Nateglinide alone or with metformin safely improves glycaemia to target in patients up to an age of 84

Jola U. Weaver, D. Robertson, Stephen Atkin, S. Gordon, R. Hayes, S. Gilbey, S. Reith, P. O'Kane, I. Duthie, T. Blair, J. Walker, T. Jones, S. Heller, J. Vora, S. Dineen, M. Davies, M. Gibson, J. Reckless, J. O'Hare, P. EvansD. Robertson, A. Barnett, L. Gnudi, P. Hyatt, K. Steer, M. Press, H. Simpson, C. Strang, D. Kerr, I. Gallen, K. Earle, S. Hurel

Research output: Contribution to journalArticle

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Abstract

Aim: To assess the effect of nateglinide on efficacy [fasting plasma glucose (FPG), postprandial plasma glucose (PPG) plasma glucose and HbA1c], tolerability and safety in patients with type 2 diabetes mellitus (T2DM) on diet alone or on metformin in subjects up to an age of 84. Methods: In an open-labelled 12-week, parallel study of 358 patients, aged 35-84 years with T2DM, nateglinide was given as either monotherapy in patients previously on diet alone or low-dose sulfonylureas, which required washout before the study (group 1), or as an addition therapy in patients on steady dose of metformin (group 2). Nateglinide 120 mg was given before main meals. HbA1c, FPG and PPG values were taken at the time of breakfast at the beginning and the end of the study. Results: HbA1c fell by a mean of 0.83%, 95% confidence interval (CI) (-0.97, -0.69) (p < 0.001) in group 1, and 0.67%, 95% CI (-0.77, -0.58) (p < 0.001) in group 2. There was a significant improvement in PPG in group 1 by a mean reduction of -3.47 mmol/l, 95% CI (-4.08, -2.87 (p < 0.0001) and in group 2 of -2.41 mmol/l, 95% CI (-2.84, -1.99) (p < 0.0001). There was an improvement in FPG of -1.2 mmol/l, 95% CI (-1.49, -0.81) (p < 0.0001) and -0.8 mmol/l, 95% CI -(1.07, -0.53) (p < 0.0001) in group 1 and 2 respectively. 44% of patients in group 1 and 34% in group 2 achieved target of HbA1c <7.0 and 66% in group 1 and 59% in group 2 achieved of HbA1c <7.5%. Only one subject on nateglinide and metformin was withdrawn due to the side effect of hypoglycaemia. No patient required third-party assistance nor was admitted to hospital due to hypoglycaemia. Conclusion: These data demonstrate that nateglinide is a safe and effective agent in treatment to target in patients with T2DM up to an age of 84 years.

Original languageEnglish
Pages (from-to)344-352
Number of pages9
JournalDiabetes, Obesity and Metabolism
Volume6
Issue number5
DOIs
Publication statusPublished - Sep 2004
Externally publishedYes

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nateglinide
Metformin
Glucose
Confidence Intervals
Type 2 Diabetes Mellitus
Fasting
Hypoglycemia
Diet
Breakfast
Patient Safety
Meals

Keywords

  • First-phase insulin secretion
  • Hypoglycaemia
  • Postprandial plasma glucose
  • Prospective study
  • Type 2 diabetes mellitus

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology
  • Endocrinology, Diabetes and Metabolism

Cite this

Nateglinide alone or with metformin safely improves glycaemia to target in patients up to an age of 84. / Weaver, Jola U.; Robertson, D.; Atkin, Stephen; Gordon, S.; Hayes, R.; Gilbey, S.; Reith, S.; O'Kane, P.; Duthie, I.; Blair, T.; Walker, J.; Jones, T.; Heller, S.; Vora, J.; Dineen, S.; Davies, M.; Gibson, M.; Reckless, J.; O'Hare, J.; Evans, P.; Robertson, D.; Barnett, A.; Gnudi, L.; Hyatt, P.; Steer, K.; Press, M.; Simpson, H.; Strang, C.; Kerr, D.; Gallen, I.; Earle, K.; Hurel, S.

In: Diabetes, Obesity and Metabolism, Vol. 6, No. 5, 09.2004, p. 344-352.

Research output: Contribution to journalArticle

Weaver, JU, Robertson, D, Atkin, S, Gordon, S, Hayes, R, Gilbey, S, Reith, S, O'Kane, P, Duthie, I, Blair, T, Walker, J, Jones, T, Heller, S, Vora, J, Dineen, S, Davies, M, Gibson, M, Reckless, J, O'Hare, J, Evans, P, Robertson, D, Barnett, A, Gnudi, L, Hyatt, P, Steer, K, Press, M, Simpson, H, Strang, C, Kerr, D, Gallen, I, Earle, K & Hurel, S 2004, 'Nateglinide alone or with metformin safely improves glycaemia to target in patients up to an age of 84', Diabetes, Obesity and Metabolism, vol. 6, no. 5, pp. 344-352. https://doi.org/10.1111/j.1462-8902.2004.00353.x
Weaver, Jola U. ; Robertson, D. ; Atkin, Stephen ; Gordon, S. ; Hayes, R. ; Gilbey, S. ; Reith, S. ; O'Kane, P. ; Duthie, I. ; Blair, T. ; Walker, J. ; Jones, T. ; Heller, S. ; Vora, J. ; Dineen, S. ; Davies, M. ; Gibson, M. ; Reckless, J. ; O'Hare, J. ; Evans, P. ; Robertson, D. ; Barnett, A. ; Gnudi, L. ; Hyatt, P. ; Steer, K. ; Press, M. ; Simpson, H. ; Strang, C. ; Kerr, D. ; Gallen, I. ; Earle, K. ; Hurel, S. / Nateglinide alone or with metformin safely improves glycaemia to target in patients up to an age of 84. In: Diabetes, Obesity and Metabolism. 2004 ; Vol. 6, No. 5. pp. 344-352.
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abstract = "Aim: To assess the effect of nateglinide on efficacy [fasting plasma glucose (FPG), postprandial plasma glucose (PPG) plasma glucose and HbA1c], tolerability and safety in patients with type 2 diabetes mellitus (T2DM) on diet alone or on metformin in subjects up to an age of 84. Methods: In an open-labelled 12-week, parallel study of 358 patients, aged 35-84 years with T2DM, nateglinide was given as either monotherapy in patients previously on diet alone or low-dose sulfonylureas, which required washout before the study (group 1), or as an addition therapy in patients on steady dose of metformin (group 2). Nateglinide 120 mg was given before main meals. HbA1c, FPG and PPG values were taken at the time of breakfast at the beginning and the end of the study. Results: HbA1c fell by a mean of 0.83{\%}, 95{\%} confidence interval (CI) (-0.97, -0.69) (p < 0.001) in group 1, and 0.67{\%}, 95{\%} CI (-0.77, -0.58) (p < 0.001) in group 2. There was a significant improvement in PPG in group 1 by a mean reduction of -3.47 mmol/l, 95{\%} CI (-4.08, -2.87 (p < 0.0001) and in group 2 of -2.41 mmol/l, 95{\%} CI (-2.84, -1.99) (p < 0.0001). There was an improvement in FPG of -1.2 mmol/l, 95{\%} CI (-1.49, -0.81) (p < 0.0001) and -0.8 mmol/l, 95{\%} CI -(1.07, -0.53) (p < 0.0001) in group 1 and 2 respectively. 44{\%} of patients in group 1 and 34{\%} in group 2 achieved target of HbA1c <7.0 and 66{\%} in group 1 and 59{\%} in group 2 achieved of HbA1c <7.5{\%}. Only one subject on nateglinide and metformin was withdrawn due to the side effect of hypoglycaemia. No patient required third-party assistance nor was admitted to hospital due to hypoglycaemia. Conclusion: These data demonstrate that nateglinide is a safe and effective agent in treatment to target in patients with T2DM up to an age of 84 years.",
keywords = "First-phase insulin secretion, Hypoglycaemia, Postprandial plasma glucose, Prospective study, Type 2 diabetes mellitus",
author = "Weaver, {Jola U.} and D. Robertson and Stephen Atkin and S. Gordon and R. Hayes and S. Gilbey and S. Reith and P. O'Kane and I. Duthie and T. Blair and J. Walker and T. Jones and S. Heller and J. Vora and S. Dineen and M. Davies and M. Gibson and J. Reckless and J. O'Hare and P. Evans and D. Robertson and A. Barnett and L. Gnudi and P. Hyatt and K. Steer and M. Press and H. Simpson and C. Strang and D. Kerr and I. Gallen and K. Earle and S. Hurel",
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language = "English",
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TY - JOUR

T1 - Nateglinide alone or with metformin safely improves glycaemia to target in patients up to an age of 84

AU - Weaver, Jola U.

AU - Robertson, D.

AU - Atkin, Stephen

AU - Gordon, S.

AU - Hayes, R.

AU - Gilbey, S.

AU - Reith, S.

AU - O'Kane, P.

AU - Duthie, I.

AU - Blair, T.

AU - Walker, J.

AU - Jones, T.

AU - Heller, S.

AU - Vora, J.

AU - Dineen, S.

AU - Davies, M.

AU - Gibson, M.

AU - Reckless, J.

AU - O'Hare, J.

AU - Evans, P.

AU - Robertson, D.

AU - Barnett, A.

AU - Gnudi, L.

AU - Hyatt, P.

AU - Steer, K.

AU - Press, M.

AU - Simpson, H.

AU - Strang, C.

AU - Kerr, D.

AU - Gallen, I.

AU - Earle, K.

AU - Hurel, S.

PY - 2004/9

Y1 - 2004/9

N2 - Aim: To assess the effect of nateglinide on efficacy [fasting plasma glucose (FPG), postprandial plasma glucose (PPG) plasma glucose and HbA1c], tolerability and safety in patients with type 2 diabetes mellitus (T2DM) on diet alone or on metformin in subjects up to an age of 84. Methods: In an open-labelled 12-week, parallel study of 358 patients, aged 35-84 years with T2DM, nateglinide was given as either monotherapy in patients previously on diet alone or low-dose sulfonylureas, which required washout before the study (group 1), or as an addition therapy in patients on steady dose of metformin (group 2). Nateglinide 120 mg was given before main meals. HbA1c, FPG and PPG values were taken at the time of breakfast at the beginning and the end of the study. Results: HbA1c fell by a mean of 0.83%, 95% confidence interval (CI) (-0.97, -0.69) (p < 0.001) in group 1, and 0.67%, 95% CI (-0.77, -0.58) (p < 0.001) in group 2. There was a significant improvement in PPG in group 1 by a mean reduction of -3.47 mmol/l, 95% CI (-4.08, -2.87 (p < 0.0001) and in group 2 of -2.41 mmol/l, 95% CI (-2.84, -1.99) (p < 0.0001). There was an improvement in FPG of -1.2 mmol/l, 95% CI (-1.49, -0.81) (p < 0.0001) and -0.8 mmol/l, 95% CI -(1.07, -0.53) (p < 0.0001) in group 1 and 2 respectively. 44% of patients in group 1 and 34% in group 2 achieved target of HbA1c <7.0 and 66% in group 1 and 59% in group 2 achieved of HbA1c <7.5%. Only one subject on nateglinide and metformin was withdrawn due to the side effect of hypoglycaemia. No patient required third-party assistance nor was admitted to hospital due to hypoglycaemia. Conclusion: These data demonstrate that nateglinide is a safe and effective agent in treatment to target in patients with T2DM up to an age of 84 years.

AB - Aim: To assess the effect of nateglinide on efficacy [fasting plasma glucose (FPG), postprandial plasma glucose (PPG) plasma glucose and HbA1c], tolerability and safety in patients with type 2 diabetes mellitus (T2DM) on diet alone or on metformin in subjects up to an age of 84. Methods: In an open-labelled 12-week, parallel study of 358 patients, aged 35-84 years with T2DM, nateglinide was given as either monotherapy in patients previously on diet alone or low-dose sulfonylureas, which required washout before the study (group 1), or as an addition therapy in patients on steady dose of metformin (group 2). Nateglinide 120 mg was given before main meals. HbA1c, FPG and PPG values were taken at the time of breakfast at the beginning and the end of the study. Results: HbA1c fell by a mean of 0.83%, 95% confidence interval (CI) (-0.97, -0.69) (p < 0.001) in group 1, and 0.67%, 95% CI (-0.77, -0.58) (p < 0.001) in group 2. There was a significant improvement in PPG in group 1 by a mean reduction of -3.47 mmol/l, 95% CI (-4.08, -2.87 (p < 0.0001) and in group 2 of -2.41 mmol/l, 95% CI (-2.84, -1.99) (p < 0.0001). There was an improvement in FPG of -1.2 mmol/l, 95% CI (-1.49, -0.81) (p < 0.0001) and -0.8 mmol/l, 95% CI -(1.07, -0.53) (p < 0.0001) in group 1 and 2 respectively. 44% of patients in group 1 and 34% in group 2 achieved target of HbA1c <7.0 and 66% in group 1 and 59% in group 2 achieved of HbA1c <7.5%. Only one subject on nateglinide and metformin was withdrawn due to the side effect of hypoglycaemia. No patient required third-party assistance nor was admitted to hospital due to hypoglycaemia. Conclusion: These data demonstrate that nateglinide is a safe and effective agent in treatment to target in patients with T2DM up to an age of 84 years.

KW - First-phase insulin secretion

KW - Hypoglycaemia

KW - Postprandial plasma glucose

KW - Prospective study

KW - Type 2 diabetes mellitus

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