Transferring to insulin detemir from NPH insulin or insulin glargine in type 2 diabetes patients on basal‐only therapy with oral antidiabetic drugs improves glycaemic control and reduces weight gain and risk of hypoglycaemia: 14‐week follow‐up data from PREDICTIVE™

Dornhorst, Anne; Hj, Lüddeke; Koenen, Christoph; Meriläinen, Markus; King, Abby C.; Robinson, Anthony; Sreenan, Séamus

doi:10.1111/j.1463-1326.2007.00816.x

Cited by 53 publications

(38 citation statements)

References 15 publications

(23 reference statements)

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“…Fourteen weeks after the switch to detemir, mean body weight was significantly reduced in patients previously using both NPH insulin (-0.7 kg; P<0.01) and insulin glargine (-0.5 kg; P<0.05). 102 Other studies have documented weight increases or weight stasis after treatment with glargine, although the weight increases, when observed, tended to be less than those occurring with NPH insulin. [103][104][105][106][107][108][109][110][111][112][113][114] The mechanisms behind the weight-sparing trait of insulin detemir have yet to be fully clarified.…”

Section: Weight Gainmentioning

confidence: 99%

Insulin Analogs: Impact on Treatment Success, Satisfaction, Quality of Life, and Adherence

Hartman

2008

Clinical Medicine & Research

115

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Despi te 85 years of research since Banting and Best's isolation of insulin-containing extracts, 1 diabetes still remains one of the most significant causes of morbidity and mortality in the world, and its global impact is likely to accelerate over the coming decades. 2,3 Much of the medical and economic consequences of diabetes are attributable to its associated microvascular and macrovascular complications. [4][5][6] Two classic large-scale clinical studies, the Diabetes Control and Complications Trial (DCCT) 6 and the UK Prospective Diabetes Study (UKPDS), 7 demonstrated that intensive blood-glucose control policies can decrease the frequency of complications, arguing that physicians and patients should strive to mimic, as closely as possible, the serum levels of insulin produced by a healthy person. Secretion of insulin by the pancreas, however, is under complex regulation that depends on the intake of nutrients, other gastrointestinal peptides (e.g., incretins), and overall metabolic levels (i.e., exercise versus rest). 8 These physiological variables, which pose real challenges to the accurate metabolic replacement of insulin, are further complicated by the fact that diabetes requires self-management and therefore depends on the psychology, motivation, and understanding of the patient. A growing body of medical research has demonstrated that intensive control of serum glucose levels can minimize the development of diabetes-related complications. Success with insulin management ultimately depends on how closely a given regimen can mimic normal physiologic insulin release patterns.The new insulin analogs, including the rapid-acting analogs (aspart, lispro, glulisine), the long-acting basal analogs (glargine, detemir), and the premixed insulin analog formulations (75% neutral protamine lispro, 25% lispro; 50% neutral protamine lispro, 50% lispro; 70% protamine aspart, 30% aspart) have been formulated to allow for a closer replication of a normal insulin profile.The rapid-acting analogs can be administered at mealtimes and produce a rapid and short-lived insulin spike to address postprandial glucose elevations, while the long-acting analogs come close to the ideal of a smooth, relatively flat, 24-hour basal insulin supply, with less variability in action compared to NPH insulin. Despite these clear pharmacologic advantages, measurable clinical benefits in a complex disease such as diabetes can be hard to measure.To date, reviews of insulin analog studies have not found a dramatic overall improvement in glycosylated hemoglobin (HbA1c) outcomes compared to traditional human insulins, although all-analog basal-bolus regimens were associated with significantly lower HbA1c than all-human-insulin basal bolus regimens in some studies. Beyond HbA1c comparisons, however, insulin analogs have been shown in many instances to be associated with lower risks of hypoglycemia, lower levels of postprandial glucose excursions, better patient adherence, greater quality of life, and higher satisfaction with treatment.The long-act...

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Section: Weight Gainmentioning

confidence: 99%

Insulin Analogs: Impact on Treatment Success, Satisfaction, Quality of Life, and Adherence

Hartman

2008

Clinical Medicine & Research

115

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“…Randomized controlled trials have demonstrated that insulin detemir is an effective OD basal insulin for use in patients with T2DM 8,12 , with observational data further supporting its effectiveness in many patients 18,20 . PREDICTIVE* is a large, observational study of the empirical use of insulin detemir in patients with type 1 or type 2 diabetes in a representative clinical setting.…”

Section: Introductionmentioning

confidence: 98%

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

Meneghini

Dornhorst

Sreenan

2009

Current Medical Research and Opinion

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C o p y r i g h t © 2 0 0 9 I n f o r m a U K L i m i t e d N o t f o r S a l e o r C o m m e r c i a l D i s t r i b u t i o n U n a u t h o r i z e d u s e p r o h i b i t e d . A u t h o r i s e d u s e r s c a n d o w n l o a d ,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 AE 10.9 years, BMI 29.8 AE 4.8 kg/m 2 , and HbA 1C 8.82 AE 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 ¼ 0.4513), and no serious adverse drug reactions were observed during the 12 weeks of treatment. HbA 1C decreased by a mean 1.25% (SD AE 1.25%; p50.0001), with 30% of patients (n ¼ 383) achieving HbA 1C 57% at 12 weeks. Mean changes in fasting blood glucose and fasting blood glucose variability were -3.62 mmol/L (SD AE 2.93; p50.0001) and À0.48 mmol/L (SD AE 1.03; p50.0001), respectively. Body weight decreased by a mean 0.5 kg (SD AE 3.3; p50.0001), with weight loss or no weight change occurring in a substantial percentage of patients in each BMI category ( 525,(25)(26)(27)(28)(29)(30)(30)(31)(32)(33)(34)(35), and 435 kg/m 2 ). Patients with higher baseline BMI lost the most weight, with the greatest weight loss (-1.20 kg) reported in those with BMI 435 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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“…This was also observed in European cohort of PREDICTIVE study in T2DM patients, where switching to detemir from prior insulins (glargine and NPH) resulted in more pronounced effect, with HbA1c reductions up to 0.6%. 25 The reduced subject variability, improved diabetes care, and continued follow-up also resulted in a better compliance, thus achieving better glycemic control.…”

Section: Discussionmentioning

confidence: 99%

Safety and Efficacy of Insulin Detemir Among Adult Filipino Patients with Type 2 Diabetes: The Philippine Cohort of the Global A1chieve Study

Sy¹,

Mirasol

Pasaporte³

et al. 2013

JAFES

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Objective. To present the results from the Philippine cohort of the A1chieve study receiving insulin detemir (IDet) ± oral antidiabetic drugs.Methodology. A1chieve is a multinational, 6-month, observational study of 66,726 people with type 2 diabetes mellitus (T2DM), both insulin users and non-insulin users, started on IDet, insulin aspart or biphasic insulin aspart in 28 countries across four continents. This subgroup analysis evaluates the safety and effectiveness of IDet in 988 subjects from the Philippines.Results. At baseline the mean age, duration of diabetes and mean BMI were found to be 57±11.9 yrs, 6.9±5.3 yrs and 26±4.8 kg/m 2 respectively. Majority of subjects were insulin-naive (84.3%) and glycemic control was poor in all the groups at baseline. At the end of 24 weeks, there were significant improvements following IDet initiation with a 2.1% reduction in mean HbA1c. The HbA1c target of <7% was achieved by 46.8% subjects at the study end. Although not statistically significant, there was a modest decrease in body weight in all the groups. There was no increase in the incidence of hypoglycemia among baseline insulin-naive subjects, while a significant reduction in hypoglycemia was seen among prior insulin users.Conclusions. IDet appears to be an effective and safe option for individuals with T2DM in the Philippines. HbA1C was lowered to target, and there was no increase in incidence of hypoglycemia and body weight with IDet.

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Transferring to insulin detemir from NPH insulin or insulin glargine in type 2 diabetes patients on basal‐only therapy with oral antidiabetic drugs improves glycaemic control and reduces weight gain and risk of hypoglycaemia: 14‐week follow‐up data from PREDICTIVE™

Abstract: These results indicate that in type 2 diabetes, transferring from other basal insulins to insulin detemir in combination with OADs was associated with improvements in glycaemic control, which were accompanied by a reduced risk of hypoglycaemia and a reduction in body weight.

Cited by 53 publications

References 15 publications

Insulin Analogs: Impact on Treatment Success, Satisfaction, Quality of Life, and Adherence

Insulin Analogs: Impact on Treatment Success, Satisfaction, Quality of Life, and Adherence

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

Safety and Efficacy of Insulin Detemir Among Adult Filipino Patients with Type 2 Diabetes: The Philippine Cohort of the Global A1chieve Study

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