None listed
Conditions
Interventions
Group 1 Type of group
Nateglinide active from 60 mg ac to 180 mg ac + Glibenclamide placebo
Nateglinide placebo + Glibenclamide placebo for 24 weeks
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Symptoms of hypoglycemia are usually non-specific and a diagnosis of hypoglycemia cannot be made on signs and symptoms alone. These symptoms should be associated with a low blood glucose level and should reverse after carbohydrate intake (Whipple triad). Measure:Incidence of hypoglycemic events Timepoints:Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:This will use the last observation carried forward (LOCF) algorithm for subjects who did not have a week 24 HbAic measurement. Measure:Change from baseline in HbA1c at the end of the study Timepoints:Week 24 ; Outcome name:Change from baseline after 24 weeks Measure:Fasting plasma glucose Timepoints:24 weeks ; Outcome name:Change from baseline after 24 weeks Measure:Body weight, post-meal excursion in glucose (2hrs), and insulin (30 min) values Timepoints:24 weeks ; Outcome name:Change from baseline after 24 weeks Measure:Pro-insulin (absolute value at 30 mins) Timepoints:24 weeks | — |
Outcome results
None listed