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
Natalia McInnesStephanie HallIrene HramiakRonald J. SigalRonald GoldenbergNikhil GuptaRémi Rabasa‐LhoretManoela BragaVincent WooFarah SultanR. OttoAda SmithDiana SherifaliYan Yun LiuHertzel C. Gerstein
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Abstract:
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.In this open multicenter trial, 102 patients with type 2 diabetes were randomized to 1) a 12-week intervention with sitagliptin/metformin, insulin glargine, and lifestyle therapy or 2) 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, and reinitiation of diabetes medications with or without abnormal fasting plasma glucose (FPG) or 2-h 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.With the FPG/OGTT relapse criteria included, the hazard ratio (HR) of relapse was 0.72 (95% CI 0.47-1.10) in the intervention group compared with 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, HR 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.Although our primary outcome was not statistically significant, the tested approach deserves further study with further optimization of its components.Background: Efficacy of Dapagliflozin in combination with Metformin versus Sitagliptin in type 2 diabetic patients in hayat abad medical complex hospital Peshawar to check the efficacy of these anti Diabetic drug on patients and check the results of these two double combination drug using long tram and short tram treatment check effectiveness, safety side effects.
Purpose: Randomized Measured study in Department of diabetes and Endocrinology HMC Hospital, Peshawar after the hospital ethical committee approval for one year i.e. 12-11-2017 to 12-12-2018 check the efficy of dapagliflozin in combination with metformin versus sitagliptin local setting.
Methodology: three hundred subjects were selected via Hospital and opd, Patients were randomly divided into two groups. In Group-A, patients were given 100mg q.d sitagliptin plus 850 mg metformin twice a day. In Group-B, patients were given 10mg qd dapagliflozin plus 850mg metformin twice a day. Patients were followed up in OPD for 7/24 weeks. After 7/24 weeks, blood sample was obtained for assessment of HbA1c. Reports were measured and if HbA1c is < 6.0 then efficacy achieved. All this information was recorded on Performa.
Results: the efficacy dapagliflozin and metformin versus sitagliptin and metformin in type 2 diabetes mellitus patients shows that 105(35.5% in Group A and 81(25.5%) in Group-B had efficacy and p value was 0.10.
Conclusion: the study showed that Role of Efficacy of Metformin and Dapagliflozin is not significantly different when compared with Metformin and Sitagliptin in Diabetes Mellitus Type 2 patients.
Dapagliflozin
Sitagliptin Phosphate
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Tight glycaemic control is key to reducing the risk of cardiovascular and microvascular complications in people with type 1 diabetes. 1 Standard treatment involves optimising insulin therapy to achieve an HbA 1c level of 48mmol/mol (6.5%) or lower. Although not licensed for use in type 1 diabetes, metformin is included in some clinical guidelines as adjuvant therapy for people with type 1 diabetes who are overweight and wish to improve glycaemic control while minimising the dose of insulin. 1,2 The REMOVAL study is the largest trial to date that has investigated the longer-term effects of metformin in people with type 1 diabetes. 3 Here, we consider the role of metformin in individuals with type 1 diabetes in light of these results and other study findings.
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To evaluate evidence from the medical literature that metformin is effective in preventing type 2 diabetes.Primary literature was accessed via a MEDLINE search (1966-December 2003) using the terms metformin, type 2 diabetes, and prevention.Two studies evaluated metformin's potential to prevent type 2 diabetes, finding that metformin maintained or reduced fasting blood glucose in non-diabetics. Recently, a large study by the Diabetes Prevention Program showed that metformin may reduce the incidence of diabetes. Researchers compared lifestyle changes, metformin therapy, and placebo groups. They found that both lifestyle changes (58%) and metformin therapy (31%) significantly reduced the occurrence of type 2 diabetes versus placebo.These studies provide evidence that metformin may reduce the occurrence of type 2 diabetes. Because long-term efficacy has not been determined, further studies are needed.
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Objective:to observe the curative effect of type 2 diabetes treated with novonorm combined with metformin. Method:34 patients diagnosed with type 2 diabetes on clinic were treated with novonorm combined with metformin for 6 months.Results:the comparison between fasting blood - glucose,postprandial plasma glucose and glycosylated hemoglobin before and after administration indicated significant difference(P0.05).Conclusion:the curative effect of type 2 diabetes treated with novonorm combined with metformin was prominent.
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Background: Type 2 diabetes is a chronic disease characterized by various metabolic defects. Uncontrolled diabetes mellitus gives rise to a number of life-threatening complications that can increase mortality and morbidity.
Objectives: This study was carried out to compare the effectiveness of glycemic control between combined therapy of sitagliptin-metformin and metformin monotherapy.
Materials and Methods: Total data of 40 newly diagnosed type-2 diabetic patients were compiled in the study. Those patients having HbA1c more than 6% were considered as uncontrolled diabetes. The total subjects were randomly divided into two experimental groups, treated by metformin alone and treated by sitagliptin-metformin combination. Both groups were treated for three consecutive months and they were followed up after 12 weeks of treatment. Fasting blood sugar (FBS), blood sugar 2 hours after breakfast (2-ABF) and glycated hemoglobin A1c(HbA1c) were estimated in both experimental groups before starting of treatment and after 12 weeks of treatment.
Results: HbA1c change from baseline was 0.82% with metformin and 1.83% with sitagliptin-metformin combination. Fasting blood glucose changed from 9.41±1.34mmol/l to 8.04±1.10mmol/l with metformin and from 9.75±1.40mmol to 7.25±0.80 with sitagliptin-metformin therapy. Blood sugar 2hours after breakfast changed from 12.68±1.07mmol/l to 10.34±1.68mmol/l with metformin and from 12.65±1.90mmol to 8.74±0.68 with sitagliptin-metformin therapy. The results showed that though both experimental groups reduced FBS, blood sugar 2-ABF, HbA1c at an acceptable level the combined therapy was found to be superior in terms of effectiveness.
Conclusion: The administration of sitagliptin-metformin combined therapy to control hyperglycemia uniquely is preferable.
KYAMC Journal Vol. 11, No.-3, October 2020, Page 150-153
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Metformin has been used for the treatment of type 2 diabetes by suppressing hepatic gluconeogenesis. It has been shown that the subclinical inflammatory responses play important roles in the pathogenesis of type 2 diabetes. In the present study, we determined the effects of metformin on the levels of pro-inflammatory cytokines (i.e., IL-6, TNF-α, and MCP-1) and anti-inflammatory mediator IL-10 in blood and urine of patients with type 2 diabetes. There were 210 patients with type 2 diabetes, which were randomized into metformin (n = 112) and non-metformin (gliclazide, acarbose, and repaglinide, n = 98) groups. The levels of cytokines were measured by the ELISA.We found that metformin reduced the levels of IL-6 in blood and MCP-1 in urine, but increased IL-10 levels in blood of patients with type 2 diabetes. There were no significant differences of TNF-α between metformin and non-metformin groups. Furthermore, compared to individual drug treatment, metformin significantly reduced the levels of serum IL-6 and TNF-α, as well as urine MCP-1. When the patients were stratified based on the durations and doses of metformin, we found that there was only change (i.e., increase) in serum IL-10 levels in patients with metformin for more than 1 year compared to treatment for less than 1 year. Metformin (1.5 g) treatment reduced the urinary levels of MCP-1 as compared with dose of 1.0 g in patients with type 2 diabetes.Metformin reduces inflammatory responses without influence on renal function in type 2 diabetic patients.
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This study was conducted to compare the glycaemic efficacy and safety of initial combination therapy with the fixed-dose combination of sitagliptin and metformin versus metformin monotherapy in drug-naive patients with type 2 diabetes.This double-blind study (18-week Phase A and 26-week Phase B) randomized 1250 drug-naÏve patients with type 2 diabetes [mean baseline haemoglobin A1c (HbA1c) 9.9%] to sitagliptin/metformin 50/500 mg bid or metformin 500 mg bid (uptitrated over 4 weeks to achieve maximum doses of sitagliptin/metformin 50/1000 mg bid or metformin 1000 bid). Results of the primary efficacy endpoint (mean HbA1c reductions from baseline at the end of Phase A) are reported herein.At week 18, mean change from baseline HbA1c was -2.4% for sitagliptin/metformin FDC and -1.8% for metformin monotherapy (p < 0.001); more patients treated with sitagliptin/metformin FDC had an HbA1c value <7% (p < 0.001) versus metformin monotherapy. Changes in fasting plasma glucose were significantly greater with sitagliptin/metformin FDC (-3.8 mmol/l) versus metformin monotherapy (-3.0 mmol/l; p < 0.001). Homeostasis model assessment of β-cell function (HOMA-β) and fasting proinsulin/insulin ratio were significantly improved with sitagliptin/metformin FDC versus metformin monotherapy. Baseline body weight was reduced by 1.6 kg in each group. Both treatments were generally well tolerated with a low and similar incidence of hypoglycaemia. Abdominal pain (1.1 and 3.9%; p = 0.002) and diarrhoea (12.0 and 16.6%; p = 0.021) occurred significantly less with sitagliptin/metformin FDC versus metformin monotherapy; the incidence of nausea and vomiting was similar in both groups.Compared with metformin monotherapy, initial treatment with sitagliptin/metformin FDC provided superior glycaemic improvement with a similar degree of weight loss and lower incidences of abdominal pain and diarrhoea.
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Objective To evaluate the efficacy and safety of sitagliptin insulin glargine in the treatment of type 2 diabetes mellitus.Methods 46 patients with 2 or more oral hypoglycemic agent treatmented and unexpected efficacy,were randomly assigned to 2 groups: each group were 23 patients,Group A received sitagliptin insulin glargine,Group B received premix insulin.FPG 3.9-7.2mmol/L was the therapeutic goal after 12 weeks treatment.FPG,2hPG,Hba1c and BMI before and after 12 weeks were compred.Results After 12 weeks treatment,the levels of FPG,2HPG,HbA1c decreased significantly compared to baseline in both groups(P0.001),and there was no significant difference between the 2 groups(P0.05),BMI of sitagliptin group was no significant difference,BMI of premix insulin group was increased(P0.05).Conclusions The method can reduce glycaemia frequency.and the treatment is safe and has good compliance.
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