Comparison between vildagliptin and metformin to sustain reductions in HbA<sub>1c</sub> over 1 year in drug‐naïve patients with Type 2 diabetes

Schweizer, Anja; Couturier, A.; Foley, James E.; Dejager, S.

doi:10.1111/j.1464-5491.2007.02191.x

Cited by 235 publications

(247 citation statements)

References 23 publications

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“…As seen consistently in previous studies [6,7,11,13,14], vildagliptin was weight-neutral. Although vildagliptin is thought to act primarily through increasing plasma levels of the active form of GLP-1 and GLP-1 agonists can lead to substantial weight loss [20], the degree of GLP-1 receptor signalling induced by the more physiological levels of GLP-1 achieved with vildagliptin may underlie the lack of weight gain but be insufficient to elicit significant weight loss.…”

Section: Discussionsupporting

confidence: 58%

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Comparison of vildagliptin and acarbose monotherapy in patients with Type 2 diabetes: a 24‐week, double‐blind, randomized trial

et al. 2008

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Aims To compare the efficacy and tolerability of the dipeptidyl peptidase-4 inhibitor, vildagliptin, with the alpha glucosidase inhibitor, acarbose, in drug-naive patients with Type 2 diabetes.Methods This multi-centre, randomized, double-blind, parallel-arm study compared the efficacy and tolerability of vildagliptin (100 mg daily, given as 50 mg twice daily, n = 441) and acarbose (up to 300 mg daily, given as three equally divided doses, n = 220) during 24-week treatment in drug-naive patients with Type 2 diabetes.Results Monotherapy with vildagliptin or acarbose decreased glycated haemoglobin (HbA 1c ) (baseline ≈ 8.6%) to a similar extent during 24-week treatment. The adjusted mean change from baseline to end-point (AM Δ ) in HbA 1c was − 1.4 ± 0.1% and − 1.3 ± 0.1% in patients receiving vildagliptin and acarbose, respectively, meeting the statistical criterion for non-inferiority (upper limit of 95% confidence interval for between-treatment difference ≤ 0.4%). The decrease in fasting plasma glucose was similar with acarbose ( − 1.5 ± 0.2 mmol/l) and vildagliptin ( − 1.2 ± 0.1 mmol/l). Body weight did not change in vildagliptin-treated patients ( − 0.4 ± 0.1 kg) but decreased in acarbose-treated patients ( − 1.7 ± 0.2 kg, P < 0.001 vs. vildagliptin). The proportion of patients experiencing any adverse event (AE) was 35% vs. 51% in patients receiving vildagliptin or acarbose, respectively; gastrointestinal AEs were significantly more frequent with acarbose (25.5%) than vildagliptin (12.3%, P < 0.001). No hypoglycaemia was reported for either group. ConclusionsVildagliptin is effective and well tolerated in patients with Type 2 diabetes, demonstrating similar glycaemic reductions to acarbose, but with better tolerability. Diabet. Med. 25, 435-441 (2008)

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Section: Discussionsupporting

confidence: 58%

“…In such head-to-head studies, vildagliptin (100 mg daily) is non-inferior to rosiglitazone (8 mg daily) [13] but not to metformin (2000 mg daily) [14]. The alpha-glucosidase inhibitor acarbose is commonly used as first-line therapy in several countries, including China, but gastrointestinal side-effects can be problematic.…”

Section: Introductionmentioning

confidence: 99%

Comparison of vildagliptin and acarbose monotherapy in patients with Type 2 diabetes: a 24‐week, double‐blind, randomized trial

et al. 2008

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“…In a 24-week study involving 354 people with type 2 diabetes, vildagliptin monotherapy (50 mg once daily, 50 mg twice daily or 100 mg once daily) improved glycaemic control but did not produce significant body weight change. Weight reduction relative to baseline was ≤0.4 kg in each treatment group, whereas placebo was associated with a weight reduction of 1.4 kg [120].While the available clinical data suggest that vildagliptin monotherapy significantly lowers HbA1c, it was not as effective as metformin alone (−1.0 vs. −1.4 for vildagliptin and metformin, respectively) [121]. Compared with vildagliptin, metformin monotherapy produced statistically significant reductions in weight (−1.9 ± 0.3 kg; p < 0.001) [121].…”

mentioning

confidence: 80%

“…Compared with vildagliptin, metformin monotherapy produced statistically significant reductions in weight (−1.9 ± 0.3 kg; p < 0.001) [121].…”

Section: Dpp-4mentioning

confidence: 99%

Diabesity: therapeutic options

Colagiuri¹

2010

Diabetes Obesity Metabolism

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A pathogenic relationship exists between type 2 diabetes and obesity. Over the last decade, the escalation in diabetes cases has paralleled the rapid increase in obesity rates, constituting a global health crisis. Environmental risk factors attributed to the global increase in obesity include the consumption of high-calorie, high-fat foods and inadequate physical activity. Obese individuals may also have a genetic predisposition for obesity. Both diabetes and obesity confer an elevated risk of developing a range of complications and comorbidities, including cardiovascular disease, hypertension and stroke, which can complicate disease management. This review examines the aetiology of the linkages between diabetes and obesity and the range of available therapies. Recent clinical evidence substantiating the efficacy and safety of incretin-based antidiabetic therapies is analysed, in addition to data on antiobesity therapeutic strategies, such as antiobesity agents, behaviour modification and bariatric surgery. Glucose control is often accompanied by weight-neutral or modest weight reduction effects with DPP-4 inhibitor treatment (sitagliptin, vildagliptin, saxagliptin) and weight loss with GLP-1 receptor agonist therapy (exenatide, liraglutide). Studies of antiobesity agents including orlistat, sibutramine and rimonabant have shown attrition rates of 30-40%, and the long-term effects of these agents remain unknown. Bariatric surgical procedures commonly performed are laparoscopic adjustable banding of the stomach and the Roux-en-Y gastric bypass, and have produced type 2 diabetes remission rates of up to 73%. Therapeutic strategies that integrate glycaemic control and weight loss will assume greater importance as the prevalence of diabetes and obesity increase. Keywords: DPP-4, exenatide, GLP-1 analogue, human, incretin, liraglutide, once-daily, type 2 diabetes mellitus Date submitted 2 June 2009; date of first decision 2 November 2009; date of final acceptance 4 November 2009 IntroductionThe term 'diabesity', coined by Sims and colleagues [1] in the 1970s, describes the strong link between type 2 diabetes and obesity [1,2]. As evidence of this pathogenic interrelationship continues to accumulate, so does the appearance of the term in the clinical literature. A large body of clinical evidence attests to the relationship between being overweight or obese and being at an elevated risk for development of type 2 diabetes [3][4][5][6][7]. The risk escalates with the degree of excess weight, increasing threefold with a body mass index (BMI) of 25.0-29.9 kg/m 2 and 20-fold with a BMI over 30 kg/m 2 [4]. In particular, abdominal fat accumulation exacerbates insulin resistance and confers a strong, independent risk of developing diabetes [8]. Global diabetes prevalence is estimated at 171 million and is projected to more than double, to 366 million, by 2030 [9]. Countries with the highest numbers of diabetes cases include India, China, USA, Indonesia and Japan [9][10][11]. The greatest relative increases in diabetes incide...

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“…As metformin is considered the first-line drug therapy for the management of T2DM [10,11], it is of interest to compare the efficacy (and safety) of aDPP-4 inhibitor with that of metformin in drug-naive T2DM patients insufficiently controlled with diet and exercise [12][13][14][15][16][17][18][19][20][21]. Overall, metformin (1000-2000 mg/day) demonstrated slightly (but significantly) greater reductions in both HbA 1c and body weight ( Table 1, Fig.…”

Section: Gliptins As Monotherapymentioning

confidence: 99%

DPP-4 inhibitors in the management of type 2 diabetes: A critical review of head-to-head trials

Scheen¹

2012

Diabetes & Metabolism

170

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Dipeptidyl peptidase-4 (DPP-4) inhibitors offer new options for the management of type 2 diabetes. Direct comparisons with active glucose-lowering comparators in drug-naive patients have demonstrated that DPP-4 inhibitors exert slightly less pronounced HbA 1c reduction than metformin (with the advantage of better gastrointestinal tolerability) and similar glucose-lowering effects as with a thiazolidinedione (TZD; with the advantage of no weight gain). In metformin-treated patients, gliptins were associated with similar HbA 1c reductions compared with a sulphonylurea (SU; with the advantage of no weight gain, considerably fewer hypoglycaemic episodes and no need for titration) and a TZD (with the advantage of no weight gain and better overall tolerability). DPP-4 inhibitors also exert clinically relevant glucose-lowering effects compared with a placebo in patients treated with SU or TZD (of potential interest when metformin is either not tolerated or contraindicated), and as oral triple therapy with a good tolerability profile when added to a metformin-SU or pioglitazone-SU combination. Several clinical trials also showed a consistent reduction in HbA 1c when DPP-4 inhibitors were added to basal insulin therapy, with no increased risk of hypoglycaemia. Because of the complex pathophysiology of type 2 diabetes and the complementary actions of glucose-lowering agents, initial combination of a DPP-4 inhibitor with either metformin or a glitazone may be applied in drug-naive patients, resulting in greater efficacy and similar safety compared with either drug as monotherapy. However, DPP-4 inhibitors were less effective than GLP-1 receptor agonists for reducing HbA 1c and body weight, but offer the advantage of being easier to use (oral instead of injected administration) and lower in cost. Only one head-tohead trial demonstrated the non-inferiority of saxagliptin vs sitagliptin. Clearly, more trials of direct comparisons between different incretin-based therapies are needed. Because of their pharmacokinetic characteristics, pharmacodynamic properties (glucose-dependent glucose-lowering effect) and good overall tolerability profile, DPP-4 inhibitors may have a key role to play in patients with renal impairment and in the elderly. The role of DPP-4 inhibitors in the therapeutic armamentarium of type 2 diabetes is rapidly evolving as their potential strengths and weaknesses become better defined mainly through controlled clinical trials. Keywords:Clinical trial-DPP-4 inhibitor; Alogliptin; Linagliptin; Saxagliptin; Sitagliptin; Vildagliptin; Type 2 diabetes mellitus; Review Résumé Les inhibiteurs de la DPP-4 dans le traitement du diabète de type 2 : revue critique des essais cliniques contrôlés.Les inhibiteurs de la dipeptidylpeptidase-4 (DPP-4) offrent de nouvelles options pour le traitement du diabète de type 2. Des comparaisons directes avec d'autres médicaments antidiabétiques chez des patients naïfs de tout traitement ont démontré que les inhibiteurs de la DPP-4 étaient un peu moins puissants pour diminuer ...

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Comparison between vildagliptin and metformin to sustain reductions in HbA_1c over 1 year in drug‐naïve patients with Type 2 diabetes

Cited by 235 publications

References 23 publications

Comparison of vildagliptin and acarbose monotherapy in patients with Type 2 diabetes: a 24‐week, double‐blind, randomized trial

Comparison of vildagliptin and acarbose monotherapy in patients with Type 2 diabetes: a 24‐week, double‐blind, randomized trial

Diabesity: therapeutic options

DPP-4 inhibitors in the management of type 2 diabetes: A critical review of head-to-head trials

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Comparison between vildagliptin and metformin to sustain reductions in HbA1c over 1 year in drug‐naïve patients with Type 2 diabetes

Cited by 235 publications

References 23 publications

Comparison of vildagliptin and acarbose monotherapy in patients with Type 2 diabetes: a 24‐week, double‐blind, randomized trial

Comparison of vildagliptin and acarbose monotherapy in patients with Type 2 diabetes: a 24‐week, double‐blind, randomized trial

Diabesity: therapeutic options

DPP-4 inhibitors in the management of type 2 diabetes: A critical review of head-to-head trials

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Comparison between vildagliptin and metformin to sustain reductions in HbA_1c over 1 year in drug‐naïve patients with Type 2 diabetes