OPEN MULTICENTRIC STUDY TO EVALUATE THE EFFECTS ON POSTPANDRIAL GLUCEMIA AT 2 HOURS AND THE TOLERABILITY OF THE ADMINISTRATION OF NATEGLINIDA 120 MG BEFORE EACH MAIN MEAL IN PATIENTS WITH DIABETES MELLITUS TYPE 2 UNDICTEDLY CONTROLLED WITH DIET

Not Applicable

• Conditions: -E119 Non-insulin-dependent diabetes mellitus, without complications; Non-insulin-dependent diabetes mellitus, without complications; E119

• Registration Number: PER-064-00
• Lead Sponsor: OVARTIS BIOSCIENSES PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-01-01
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified