idegasp is a dual action insulin , which provides both prandial and basal glycemic coverage without the need for multiple injections . while robust data from randomized controlled trials ( rcts ) have been published , there is scarce data from observational trials or real world settings . this may be due to the fact that the co - formulation is available only in three countries so far : mexico , india , and bangladesh . this retrospective study shares data of 48 patients who have received idegasp for 12 months or more , at two endocrine centers in india . all patients visiting the outdoor clinic of two endocrine centers in india from 15 december to 15 january 2015 were assessed for type of diabetes therapy . patients who had been on idegasp therapy for 52 weeks or more were included in the study . details were collected regarding basic demographics , anthropometry , dosage and frequency of insulin , usage of oral glucose - lowering drugs , and glycemic control . data at baseline , at 26 ( 2 ) weeks , and at 52 ( 2 ) weeks were used for analysis . subjects were queried as to the frequency of hypoglycemia ( major , minor , and nocturnal ) during the past 4 weeks . idegasp usage was classified as initiation ( use in insulin - nave patients ) , intensification or step - up ( from basal insulin ) , de - escalation or step - down ( from 4 to 5 dose basal bolus therapy ) , or interchange ( switch ) therapy ( from premixed insulin ) . forty - eight subjects met the inclusion criteria of having used idegasp for 52 weeks or more . these included 40 men and 8 women , with a mean age of 54.33  9.63 years and a mean duration of diabetes of 6.33  2.96 years . of these , 16 subjects had started idegasp as insulin of initiation , 4 had used it as an intensification or step - up regime , from basal insulin , 16 had utilized it as a de - escalation regime or step - down from basal - bolus therapy ( 45 doses ) , while 12 had taken advantage of idegasp to switch from other dual action / premixed insulin . eight subjects administered idegasp once daily ( these included 4 who intensified from basal insulin and 4 who switched from once daily premixed insulin ) whereas 36 received idegasp twice daily . sixteen subjects had been de - escalated to a thrice daily idegasp basal regime ( two doses of aspart and one of idegasp ) [ table 1 ] . dose ( u / kg ) and frequency of insulin degludec aspart the choice of idegasp as an injectable therapy was based upon a process of informed , shared decision making , which took into account the pharmacokinetic and pharmacodynamic properties of idegasp , its potential advantages , and its cost . idegasp was used as a therapy of initiation in persons with oral hypoglycemic agent inadequacy , who needed safe glycemic control for elective surgery ( 2 ) , control of concurrent dermatological or genital infection ( 3 ) management of diabetes foot ( 4 ) , and resolution of osmotic symptoms / neuropathy ( 6 ) . idegasp was chosen as step - up or intensification therapy by four persons with basal insulin inadequacy , all of whom wished to remain on once daily injection and have flexibility in injection timing . two of these had concomitant depression and exhibited poor self - care ability . from basal bolus regime , de - escalation or step down to a three dose idegasp based regime was preferred by 16 subjects , all of whom wished to take advantage of the lower number of closer required with idegasp . these included high fasting glucose in 6 subjects , recurrent hypoglycemia in 2 , marked glycemic variability in 2 , poor response to management of concomitant foot infection in 1 , and infections documented at the onset of therapy with idegasp included diabetic foot ( 4 ) , pruritus vulvae ( 2 ) , acute or recurrent balanoposthitis ( 8) , carbuncles ( 2 ) , and pulmonary koch 's ( 3 ) . the initial dose of idegasp was 43.17  21.18 u / day or 0.56  0.23 u / kg . the starting dose varied according to dosage frequency . while subjects on once daily idegasp were begun on 0.35  0.21 u / kg , twice daily users started 0.60  0.24 u / kg ( p < 0.01 ) , and those on a three dose regime ( iasp - iasp - idegasp ) began a total of 0.83  0.12 u / kg of insulin . twice daily users began morning and evening doses in a 50:50 ratio . at 24 weeks , the dose was 37.75  17.13 u / day , ( 0.51  0.12 u / kg ) while at 52 weeks , it was 41.41  15.33 u / day ( 0.56  0.17 u / kg ) [ table 2 ] . all eight subjects who received three doses at onset of therapy were still on three doses after 1 year . of the 24 who began twice daily idegasp , 8 needed intensification to three dose regime at 24 weeks . of these , 4 had reverted to twice daily dosage at 52 weeks . of once daily users of idegasp , 3 had stepped up to twice daily idegasp at 24 weeks and another 3 required two doses by 52 weeks . twice daily idegasp users reported morning  evening dose distribution in a ratio of 46:54 , with the proportion of morning dose being 0.46  0.046 . the interchange therapy cohort had been on a mean dose of 64.0  29.79 u / day ( 0.61  0.26 u / kg ) premixed insulin and were shifted to 53.17  21.18 u / day ( 0.56  0.23 u / kg ) of idegasp . the cohort 's average dose at 26 weeks and 52 weeks was similar to that of the overall group . ( hba1c ) , which was 9.52  1.27% at the start of therapy , fell to 7.51  0.46% at 26 weeks and to 7.48  0.40% . fasting plasma glucose ( fpg ) fell from 154.08  33.30 mg% to 108.58  22.26 mg% at 26 weeks and 102.17  12.79 mg% at 52 weeks . of the 48 subjects , 39 ( 81.25% ) achieved a target of hba1c < 7.0% at both 26 and 52 weeks . concomitant oral medication therapy was assessed at baseline , 26 weeks , and 52 weeks . of the 48 subjects , 19 were on insulin monotherapy , 30 were on metformin , 10 on dipeptidyl peptidase-4 inhibitor + metformin , 3 on metformin + sulfonylurea , and 4 on metformin + acarbose therapy at baseline . this is the first real world evidence of the use of idegasp over a 52-week long period . while this analysis is retrospective , not controlled , and is limited by the fact that drop outs were not studied , it does add value to existing literature . it must be noted that this study was performed in a nonreimbursed environment , where patients have to pay from pocket for insulin and other supplies . the data reflect real world usage of idegasp , highlighting the various patterns and regimes it can be used in , its average dose requirements , and dose distribution according to meal times . the dose requirement of idegasp appears lower than that of other premixed insulin , and it allows basal bolus users to shift to a three injection regime . relatively few persons use the flexibility of time of administration that idegasp allows ( e.g. , shifting from breakfast to lunch or dinner ) . the long - term tolerability and lack of major hypoglycemia niskanen et al . in a 16-week long exploratory study found that idegasp was able to achieve target hba1c < 7.0% , without confirmed hypoglycemia in 67% subjects ( who were poorly controlled on metformin ) . the daily dose requirement of idegasp was 0.57  0.23 u / kg and was 13% lower than that of biphasic insulin aspart ( biasp ) . significantly lower fpg and confirmed hypoglycemia were noted . in a 26-week long treat - to - target trial , fulcher et al . included subjects with inadequate control on once daily or twice daily , premixed or self - mixed insulin . idegasp was able to achieve hba1c targets that were noninferior to biasp , with superior fpg control , less weight gain , and a lower dose ( 1.08 u / kg ) . lower rates of confirmed hypoglycemia ( 14 episodes per year [ epy ] ) and confirmed nocturnal hypoglycemia ( 2.5 epy ) week were noted . a 26-week long asian study observed lower dose requirement of once daily idegasp ( 0.79 u / kg ) , as compared to biasp , in controlling hba1c , with lower fpg and similar ( low ) risk of severe hypoglycemia . our study reveals lower dose requirements in comparison to previously used premixed insulin ( in patients who switch therapy ) and also in relation to those in rcts . the lower dose requirement may reflect indian clinical practice or may be due to sustained emphasis on ( and adherence to ) lifestyle modification . thus , the experience at our center supports the use of idegasp as a preferred injection of choice for initiation , intensification , de - escalation or step down from bolus therapy , and interchange from other premixed insulin . the one - year in - clinic experience at two endocrine centers in india reveals the efficacy , safety , tolerability , and versatility of idegasp as an insulin for initiation , intensification , de - escalation and interchange ( switch ) therapy , as monotherapy , or in combination with oral hypoglycemic agents .
background : this retrospective analysis describes the use of insulin degludec aspart ( idegasp ) in india.material and methods : all subjects who had received idegasp for 52 weeks at two endocrine centers were included in this study.results:forty-eight subjects ( 40 men ) , with mean age of 54.33  9.63 years and mean duration of diabetes of 6.33 
 2.96 years , started idegasp as insulin of initiation ( 16 ) , as an intensification regime ( 4 ) , as de - escalation from basal - bolus therapy ( 16 ) , or as switch from premixed insulin ( 12 ) . 
 the dose of idegasp fell from 43.17  21.18 u / day or 0.56  0.23 u / kg to 37.75  17.13u / day ( 0.51  0.12 u / kg ) at 24 weeks and 41.41  15.33 u / day ( 0.56  0.17 u / kg ) at 52 weeks . 
 hemoglobin a1c 
 ( hba1c ) , which was 9.52  1.27% at the start of therapy , fell to 7.51  0.46% at 26 weeks and to 7.48  0.40% at 52 weeks . fasting 
 plasma glucose fell from 154.08  33.30 mg% to 108.58  22.26 mg% at 26 weeks and 102.17  12.79 mg% at 52 weeks . 
 of the 48 subjects , 39 ( 81.25% ) achieved a target of hba1c < 7.0% at both 26 and 52 weeks . 
 no episode of hypoglycemia was reported in the 4 weeks preceding the analysis.conclusion:this communication highlights the efficacy , safety , and tolerability , while providing insight into the usage patterns of idegasp .