Multicentre, randomised, double-blind, parallel-group, placebo-controlled clinical trial, comparing nateglinide versus placebo to assess the efficacy and tolerability of nateglinide in patients with type two diabetes mellitus
- Conditions
- Type two diabetes mellitus with more than five years of evolutionNutritional, Metabolic, EndocrineDiabetes
- Registration Number
- ISRCTN04296019
- Lead Sponsor
- ovartis Pharma (Novartis Farmacéutica SA) (Spain)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 102
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
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/
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in HbA1c levels between the two study groups, at 12 weeks of follow-up
- Secondary Outcome Measures
Name Time Method At 12 weeks of follow-up:<br>1. Fasting plasma glucose<br>2. Incremental Areas Under the Curve for glucose (IAUCglucose) and C-Peptide (IAUCC-peptide) after a breakfast challenge test<br>3. Weight, heart rate and blood pressure<br>4. Haemoglobin, hematocrit and blood cell counts<br>5. Creatinine<br>6. ALT and AST levels <br>7. Fasting triglycerides <br>8. Total cholesterol <br>9. Homeostasis Model Assessment (HOMA)-%B (insulin secretion) and HOMA-%S (insulin sensitivity)