Once-daily insulin detemir in a cohort of insulin-naïve patients with type 2 diabetes: A sub-analysis from the PREDICTIVE study

Luigi F. Meneghini, A. Dornhorst, S. Sreenan

Research output: Contribution to journalArticle

20 Citations (Scopus)

Abstract

Objective: PREDICTIVE* is a large, observational study of the empirical use of insulin detemir in patients with type 1 or type 2 diabetes (T1DM/T2DM). This post hoc analysis evaluates insulin-naïve patients with T2DM uncontrolled on oral antidiabetic drugs (OADs) who were initiated and remained on once-daily insulin detemir for 12 weeks. Research design and methods: This observational, multinational, multi-center, open-label prospective study evaluated the efficacy and safety of insulin detemir in 1653 insulin-naïve patients with T2DM (mean age 60.8 ± 10.9 years, BMI 29.8 ± 4.8 kg/m2, and HbA1C 8.82 ± 1.50%). Statistical comparisons were made between baseline and 12-week follow up data. Our study was subject to the usual limitations of observational studies. Main outcome measures: Endpoints were: incidence of serious adverse drug reactions, including number of hypoglycemic events (total, major, and nocturnal), glycemic parameters, and weight change. Results: Following insulin initiation, no significant change occurred in the number of nocturnal hypoglycemic events or total hypoglycemic events (p = 0.4513), and no serious adverse drug reactions were observed during the 12 weeks of treatment. HbA1C decreased by a mean 1.25% (SD ± 1.25%; p<0.0001), with 30% of patients (n = 383) achieving HbA1C <7% at 12 weeks. Mean changes in fasting blood glucose and fasting blood glucose variability were -3.62 mmol/L (SD ± 2.93; p<0.0001) and -0.48 mmol/L (SD ± 1.03; p<0.0001), respectively. Body weight decreased by a mean 0.5 kg (SD ± 3.3; p<0.0001), with weight loss or no weight change occurring in a substantial percentage of patients in each BMI category (<25, 25-30, 30-35, and >35 kg/m2). Patients with higher baseline BMI lost the most weight, with the greatest weight loss (-1.20 kg) reported in those with BMI >35 kg/m 2. Conclusions: Empirical use of insulin detemir as an insulin initiation strategy can improve glycemic control with good tolerability, including a low risk of hypoglycemia and a weight benefit, in a majority of insulin-naïve patients uncontrolled on OADs.

Original languageEnglish
Pages (from-to)1029-1035
Number of pages7
JournalCurrent Medical Research and Opinion
Volume25
Issue number4
DOIs
StatePublished - Apr 1 2009

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Hypoglycemic Agents
Type 2 Diabetes Mellitus
Insulin
Drug-Related Side Effects and Adverse Reactions
Weights and Measures
Observational Studies
Hypoglycemia
Weight Loss
Research Design
Outcome Assessment (Health Care)
Insulin Detemir
Prospective Studies
Safety
Incidence
Therapeutics

Keywords

  • Glycemic control
  • Insulin detemir
  • Insulin therapy
  • Once daily
  • Type 2 diabetes
  • Weight gain

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Once-daily insulin detemir in a cohort of insulin-naïve patients with type 2 diabetes : A sub-analysis from the PREDICTIVE study. / Meneghini, Luigi F.; Dornhorst, A.; Sreenan, S.

In: Current Medical Research and Opinion, Vol. 25, No. 4, 01.04.2009, p. 1029-1035.

Research output: Contribution to journalArticle

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abstract = "Objective: PREDICTIVE* is a large, observational study of the empirical use of insulin detemir in patients with type 1 or type 2 diabetes (T1DM/T2DM). This post hoc analysis evaluates insulin-na{\"i}ve patients with T2DM uncontrolled on oral antidiabetic drugs (OADs) who were initiated and remained on once-daily insulin detemir for 12 weeks. Research design and methods: This observational, multinational, multi-center, open-label prospective study evaluated the efficacy and safety of insulin detemir in 1653 insulin-na{\"i}ve patients with T2DM (mean age 60.8 ± 10.9 years, BMI 29.8 ± 4.8 kg/m2, and HbA1C 8.82 ± 1.50{\%}). Statistical comparisons were made between baseline and 12-week follow up data. Our study was subject to the usual limitations of observational studies. Main outcome measures: Endpoints were: incidence of serious adverse drug reactions, including number of hypoglycemic events (total, major, and nocturnal), glycemic parameters, and weight change. Results: Following insulin initiation, no significant change occurred in the number of nocturnal hypoglycemic events or total hypoglycemic events (p = 0.4513), and no serious adverse drug reactions were observed during the 12 weeks of treatment. HbA1C decreased by a mean 1.25{\%} (SD ± 1.25{\%}; p<0.0001), with 30{\%} of patients (n = 383) achieving HbA1C <7{\%} at 12 weeks. Mean changes in fasting blood glucose and fasting blood glucose variability were -3.62 mmol/L (SD ± 2.93; p<0.0001) and -0.48 mmol/L (SD ± 1.03; p<0.0001), respectively. Body weight decreased by a mean 0.5 kg (SD ± 3.3; p<0.0001), with weight loss or no weight change occurring in a substantial percentage of patients in each BMI category (<25, 25-30, 30-35, and >35 kg/m2). Patients with higher baseline BMI lost the most weight, with the greatest weight loss (-1.20 kg) reported in those with BMI >35 kg/m 2. Conclusions: Empirical use of insulin detemir as an insulin initiation strategy can improve glycemic control with good tolerability, including a low risk of hypoglycemia and a weight benefit, in a majority of insulin-na{\"i}ve patients uncontrolled on OADs.",
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N2 - Objective: PREDICTIVE* is a large, observational study of the empirical use of insulin detemir in patients with type 1 or type 2 diabetes (T1DM/T2DM). This post hoc analysis evaluates insulin-naïve patients with T2DM uncontrolled on oral antidiabetic drugs (OADs) who were initiated and remained on once-daily insulin detemir for 12 weeks. Research design and methods: This observational, multinational, multi-center, open-label prospective study evaluated the efficacy and safety of insulin detemir in 1653 insulin-naïve patients with T2DM (mean age 60.8 ± 10.9 years, BMI 29.8 ± 4.8 kg/m2, and HbA1C 8.82 ± 1.50%). Statistical comparisons were made between baseline and 12-week follow up data. Our study was subject to the usual limitations of observational studies. Main outcome measures: Endpoints were: incidence of serious adverse drug reactions, including number of hypoglycemic events (total, major, and nocturnal), glycemic parameters, and weight change. Results: Following insulin initiation, no significant change occurred in the number of nocturnal hypoglycemic events or total hypoglycemic events (p = 0.4513), and no serious adverse drug reactions were observed during the 12 weeks of treatment. HbA1C decreased by a mean 1.25% (SD ± 1.25%; p<0.0001), with 30% of patients (n = 383) achieving HbA1C <7% at 12 weeks. Mean changes in fasting blood glucose and fasting blood glucose variability were -3.62 mmol/L (SD ± 2.93; p<0.0001) and -0.48 mmol/L (SD ± 1.03; p<0.0001), respectively. Body weight decreased by a mean 0.5 kg (SD ± 3.3; p<0.0001), with weight loss or no weight change occurring in a substantial percentage of patients in each BMI category (<25, 25-30, 30-35, and >35 kg/m2). Patients with higher baseline BMI lost the most weight, with the greatest weight loss (-1.20 kg) reported in those with BMI >35 kg/m 2. Conclusions: Empirical use of insulin detemir as an insulin initiation strategy can improve glycemic control with good tolerability, including a low risk of hypoglycemia and a weight benefit, in a majority of insulin-naïve patients uncontrolled on OADs.

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