A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerabllity of 24 Weeks of Nateglinide, Giibenciamide, or Placebo Treatment in Eiderly Type 2 Diabetes Mellitus Patients

Not Applicable

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

• Registration Number: PER-071-01
• 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: 2001-11-22
• 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.
• Male or female patients aged >65 years, diagnosed with type 2 diabetes mellitus at least 3 months prior to the week 0 visit.
• HbA1c 6.5-9.0%, inclusive.
• Patients on diet for at least 2 months.
• Agreement to maintain prior diet and exercise habits for the full course of the study.
• Ability to comply with all study requirements.

Exclusion Criteria

• FPG >11.1 mmol/l (200 mg/dl).
• Treatment with any oral antidiabetic medications within 3 months of the week O visit.
• History of chronic insulin treatment (defined as 4 weeks of treatment in the absence of an intercurrent illncss) within the past 6 months.
• History of insulin-dependent diabetes mellitus (IDDM), diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing´s syndrome or acromegaly.
• History of acute metabolic diabetic complications such as ketoacidosis or hyperosmolar State (coma).
• Significant diabetic complications, e.g., unstable angina or gastroparesis.
• Serum creatinine >2.5mg/dl at week -2.
• Liver disease such as cirrhosis or chronic active hepatitis, or persistent ALT, AST, or alkaline phosphatase increases greater than 3 times the ULN at week -2.
• Total bilirubin greater than 2 times the ULN at week -2.
• Fasting triglycerides >750 mg/dl at week -2.
• Treatment with any drug with a known and frequent toxicity to a major organ system within the past 3 months (eg, cytostatic drugs).
• Corticosteroid treatment (except topical or inhaled) after week -2.
• Patients requiring thyroid hormone replacement who have not been on a stable dose for 3 months prior to week 0.
• Patients with abnormal TSH.
• History of active substance abuse (including alcohol) within the past 2 years.
• A myocardial infarction (MI), coronary surgery, ventricular tachycardia, or ventricular fibrillation within the past 6 months.
• Acute infections, which may affect blood glucose control, within the past 4 weeks.
• Concurrent medical conditions that may interfere with the interpretation of efficacy and safety evaluations during the study.
• Donation of one unit (500 ml) or more of blood, significant blood loss equalling at least one unit of blood within the past 12 weeks or receipt of a blood transfusion within the past 8 weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified