***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: OBJECTIVE Although black/African American individuals are disproportionately affected by type 2 diabetes , there is scant clinical trial information available on antidiabetes therapies in this group . We compared linagliptin with placebo in black/African American adults who were treatment-naïve or receiving one oral antidiabetes drug . METHODS Of 226 patients r and omized to 24 weeks ' linagliptin 5 mg/day or placebo , 208 had baseline and at least one on-treatment glycated hemoglobin ( HbA1c ) measurement . Mean baseline HbA1c was 8.6 % in the linagliptin group ( n = 98 ) and 8.68 % in the placebo group ( n = 110 ) . The primary outcome was change in HbA1c from baseline to week 24 . RESULTS By week 24 , mean HbA1c changes were -0.84 % with linagliptin and -0.25 % with placebo ( treatment difference , -0.58 % ; P<.001 ) , and more patients in the linagliptin group achieved HbA1c < 7.0 % ( 26.8 % vs. 8.3 % ; P = .001 ) or an HbA1c reduction ≥0.5 % ( 54.1 % vs. 30.0 % ; P<.001 ) . Mean weight loss was -1.1 kg in both groups . During the treatment period , 8 of 98 linagliptin-group patients and 17 of 110 placebo-group patients required rescue therapy ( odds ratio , 0.5 ; P = .14 ) . For postpr and ial glucose , values were available for few patients ( 11 placebo , 10 linagliptin ) , and thus the between-group difference was associated with wide confidence intervals ( CIs ) ( difference , -1.97 mg/dL ; 95 % CI , -53.80 to 49.86 ; P = .94 ) . In the overall study population , a similar proportion of patients in both groups had adverse events ( 58.5 % vs. 61.7 % ) ; most events were mild or moderate and considered unrelated to study drug . Investigator-defined hypoglycemia was rare ( 3 linagliptin-group patients and 1 placebo-group patient ) , with no severe events ( requiring external assistance ) . CONCLUSION This study confirms that linagliptin is efficacious and well tolerated in black/African American patients with type 2 diabetes Aims : Assess the efficacy and safety of saxagliptin added to a submaximal sulphonylurea dose vs. uptitration of sulphonylurea monotherapy in patients with type 2 diabetes and inadequate glycaemic control with sulphonylurea monotherapy . Methods and patients : A total of 768 patients ( 18–77 years ; HbA1c screening ≥ 7.5 to ≤ 10.0 % ) were r and omised and treated with saxagliptin 2.5 or 5 mg in combination with glyburide 7.5 mg vs. glyburide 10 mg for 24 weeks . Blinded uptitration glyburide was allowed in the glyburide-only arm to a maximum total daily dose of 15 mg . Efficacy analyses were performed using ANCOVA and last-observation-carried-forward methodology . Results : At week 24 , 92 % of glyburide-only patients were uptitrated to a total glyburide dose of 15 mg/day . Saxagliptin 2.5 and 5 mg provided statistically significant adjusted mean decreases from baseline to week 24 vs. uptitrated glyburide , respectively , in HbA1c ( −0.54 % , −0.64 % vs. + 0.08 % ; both p < 0.0001 ) and fasting plasma glucose ( −7 , −10 vs. + 1 mg/dl ; p = 0.0218 and p = 0.002 ) . The proportion of patients achieving an HbA1c < 7 % was greater for saxagliptin 2.5 and 5 mg vs. uptitrated glyburide ( 22.4 % and 22.8 % vs. 9.1 % ; both p < 0.0001 ) . Postpr and ial glucose area under the curve was reduced for saxagliptin 2.5 and 5 mg vs. uptitrated glyburide ( −4296 and −5000 vs. + 1196 mg·min/dl ; both p < 0.0001 ) . Adverse event occurrence was similar across all groups . Reported hypoglycaemic events were not statistically significantly different for saxagliptin 2.5 ( 13.3 % ) and 5 mg ( 14.6 % ) vs. uptitrated glyburide ( 10.1 % ) . Conclusion : Saxagliptin added to submaximal glyburide therapy led to statistically significant improvements vs. uptitration of glyburide alone across key glycaemic parameters and was generally well tolerated Background In a previous pooled analysis of 12 double-blind clinical studies that included data on 6,139 patients with type 2 diabetes , treatment with sitagliptin  , a dipeptidyl peptidase-4 ( DPP-4 ) inhibitor , was shown to be generally well tolerated compared with treatment with control agents . As clinical development of sitagliptin continues , additional studies have been completed , and more patients have been exposed to sitagliptin . The purpose of the present analysis is to up date the safety and tolerability assessment of sitagliptin by pooling data from 19 double-blind clinical studies . Methods The present analysis included data from 10,246 patients with type 2 diabetes who received either sitagliptin 100 mg/day ( N = 5,429 ; sitagliptin group ) or a comparator agent ( placebo or an active comparator ) ( N = 4,817 ; non-exposed group ) . The 19 studies from which this pooled population was drawn represent the double-blind , r and omized studies that included patients treated with the usual clinical dose of sitagliptin ( 100 mg/day ) for between 12 weeks and 2 years and for which results were available as of July 2009 . These 19 studies assessed sitagliptin taken as monotherapy , initial combination therapy with metformin or pioglitazone , or as add-on combination therapy with other antihyperglycemic agents ( metformin , pioglitazone , a sulfonylurea ± metformin , insulin ± metformin , or rosiglitazone + metformin ) . Patients in the non-exposed group were taking placebo , metformin , pioglitazone , a sulfonylurea ± metformin , insulin ± metformin , or rosiglitazone + metformin . The analysis used patient-level data from each study to evaluate between-group differences in the exposure-adjusted incidence rates of adverse events . Results Summary measures of overall adverse events were similar in the sitagliptin and non-exposed groups , except for an increased incidence of drug-related adverse events in the non-exposed group . Incidence rates of specific adverse events were also generally similar between the two groups , except for increased incidence rates of hypoglycemia , related to the greater use of a sulfonylurea , and diarrhea , related to the greater use of metformin , in the non-exposed group and constipation in the sitagliptin group . Treatment with sitagliptin was not associated with an increased risk of major adverse cardiovascular events . Conclusions In this up date d pooled safety analysis of data from 10,246 patients with type 2 diabetes  , sitagliptin 100 mg/day was generally well tolerated in clinical trials of up to 2 years in duration Purpose To assess safety and efficacy of saxagliptin in older patients with type 2 diabetes mellitus ( T2DM ) . Patients and methods This was a post hoc analysis of pooled data from older patients ( ≥65 years of age ) from five 24-week phase III trials : three studies of saxagliptin versus placebo as an add-on therapy to metformin , glyburide , or a thiazolidinedione ; and two studies of saxagliptin versus placebo as monotherapy in drug-naïve patients . Separate analyses were conducted on one study of initial combination therapy with saxagliptin plus metformin versus metformin monotherapy in drug-naïve patients . The safety analysis population for the five- study pool included 428 patients ≥ 65 years of age with baseline glycated hemoglobin ( HbA1c ) 7.0 % to 10.5 % who received saxagliptin 2.5 or 5 mg or placebo  , and for the study of initial combination therapy included 69 patients ≥ 65 years of age with baseline HbA1c 8.0 % to 12.0 % who received saxagliptin 5  mg in combination with metformin or metformin monotherapy . The primary efficacy endpoint was change from baseline HbA1c . Results In the five- study pool , the differences in the adjusted mean change from baseline HbA1c among older patients receiving saxagliptin versus placebo were −0.60 % ( 95 % confidence interval [ CI ] , −0.99 % to −0.21 % ) for saxagliptin 2.5 mg and −0.55 % ( −0.97 % to −0.14 % ) for saxagliptin 5 mg ; in the initial combination study , the difference was −1.22 % ( −2.27 % to −0.17 % ) among older patients receiving saxagliptin 5 mg plus metformin versus metformin monotherapy . The results were generally similar in older and younger patients . Saxagliptin was well tolerated ; the incidence and types of adverse events were similar for saxagliptin and comparators . Hypoglycemia was reported in 3.0 % to 9.4 % of patients receiving saxagliptin ( 0%–8.0 % for comparators ) and was confirmed ( finger stick glucose ≤ 50 mg/dL , with associated symptoms ) in 0 % to 0.7 % ( 0%–0.7 % for comparators ) ; hypoglycemic episodes did not vary by age category and did not require medical intervention . Conclusion Saxagliptin was effective and well tolerated , with a low risk of hypoglycemia , when used as monotherapy , add-on therapy , or initial combination therapy with metformin in older patients with T2DM Abstract Aims / Introduction : We compared the safety and efficacy of liraglutide vs glibenclamide in patients with poorly controlled ( HbA1c , 7.4–10.4 % ) type 2 diabetes . Material s and Methods : Subjects were r and omly assigned at a 1:2 ratio to receive 1‐year treatment with glibenclamide 1.25–2.5 mg/day or liraglutide 0.9 mg/day . Other oral anti‐diabetic drugs ( OAD ) were prohibited during the trial . Adverse events ( AE ) were monitored . Results : A total of 400 patients ( liraglutide group , n = 268 ; glibenclamide group , n = 132 ) were r and omized and exposed to trial products . At week 52 vs baseline , HbA1c in the liraglutide and glibenclamide groups was reduced from 9.3 to 7.8 % and from 9.2 to 8.2 % , respectively . Treatment difference ( liraglutide – glibenclamide ) at the end of the study was −0.49 ( 95 % CI , −0.71 to −0.27 ) . In the liraglutide and glibenclamide groups , Japan Diabetes Society target HbA1c < 6.9 % was achieved by 22.1 and 8.5 % of patients , respectively . Fasting plasma glucose fell from 202.8 and 202.1 mg/dL , respectively , to 145.3 and 156.7 mg/dL , respectively . Mean plasma glucose and mean postpr and ial plasma glucose increment were lower in the liraglutide group . Mean bodyweight was reduced by −0.8 kg in the liraglutide group and increased by 1.0 kg in the glibenclamide group . The proportion of patients reporting at least one treatment‐emergent AE ( TEAE ) in the liraglutide and glibenclamide groups was 91.4 and 91.7 % , respectively . Most TEAE were mild in severity . No major hypoglycemic episode was observed . Conclusions : Once‐daily administration of liraglutide 0.9 mg for 52 weeks provides more favorable metabolic control and safety profile compared with glibenclamide . Patients on liraglutide lost bodyweight , whereas those on glibenclamide gained weight . This trial was registered with Clinical Trial.gov ( no. NCT00393718 ) . ( J Diabetes Invest , doi : 10.1111/j.2040‐1124.2011.00128.x , 2011 AIM To assess the safety and efficacy of the potent and selective dipeptidyl peptidase-4 inhibitor linagliptin 5 mg when given for 24 weeks to patients with type 2 diabetes who were either treatment-naive or who had received one oral antidiabetes drug ( O 
    Output:
    
Addition of DPP-4 inhibitors to sulphonylurea to treat people with type 2 diabetes is associated with a 50 % increased risk of hypoglycaemia and to one excess case of hypoglycaemia for every 17 patients in the first six months of treatment .