Efficacy, tolerability and safety of nateglinide in combination with metformin. Results from a study under general practice conditions

Exp Clin Endocrinol Diabetes. 2003 Aug;111(5):262-6. doi: 10.1055/s-2003-41752.

Abstract

In a general practice observation study 11,476 patients with type 2 diabetes pretreated with oral antidiabetic drugs, mainly metformin, received an oral combination therapy of nateglinide with metformin. Mean age+/-SD of the participants was 61+/-10.3 years, range 19 to 97 years, the body mass index (mean+/-SD) was 29.4+/-4.5 kg/m2, range 14.9 to 68.7 kg/m2. The observation period lasted 3 to 4 months (mean 96 days). During this period the mean HbA1c decreased from 8.4 % to 7.2%, displaying a positive relation between initial value and degree of reduction. Postprandial glucose levels dropped from a mean of 210 to 152 mg/dl. At the beginning of the study the combination of the two target values for glucose control, HbAc <7% and postprandial glucose <180 mg/dl, was reached in only 5.8% of the participants, at the end in 44.9%. During the therapy, weight and blood pressure dropped slightly. Adverse events were reported in only 2.9% of the patients and involved a broad range of symptoms with mild gastrointestinal complaints being predominant (1.3%). This study demonstrated that the combination of nateglinide with metformin can be considered as an effective and safe option for treatment of patients with type 2 diabetes, with additional beneficial effects on body weight and blood pressure.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Blood Glucose / drug effects
  • Blood Glucose / metabolism*
  • Blood Pressure
  • Body Weight
  • Cyclohexanes / adverse effects
  • Cyclohexanes / therapeutic use*
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Drug Therapy, Combination
  • Family Practice
  • Female
  • Humans
  • Hypoglycemic Agents / adverse effects
  • Hypoglycemic Agents / therapeutic use*
  • Male
  • Metformin / adverse effects
  • Metformin / therapeutic use*
  • Middle Aged
  • Nateglinide
  • Phenylalanine / adverse effects
  • Phenylalanine / analogs & derivatives
  • Phenylalanine / therapeutic use*
  • Postprandial Period
  • Product Surveillance, Postmarketing / methods

Substances

  • Blood Glucose
  • Cyclohexanes
  • Hypoglycemic Agents
  • Nateglinide
  • Phenylalanine
  • Metformin