Type 2 diabetes treated with metformin and not adequately controlled by a previous treatment with metformin and either insulin glargine or sitagliptin MedDRA version: 9.1 Level: LLT Classification code 10053247 Term: Insulin-requiring type 2 diabetes mellitus
Conditions
Sponsors
sanofi aventis Groupe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who completed the LANTU_C_02761 core study (i.e. went through the visit 14 investigation), 2. HbA1c = 7 %, 3. Dose of metformin compliant with the inclusion criteria of the core study (i.e. at least 1.7 g/day or at least 1 g/day if poorly tolerated), and maintained stable for the duration of the core study, 4. Ability and willingness to perform plasma glucose monitoring using the sponsor-provided PG meter and to complete the patient diary, 5. Signed informed consent obtained prior any study procedure, 6. Willingness and ability to comply with the study protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Treatment with oral antidiabetic drugs other than metformin and sitagliptin in the core study, 2. 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), 3. Treatment with a non-permitted drug during the core study, 4. Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method), 5. In-patient care, 6. 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, 7. Impaired renal function: serum creatinine = 1.5 mg/dL (= 133µmol/L) or = 1.4 mg/dL (=124 µmol/L) in men and women, respectively, 8. History of sensitivity to the study drugs or to drugs with a similar chemical structure, 9. Impaired hepatic function (ALAT, ASAT > 3 x upper limit of normal range), 10. Alcohol or drug abuse within the last year, 11. Night shift worker, 12. Presence of any condition (medical, psychological, social or geographical), current or anticipated that the investigators feel would compromise the patient’s safety or limit the patient successful participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study is the extension of the LANTU_C_02761 study (core study comparing insulin glargine versus sitagliptin in insulin-naïve patients treated with metformin and not adequately controlled). All patients with HbA1c = 7% at the end of the core study will have the possibility to enter this extension study if they meet the other inclusion criteria and do not present with any exclusion criteria. The main objective of the trial is to assess the glycemic control (HbA1c <7%) of a 3-month combination therapy with metformin, insulin glargine and sitagliptin in patients not adequately controlled by a previous treatment with metformin plus insulin glargine or metformin plus sitagliptin.;Secondary Objective: The secondary objectives are to assess the effect of insulin glargine in combination with sitagliptin on: Efficacy parameters: HbA1c level Fasting Plasma Glucose 7-point glucose profile Safety parameters: Hypoglycemia occurrence Body weight Overall safety ;Primary end point(s): The primary efficacy variable will be the percentage of patients achieving HbA1c <7% at study endpoint. The study endpoint is defined as the last available HbA1c value measured during the study treatment phase plus 14 days after the last treatment dose. | — |
Countries
Austria, Netherlands, Portugal, Spain, United Kingdom
Outcome results
None listed