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

1. Men or women aged over 35 years inclusively; 2. With Type 2 diabetes diagnosed for more than 1 year; 3. Insulin na?ve; 4. 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; 5. HbA1c >= 7.0 % and <= 10.5%; 6. BMI <= 40 kg/m2; 7. Ability and willingness to perform plasma glucose (PG) monitoring using the sponsor-provided glucose meter and to complete the patient diary; 8. Willingness and ability to comply with the study protocol; 9. 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

1. Treatment with GLP-1 agonists in the 3 months prior to study entry; 2. Previous treatment with insulin (except for treatment of gestational diabetes or brief treatment with insulin for less than 1 week); 3. Diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake…); 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. Hospitalized patient (except for routine diabetes check-up); 6. 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; 7. History of sensitivity to the study drugs or to drugs with a similar chemical structure; 8. Impaired renal function: creatinine clearance < 60ml/min; 9. Impaired liver function (ALT, AST greater than 3 times the upper limit of normal range); 10. Severe gastro-intestinal disease; 11. Treatment with corticosteroids with potential systemic action within the 3 months prior to study entry; 12. Likelihood of requiring treatments during the study which are not permitted; 13. Treatment with an investigational product in the 30 days prior to study entry; 14. Alcohol or drug abuse within the last 5 years 15. Night shift worker; 16. 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; 17. Patient unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits and unlikehood of completing the study; 18. Patient is the Investigator or any sub-Investigator, research assistant, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol

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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