Towards an improved global understanding of treatment and outcomes in people with type 2 diabetes: Rationale and methods of the DISCOVER observational study program

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Aim To assess glycaemic control and factors associated with poor glycaemic control at initiation of second‐line therapy in the DISCOVER programme. Materials and methods DISCOVER (NCT02322762 and NCT02226822) comprises two similar prospective observational studies of 15 992 people with type 2 diabetes (T2D) initiating second‐line glucose‐lowering therapy in 38 countries across six regions (Africa, Americas, South‐East Asia, Eastern Mediterranean, Europe and Western Pacific). Data were collected using a standardized case report form. Glycated haemoglobin (HbA1c) levels were measured according to standard clinical practice in each country, and factors associated with poor glycaemic control (HbA1c >8.0%) were evaluated using hierarchical regression models. Results HbA1c levels were available for 80.9% of patients (across‐region range [ARR] 57.5%‐97.5%); 92.2% (ARR 59.2%‐99.1%) of patients had either HbA1c or fasting plasma glucose levels available. The mean HbA1c was 8.3% (ARR 7.9%‐8.7%). In total, 26.7% of patients had an HbA1c level ≥9.0%, with the highest proportions in South‐East Asia (35.6%). Factors associated with having HbA1c >8.0% at initiation of second‐line therapy included low education level, low country income, and longer time since T2D diagnosis. Conclusions The poor levels of glycaemic control at initiation of second‐line therapy suggest that intensification of glucose‐lowering treatment is delayed in many patients with T2D. In some countries, HbA1c levels are not routinely measured. These findings highlight an urgent need for interventions to improve monitoring and management of glycaemic control worldwide, particularly in lower‐middle‐ and upper‐middle‐income countries.

Section: Discussionmentioning

confidence: 99%

Glycaemic control in patients with type 2 diabetes initiating second‐line therapy: Results from the global DISCOVER study programme

Khunti

Chen

Cid‐Ruzafa³

et al. 2019

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“…The methods for the DISCOVER study programme have been reported in detail elsewhere, and are briefly summarized below.…”

Section: Methodsmentioning

confidence: 99%

Treatment patterns and associated factors in 14 668 people with type 2 diabetes initiating a second‐line therapy: Results from the global DISCOVER study programme

Nicolucci

Charbonnel

Gomes

et al. 2019

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Aim To evaluate treatment data from DISCOVER (NCT02322762 and NCT02226822), a global, prospective, observational study programme of patients with type 2 diabetes initiating a second‐line glucose‐lowering therapy. Materials and Methods Data were collected using a standardized case report form. First‐ and second‐line treatments were assessed in 14 668 patients from 37 countries across six regions. Among patients prescribed first‐line metformin monotherapy, Firth logistic regression models were used to assess factors associated with second‐line treatment choices. Results The most common first‐line therapies were metformin monotherapy (57.9%) and combinations of metformin with a sulphonylurea (14.6%). The most common second‐line therapies were combinations of metformin with other agents (72.2%), including dipeptidyl peptidase‐4 (DPP‐4) inhibitors (25.1%) or sulphonylureas (21.3%). Among patients prescribed first‐line metformin monotherapy, the most common second‐line therapies were combinations of metformin with a DPP‐4 inhibitor [32.8%; across‐region range (ARR): 2.4%‐51.3%] or a sulphonylurea (30.0%; ARR: 18.3%‐63.6%); only a few patients received combinations of metformin with sodium‐glucose co‐transporter‐2 inhibitors (6.7%; ARR: 0.0%‐10.8%) or glucagon‐like peptide‐1 receptor agonists (1.9%; ARR: 0.1%‐4.5%). Both clinical and non‐medical factors were associated with choice of second‐line therapy after metformin monotherapy. Conclusions Fewer patients than expected received metformin monotherapy at first line, and the use of newer therapies at second line was uncommon in some regions of the world. Patients' socioeconomic status was associated with treatment patterns, suggesting that therapy choices are influenced by cost and access.

“…The scope of DISCOVER is ambitious and holistic, with the goal of obtaining as detailed a picture as possible of the management of T2D across the globe, and to highlight specific areas for improvement in the included countries that might also be applicable to other countries. Data on physiological variables (including height, weight and seated blood pressure), laboratory test results (including glycated haemoglobin [HbA1c] and fasting plasma glucose measurements), glucose‐lowering treatments (including reasons for treatment selection), socio‐economic and demographic characteristics, and clinical and patient‐reported outcomes are collected by clinicians during routine visits . A mixed methodology is used for data collection: investigators use an electronic (or paper) case report form to record patient clinical data at study visits and information from patient medical records is automatically extracted in countries where this is possible (Canada, Denmark, France, Norway and Sweden).…”

Section: The Global Discover Studymentioning

confidence: 99%

“…The DISCOVER study programme (http://clinicaltrials.gov identifiers: NCT02322762 and NCT02226822 [J‐DISCOVER, in Japan]) was set up to address the knowledge gaps in the management and clinical outcomes of people with T2D. The overarching aim of the programme is to describe patient characteristics, evolution of disease management patterns and clinical outcomes over 3 years in people with T2D who are initiating a second‐line glucose‐lowering therapy in a real‐world setting.…”

Section: The Global Discover Studymentioning

confidence: 99%

“…Major strengths of DISCOVER are the large number of patients enrolled and the long follow‐up period, which will provide valuable data on the association between second‐line treatment selection and clinical outcomes . DISCOVER is limited by issues inherent to observational research, including the potential for patient selection bias.…”

Section: The Global Discover Studymentioning

confidence: 99%

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Type 2 diabetes treatment and outcomes worldwide: A short review of the DISCOVER study programme

Khunti

Medina

et al. 2019

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The global burden of type 2 diabetes (T2D) is increasing, indicating an urgent need for improved disease prevention and management strategies. Contemporary, global, real‐world data, collected in a consistent way, on the characteristics, treatment and outcomes of people with T2D are lacking, particularly in low‐ and middle‐income countries where disease burden is increasing most rapidly. The DISCOVER study programme (http://clinicaltrials.gov identifiers: NCT02322762 and NCT02226822) is a global, prospective, 3‐year programme of observational research, which has been designed to fill this knowledge gap. DISCOVER is being conducted in 38 countries across six continents, including several lower‐middle‐ and upper‐middle‐income countries where patients have rarely or never been studied previously. In total, 15 992 people with T2D who had initiated a second‐line glucose‐lowering therapy have been recruited. Data being collected include information on demographics, clinical and treatment characteristics, socio‐economic status, clinical outcomes and patient‐reported outcomes. Findings from DISCOVER will provide unique insights into current patterns of T2D care worldwide, which should contribute to informing clinical guidelines and health policy, and may help to improve patient care.