Efficacy of benfluorex in combination with sulfonylurea in type 2 diabetic patients: An 18 to 34-week, open-label, extension period

2009 ◽  
Vol 35 (1) ◽  
pp. 64-70 ◽  
Author(s):  
P. Moulin ◽  
M. André ◽  
H. Alawi ◽  
L.C. Dos Santos ◽  
A.K. Khalid ◽  
...  
Keyword(s):  
Diabetic Patients ◽  
Open Label ◽  
Type 2 Diabetic Patients ◽  
Open Label Extension ◽  
Type 2 Diabetic ◽  
Extension Period

scholarly journals Treatment withα-Lipoic Acid over 16 Weeks in Type 2 Diabetic Patients with Symptomatic Polyneuropathy Who Responded to Initial 4-Week High-Dose Loading

2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Hector Garcia-Alcala ◽  
Celia Isabel Santos Vichido ◽  
Silverio Islas Macedo ◽  
Christelle Nathalie Genestier-Tamborero ◽  
Marissa Minutti-Palacios ◽  
...  
Keyword(s):  
Lipoic Acid ◽  
Phase 1 ◽  
Treated Group ◽  
Diabetic Patients ◽  
High Dose ◽  
Phase 2 ◽  
Open Label ◽  
Type 2 Diabetic Patients ◽  
Type 2 Diabetic

Effective treatment of diabetic sensorimotor polyneuropathy remains a challenge. To assess the efficacy and safety ofα-lipoic acid (ALA) over 20 weeks, we conducted a multicenter randomized withdrawal open-label study, in which 45 patients with type 2 diabetes and symptomatic polyneuropathy were initially treated with ALA (600 mg tid) for 4 weeks (phase 1). Subsequently, responders were randomized to receive ALA (600 mg qd;n=16) or to ALA withdrawal (n=17) for 16 weeks (phase 2). During phase 1, the Total Symptom Score (TSS) decreased from 8.9 ± 1.8 points to 3.46 ± 2.0 points. During phase 2, TSS improved from 3.7 ± 1.9 points to 2.5 ± 2.5 points in the ALA treated group (p<0.05) and remained unchanged in the ALA withdrawal group. The use of analgesic rescue medication was higher in the ALA withdrawal group than ALA treated group (p<0.05). In conclusion, in type 2 diabetic patients with symptomatic polyneuropathy who responded to initial 4-week high-dose (600 mg tid) administration of ALA, subsequent treatment with ALA (600 mg qd) over 16 weeks improved neuropathic symptoms, whereas ALA withdrawal was associated with a higher use of rescue analgesic drugs. This trial is registered with ClinicalTrials.gov Identifier:NCT02439879.

scholarly journals Preventing microalbuminuria with benazepril, valsartan, and benazepril–valsartan combination therapy in diabetic patients with high-normal albuminuria: A prospective, randomized, open-label, blinded endpoint (PROBE) study

PLoS Medicine ◽  
2021 ◽  
Vol 18 (7) ◽  
pp. e1003691
Author(s):  
Piero Ruggenenti ◽  
Monica Cortinovis ◽  
Aneliya Parvanova ◽  
Matias Trillini ◽  
Ilian P. Iliev ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Angiotensin Receptor Blockers ◽  
Combined Therapy ◽  
Accelerated Failure Time Model ◽  
Diabetic Patients ◽  
Open Label ◽  
Type 2 Diabetic Patients ◽  
Link Type ◽  
Type 2 Diabetic

Background Angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) prevent microalbuminuria in normoalbuminuric type 2 diabetic patients. We assessed whether combined therapy with the 2 medications may prevent microalbuminuria better than ACE inhibitor or ARB monotherapy. Methods and findings VARIETY was a prospective, randomized, open-label, blinded endpoint (PROBE) trial evaluating whether, at similar blood pressure (BP) control, combined therapy with benazepril (10 mg/day) and valsartan (160 mg/day) would prevent microalbuminuria more effectively than benazepril (20 mg/day) or valsartan (320 mg/day) monotherapy in 612 type 2 diabetic patients with high-normal albuminuria included between July 2007 and April 2013 by the Istituto di Ricerche Farmacologiche Mario Negri IRCCS and 8 diabetology or nephrology units in Italy. Time to progression to microalbuminuria was the primary outcome. Analyses were intention to treat. Baseline characteristics were similar among groups. During a median [interquartile range, IQR] follow-up of 66 [42 to 83] months, 53 patients (27.0%) on combination therapy, 57 (28.1%) on benazepril, and 64 (31.8%) on valsartan reached microalbuminuria. Using an accelerated failure time model, the estimated acceleration factors were 1.410 (95% CI: 0.806 to 2.467, P = 0.229) for benazepril compared to combination therapy, 0.799 (95% CI: 0.422 to 1.514, P = 0.492) for benazepril compared to valsartan, and 1.665 (95% CI: 1.007 to 2.746, P = 0.047) for valsartan compared to combination therapy. Between-group differences in estimated acceleration factors were nonsignificant after adjustment for predefined confounders. BP control was similar across groups. All treatments were safe and tolerated well, with a slight excess of hyperkalemia and hypotension in the combination therapy group. The main study limitation was the lower than expected albuminuria at inclusion. Conclusions Risk/benefit profile of study treatments was similar. Dual renin–angiotensin system (RAS) blockade is not recommended as compared to benazepril or valsartan monotherapy for prevention of microalbuminuria in normoalbuminuric type 2 diabetic patients. Trial registration EudraCT 2006-005954-62; ClinicalTrials.gov NCT00503152.

Efficacy and safety of atorvastatin in hyperlipidemic, type 2 diabetic patients. A 34-week, multicenter, open-label study

2000 ◽  
Vol 152 (2) ◽  
pp. 489-496 ◽  
Author(s):  
Carlos A. Aguilar-Salinas ◽  
Francisco J. Gómez-Pérez ◽  
Carlos Posadas-Romero ◽  
Cuauhtémoc Vázquez-Chávez ◽  
Eduardo Meaney ◽  
...  
Keyword(s):  
Diabetic Patients ◽  
Efficacy And Safety ◽  
Open Label ◽  
Type 2 Diabetic Patients ◽  
Open Label Study ◽  
Label Study ◽  
Type 2 Diabetic

scholarly journals Dapagliflozin in the management of type 2 diabetes mellitus: a real-life experience in Bangladesh

2020 ◽  
Vol 11 (1) ◽  
pp. 57-62
Author(s):  
Mohammad Feroz Amin ◽  
Faria Afsana ◽  
Sultana Marufa Shefin ◽  
Shahjada Selim ◽  
Mahboob Ifhtekhar
Keyword(s):  
Type 2 Diabetes ◽  
Life Experience ◽  
Real Life ◽  
Diabetic Patients ◽  
Base Line ◽  
Open Label ◽  
Type 2 Diabetic Patients ◽  
Life Study ◽  
Type 2 Diabetic

Background: Dapagliflozin, a selective renal sodium-glucose cotransporter-2 inhibitor (SGLT2i), lowers plasma glucose by increasing urinary excretion of glucose. This study evaluated the efficacy and safety of dapagliflozin as add on therapy for a selected group of Bangladeshi type 2 diabetic patients. Methods: This was a 24-week, open-label, prospective, real-life study including type 2 diabetic patients with glycated hemoglobin (HbA1c) 7.0–10% (N =53). Study subjects were selectively assigned to dapagliflozin 5 mg once-daily in the morning along with ongoing oral anti-diabetic drug (OAD). The primary end point was to see the safety (adverse events) and efficacy (reduction of fasting and post-prandial blood glucose, HbA1c) of dapagliflozin. Results: Mean HbA1c changes from baseline to week 24 was – 1.15 ± 0.82 % (P = 0.000) and weight reduction was – 2.49 ± 0.32 kg from base line (P=0.000). Among total study subjects, 6 (11.3 %) had developed urinary tract infection (UTI). There were no major episodes of hypoglycemia or renal function deterioration. Conclusion: Dapagliflozin showed significant reduction of HbA1c as add on therapy. The low incidence of hypoglycemia and UTI make dapagliflozin as an acceptable addition to existing treatment option for type 2 diabetes in Bangladeshi population. Birdem Med J 2021; 11(1): 57-62

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