Remission of Type 2 Diabetes Following a Short-term Intervention With Insulin Glargine, Metformin, and Dapagliflozin

Abstract Objective To examine diabetes remission following a short-term intensive metabolic intervention combining lifestyle and glucose-lowering approaches. Methods We conducted an open-label, randomized controlled trial in 154 patients with type 2 diabetes up to 8 years in duration on 0 to 2 glucose-lowering medications. Participants were randomized to (a) a 12-week intensive intervention comprising lifestyle approaches and treatment with insulin glargine, metformin, and dapagliflozin or (b) standard diabetes care. At 12 weeks, diabetes medications were discontinued in participants with hemoglobin A1c (HbA1C) < 7.3% (56 mmol/mol). Participants were then followed for diabetes relapse until 64 weeks. The primary outcome was complete or partial diabetes remission (HbA1C < 6.5% [48 mmol/mol] off chronic diabetes drugs) at 24 weeks. Main secondary outcomes were complete or partial diabetes remission at 36, 48, and 64 weeks. Results The primary outcome was achieved in 19 (24.7%) intervention group participants and 13 (16.9%) control group participants at 24 weeks (relative risk [RR] 1.5; 95% confidence interval [CI], 0.8-2.7). The relative risks of remission at 36, 48, and 64 weeks were 2.4 (95% CI, 1.2-5.0), 2.1 (95% CI, 1.0-4.4), and 1.8 (95% CI, 0.7-4.7), respectively. In an exploratory analysis, the intervention reduced the hazard of diabetes relapse with overt hyperglycemia by 43% (hazard ratio 0.57; 95% CI, 0.39-0.81). Conclusions Our primary outcome of diabetes remission at 24 weeks was not statistically significantly different. However, our overall results suggest that some patients with early type 2 diabetes are able to achieve sustained diabetes remission following a short-term intensive intervention. Further studies are needed to optimize the combined therapeutic approach used.

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Remission of type 2 diabetes following a short-term intensive intervention with insulin glargine, sitagliptin and metformin: results of an open-label randomized parallel-design trial

10.2337/figshare.16709122.v1 ◽

2021 ◽

Author(s):

Natalia McInnes ◽

Stephanie Hall ◽

Irene Hramiak ◽

Ronald J. Sigal ◽

Ronald Goldenberg ◽

...

Keyword(s):

Type 2 Diabetes ◽

Insulin Glargine ◽

Plasma Glucose ◽

Intervention Group ◽

Hazard Ratio ◽

Control Group ◽

Short Term ◽

Primary Analysis ◽

Treatment Groups

Objective The aim of the study was to evaluate remission of type 2 diabetes following a short-term intervention with insulin glargine, sitagliptin/metformin and lifestyle approaches. Research Design and Methods In this open multicenter trial, 102 patients with type 2 diabetes were randomized to (i) a 12-week intervention with sitagliptin/metformin, insulin glargine and lifestyle therapy or (ii) control group. Participants with HbA1C<7.3% [<56 mmol/mol] at 12 weeks were asked to stop diabetes medications and were followed for evidence of relapse over 52 weeks. Diabetes relapse criteria included HbA1C ≥6.5% [≥48 mmol/mol], ≥50% of capillary glucose readings >10 mmol/L over 1 week, re-initiation of diabetes medications ± abnormal fasting plasma glucose (FPG) or 2-hour plasma glucose on an oral glucose tolerance test (OGTT). Time-to-relapse analysis was conducted to compare the treatment groups with (primary analysis) and without (supplementary analysis) FPG/OGTT relapse criteria. Results <a>With the FPG/OGTT relapse criteria included, the hazard ratio of relapse was 0.72 (95% CI 0.47-1.10) in the intervention group compared to the control group (primary analysis), and the number of participants remaining in remission was not significantly different between treatment groups at 24, 36, 48 and 64 weeks. In the supplementary analyses without these criteria, hazard ratio of relapse was 0.60 (95% CI 0.39-0.95), and the number of participants remaining in remission was significantly higher (26 vs 10%) in the intervention group at 36 weeks.</a> Conclusions <a>Although our primary outcome was not statistically significant, the tested approach deserves further study with further optimization of its components. </a>

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Remission of type 2 diabetes following a short-term intensive intervention with insulin glargine, sitagliptin and metformin: results of an open-label randomized parallel-design trial

10.2337/figshare.16709122 ◽

2021 ◽

Author(s):

Natalia McInnes ◽

Stephanie Hall ◽

Irene Hramiak ◽

Ronald J. Sigal ◽

Ronald Goldenberg ◽

...

Keyword(s):

Type 2 Diabetes ◽

Insulin Glargine ◽

Plasma Glucose ◽

Intervention Group ◽

Hazard Ratio ◽

Control Group ◽

Short Term ◽

Primary Analysis ◽

Treatment Groups

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Exenatide and Renal Outcomes in Patients with Type 2 Diabetes and Diabetic Kidney Disease

American Journal of Nephrology ◽

10.1159/000510255 ◽

2020 ◽

Vol 51 (10) ◽

pp. 806-814 ◽

Cited By ~ 5

Author(s):

Xiangyu Wang ◽

Huijie Zhang ◽

Qian Zhang ◽

Meiping Guan ◽

Shuyue Sheng ◽

...

Keyword(s):

Type 2 Diabetes ◽

Kidney Disease ◽

Insulin Glargine ◽

Diabetic Kidney Disease ◽

Intervention Group ◽

Percentage Change ◽

Control Group ◽

Diabetic Kidney ◽

Renal Outcomes

Background: Cardiovascular outcomes in clinical trials with type 2 diabetes mellitus (T2DM) patients have shown that glucagon-like peptide-1 receptor agonist can have a beneficial effect on the kidney. This trial aimed to assess the effects of exenatide on renal outcomes in patients with T2DM and diabetic kidney disease (DKD). Methods: We performed a randomized parallel study encompassing 4 general hospitals. T2DM patients with an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 and macroalbuminuria, defined as 24-h urinary albumin excretion rate (UAER) >0.3 g/24 h were randomized 1:1 to receive exenatide twice daily plus insulin glargine (intervention group) or insulin lispro plus glargine (control group) for 24 weeks. The primary outcome was the UAER percentage change from the baseline after 24 weeks of intervention. The rates of hypoglycemia, adverse events (AEs), and change in eGFR during the follow-up were measured as safety outcomes. Results: Between March 2016 and April 2019, 92 patients were randomized and took at least 1 dose of the study drug. The mean age of the participants was 56 years. At baseline, the median UAER was 1,512.0 mg/24 h and mean eGFR was 70.4 mL/min/1.73 m2. After 24 weeks of treatment, the UAER percentage change was significantly lower in the intervention group than in the control group (p = 0.0255). Moreover, the body weight declined by 1.3 kg in the intervention group (the difference between the 2 groups was 2.7 kg, p = 0.0001). Compared to the control group, a lower frequency of hypoglycemia and more gastrointestinal AEs were observed in the intervention group. Conclusion: Exenatide plus insulin glargine treatment for 24 weeks resulted in a reduction of albuminuria in T2DM patients with DKD.

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Treatment with a DPP-4 inhibitor at time of hospital admission for COVID-19 is not associated with improved clinical outcomes: data from the COVID-PREDICT cohort study in The Netherlands

Journal of Diabetes & Metabolic Disorders ◽

10.1007/s40200-021-00833-z ◽

2021 ◽

Author(s):

Rick I. Meijer ◽

Trynke Hoekstra ◽

Niels C. Gritters van den Oever ◽

Suat Simsek ◽

Joop P. van den Bergh ◽

...

Keyword(s):

Type 2 Diabetes ◽

Cohort Study ◽

Hospital Admission ◽

Clinical Outcomes ◽

Primary Outcome ◽

Infectious Complications ◽

Glucose Lowering ◽

Diabetes Severity ◽

Outcome Mortality

Abstract Purpose Inhibition of dipeptidyl peptidase (DPP-)4 could reduce coronavirus disease 2019 (COVID-19) severity by reducing inflammation and enhancing tissue repair beyond glucose lowering. We aimed to assess this in a prospective cohort study. Methods We studied in 565 patients with type 2 diabetes in the CovidPredict Clinical Course Cohort whether use of a DPP-4 inhibitor prior to hospital admission due to COVID-19 was associated with improved clinical outcomes. Using crude analyses and propensity score matching (on age, sex and BMI), 28 patients using a DPP-4 inhibitor were identified and compared to non-users. Results No differences were found in the primary outcome mortality (matched-analysis = odds-ratio: 0,94 [95% confidence interval: 0,69 – 1,28], p-value: 0,689) or any of the secondary outcomes (ICU admission, invasive ventilation, thrombotic events or infectious complications). Additional analyses comparing users of DPP-4 inhibitors with subgroups of non-users (subgroup 1: users of metformin and sulphonylurea; subgroup 2: users of any insulin combination), allowing to correct for diabetes severity, did not yield different results. Conclusions We conclude that outpatient use of a DPP-4 inhibitor does not affect the clinical outcomes of patients with type 2 diabetes who are hospitalized because of COVID-19 infection.

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Shared decision making and patient-centeredness for patients with poorly controlled type 2 diabetes mellitus in primary care—results of the cluster-randomised controlled DEBATE trial

BMC Family Practice ◽

10.1186/s12875-021-01436-6 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Anja Wollny ◽

Christin Löffler ◽

Eva Drewelow ◽

Attila Altiner ◽

Christian Helbig ◽

...

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Decision Making ◽

Type 2 Diabetes Mellitus ◽

Shared Decision Making ◽

Intervention Group ◽

Control Group ◽

Shared Decision ◽

Patient Centeredness

Abstract Background We investigate whether an educational intervention of GPs increases patient-centeredness and perceived shared decision making in the treatment of patients with poorly controlled type 2 diabetes mellitus? Methods We performed a cluster-randomized controlled trial in German primary care. Patients with type 2 diabetes mellitus defined as HbA1c levels ≥ 8.0% (64 mmol/mol) at the time of recruitment (n = 833) from general practitioners (n = 108) were included. Outcome measures included subjective shared decision making (SDM-Q-9; scale from 0 to 45 (high)) and patient-centeredness (PACIC-D; scale from 1 to 5 (high)) as secondary outcomes. Data collection was performed before intervention (baseline, T0), at 6 months (T1), at 12 months (T2), at 18 months (T3), and at 24 months (T4) after baseline. Results Subjective shared decision making decreased in both groups during the course of the study (intervention group: -3.17 between T0 and T4 (95% CI: -4.66, -1.69; p < 0.0001) control group: -2.80 (95% CI: -4.30, -1.30; p = 0.0003)). There were no significant differences between the two groups (-0.37; 95% CI: -2.20, 1.45; p = 0.6847). The intervention's impact on patient-centeredness was minor. Values increased in both groups, but the increase was not statistically significant, nor was the difference between the groups. Conclusions The intervention did not increase patient perceived subjective shared decision making and patient-centeredness in the intervention group as compared to the control group. Effects in both groups might be partially attributed to the Hawthorne-effect. Future trials should focus on patient-based intervention elements to investigate effects on shared decision making and patient-centeredness. Trial registration The trial was registered on March 10th, 2011 at ISRCTN registry under the reference ISRCTN70713571.

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Influence of physical activity on periodontal health in patients with type 2 diabetes mellitus. A blinded, randomized, controlled trial

Clinical Oral Investigations ◽

10.1007/s00784-021-03908-6 ◽

2021 ◽

Author(s):

K. Wernicke ◽

J. Grischke ◽

M. Stiesch ◽

S. Zeissler ◽

K. Krüger ◽

...

Keyword(s):

Physical Activity ◽

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Periodontal Health ◽

Randomized Controlled ◽

Hba1c Levels

Abstract Objectives The aim was to investigate the effect of physical activity on periodontal health and HbA1c levels in patients with type 2 diabetes mellitus (T2DM) over a period of 6 months. Materials and methods Thirty-seven patients with non-insulin-dependent T2DM were included in the study. The intervention group (n=20) performed physical activity over a period of 6 months. The control group (n=17) did not receive any intervention. Baseline and final examinations included dental parameters and concentrations of glycosylated hemoglobin (HbA1c) and high-sensitivity C-reactive protein (hsCRP). Results Physical activity showed a positive effect on periodontal health. Both the BOP (p= 0.005) and the severity of periodontitis (p= 0.001) were significantly reduced in the intervention group compared to the control group. Furthermore, HbA1c levels were reduced (p= 0.010) significantly in the intervention group while hsCRP levels significantly increased in the control group (p= 0.04). Conclusions Within the limitations of this randomized, controlled trial, physical activity over a period of 6 months is a health-promoting measure for patients with T2DM and improves both periodontal health and HbA1c concentrations.

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High Fiber Caribbean Diets with Low-Intermediate GI Improve Glycemic Control, Cardiovascular and Inflammatory Indicators in Overweight Persons with Type 2 Diabetes: A Randomized Control Study

Current Research in Nutrition and Food Science Journal ◽

10.12944/crnfsj.3.1.05 ◽

2015 ◽

Vol 3 (1) ◽

pp. 36-45 ◽

Cited By ~ 1

Author(s):

Perceval Singh ◽

Cliff K Riley ◽

Andrew Wheatley ◽

Michael Boyne ◽

Errol Morrison ◽

...

Keyword(s):

Type 2 Diabetes ◽

Fasting Blood Glucose ◽

Intervention Group ◽

Dietary Treatment ◽

Treatment Modalities ◽

Control Group ◽

Haemoglobin A1c ◽

High Fiber ◽

Hs Crp

This study focused on the effect of consumption of indigenous Caribbean foods with low and intermediate glycemic index (GI) high fiber contents on glycated haemoglobin (A1c), insulin, fasting blood glucose, homocysteine (tHCY), high sensitivity C-reactive protein (hs-CRP), HOMA-IR and lipoprotein profile levels in overweight persons with type 2 diabetes. The methodology followed a randomized controlled parallel design, which compared two dietary treatment modalities in adult Jamaicans who were overweight and diagnosed with type 2 diabetes (mean age 42.5 ± 2.0 years, 55% females, mean A1c 9.30 ± 0.56%) over six months. The intervention group (n=32) underlined the consumption of low-intermediate-GI foods, whereas the control group (n = 33) were not so advised and consumed a high-GI diet. Attempts were made to ensure that both groups were isocaloric with 45-50% of energy from carbohydrates. Consumption of low-intermediate GI foods resulted in significant reductions (p<0.005) in A1C compared to participants who consumed high GI foods (-0.84 ± 0.26 vs. -0.35 ± 0.04%), hs-CRP (-0.52 ± 0.17 vs. -0.17 ± 0.31 mg/dL) and tHCY (-1.32 ± 0.39 vs. -0.59 ± 0.38 µmol/L). Insulin sensitivity, HDL-C and triglycerides significantly improved in participants who consumed the low-intermediate-GI diet. The data strengthen the metabolic benefits of meal plans that emphasize the consumption of low and intermediate GI high fiber foods, particularly, indigenous Caribbean complex starchy foods.

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The effects of Anethum graveolens (dill) powder supplementation on clinical and metabolic status in patients with type 2 diabetes

10.21203/rs.2.12262/v2 ◽

2020 ◽

Author(s):

Fatemeh Haidari ◽

Mehrnoosh Zakerkish ◽

Fatemeh Borazjani ◽

Kambiz Ahmadi Angali ◽

Golnaz Amoochi

Keyword(s):

Type 2 Diabetes ◽

Lipid Profile ◽

Intervention Group ◽

Gastrointestinal Symptoms ◽

Control Group ◽

Diabetic Patients ◽

Anethum Graveolens ◽

Type 2 Diabetic Patients ◽

The Mean

Abstract Background: The objective of this study was to investigate the effects of anethum graveolens (dill) powder supplementation on glycemic control, lipid profile, some antioxidants and inflammatory markers, and gastrointestinal symptoms in type 2 diabetic patients. Material and methods: In this study, 42 patients with type 2 diabetes were randomly allocated to intervention and control groups and received either 3g/day dill powder or placebo (3 capsules/day, 1 g each). Fasting blood sugar (FBS), insulin, homeostatic model assessment of insulin resistance (HOMA- IR), lipid profile, hs-C-reactive protein (hs-CRP), total antioxidant capacity (TAC), malondialdehyde (MDA), and gastrointestinal symptoms were measured in all of the subjects at baseline and post-intervention. Results: The dill powder supplementation significantly decreased the mean serum levels of insulin, HOMA-IR, LDL-C, TC, and MDA in the intervention group in comparison with the baseline measurements (p < 0.05). Also, the mean serum levels of HDL and TAC were significantly increased in the intervention group in comparison with the baseline measurement (p < 0.05). Colonic motility disorder was the only gastrointestinal symptom whose frequency was significantly reduced by supplementation (P = 0.01). The mean changes of insulin, LDL-C , TC, and MDA were significantly lower in the intervention group than in the control group (p < 0.05). In addition, the mean changes in HDL were significantly higher in the intervention group than in the control group (p < 0.05). Conclusion: Dill powder supplementation can be effective in controlling the glycemic, lipid, stress oxidative, and gastrointestinal symptoms in type 2 diabetic patients. Keywords: Type 2 diabetes; Dill powder; Glycemic control; Lipid profile; Stress oxidative status

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The individual empowerment program improves glycemic and lipid controls in admitted type 2 DM patients

Diabetes Mellitus ◽

10.14341/dm8339 ◽

2018 ◽

Vol 21 (2) ◽

pp. 113-117

Author(s):

Ampornpan Theeranut ◽

Nonglak Methakanjanasak ◽

Pattama Surit ◽

Wasana Ruaisungnoen ◽

Kittisak Sawanyawisuth ◽

...

Keyword(s):

Intervention Group ◽

Control Group ◽

P Value ◽

Inpatient Setting ◽

Short Term ◽

The Mean ◽

The Individual ◽

Diabetes Patients ◽

Empowerment Program

Aim. To evaluate the short-term effects of the empowerment program on glycemic and lipid profiles in an inpatient setting for DM type 2 patients. Materials and methods. This was a quasi-experimental study conducted between October 2013 and June 2015. We enrolled diabetes patients admitted to the hospital, age over 35 years, and HbA1c 7%. During the admission, the intervention group received the empowerment course three times prior to discharge, the control group received standard diabetes and nursing care. All patients body weight, HbA1c, HDL-c, and LDL levels were evaluated at three and six months after discharge. All outcomes were compared between the control and intervention group. Results. A total of 57 diabetes patients participated in the study, with 27 in the intervention group and 30 in the control group. The intervention group had significantly higher HbA1c levels than the control group (10.3% vs 8.0%; p value 0.001). After discharge, the mean HbA1c and LDL-c levels of the intervention group were significantly lower than those of the control group at three and six months, while the mean HDL-c level of the intervention group was significantly higher than that of the control group at six months (1.54 vs 1.29 mmol/L; p value 0.001). The average body mass index of the intervention group was also significantly lower than that of the control group at six months (22.74 vs 25.54 kg/m2; p value = 0.016). Conclusion. The individual empowerment program improved short-term glycemic and lipid outcomes in admitted diabetes mellitus patients.

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