Type 2 diabetes not adequately controlled MedDRA version: 14.1 Level: LLT Classification code 10063624 Term: Type II diabetes mellitus inadequate control System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
SANOFI AVENTIS GROUPE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for the comparative period: - Patients aged from 35 to 75 years inclusively, - 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 DPP-IV inhibitor), for more than 3 months, - 7.5% =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria for the comparative period: - Previous treatment with GLP-1 analogues or insulin in the past year (except in case of temporary treatment for gestational diabetes, surgery, hospitalization… ), - Treatment with thiazolidinediones or a-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 (ALT, AST = 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 patient’s safety or limit the patient successful participation in the study. 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, - Pregnant women (women of childbearing potential must have a negative pregnancy test at extension period entry and a medically approved contraception method), - Lactating women, - Hospitalized patients (except hospitalization for routine diabetes check-up), - Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence during the comparative period, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the extension period, - Impaired renal function (creatinine clearance < 60 mL/mn), - Impaired hepatic function (ALT, AST = 2.5 times the upper limit of normal range), - History of sensitivity to insulin glargine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate the superiority of insulin glargine over liraglutide in terms of percentage of patients reaching a HbA1c < 7% at the end of the comparative period in Type 2 diabetic patients failing lifestyle management and oral agents. ;Secondary Objective: The main secondary objectives of this study are 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 - Patient reported outcome measures (PROMs): DTSQs, DTSQc and ADDQoL - Diabetes specific treatment costs The objectives of the extension period are 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 - PROMs: DTSQs, DTSQc and ADDQoL;Primary end point(s): The main criterion will be the percentage of patients reaching a HbA1c < 7% at the end of the comparative period (Visit 12). | — |
Countries
Austria, Czech Republic, Finland, France, Greece, Ireland, Netherlands, Spain, Sweden
Contacts
Public Contactwww.sanofi-aventis.cz
sanofi-aventis, s.r.o.
Outcome results
None listed