Type two diabetes mellitus with more than five years of evolution Nutritional, Metabolic, Endocrine Diabetes
Conditions
Interventions
This study only compares Nateglinide (120 mg, three times daily) versus placebo. No other interventions were carried out nor compared.
Sponsors
Novartis Pharma (Novartis Farmacéutica SA) (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Drug-naive 30 to 75 year old subjects with type two Diabetes Mellitus (DM) and less than five years of evolution, who met the following criteria: 1. Body Mass Index (BMI): 22 to 35 kg/m^2 2. Fasting Plasma Glucose (FPG) less than 13.3 mmol/l 3. HbA1c: 6.5 to 8.5% 4. Not taking anti-hypertensive drugs To be included, participants were in agreement neither to change their prior diet nor exercise activity during follow-up
Exclusion criteria
Exclusion criteria: 1. Type one diabetes mellitus 2. Pregnancy or childbearing females not using oral contraceptives 3. Drug-abuse 4. Severe psychiatric disorders 5. Treatment with oral corticosteroids, insulin or other oral hypoglycemic agents 6. Serum creatinine more than 160 mmol/L 7. Alanine Transaminase (ALT) and/or Aspartate Transaminase (AST) more than 2.0 x Upper Limit of Normal (ULN) 8. Thyroid dysfunction 9. Fasting triglycerides more than 7.0 mmol/L 10. Total cholesterol more than 9.1 mmol/L
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in HbA1c levels between the two study groups, at 12 weeks of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| At 12 weeks of follow-up: 1. Fasting plasma glucose 2. Incremental Areas Under the Curve for glucose (IAUCglucose) and C-Peptide (IAUCC-peptide) after a breakfast challenge test 3. Weight, heart rate and blood pressure 4. Haemoglobin, hematocrit and blood cell counts 5. Creatinine 6. ALT and AST levels 7. Fasting triglycerides 8. Total cholesterol 9. Homeostasis Model Assessment (HOMA)-%B (insulin secretion) and HOMA-%S (insulin sensitivity) | — |
Countries
Spain
Outcome results
None listed