A 24-week, open, multicenter, comparative study of 2 strategies (including insulin glargine versus premixed insulin) for the therapeutic management of patients with type 2 diabetes failing oral agents - GALAPAGOS

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 870

Inclusion Criteria

- Men or women = 35 years old
- With Type 2 diabetes diagnosed for more than 1 year
- Insulin naïve
- Treated with lifestyle interventions and oral antidiabetic drugs, at least metformin at the maximum tolerated dose (with a minimum dose of 1g/day), for at least 3 months
- HbA1c = 7.0 % and = 10.5%
- BMI = 40 kg/m2
- Ability and willingness to perform plasma glucose (PG) 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 any study procedure

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

- Treatment with GLP-1 agonists in the 3 months prior to study entry
- Previous treatment with insulin (except for treatment of gestational diabetes or brief treatment with insulin for less than 1 week)
- Diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake…)
- Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method)
- Hospitalized patient (except 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 retina examination, in the 2 years prior to study entry
- History of sensitivity to the study drugs or to drugs with a similar chemical structure
- Impaired renal function: creatinine clearance < 60ml/min
- Impaired liver function (ALT, AST > 3 x upper limit of normal range)
- Severe gastro-intestinal disease
- Treatment with corticosteroids with potential systemic action within the 3 months prior to study entry
- Alcohol or drug abuse within the last 5 years
- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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