scholarly journals Risk of anaemia with metformin use in type 2 diabetes: A MASTERMIND study

2020 ◽  
Author(s):  
Louise A Donnelly ◽  
John M Dennis ◽  
Ruth L Coleman ◽  
Naveed Sattar ◽  
Andrew T Hattersley ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Real World ◽  
Time Course ◽  
Controlled Trial ◽  
Vitamin B12 Deficiency ◽  
Population Data ◽  
World Population ◽  
Metformin Group ◽  
Randomised Controlled

<b>Objective:</b> To evaluate the association between metformin use and anaemia risk in type 2 diabetes, and the time-course for this, in randomised controlled trial (RCT) and real-world population data. <p><b>Research design and methods:</b> Anaemia was defined as a haemoglobin measure less than 11g/dL. In RCTs (ADOPT (n=3,967), UKPDS (n=1,473)), logistic regression was used to model anaemia risk and non-linear mixed models for change in haematological parameters.In the observational GoDARTS population (n=3,485), discrete-time failure analysis was used to model the effect of cumulative metformin exposure on anaemia risk. </p> <p><b>Results:</b> In ADOPT, compared with sulfonylureas, the odds ratio(OR)(95%CI) for anaemia was 1.93(1.10,3.38) for metformin and 4.18(2.50,7.00) for thiazolidinediones. In UKPDS, compared with diet, the OR(95%CI) was 3.40(1.98,5.83) for metformin, 0.96(0.57,1.62) for sulfonylureas and 1.08(0.62,1.87) for insulin. </p> <p>In ADOPT, haemoglobin and haematocrit dropped following metformin initiation by six months, with no further decrease after three years. In UKPDS, haemoglobin fell by three years in the metformin group compared to other treatments. At years six and nine, haemoglobin was reduced in all treatment groups, with no greater difference seen in the metformin group. In GoDARTS, each 1g/day of metformin use was associated with a 2% higher annual risk of anaemia. </p> <p><b>Conclusions:</b> Metformin use is associated with early risk of anaemia in individuals with type 2 diabetes, a finding consistent across two RCTs and replicated in one real-world study. The mechanism for this early fall in haemoglobin is uncertain, but given the time course is unlikely to be due to vitamin B12 deficiency alone.</p>

scholarly journals Risk of anaemia with metformin use in type 2 diabetes: A MASTERMIND study

2020 ◽  
Author(s):  
Louise A Donnelly ◽  
John M Dennis ◽  
Ruth L Coleman ◽  
Naveed Sattar ◽  
Andrew T Hattersley ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Real World ◽  
Time Course ◽  
Controlled Trial ◽  
Vitamin B12 Deficiency ◽  
Population Data ◽  
World Population ◽  
Metformin Group ◽  
Randomised Controlled

<b>Objective:</b> To evaluate the association between metformin use and anaemia risk in type 2 diabetes, and the time-course for this, in randomised controlled trial (RCT) and real-world population data. <p><b>Research design and methods:</b> Anaemia was defined as a haemoglobin measure less than 11g/dL. In RCTs (ADOPT (n=3,967), UKPDS (n=1,473)), logistic regression was used to model anaemia risk and non-linear mixed models for change in haematological parameters.In the observational GoDARTS population (n=3,485), discrete-time failure analysis was used to model the effect of cumulative metformin exposure on anaemia risk. </p> <p><b>Results:</b> In ADOPT, compared with sulfonylureas, the odds ratio(OR)(95%CI) for anaemia was 1.93(1.10,3.38) for metformin and 4.18(2.50,7.00) for thiazolidinediones. In UKPDS, compared with diet, the OR(95%CI) was 3.40(1.98,5.83) for metformin, 0.96(0.57,1.62) for sulfonylureas and 1.08(0.62,1.87) for insulin. </p> <p>In ADOPT, haemoglobin and haematocrit dropped following metformin initiation by six months, with no further decrease after three years. In UKPDS, haemoglobin fell by three years in the metformin group compared to other treatments. At years six and nine, haemoglobin was reduced in all treatment groups, with no greater difference seen in the metformin group. In GoDARTS, each 1g/day of metformin use was associated with a 2% higher annual risk of anaemia. </p> <p><b>Conclusions:</b> Metformin use is associated with early risk of anaemia in individuals with type 2 diabetes, a finding consistent across two RCTs and replicated in one real-world study. The mechanism for this early fall in haemoglobin is uncertain, but given the time course is unlikely to be due to vitamin B12 deficiency alone.</p>

scholarly journals Indigenous health worker support for patients with poorly controlled type 2 diabetes: study protocol for a cluster randomised controlled trial of the Mana Tū programme

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e019572
Author(s):  
Vanessa Selak ◽  
Tereki Stewart ◽  
Yannan Jiang ◽  
Jennifer Reid ◽  
Taria Tane ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
New Zealand ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Determinants Of Health ◽  
Pacific People ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionType 2 diabetes mellitus (T2DM) and its complications are more common among Māori and Pacific people compared with other ethnic groups in New Zealand. Comprehensive and sustained approaches that address social determinants of health are required to address this condition, including culturally specific interventions. Currently, New Zealand has no comprehensive T2DM management programme for Māori or Pacific people.Methods and analysisThe Mana Tū programme was developed by a Māori-led collaborative of primary healthcare workers and researchers, and codesigned with whānau (patients and their families) in order to address this gap. The programme is based in primary care and has three major components: a Network hub, Kai Manaaki (skilled case managers who work with whānau with poorly controlled diabetes) and a cross-sector network of services to whom whānau can be referred to address the wider determinants of health. The Network hub supports the delivery of the intervention through training of Kai Manaaki, referrals management, cross-sector network development and quality improvement of the programme. A two-arm cluster randomised controlled trial will be conducted to evaluate the effectiveness of the Mana Tū programme among Māori, Pacific people or those living in areas of high socioeconomic deprivation who also have poorly controlled diabetes (glycated haemoglobin, HbA1c, >65 mmol/mol (8%)), compared with being on a wait list for the programme. A total of 400 participants will be included from 10 general practices (5 practices per group, 40 participants per practice). The primary outcome is HbA1c at 12 months. Secondary outcomes include blood pressure, lipid levels, body mass index and smoking status at 12 months. This protocol outlines the proposed study design and analysis methods.Ethics and disseminationEthical approval for the trial has been obtained from the New Zealand Health and Disability Ethics Committee (17/NTB/249). Findings will be presented to practices and their patients at appropriate fora, and disseminated widely through peer-reviewed publications and conference presentations.Trial registration numberACTRN12617001276347; Pre-result.

scholarly journals Effect of Diabetes Treatment-Related Attributes on Costs to Type 2 Diabetes Patients in a Real-World Population

2017 ◽  
Vol 23 (4) ◽  
pp. 446-452 ◽  
Author(s):  
Jie Meng ◽  
Roman Casciano ◽  
Yi-Chien Lee ◽  
Lee Stern ◽  
Dmitry Gultyaev ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Real World ◽  
World Population ◽  
Diabetes Treatment ◽  
Diabetes Patients

scholarly journals CopenFast trial: Faster-acting insulin Fiasp versus insulin NovoRapid in the treatment of women with type 1 or type 2 diabetes during pregnancy and lactation - a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e045650
Author(s):  
Sidse Kjærhus Nørgaard ◽  
Elisabeth Reinhardt Mathiesen ◽  
Kirsten Nørgaard ◽  
Tine Dalsgaard Clausen ◽  
Peter Damm ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Insulin Pump ◽  
Controlled Trial ◽  
Insulin Pump Therapy ◽  
Pump Therapy ◽  
Acting Insulin ◽  
Pregnancy And Lactation ◽  
Randomised Controlled

IntroductionFaster-acting insulin aspart (Fiasp) is approved for use in pregnancy and lactation, but no clinical study has evaluated its effects during this life stage in women with pre-existing diabetes. The aim of the CopenFast trial is to evaluate the effect of Fiasp compared with insulin aspart (NovoRapid) on maternal glycaemic control during pregnancy, delivery and lactation and on fetal growth and infant health.Methods and analysisAn open-label randomised controlled trial of pregnant women with type 1 or type 2 diabetes including women on multiple daily injection (MDI) therapy or insulin pump therapy. During a 2-year inclusion period, approximately 220 women will be randomised 1:1 to Fiasp or NovoRapid in early pregnancy and followed until 3 months after delivery. At 9, 21 and 33 gestational weeks and during planned induction of labour or caesarean section, women are offered blinded continuous glucose monitoring (CGM) for 7 days. Randomisation will stratify for type of diabetes and insulin treatment modality (MDI or insulin pump therapy, respectively). Health status of the infants will be followed until 3 months of age. The primary outcome is birth weight SD score adjusted for gestational age and gender. Secondary outcomes include maternal glycaemic control including glycated haemoglobin, preprandial and postprandial self-monitored plasma glucose levels, episodes of mild and severe hypoglycaemia, maternal gestational weight gain and weight retention, CGM time spent in, above and below target ranges as well as pregnancy outcomes including pre-eclampsia, preterm delivery, perinatal mortality and neonatal morbidity. Data analysis will be performed according to the intention-to-treat principle.Ethics and disseminationThe trial has been approved by the Regional Ethics Committee (H-19029966) on 7 August 2019. Results will be sought disseminated in peer-reviewed journals and at scientific meetings.Trial registration numberNCT03770767

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