Early glycaemic control in metformin users receiving their first add-on therapy: a population-based study of 4,734 people with type 2 diabetes

Thomsen, Reimar Wernich; Baggesen, Lisbeth M.; Søgaard, Mette; Pedersen, Lars; Nørrelund, Helene; Buhl, Esben S.; Haase, Christiane L

doi:10.1007/s00125-015-3698-1

Cited by 31 publications

(41 citation statements)

References 8 publications

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“…Thomsen et al 7 also noted that the threshold for intensification had fallen over the years, from about 8.8% in 2000-3 to about 8.1% in 2010-12 (estimated from graph in supplementary material; figure 3). If this has also occurred in the UK, it reinforces the need to be selective in extracting effect sizes for modelling.…”

Section: Triple Therapymentioning

confidence: 97%

Canagliflozin, dapagliflozin and empagliflozin monotherapy for treating type 2 diabetes: systematic review and economic evaluation

Johnston

Uthman

Cummins

et al. 2017

Health Technol Assess

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Background Most people with type 2 diabetes are overweight, so initial treatment is aimed at reducing weight and increasing physical activity. Even modest weight loss can improve control of blood glucose. If drug treatment is necessary, the drug of first choice is metformin. However, some people cannot tolerate metformin, which causes diarrhoea in about 10%, and it cannot be used in people with renal impairment. This review appraises three of the newest class of drugs for monotherapy when metformin cannot be used, the sodium–glucose co-transporter 2 (SGLT2) inhibitors. Objective To review the clinical effectiveness and cost-effectiveness of dapagliflozin (Farxiga, Bristol-Myers Squibb, Luton, UK), canagliflozin (Invokana, Janssen, High Wycombe, UK) and empagliflozin (Jardiance, Boehringer Ingelheim, Ingelheim, Germany/Eli Lilly and Company, Indianapolis, IN, USA), in monotherapy in people who cannot take metformin. Sources MEDLINE (1946 to February 2015) and EMBASE (1974 to February 2015) for randomised controlled trials lasting 24 weeks or more. For adverse events, a wider range of studies was used. Three manufacturers provided submissions. Methods Systematic review and economic evaluation. A network meta-analysis was carried out involving the three SGLT2 inhibitors and key comparators. Critical appraisal of submissions from three manufacturers. Results We included three trials of dapagliflozin and two each for canagliflozin and empagliflozin. The trials were of good quality. The canagliflozin and dapagliflozin trials compared them with placebo, but the two empagliflozin trials included active comparators. All three drugs were shown to be effective in improving glycaemic control, promoting weight loss and lowering blood pressure (BP). Limitations There were no head-to-head trials of the different flozins, and no long-term data on cardiovascular outcomes in this group of patients. Most trials were against placebo. The trials were done in patient groups that were not always comparable, for example in baseline glycated haemoglobin or body mass index. Data on elderly patients were lacking. Conclusions Dapagliflozin, canagliflozin and empagliflozin are effective in improving glycaemic control, with added benefits of some reductions in BP and weight. Adverse effects are urinary and genital tract infections in a small proportion of users. In monotherapy, the three drugs do not appear cost-effective compared with gliclazide or pioglitazone, but may be competitive against sitagliptin (Januvia, Merck Sharp & Dohme Limited, Kenilworth, NJ, USA). Funding The National Institute for Health Research Health Technology Assessment programme.

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Section: Triple Therapymentioning

confidence: 97%

Canagliflozin, dapagliflozin and empagliflozin monotherapy for treating type 2 diabetes: systematic review and economic evaluation

Johnston

Uthman

Cummins

et al. 2017

Health Technol Assess

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“…GLP-1 RAs are broadly recommended as add-on to monotherapy with metformin or in combination with multiple oral agents and insulin for patients with poorly controlled diabetes (21,24). In this study, greater efficacy was observed in the subgroup of patients who were not receiving an SU.…”

Section: Discussionmentioning

confidence: 62%

Efficacy and Safety of ITCA 650, a Novel Drug-Device GLP-1 Receptor Agonist, in Type 2 Diabetes Uncontrolled With Oral Antidiabetes Drugs: The FREEDOM-1 Trial

et al. 2017

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OBJECTIVEITCA 650 (exenatide in osmotic mini-pump) continuously delivers exenatide subcutaneously for 3-6 months. Two doses of ITCA 650 were compared with placebo in patients with uncontrolled type 2 diabetes. RESEARCH DESIGN AND METHODSThis 39-week, phase 3, double-blind, placebo-controlled trial randomized 460 patients aged 18-80 years with glycated hemoglobin (HbA 1c ) 7.5-10% [58-86 mmol/mol] 1:1:1 to placebo, ITCA 650 40 mg/day, or ITCA 650 60 mg/day. Primary end point was change in HbA 1c at 39 weeks. was attained in 37%, 44%, and 9% of ITCA 650 40 mg/day, ITCA 650 60 mg/day, and placebo groups, respectively (P < 0.001 each dose vs. placebo). LS mean change from baseline body weight was 22.3 kg and 23.0 kg for ITCA 650 40 and 60 mg/day, respectively (P £ 0.015 vs. placebo 21.0 kg). Nausea was the most common adverse event (AE) and subsided over time. Discontinuation for gastrointestinal AEs occurred in 7.2% with ITCA and 1.3% with placebo. Most AEs associated with procedures to place and remove ITCA 650 were mild and transient. RESULTS Least squares (LS) mean change from baseline CONCLUSIONSITCA 650 significantly reduced HbA 1c and weight compared with placebo and was well tolerated in patients with uncontrolled type 2 diabetes on oral antidiabetes medications.

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“…Overall, 29.3–64.5% [28–32, 34, 36, 39, 42, 43, 45, 46, 48, 49, 52–54, 56–58, 70, 73] and 22.05–41.03% [28, 42, 45, 49, 52, 53, 56] patients with T2DM treated with liraglutide met the <7% and ≤6.5% HbA1c targets, respectively (for baseline characteristics of study population in these studies; see supplementary file 2).…”

Section: Resultsmentioning

confidence: 99%

Clinical Effectiveness of Liraglutide in Type 2 Diabetes Treatment in the Real-World Setting: A Systematic Literature Review

Ostawal¹,

Mocevic

Kragh

et al. 2016

Diabetes Ther

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IntroductionIn clinical trials, liraglutide has proven to be an effective drug for the treatment of type 2 diabetes mellitus (T2DM). The real-world effectiveness of liraglutide has been investigated in numerous studies. The aim of this systematic literature review is to collate evidence on the real-world clinical effectiveness of liraglutide.MethodsA review of publications from Medline, EMBASE, the Cochrane Library, and conference proceedings was conducted to identify observational studies that assessed the clinical effectiveness of liraglutide in real-world clinical practice. This review was conducted according to the National Institute of Health and Care Excellence (NICE) guidance. No language or time limits were applied, except to the conference proceedings (2013–2015). Endpoints for data extraction were decided a priori. Study quality appraisal was done for full-text journal articles.ResultsOf 124 publications included in the review, 43 were full-text articles. Liraglutide significantly reduces glycated hemoglobin (HbA1c) within 6 months of initiating treatment (mean change in HbA1c from baseline: −0.9% to −2.2%; HbA1c <7.0%: 29.5–65.0%). The NICE composite endpoint (HbA1c reduction ≥1% and weight reduction ≥3%) was met in 16.9–47.0% of patients with liraglutide treatment. Liraglutide therapy led to a mean change in absolute weight from baseline of −1.3 to −8.65 kg. Liraglutide treatment was well tolerated in patients with T2DM. The rate of occurrence of hypoglycemia with liraglutide monotherapy was ≤0.8%. Hypoglycemia was more common in patients taking antidiabetic medications (0.0–15.2%) together with liraglutide. The beneficial glycemic and weight effect of liraglutide therapy in patients with T2DM was maintained for at least 12 months.ConclusionEvidence from observational studies reflecting real-world clinical practice demonstrates that liraglutide therapy improves glycemic control with a low risk of hypoglycemia, and is associated with significant weight loss in patients with T2DM. These observations are consistent with clinical trial findings.FundingNovo Nordisk A/S, Søborg, Denmark.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-016-0180-0) contains supplementary material, which is available to authorized users.

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Early glycaemic control in metformin users receiving their first add-on therapy: a population-based study of 4,734 people with type 2 diabetes

Cited by 31 publications

References 8 publications

Canagliflozin, dapagliflozin and empagliflozin monotherapy for treating type 2 diabetes: systematic review and economic evaluation

Canagliflozin, dapagliflozin and empagliflozin monotherapy for treating type 2 diabetes: systematic review and economic evaluation

Efficacy and Safety of ITCA 650, a Novel Drug-Device GLP-1 Receptor Agonist, in Type 2 Diabetes Uncontrolled With Oral Antidiabetes Drugs: The FREEDOM-1 Trial

Clinical Effectiveness of Liraglutide in Type 2 Diabetes Treatment in the Real-World Setting: A Systematic Literature Review

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