Synopsis. Abstracts submitted to the EASD 2006 and IDF 2006 conferences. 7 June May Phase 4
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1 Report Body and Synopsis Page: 3 of 81 Synopsis TITLE OF TRIAL A 24-week, multi-centre, controlled, open-labelled, parallel, randomised efficacy and safety comparison of biphasic insulin aspart 30 once daily with metformin vs biphasic insulin aspart 30 monotherapy twice daily in subjects with type 2 diabetes INVESTIGATORS Signatory investigator Dr Hemant A Makan Johannesburg Principal investigators Dr Deepak R Lakha Johannesburg Dr Elizabeth C van den Berg Pretoria Dr Derek Miller Cape Town Dr Essop J Solomon Pietermaritzburg Dr Johann J Viljoen Bloemfontein Dr Frieda D Pienaar Bloemfontein Dr Hans H Snyman Brits Dr Joseph H Mynhardt Kimberley Dr Eric C Kok Cape Town Dr Dudley M Kelbe Richards Bay Dr Hilton Kaplan Cape Town Dr Puvanesveri Naiker Durban Prof Mahomed Abdool Khalek Omar Durban Dr Essack A Mitha Johannesburg Dr Ismail H Mitha Johannesburg TRIAL SITES 80 Gemsbok Avenue, 1827 Johannesburg Starling Street, 1827 Johannesburg. Zuid Afrikaans Hospital, Clinic 2, 0002 Pretoria. 103 Constantiaberg Mediclinic, 7800 Cape Town. Mediclinic Hospital, Payne Street, Block 3 1 st Floor, 3235 Pietermaritzburg. 55 Reid Street, 9301 Bloemfontein. Bloemfontein Mediclinic, Lower Ground Floor Room 1, 9301 Bloemfontein. Armansis Medical Centre, 12 Ludorf Street, 0250 Brits. 153 Du Toitspan Road, 8301 Kimberley. Kenilworth Medical Centre, 67 Rosmead Avenue, 7708 Cape Town. Richards Bay Trial Centre, Suite 6 Calypso Center, Kruger Rand Road, 3900 Richards Bay. 249 Main Road, 7708 Cape Town. 107 Chelmsford Road, St Augustine Hospital, 4001 Durban. 75 Hopelands Road, Centre for Diabetes & Endocrinology, 4091 Durban. Suite DF3, Newgate Centre, 2118 Johannesburg. No 1, Mowbray Avenue, Benoni, 1501 Johannesburg. PUBLICATIONS Abstracts submitted to the EASD 2006 and IDF 2006 conferences. TRIAL PERIOD 7 June May DEVELOPMENT PHASE Phase 4
2 Report Body and Synopsis Page: 4 of 81 OBJECTIVES Primary Objective: To compare the glycaemic control, measured as the level of glycosylated haemoglobin A 1c (HbA 1c ), of biphasic insulin aspart 30 (BIAsp 30) administered once daily plus metformin with that of BIAsp 30 administered twice daily in subjects with type 2 diabetes. Secondary Objectives: To compare the overall glycaemic control, between the two treatments, as measured by fasting plasma glucose (FPG), 8-point plasma glucose (PG) profiles (pre and post meals, bedtime and 2am) performed during the last week prior to Visits 2 and 7 (end of treatment) and 7-point PG profiles (pre and post meals and bedtime) performed during the last week prior to Visits 3 to 6. These comparisons are to include variations in postprandial increments. The incidence of hypoglycaemic episodes (minor, major and symptomatic) recorded during the 20-week maintenance period (nocturnal 23:00-06:00 and diurnal 06:00-23:00). The cardiovascular risk factors as assessed by triglyceride, total cholesterol, LDL- and HDL-cholesterol after 24 weeks of treatment. The safety profile as measured by the incidence of adverse events (AEs) during the treatment period. The safety profile as measured by laboratory safety parameters (haematology and biochemistry and physical examination). Weight and vital signs measured during the treatment period. METHODOLOGY This was a multi-centre, open-labelled, symmetrically randomised (1:1) two-armed parallel group trial of 24 weeks duration comparing BIAsp 30 administered once daily at dinner plus metformin dosed, at the Investigator s discretion, as per local practice, up to 3000mg a day to BIAsp 30 administered twice daily, once in the morning and once at dinnertime, to subjects with type 2 diabetes. NUMBER OF SUBJECTS PLANNED AND ANALYSED 160 subjects were planned to enter this trial. 140 subjects were randomised into treatment groups and exposed to trial product. 5 subjects with no post baseline HbA 1c data were excluded from the intent-to-treat (ITT) population. 135 subjects constituted the ITT population. 14 subjects withdrew from the trial due to AEs (3 subjects), ineffective therapy (3 subjects), non-compliance with therapy (4 subjects) and other reasons (4 subjects). 126 subjects completed the trial. 91 subjects constituted the per protocol (PP) population. DIAGNOSIS AND MAIN CRITERIA FOR INCLUSION Subjects with type 2 diabetes who were being treated with maximum doses of sulphonylurea or metformin monotherapy or oral combination therapy for at least 2 months. Aged 18 years. Body mass index (BMI) 40.0kg/m 2. HbA 1c 7.5% and 13.0%. TEST PRODUCT, DOSE AND MODE OF ADMINISTRATION, BATCH NUMBER BIAsp 30 (Batch no. B NP51475) 100U/mL, administered using pre-filled 3mL FlexPen delivery device. BIAsp 30 was injected subcutaneously once or twice daily at individualised doses. Rolab metformin HCl 500mg or 850mg were administered orally for subjects in the combination therapy group. DURATION OF TREATMENT A total of 24 weeks which included a 4-week titration period and a 20-week maintenance period. REFERENCE THERAPY, DOSE AND MODE OF ADMINISTRATION, BATCH NUMBER None.
3 Report Body and Synopsis Page: 5 of 81 CRITERIA FOR EVALUATION EFFICACY The primary efficacy endpoint was: HbA 1c. The secondary efficacy endpoints were: 7-point and 8-point PG profiles (pre and post meals, bedtime and 2am). Cardiovascular risk factors (triglyceride, total cholesterol, LDL- and HDL-cholesterol). CRITERIA FOR EVALUATION SAFETY Incidence of hypoglycaemic episodes (minor, major and symptomatic nocturnal and diurnal). AEs. Haematology and biochemistry. STATISTICAL METHODS Three trial populations were defined for the statistical analysis, the intent-to-treat (ITT) population, a per-protocol (PP) population and a safety population. The primary efficacy analysis was based on both the ITT and PP analysis sets. All other analyses were based on the ITT analysis sets. Exploratory analysis based on the PP population was also presented for the secondary efficacy endpoints if > 20% of the completed subjects were excluded from the PP population. Statistical test was not performed if > 35% of the completed subjects had missing data in the endpoints. Efficacy was assessed by HbA 1c, FPG, 7-point and 8-point PG profiles (pre and post meals, bedtime and 2am, including prandial PG increments [2 hours postprandial minus preprandial value]) and plasma lipids. HbA 1c at 24 weeks was analysed using ANOVA with adjustment to baseline. Comparison between treatments was performed using a predefined non-inferiority criterion of 0.6%. Safety was evaluated by incidence of hypoglycaemic episodes and AEs. DEMOGRAPHY OF TRIAL POPULATION As summarised in the table below, demography and baseline characteristics of subjects appeared similar in both treatment groups. BIAsp30 + MET BIAsp30 o.d. b.i.d Number of Subjects Exposed Age, years Mean (SD) 52.9 ( 9.4) 53.3 (10.4) Median Min - Max Sex, N (%) Female 30 (45.5%) 30 (43.5%) Male 36 (54.5%) 39 (56.5%) BMI, kg/m^2 Mean (SD) 28.8 ( 5.0) 29.5 ( 4.4) Median Min - Max Duration of Diagnosed Diabetes, years Mean (SD) 9.7 ( 7.0) 8.2 ( 5.9) Median Min - Max Retinopathy, N (%) No 58 (87.9%) 61 (88.4%) Yes 8 (12.1%) 8 (11.6%) Neuropathy, N (%) No 59 (89.4%) 59 (85.5%) Yes 7 (10.6%) 10 (14.5%)
4 Report Body and Synopsis Page: 6 of 81 Nephropathy, N (%) No 64 (97.0%) 65 (94.2%) Yes 2 ( 3.0%) 4 ( 5.8%) Macroangiopathy, N (%) No 57 (86.4%) 64 (92.8%) Yes 9 (13.6%) 5 ( 7.2%) HbA1c at Visit 1, % Mean (SD) 10.1 ( 1.4) 10.2 ( 1.4) Median Min - Max Diabetes Therapy at baseline, N (%) Monotherapy 6 ( 9.1%) 5 ( 7.2%) Oral Combination Therapy 60 (90.9%) 64 (92.8%) Duration of Current Diabetes Therapy, years Mean (SD) 3.1 ( 4.2) 2.1 ( 2.7) Median Min - Max Types of OADs, N (%) VISIT 2 (taken on day of 8-point PG profile) Biguanides and Meglitinides 1 ( 1.5%) 1 ( 1.4%) Biguanides and Sulphonlyureas 57 (86.4%) 63 (91.3%) Biguanides only 4 ( 6.1%) 0 ( 0.0%) Sulphonlyureas and TZD 0 ( 0.0%) 1 ( 1.4%) Sulphonlyureas and alpha-gi 1 ( 1.5%) 0 ( 0.0%) Sulphonlyureas only 2 ( 3.0%) 4 ( 5.8%) EFFICACY RESULTS After 24 weeks of treatment, glycaemic control was improved in both treatment groups: HbA 1c was reduced by 1.90 ± 1.44% in the once daily BIAsp 30 with metformin group and 1.62 ± 1.74% in the twice daily BIAsp 30 monotherapy group. Non-inferiority of once daily BIAsp 30 with metformin to twice daily BIAsp 30 monotherapy was shown (difference %; 95% CI [-0.752; 0.129]). Mean FPG decreased from baseline in the once daily BIAsp 30 with metformin group (-2.99 ± 3.13mmol/L) and in the twice daily BIAsp 30 monotherapy group (-2.16 ± 3.93mmol/L). The statistically significant treatment difference in FPG was mmol/L (95% CI ; ; p=0.010). At the final visit (LOCF), a lower prandial increment in PG at breakfast was observed in the twice daily BIAsp 30 monotherapy group (0.234mmol/L) than in the once daily BIAsp 30 with metformin group (2.275mmol/L). The change in breakfast prandial PG increment from baseline (Visit 2) to the final visit (LOCF) was -0.39mmol/L in the once daily BIAsp 30 with metformin group and -2.25mmol/L in the twice daily BIAsp 30 monotherapy group. After adjusting for baseline, there was a statistically significant treatment difference of ± 0.51mmol/L, 95% CI=1.025;3.057, p<0.001 at the final visit. However, a lower prandial increment in PG at lunch at the final visit (LOCF) was observed in the once daily BIAsp 30 with metformin group (1.324mmol/L) than in the twice daily BIAsp 30 monotherapy group (2.922mmol/L). The change in lunch prandial PG increment from baseline (Visit 2) to the final visit (LOCF) was -0.35mmol/L in the once daily BIAsp 30 with metformin group and 1.30mmol/L in the twice daily BIAsp 30 monotherapy group. After adjusting for baseline, there was a statistically significant treatment difference of ± 0.56mmol/L, 95% CI= ;-0.479, p=0.006 at the final visit. Similar to the result at lunch, a lower prandial increment in PG at dinner at the final visit (LOCF) was observed in the once daily BIAsp 30 with metformin group (-0.109mmol/L) than in the twice daily BIAsp 30 monotherapy group (0.907mmol/L). The change in dinner prandial PG increment from baseline (Visit 2) to the final visit (LOCF) was -2.76mmol/L in the once daily BIAsp 30 with metformin group and -1.29mmol/L in the twice daily BIAsp 30 monotherapy group. After adjusting for baseline, there was a statistically significant treatment difference of ± 0.50mmol/L, 95% CI=-2.012;-0.019, p=0.046 at the final visit. At the final visit (LOCF), a lower PG at bedtime was observed in the once daily BIAsp 30 with metformin group (7.249mmol/L) than in the twice daily BIAsp 30 monotherapy group (7.574mmol/L). The change in bedtime
5 Report Body and Synopsis Page: 7 of 81 prandial PG value from baseline (Visit 2) to the final visit (LOCF) was -4.17mmol/L in the once daily BIAsp 30 with metformin group and -4.04mmol/L in the twice daily BIAsp 30 monotherapy group. After adjusting for baseline, the non-statistically significant treatment difference was ± 0.67mmol/L, 95% CI=-1.645;0.995, p=0.626 at the final visit. At the final visit (LOCF), a lower PG at 2am was observed in the once daily BIAsp 30 with metformin group (6.964mmol/L) than in the twice daily BIAsp 30 monotherapy group (7.399mmol/L). The change in 2am PG value from baseline (Visit 2) to the final visit (LOCF) was -3.39mmol/L in the once daily BIAsp 30 with metformin group and -2.88mmol/L in the twice daily BIAsp 30 monotherapy group. After adjusting for baseline, the nonstatistically significant treatment difference was ± 0.58mmol/L, 95% CI=-1.589;0.720, p=0.457 at the final visit. Total cholesterol decreased by 0.12 ± 1.02mmol/L in the once daily BIAsp 30 with metformin group and increased by 0.21 ± 0.88mmol/L in the twice daily BIAsp 30 monotherapy group (statistically significant treatment difference -0.34mmol/L; 95% CI [-0.678; ]). Other parameters (LDL-, HDL-cholesterol and triglycerides) were comparable in the change from baseline (Visit 2) to the final visit (LOCF) in both treatment groups. SAFETY RESULTS After 24 weeks of treatment with either once daily BIAsp 30 with metformin or twice daily BIAsp 30 monotherapy: The AE profile was comparable between treatment groups, with a total of 275 events reported by 108 subjects: 73% reported 124 TEAEs in the once daily BIAsp 30 with metformin group and 81% reported 151 TEAEs in the twice daily BIAsp 30 monotherapy group. The majority of subjects reported AEs in both treatment groups were mild (61% in the once daily BIAsp 30 with metformin group and 60% in the twice daily BIAsp 30 monotherapy group) or moderate (33% in the once daily BIAsp 30 with metformin group and 50% in the twice daily BIAsp 30 monotherapy group). These AEs were unlikely to be related to trial product (71% in the once daily BIAsp 30 with metformin group reported 114 events and 79% in the twice daily BIAsp 30 monotherapy group reported 145 events), as judged by the Investigator and Sponsor. A total of 3 subjects from the twice daily BIAsp 30 monotherapy group were withdrawn due to AEs. The events leading to withdrawal were: fibromyalgia (severe and probable relation), insulin resistance (mild severity and probable relation) and weight gain (moderate severity and probable relation). A total of 262 non-saes were reported by 107 subjects: 73% reported 122 events in the once daily BIAsp 30 with metformin group and 80% reported 140 events in the twice daily BIAsp 30 monotherapy group. There were 13 SAEs reported by 9 subjects: 2 SAEs reported by 1 subject in the once daily BIAsp 30 with metformin group and 11 SAEs reported by 8 subjects in the twice daily BIAsp 30 monotherapy group. Except for 1 subject (Screening ID 0518) who had recovered with sequelae, all the subjects with treatment emergent SAEs had recovered from the event. All the events were judged by the Investigator and Sponsor as unlikely to be related to trial product. A total of 94 hypoglycaemic episodes were reported by 28 subjects (40%) on once daily BIAsp 30 with metformin and 147 hypoglycaemic episodes by 30 subjects (43%) on twice daily BIAsp 30 monotherapy, of which the majority were minor (29% and 27%) or symptomatic (23% and 31%). A major episode of hypoglycaemia was reported in the once daily BIAsp 30 with metformin group. In both treatment groups, minor/symptoms only hypoglycaemic episodes mostly (71 out of 88 events and 129 out of 144 events) occurred during the day. The change in body weight was 0.50 ± 3.33kg in the once daily BIAsp 30 with metformin group and 3.69 ± 4.91kg in the twice daily BIAsp 30 monotherapy group. Vital signs or the results of physical examinations remained generally unchanged in both treatment groups. ECG and fundoscopy results were normal in 79% and 83% of the subjects, respectively in both treatment groups. CONCLUSIONS After 24 weeks of treatment with either once daily BIAsp 30 with metformin or twice daily BIAsp 30 monotherapy in type 2 diabetes subjects: Comparable improvements in glycaemic control as observed in HbA 1c and PG were achieved in both treatment groups with non-inferiority of once daily BIAsp 30 with metformin to twice daily BIAsp 30 monotherapy
6 Report Body and Synopsis Page: 8 of 81 confirmed. An improvement in total cholesterol was observed in the once daily BIAsp 30 with metformin group. Other parameters in the lipids profile were comparable between treatment groups. The occurrence of hypoglycaemic episodes of which the majority were minor or symptomatic was comparable between treatment groups. Similarly, the incidences of AEs of which the majority were mild in severity and considered unlikely to be related to trial product were comparable between treatment groups. The trial was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice.
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