Entries Tagged as 'Diabetes Obes Metab'
Introducing a simplified approach to insulin therapy in type 2 diabetes: a comparison of two single-dose regimens of insulin glulisine plus insulin glargine and oral antidiabetic drugs.
Diabetes Obes Metab. 2008 Dec;10(12):1178-85
Authors: Lankisch MR, Ferlinz KC, Leahy JL, Scherbaum WA,
AIM: To investigate whether the addition of a single bolus of insulin glulisine (glulisine), administered at either breakfast or main mealtime, in combination with basal insulin glargine (glargine) and oral antidiabetic drugs (OADs), provides equivalent glycaemic control in patients with type 2 diabetes, irrespective of the time of glulisine injection. METHODS: A national, multicentre, randomized, open-label, parallel-group study of 393 patients with type 2 diabetes who were suboptimally controlled [haemoglobin A(1c) (HbA(1c)) > 6.5-9.0% and fasting blood glucose (BG) <or=6.7 mmol/l] on their previous glargine and OAD regimen. A single injection of glulisine was added, either at breakfast or at main mealtime, to their existing therapy. RESULTS: The per-protocol group (n = 316) showed improved HbA(1c) (baseline vs. end-point) in the breakfast (7.4 vs. 7.0%; p < 0.0001) and main mealtime groups (7.3 vs. 6.9%; p < 0.0001). Glulisine given at breakfast was equally effective in controlling HbA(1c) as glulisine given at the main mealtime [adjusted HbA(1c) mean difference (95% confidence interval): 0.0481% (-0.115 to 0.211); p < 0.0001 for equivalence]. Overall, 30.7% of patients achieved HbA(1c)<or=6.5% at end-point but slightly more patients met this target in the main mealtime group vs. the breakfast group (33.8 vs. 27.8%; p = NS). This trend continued and was more marked when considering only those patients with HbA(1c) >7.0% at baseline and who reached HbA(1c)<or=7.0% at end-point (44.1% overall), with 52.2 and 36.5% for main mealtime and breakfast groups, respectively (p = 0.028). Most postprandial BG values improved within each group, while the number of hypoglycaemias was low and comparable between the two treatment groups. CONCLUSIONS: A single bolus of glulisine, added to glargine and OADs, resulted in significantly improved HbA(1c) levels, irrespective of whether glulisine was administered at breakfast or at main mealtime. These results may represent a simplified and effective approach to treatment intensification in type 2 diabetes patients.
PMID: 19040645 [PubMed - indexed for MEDLINE]
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Pioglitazone and cardiovascular risk. A comprehensive meta-analysis of randomized clinical trials.
Diabetes Obes Metab. 2008 Dec;10(12):1221-38
Authors: Mannucci E, Monami M, Lamanna C, Gensini GF, Marchionni N
AIM: The aim of this meta-analysis of randomized clinical trials (RCT) was to assess whether pioglitazone is also associated with increased cardiovascular risk, as recently reported for rosiglitazone. METHODS: RCT of pioglitazone were retrieved from Medline (any date up to 31 August 2007; English language only). Unpublished RCT were identified through http://www.clinicaltrials.gov or http://www.fda.gov websites, and results on cardiovascular outcomes were retrieved from investigators and/or sponsors, whenever possible. RCT were included in meta-analysis if pioglitazone was compared with other treatments (placebo, active comparators or no treatment) for at least 4 weeks. Ninety-four trials, 10 of which were unpublished, were retrieved; those included in the analysis, which excluded PROspective PioglitAzone Clinical Trial In MacroVascular Events (PROACTIVE), enrolled 11 268 and 9912 patients in the pioglitazone and comparator groups respectively. Data for analysis, extracted independently by two observers, included all-cause and cardiovascular mortality and incidence of non-fatal coronary events and heart failure. Proportions of outcome measures across treatment groups were compared by odds ratios (ORs) and 95% confidence interval. RESULTS: Pioglitazone was associated with reduced all-cause mortality [OR 0.30 (0.14-0.63); p < 0.05], with no relevant effect on non-fatal coronary events. The observed increase in incidence of non-fatal heart failure was not statistically significant [OR 1.38 (0.90-2.12)]. CONCLUSION: The use of pioglitazone does not appear to be harmful in terms of cardiovascular events and all-cause deaths.
PMID: 18505403 [PubMed - indexed for MEDLINE]
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Comparison of twice-daily injections of biphasic insulin lispro and basal-bolus therapy: glycaemic control and quality-of-life of insulin-naïve type 2 diabetic patients.
Diabetes Obes Metab. 2008 Dec;10(12):1261-5
Authors: Masuda H, Sakamoto M, Irie J, Kitaoka A, Shiono K, Inoue G, Atsuda K, Yamada S
OBJECTIVE: The aim of this study was to evaluate twice-daily injections of biphasic insulin lispro vs. basal-bolus (BB) therapy with regard to quality-of-life (QOL) and glycaemic control in insulin-naïve type 2 diabetic patients. METHODS: Twenty-eight patients with type 2 diabetes were randomized to receive either twice-daily 50/50 premixed insulin lispro (Mix50 group) or BB (NPH insulin at bedtime and preprandial insulin lispro) therapy (BB group) for 12 weeks. Glycated haemoglobin (HbA1C), 1,5-anhydroglucitol (1,5-AG), blood plasma glucose level, body mass index (BMI), daily total insulin dosage and insulin therapy-related QOL (ITR-QOL) were studied. RESULTS: ITR-QOL was significantly better in the Mix50 than in the BB group (103.1 +/- 9.8 vs. 90.6 +/- 19.4; p < 0.05). HbA(1c) improved in both groups (from 11.1 +/- 2.1 to 6.9 +/- 1.0% with Mix50 vs. from 11.0 +/- 2.3 to 6.6 +/- 0.8% with BB therapy). CONCLUSION: These results might suggest that twice-daily injections of premixed rapid-acting insulin analogue therapy could achieve good glycaemic control and better QOL compared with BB therapy in insulin-naïve type 2 diabetes.
PMID: 18494811 [PubMed - indexed for MEDLINE]
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Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes.
Diabetes Obes Metab. 2008 Sep;10(10):959-69
Authors: Scott R, Loeys T, Davies MJ, Engel SS,
AIM: To assess the addition of sitagliptin to ongoing metformin therapy in patients with type 2 diabetes who were inadequately controlled [haemoglobin A(1c) (HbA(1c)) 7-11%] on metformin monotherapy. METHODS: Patients (n = 273) on metformin (>/=1500 mg/day) were randomized to receive the addition of once-daily placebo, sitagliptin 100 mg or rosiglitazone 8 mg in a 1 : 1 : 1 ratio for 18 weeks. The efficacy analysis was based on the all-patients-treated population using an analysis of co-variance with change in HbA(1c) from baseline as the primary endpoint. RESULTS: The mean baseline HbA(1c) was 7.7% for the entire cohort. After 18 weeks, both active add-on therapies led to greater improvements in HbA(1c) from baseline: -0.73% for sitagliptin (p < 0.001 vs. placebo) and -0.79% for rosiglitazone compared with -0.22% for placebo. No difference was observed between the sitagliptin and rosiglitazone treatments (0.06% [95% confidence interval (CI): -0.14 to 0.25]). The proportion of patients achieving an HbA(1c) < 7% was greater with sitagliptin (55%) and rosiglitazone (63%) compared with placebo (38%). Body weight increased from baseline with rosiglitazone (1.5 kg) compared with body weight reduction with sitagliptin (-0.4 kg) and placebo (-0.8 kg). The difference in body weight between the sitagliptin and rosiglitazone groups was 1.9 kg (95% CI: 1.3-2.5). In a prespecified analysis, the proportion of patients experiencing a greater than 3-kg increase in body weight was 21% in the rosiglitazone group compared with 2% in both the sitagliptin and placebo groups. Both active treatments were generally well tolerated, with no increased risk of hypoglycaemia or gastrointestinal adverse events compared with placebo. CONCLUSIONS: In this 18-week study, the addition of sitagliptin was effective and well tolerated in patients with type 2 diabetes inadequately controlled with metformin monotherapy. Treatment with sitagliptin produced similar reductions in HbA(1c) compared with the addition of rosiglitazone.
PMID: 18201203 [PubMed - indexed for MEDLINE]
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Potential benefits of early addition of rosiglitazone in combination with glimepiride in the treatment of type 2 diabetes.
Diabetes Obes Metab. 2008 Sep;10(10):862-73
Authors: Rosenstock J, Chou HS, Matthaei S, Seidel DK, Hamann A
AIM: To assess the efficacy and tolerability of early combination therapy with rosiglitazone (RSG) and glimepiride (GLIM) vs. GLIM monotherapy in patients with type 2 diabetes mellitus (T2DM). METHODS: Strategies for the addition of RSG in combination with GLIM were evaluated with data from two randomized, double-blind, placebo (PBO)-controlled studies. Study A – addition of RSG (4 or 8 mg) or PBO to continued GLIM 3 mg once daily; study B – addition of low-dose RSG (4 mg) prior to uptitration of GLIM (from 2 to 4 mg) vs. continued uptitration of GLIM (from 2 to 8 mg). RESULTS: Study A reported significant reductions in fasting plasma glucose (FPG) from baseline to week 26 with the addition of both 4 and 8 mg RSG to GLIM 3 mg [-21 mg/dl (-1.2 mmol/l), p = 0.0019 and -43 mg/dl (-2.4 mmol/l), p < 0.0001, respectively] and in haemoglobin A(1c) (HbA(1c)) (-0.63%, p = 0.00015 and -1.17%, p < 0.0001, respectively) from a baseline of 8.2 and 8.1%, respectively. At the end of the study, target HbA(1c) <7.0% was achieved in 43 and 68% of patients in the RSG 4 mg + GLIM and RSG 8 mg + GLIM groups, respectively, compared with 32% in the PBO + GLIM (GLIM alone) group. In study B, addition of RSG to GLIM reduced mean FPG and HbA(1c) levels at week 24 from baseline [-28 mg/dl (-1.5 mmol/l), p < 0.0001, and -0.68%, p < 0.0001, respectively]. There were no significant changes with GLIM monotherapy in either study. Favourable effects of RSG + GLIM on insulin sensitivity, beta-cell function and cardiovascular disease biomarkers were also observed. All treatments were similarly well tolerated. CONCLUSIONS: Early addition of RSG to GLIM is an effective and well-tolerated treatment option to improve glycaemic control in sulphonylurea-treated patients with T2DM.
PMID: 18201206 [PubMed - indexed for MEDLINE]
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Insulin therapy in renal disease.
Diabetes Obes Metab. 2008 Sep;10(10):811-23
Authors: Iglesias P, Díez JJ
Diabetes mellitus (DM) is the main cause of end-stage renal disease (ESRD). Conversely, chronic renal failure (CRF) is also associated with diverse alterations in carbohydrate and insulin metabolism. CRF-induced metabolic disorders should be borne in mind when treating diabetic patients, to ensure the introduction of adequate therapy adjustments that are in line with the onset of renal function decline. Moreover, several specific therapies employed in CRF may also influence pharmacological therapy of DM in uraemic patients. Adequate glycaemic control has also been associated with a reduction in the onset and progression of diabetic nephropathy as well as in the morbidity and mortality in uraemic diabetic patients during dialysis. Intensive insulin therapy can notably improve glycemic control and it should be considered part of the management of insulin-treated CRF diabetic patients. Insulin analogues have been recently evaluated in CRF diabetic patients, with encouraging results. In this study, we review the more relevant aspects related to insulin therapy in diabetic patients with different degrees of renal failure and in patients with ESRD, both in conservative therapy and dialysis.
PMID: 18248491 [PubMed - indexed for MEDLINE]
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Insulin management in overweight or obese type 2 diabetes patients: the role of insulin glargine.
Diabetes Obes Metab. 2008 Jul;10 Suppl 2:42-9
Authors: Davies M, Khunti K
Type 2 diabetes mellitus (T2DM) and obesity commonly co-exist. Improved clinical management of T2DM and improved glycaemic control with traditional therapies including insulin usually result in some weight gain – a frequently perceived barrier to the introduction of insulin by both patient and healthcare professionals. Weight gain of 2.5 kg per 1% change in haemoglobin A(1c) (HbA(1c)) is common in many studies. Strategies to minimize weight gain, particularly in obese patients, are essential to help patients better manage their diabetes and improve quality of life. Insulin analogues with lower risk of hypoglycaemia and better within-patient variability compared with human insulin may help facilitate reaching treatment goals. Moreover, weight gain can be minimized by earlier insulinization and the use of basal insulin, such as insulin glargine, instead of premixed insulin. Data specific to the obese patient with T2DM are presented; they are currently limited but do indicate that insulin glargine therapy is associated with improved glycaemic control as well as less weight gain than other insulins, such as premixed insulin and prandial insulin regimens. Retrospective subanalyses of earlier trials and ongoing studies would shed further light on the impact of insulin therapy in obese people with T2DM in addition to determination of optimal therapeutic strategies.
PMID: 18577156 [PubMed - indexed for MEDLINE]
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Insulin therapy in elderly patients with type 2 diabetes: the role of insulin glargine.
Diabetes Obes Metab. 2008 Jul;10 Suppl 2:35-41
Authors: Janka HU
Within the USA, between 1980 and 2005, the prevalence of diagnosed diabetes has increased in all age groups, with the age group 65-74 years having the highest prevalence. The treatment of type 2 diabetes mellitus (T2DM) in elderly people is made more difficult than in their younger counterparts, primarily owing to the impact of co-morbidities, complications and hypoglycaemia as well as technical difficulties with insulin injections. Accordingly, the treatment approach for elderly patients with T2DM may need to be modified to accommodate co-morbidities and illnesses associated with ageing. Risks associated with insulin therapy, particularly hypoglycaemia, have traditionally limited the use of insulin in this patient population. Insulin glargine is associated with a low risk of hypoglycaemia compared with neutral protamine Hagedorn insulin, for example, and could thus provide a treatment of choice for healthcare providers when considering the increasing prevalence of diabetes in the elderly population. A regimen based on insulin glargine plus oral agents provides clinicians with a tool to help meet therapeutic targets in this population without increasing risk of hypoglycaemia.
PMID: 18577155 [PubMed - indexed for MEDLINE]
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Initiation of insulin glargine therapy in type 2 diabetes subjects suboptimally controlled on oral antidiabetic agents: results from the AT.LANTUS trial.
Diabetes Obes Metab. 2008 May;10(5):387-99
Authors: Davies M, Lavalle-González F, Storms F, Gomis R,
OBJECTIVE: For many patients with type 2 diabetes, oral antidiabetic agents (OADs) do not provide optimal glycaemic control, necessitating insulin therapy. Fear of hypoglycaemia is a major barrier to initiating insulin therapy. The AT.LANTUS study investigated optimal methods to initiate and maintain insulin glargine (LANTUS, glargine, Sanofi-aventis, Paris, France) therapy using two treatment algorithms. This subgroup analysis investigated the initiation of once-daily glargine therapy in patients suboptimally controlled on multiple OADs. RESEARCH DESIGN AND METHODS: This study was a 24-week, multinational (59 countries), multicenter (611), randomized study. Algorithm 1 was a clinic-driven titration and algorithm 2 was a patient-driven titration. Titration was based on target fasting blood glucose < or =100 mg/dl (< or =5.5 mmol/l). Algorithms were compared for incidence of severe hypoglycaemia [requiring assistance and blood glucose <50 mg/dl (<2.8 mmol/l)] and baseline to end-point change in haemoglobin A(1c) (HbA(1c)). RESULTS: Of the 4961 patients enrolled in the study, 865 were included in this subgroup analysis: 340 received glargine plus 1 OAD and 525 received glargine plus >1 OAD. Incidence of severe hypoglycaemia was <1%. HbA(1c) decreased significantly between baseline and end-point for patients receiving glargine plus 1 OAD (-1.4%, p < 0.001; algorithm 1 -1.3% vs. algorithm 2 -1.5%; p = 0.03) and glargine plus >1 OAD (-1.7%, p < 0.001; algorithm 1 -1.5% vs. algorithm 2 -1.8%; p = 0.001). CONCLUSIONS: This study shows that initiation of once-daily glargine with OADs results in significant reduction of HbA(1c) with a low risk of hypoglycaemia. The greater reduction in HbA(1c) was seen in patients randomized to the patient-driven algorithm (algorithm 2) on 1 or >1 OAD.
PMID: 18355327 [PubMed - indexed for MEDLINE]
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Improved glycaemic control of thrice-daily biphasic insulin aspart compared with twice-daily biphasic human insulin; a randomized, open-label trial in patients with type 1 or type 2 diabetes.
Diabetes Obes Metab. 2008 Mar;10(3):229-37
Authors: Clements MR, Tits J, Kinsley BT, Råstam J, Friberg HH, Ligthelm RJ
AIM: This trial evaluated the potential for improving glycaemic control by intensifying a conventional twice-daily therapy with premixed human insulin (HI) to a thrice-daily regimen using premixed formulations of biphasic insulin aspart (BIAsp) in patients with type 1 or type 2 diabetes. METHODS: This was a multicentre, open-label, parallel group trial. After a 4-week run-in period, patients were randomized 1 : 1 to 16 weeks of treatment. A total of 748 patients were screened, 664 were exposed to trial drug and 604 completed the trial. RESULTS: Haemoglobin A(1c), the primary efficacy endpoint, was shown to be significantly lower for the BIAsp treatment group compared with the biphasic HI (BHI) 30 group [estimated mean difference: -0.32, 95% confidence interval (CI) (-0.48; -0.16), p = 0.0001]. The average blood glucose level was significantly lower in the BIAsp group [estimated mean difference: -0.79, 95% CI (-1.17; -0.40), p = 0.0001]. There were few major hypoglycaemic episodes, 11 in the BIAsp group and 7 in the BHI 30 group. Although intensification of insulin therapy with BIAsp three times a day was associated with a higher risk of minor hypoglycaemia (relative risk = 1.58, p = 0.0038), the overall rate of minor hypoglycaemia remained low with both the BIAsp and the BHI treatments (13.1 vs. 8.3 episodes/patient year respectively). Overall safety and patient satisfaction were similar with the two insulin therapies. CONCLUSIONS: This trial confirmed that a thrice-daily BIAsp regimen can safely be used to intensify treatment for patients inadequately controlled on twice-daily BHI. A treat-to-target trial is required to explore the full potential of the BIAsp regimens and evaluate their use as a viable alternative to intensification with a basal-bolus regimen.
PMID: 18269638 [PubMed - indexed for MEDLINE]
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