Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial

Exclusion Criteria

• •Treatment with oral antidiabetic drugs other than metformin and sitagliptin in the core study,
• •Treatment with insulin other than Insulin Glargine in the core study (except in case of an emergency, for a period of time less than 7 days),
• •Treatment with a non-permitted drug during the core study,
• •Pregnant or lactating women,
• •In-patient care,
• •Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study (an optic fundus examination should have been performed within the 2 years prior to study entry in the core study),
• •Impaired renal function: serum creatinine \>= 1.5 mg/dL (\>= 133µmol/L) or \>= 1.4 mg/dL (\>=124 µmol/L) in men and women, respectively,
• •History of sensitivity to the study drugs or to drugs with a similar chemical structure,
• •Impaired hepatic function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) \> 3 x upper limit of normal range,
• •Alcohol or drug abuse within the last year,
• •Night shift worker,
• •Presence of any condition (medical, psychological, social or geographical), current or anticipated that the investigator feels would compromise the patient's safety or limit the patient successful participation in the study,
• •Treatment with weight loss medications (e.g. sibutramine, orlistat, rimonabant),
• •History of pancreatitis.