A RANDOMIZED, OPEN-LABEL, PARALLEL-GROUP, MULTICENTER STUDY TO DETERMINE THE EFFICACY AND SAFETY OF ALBIGLUTIDE AS COMPARED WITH LIRAGLUTIDE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
- Conditions
- -E11 Non-insulin-dependent diabetes mellitusNon-insulin-dependent diabetes mellitusE11
- Registration Number
- PER-046-10
- Lead Sponsor
- GlaxoSmithKline,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 91
• Men or women, 18 years of age or older, with a historical diagnosis of type 2 diabetes mellitus and with insufficient glycemic control with their current metformin, TZD, SU or any combination of these oral antidiabetics
• BMI> or = 20 kg / m2 and • Fasting peptide C> or = 0.8 ng / ml (> or = 0.26 nmol / l).
• HbA1c between 7.0% and 10.0%, inclusive, in visit 5 (week -1). The HbA1c value can be measured up to four times and, if the average of these measurements meets the criteria, the patient can be randomly assigned to receive treatment.
• Regarding the regular use of other drugs (drugs excluded by the protocol are not included), it is preferable that patients are receiving a stable dose for at least four weeks before selection; however, as necessary during the period of preinclusion / stabilization and the period of treatment, the use of prescription or non-prescription drugs will be allowed, which may be adjusted by the investigator to optimize the treatment (for example, change of treatment). Dosage of medication for the treatment of blood pressure or hyperlipidemia in accordance with accepted local medical practice and relevant reference documents).
• In general, the use of oral or systemically injected glucocorticoids in the three months prior to randomization is not allowed; however, brief cycles of oral steroids (single dose or multiple doses for up to two days) may be allowed provided these cases are discussed with the medical monitor. Inhaled, intra-articular and topical corticosteroids will be allowed.
• Hemoglobin> or = 11 g / dl (> or = 110 g / l) in men and> or = 10 g / dl (> or = 100 g / l) in women.
• Creatinine clearance> 60 ml / min (calculated with the Cockcroft-Gault formula).
• Normal or clinically euthyroid thyrotropin concentration, demonstrated by additional thyroid tests (for example, T4, T3).
• Women with the ability to procreate (ie, who have not been surgically sterilized or postmenopausal) should be using appropriate contraceptive methods. Suitable contraceptive methods are: abstinence, injectable progestagen, levonorgestrel implants, estrogen vaginal ring, percutaneous contraceptive patches, intrauterine device or system, sterilization of the male partner (vasectomy with azoospermia documentation) before incorporating a woman into study, said male partner being the only couple of that woman, double barrier method (condom or occlusive cap plus nonoxynol-9) or oral contraceptives in combination with a second contraceptive method (eg, condom or occlusive cap). Appropriate contraception should be used throughout the study, including the follow-up period after the 8-week treatment.
• Ability to monitor blood glucose levels with a household glucometer and willingness to do so.
• Absence of significant diseases or weaknesses that, in the opinion of the researcher, prevent the subject from actively participating in the control of their diabetes and completing the study.
• Ability and willingness to grant written informed consent.
• History of cancer, other than a squamous cell or basal cell carcinoma of the skin, that has not been in complete remission for at least three years before selection. (The history of treated cervical intraepithelial neoplasia I or II will be allowed.)
• History of treated diabetic gastroparesis.
• Active symptomatic biliary disease or a history of pancreatitis.
• History of major gastrointestinal surgery, such as gastric bypass and elastic band placement, antrectomy, Roux Y-bypass, gastric vagotomy, small bowel resection or interventions that supposedly significantly affect upper gastrointestinal function.
• Recent cardiovascular or cerebrovascular diseases with clinical importance (as defined in the protocol)
• Hemoglobinopathy that may affect the determination of HbA1c.
• History of infection by the human immunodeficiency virus.
• History of total bilirubin> 1.5 times the LSN, unless the patient has a known history of Gilbert´s syndrome and a fractionated bilirubin that reveals a conjugated bilirubin <35% of total bilirubin.
• ALT or aspartate aminotransferase (AST)> 2.5 × LSN.
• Fasting triglyceride concentration> 850 mg / dl at the selection visit or at week -1 (visit 5). If the patient´s triglyceride concentration is> 500 mg / dL at the selection visit and at week -1, the subject will be excluded. If the patient meets the aforementioned exclusion criteria related to triglycerides, he can be treated and selectively evaluated again. Treated patients should receive a stable dose of medication for at least four weeks before undergoing a new selection.
• Acute symptomatic infection (in the three months prior to selection) by hepatitis B or C virus; however, the participation of patients with old or chronic hepatitis B or C will be allowed provided that the requirements of ALT, AST and total bilirubin are met.
• History of a psychiatric disorder that affects the subject´s ability to participate in the study.
• History of alcoholism or drug addiction during the year prior to selection.
• Toxicological analysis in positive urine at the screening visit, unless the patient is taking a prescribed drug for which a positive result simply verifies the use of the medication.
• Pregnant women (confirmed by analysis), infants or who have given birth less than 6 weeks before.
• Known allergy to any GLP-1 analogue, liraglutide, other excipients of the study medication, albiglutide excipients or brewer´s yeast.
• History of type 1 diabetes mellitus, diabetic complications (for example, active proliferative retinopathy or severe diabetic neuropathy) that, in the opinion of the researcher, may impede effective participation in the study, or a history of ketoacidosis or hyperosmolar coma.
• Contraindications (according to the data sheet) for the use of basic medicines or possible randomized study drugs (eg liraglutide).
• Reception of any investigational drug or liraglutide in the previous 30 days or 5 half-lives, whichever is longer, before selection
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Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Through laboratory tests performed during the study<br>Measure:The variation of HbA1c with respect to baseline after 32 weeks of treatment<br><br>Timepoints:32 weeks of treatment<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Through laboratory tests performed during the study<br>Measure:Variation of HbA1c with respect to baseline over time<br>Timepoints:over time<br>;<br>Outcome name:Fasting blood glucose will be measured by laboratory tests performed during the study.<br>Measure:Fasting blood glucose (GA) variation with respect to baseline over time<br>Timepoints:During the study<br>;<br>Outcome name:HbA1c will be measured by laboratory tests performed during the study.<br>Measure:Proportion of patients presenting the therapeutic objective of HbA1c of <7.0%<br>Timepoints:During the study<br>;<br>Outcome name:HbA1c will be measured by laboratory tests performed during the study.<br>Measure:HbA1c will be measured by laboratory tests performed during the study.<br>Timepoints:During the study<br>;<br>Outcome name:Through laboratory tests performed during the study<br>Measure:Time to rescue in case of hyperglycemia<br>Timepoints:During the study<br>