visit 10 (Week 12) or visit 11 (Week 18), or a HbA1c≥ 7% at visit 12 (Week 24)

• Dosage of metformin compliant with the inclusion criteria of visit 1 (i.e. maximum tolerated dosage, with a minimum daily dosage of 1g), and maintained stable during the comparative period.

Exclusion criteria:

• 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.

• History of sensitivity to insulin glargine.