None listed
Conditions
Interventions
Nateglinide 120 mg administered orally before each
Main meal (breakfast, lunch and dinner) for 8 weeks
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Written informed consent to participate in the study. • Patients older than 30 years, diagnosed with diabetes mellitus type 2 (fasting blood glucose between 126 and 180 mg / dl and HbAlc between 7 and 9%) of at least 12 weeks of evolution prior to visit 1 (week -2). • Two measurements of the GPP-2h on two separate occasions, with an absolute value> 200 mg / dl, obtained as shown in section 3 (Research Plan). • Patients with diet for at least 8 weeks before visit 1 (week -2). • Body mass index in the range of 22-35 Kg / m2. • Consent of the patient to maintain their dietary and exercise habits throughout the course of the study. • Men, non-fertile women (post-menopausal, post-hysterectomized or sterilized by tubal ligation) or fertile women using a medically approved method of contraception (eg, oral contraceptives, IUDs or barrier devices). • Ability to meet all the requirements of the study.
Exclusion criteria
Exclusion criteria: • History of type 1 diabetes mellitus. • Previous treatment with insulin or oral hypoglycemic agents during the 6 months prior to the visit 1. • History of acute metabolic complications or others caused by diabetes (eg: ketoacidosis, coma, unstable angina, serum creatinine> 2.5 mg / dl (> 220 umol / L), symptomatic autonomic neuropathy, gastroparesis, etc). • Known hypersensitivity to drugs similar to nateglinide. • Prior treatment with investigational drugs within 4 weeks prior to study entry. • Treatment with systemic corticosteroids, or drugs that produce frequent toxicity to an important organic system in the last 3 months, eg: cytostatics. • History of any relevant pathology during the 6 months prior to entering the study, eg: myocardial infarction, coronary surgery, cancer, collagenopathy, liver or kidney failure, infections, etc. • Patients requiring thyroid hormone replacement who have received the usual dose of their medication for a period less than 3 months before week -2 or whose TSH is abnormal at week -2 (visit 1). • Fasting triglycerides> 700 mg / dl (> 7.9 mmol / l) during the 3 months before entering the study. • Concomitant medical condition that may interfere with the interpretation of study data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Determination of GPP-2h Measure:Change in the absolute value of the GPP-2h Timepoints:8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The assessment of safety and tolerability will be based mainly on the frequency of adverse events and on the number of laboratory values outside the predetermined ranges. Adverse events, previous diseases and concomitant mediation will be classified by COSTART, ICD-9 and WHO-DD respectively. The incidence of adverse events will be analyzed by symptom and system. Measure:Safety and tolerability Timepoints:Weeks 0, 2 and 8 ; Outcome name:Serum determination of HbAlc Measure:Change in the HbAlc value Timepoints:8 weeks | — |
Countries
Argentina, Chile, Colombia, Ecuador, Mexico, Peru, Uruguay, Venezuela
Outcome results
None listed