Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:

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1 The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product. Before prescribing any product mentioned in this Register, healthcare professionals should consult prescribing information for the product approved in their country. Study No.: SB /007 Title: A randomized, double-blind trial to evaluate the efficacy and safety of fixed dose rosiglitazone/metformin combination therapy compared to both rosiglitazone and metformin monotherapies in drug naive type 2 diabetes mellitus subjects Rationale: In drug naïve type 2 diabetics, monotherapy is initially effective, but inadequate to maintain the majority of type 2 diabetics at glycemic target. Clinical studies with rosiglitazone (RSG) in combination with metformin (MET) have shown significant reductions in HbA1c that were sustained over time. Hence, RSG and MET in a fixed dose combination may offer a therapeutic advantage in control of glycemia. This study was performed to determine whether therapy with combination RSG/MET might prove more efficacious as first line therapy than either RSG or MET monotherapy. Phase: IIIb Study Period: 6Oct Dec2004 Study Design: This Phase IIIb study was a double-blind trial to evaluate efficacy and safety of combination RSG/MET compared to both RSG and MET monotherapies in drug naïve type 2 diabetics. This study was designed with a 2 week Screening period, followed by 32 weeks of treatment. Centres: The study was conducted in 90 centers in 7 countries: Australia (9), Brazil (2), Canada (28), Korea (3), Mexico (6), New Zealand (5) and the United States (37). Indication: Type 2 diabetes first line therapy. Treatment: RSG/MET dosing began with a total daily dose of 2mg/500mg and could be increased up to 8mg/2000mg in increments of 2mg/500mg. RSG treatment began with a total daily dose of 4mg and could be increased up to 8mg. MET dosing began with a total daily dose of 500mg and could be increased up to 2000mg in increments of 500mg. Matching placebo capsules were provided so that each treatment group would take the same number of capsules per day for each dose level and therapy was titrated to a Mean Daily Glucose (MDG) of 110mg/dL. Objectives: The primary objective of this study was to demonstrate the superiority of combination RSG/MET compared to both RSG and MET monotherapies with respect to mean change from baseline in HbA1c after 32 weeks of treatment in drug naïve type 2 diabetics. Primary Outcome/Efficacy Variable: Change in HbA1c from baseline to Week 32 Secondary Outcome/Efficacy Variable(s): The following were secondary efficacy endpoints: Change in FPG from baseline to Week 32. Proportion of HbA1c responders (i.e., reduction from baseline of 0.7% or HbA1c <7%) at Week 32. Proportion of FPG responders (i.e., reduction from baseline of 30mg/dL (1.7mmol/L) or <126mg/dL (7mmol/L) at Week 32. Change in fasting insulin, C-peptide, and fructosamine from baseline to Week 32. HOMA S, HOMA-B, and free fatty acids at Week 32. Proportion of subjects achieving defined levels of HbA1c and FPG at Week 32. Final dose at Week 32. C-reactive protein, PAI-1, adiponectin, albumin/creatinine ratio at Week 32. Lipid levels at Week 32 Proportion of subjects at each dose level (i.e., 1-4) at Week 32. Statistical Methods The primary efficacy endpoint was the change in HbA1c from baseline to Week 32 and the primary comparisons of interest were between combination RSG/MET and RSG and between combination RSG/MET and MET. For each of the two comparisons, the hypothesis of treatment difference was tested at a 0.05 significance level based on two-sided tests. No adjustment for multiple comparisons was made because the objective of the study was to show combination RSG/MET was superior to each of the monotherapy arms. Treatment differences were assessed using analysis of covariance (ANCOVA) including terms for gender, treatment, country and baseline HbA1c in the model, using the Intent-to-Treat (ITT) with last observation carried forward (LOCF) population. The ITT population consisted of all randomized subjects who received at least one dose of study medication and had at least one valid on-therapy observation for an efficacy variable. To assess the difference between treatment groups with regard to change from baseline to Week 32 in FPG, insulin, C-peptide and fructosamine, an analysis of covariance with terms for screening HbA1c, gender, treatment, country, and baseline was performed based on the ITT with LOCF population. The above mentioned ANCOVA model was also used to analyze the lipid ratios, total/hdl and LDL/HDL using the ITT without LOCF population. Analyses of HOMA-S, HOMA-B, CRP, albumin/creatinine ratio, adiponectin, free fatty acids and non-ratio lipid parameters were based on log-transformed data, and were performed in the ITT without LOCF population. To assess 1

2 the percent treatment difference with regard to each of these parameters at week 32, an analysis of covariance with terms for screening HbA1c, gender, treatment, country, and baseline measurement was performed. Differences between treatment groups in the proportion of HbA1c responders and HbA1c target achievers at week 32 was assessed by logistic regression with terms for baseline HbA1c, gender and treatment in the model. Differences between treatment groups in the proportion of FPG responders and FPG target achievers at Week 32 was assessed by logistic regression with terms for baseline FPG, screening HbA1c, gender and treatment in the model. The final dose was summarized and the mean calculated, using the ITT with LOCF population. The evaluation of safety data included summary of adverse events performed for the Safety population, which consisted of all randomized subjects who received at least one dose of double-blind study medication. Study Population: A subject was eligible for inclusion in this study if all of the following criteria applied: The subject was 18 to 70 years of age (at Screening) and gave written informed consent. The subject had a clinical diagnosis of type 2 diabetes mellitus according to guidelines set forth by the ADA, CDA or AACE and had a Quest HbA1c >7.5% and 11%, and FPG 270mg/dL (15mmol/L) at Screening. The subject had been treated with diet and/or exercise alone, or had not taken more than 15 days of OAD medication or insulin in the past 12 weeks. Subjects who met any of the following key exclusion criteria were not eligible for inclusion in the study: anemia defined by hemoglobin concentration <11.0g/dL for males or <10.0g/dL for females, hemoglobinopathy, presence of clinically significant renal or hepatic disease (i.e., male subjects with serum creatinine 1.5mg/dL; female subjects with serum creatinine 1.4mg/dL; ALT, AST, total bilirubin, or alkaline phosphatase >2.5 times the upper limit of the normal (ULN) reference range), unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring pharmacologic treatment, systolic blood pressure >170mmHg or diastolic blood pressure >100mmHg, while on antihypertensive treatment, a chronic disease requiring intermittent or chronic treatment with oral, intravenous, or intraarticular corticosteroids (i.e., only use of topical, inhaled or nasal corticosteroids was permissible), a prior history of hepatocellular reaction, severe edema or a medically serious fluid related event (e.g. heart failure) associated with troglitazone or any other thiazolidinedione (TZD), significant hypersensitivity (e.g., difficulty swallowing, difficulty breathing, tachycardia or skin reaction) to TZDs, biguanides, or compounds with similar chemical structures, acute or chronic metabolic acidosis or a history of diabetic ketoacidosis, known to have severe lactose intolerance, a diagnosis of cancer (other than squamous or basal cell) in the past 3 years and was receiving treatment for the active cancer. Number of Subjects: Planned, N Randomised, N Completed, n (%) 136 (88) 123 (80) 137 (86) Total Number Subjects Withdrawn, N (%) 19 (12) 31 (20) 22 (14) Withdrawn due to Adverse Events n (%) 2 (1) 3 (2) 5 (3) Withdrawn due to Lack of Efficacy n (%) 0 3 (2) 1 (<1) Withdrawn for other reasons n (%) 17 (5) 25 (3) 16 (1) Demographics N (Safety) Females: Males 66:89 67:87 66:93 Mean Age, years (SD) 50.1 (10.74) 51.5 (10.42) 50.6 (10.26) White, n (%) 83 (54) 90 (58) 94 (59) Primary Efficacy Results: Change in HbA1c from Baseline to Week 32 n Baseline: Mean±SD 8.86± ± ±1.045 Week 32: Mean±SD 6.59± ± ±1.390 Change from Baseline to Week 32: Mean±SD -2.27± ± ±1.326 Adjusted mean difference % CI , ,

3 p-value < Secondary Outcome Variable(s): Change in FPG (mg/dl) (ITT with LOCF), n Baseline: Mean ± SD ± ± ± Week 32: Mean ± SD ± ± ± Change from Baseline: Mean±SD ± ± ± Adjusted mean difference % CI , , Protocol-Defined HbA1c Responders 140 (92.1) 131 (87.3) 127 (81.9) Odds Ratio to RSG & MET % CI , , 5.25 Protocol-Defined FPG Responders 141 (92.8) 109 (72.7) 118 (76.1) Odds Ratio to RSG & MET % CI , , 8.13 Change in Fasting Insulin (pmol/l), n Baseline: Mean±SD ± ± ± Week 32: Mean±SD ± ± ± Change from Baseline: Mean±SD ± ± ± Adjusted mean difference % CI , , Change in C-peptide (nmol/l), n Baseline: Mean±SD 1.112± ± ± Week 32: Mean±SD 0.915± ± ± Change from Baseline: Mean±SD ± ± ± Adjusted mean difference % CI , , Change in Fructosamine (µmol/l), n Baseline: Mean±SD 343.8± ± ±67.44 Week 32: Mean±SD 254.4± ± ±63.43 Change from Baseline: Mean±SD -89.4± ± ±56.87 Adjusted mean difference % CI , , Percent Change in HOMA-B (%), n Baseline: Geometric mean Week 32: Geometric mean % Change from Baseline to Week 32 Geometric mean (%) Geometric mean ±SE (84.97, 99.74) (57.86, 69.36) (48.58, 60.25) Geometric mean (%) % CI , , Percent Change in HOMA-S (%), n

4 Baseline: Geometric mean Week 32: Geometric mean % Change from Baseline to Week 32 Geometric mean (%) Geometric mean ±SE (53.66, 70.19) (29.52, 42.66) (30.60, 41.90) Geometric mean (%) % CI , , C-Reactive Protein (µg/ml), n Baseline: geometric mean (CV %) 4.50 ( ) 3.55 ( ) 3.75 ( ) Week 32: geometric mean (CV %) 2.05 ( ) 2.28 ( ) 2.19 ( ) % Change from Baseline: geometric mean (GM -SE, GM +SE) , , , geometric mean % CI , , 3.90 Albumin/Creatinine Ratio at Week 32, n Baseline: geometric mean (CV %) ( ) ( ) ( ) Week 32: geometric mean (CV %) ( ) ( ) ( ) % Change from Baseline: geometric mean (GM -SE, GM +SE) , , , % Difference between combination RSG/MET and geometric mean % CI , , Adiponectin, n Baseline: geometric mean (CV %) 5.21 (58.864) 5.02 (57.174) 5.04 (55.881) Week 32: geometric mean (CV %) (59.713) 5.46 (55.826) (66.765) % Change from Baseline: geometric mean (GM -SE, GM +SE) (137.97, ) 8.59 (5.60, 11.67) (155.31, ) geometric mean % CI , , 3.88 Free Fatty Acid: mg/dl, n Baseline: Geometric mean Week 32: Geometric mean % Change from Baseline to Week 32 Geometric mean (%) Geometric mean ±SE , , , Geometric mean % CI , , Total Cholesterol (mg/dl), n Baseline, Geometric mean ( (19.76) (19.28) (26.63) Week 32, Geometric mean (19.82) (20.29) (27.88) 4

5 % Change from Baseline Geometric mean +/- SE -3.8, , , 7.2 geometric mean % CI - 2.6, , -3.1 HDL Cholesterol (mg/dl), n Baseline, Geometric mean 42.6 (21.76) 42.9 (23.79) 42.8 (24.50) Week 32, Geometric mean 45.0 (25.45) 43.0 (23.04) 44.1 (27.05) % Change from Baseline Geometric mean +/- SE 4.2, , , 4.7 geometric mean % CI - 1.2, , 6.4 LDL Cholesterol (mg/dl), n Baseline, Geometric mean ( (32.52) (33.88) (40.45) Week 32, Geometric mean (30.40) (35.18) (58.03) % Change from Baseline Geometric mean +/- SE -2.8, , , 8.4 % Difference between combination RSG/MET and monotherapy geometric mean % CI - 1.9, , 2.3 Triglycerides (mg/dl), n Baseline, Geometric mean ( (67.65) (62.27) (67.61) Week 32, Geometric mean (68.61) (58.34) (74.81) % Change from Baseline Geometric mean +/- SE -21.5, , , -0.9 % Difference between combination RSG/MET and monotherapy geometric mean % CI , , -4.1 TC/HDL-cholesterol ratio, n Baseline, mean±sd 4.858± ± ± Week 32, mean±sd 4.561± ± ± Change from Baseline, mean±sd ± ± ± Adjusted mean difference % CI , , LDL/HDL-cholesterol ratio, n Baseline, mean±sd 2.799± ± ± Week 32, mean±sd 2.686± ± ± Change from Baseline, mean±sd ± ± ± Adjusted mean difference % CI , , Final Dose Level at Week 32 N=152 N=150 N=155 Dose Level 1 2mg/500mg: 4 (3) 500mg:5 (3) 4mg: 4 (3) Dose Level 2 4mg/1000mg: 13 (9) 1000mg: 9 (6) 4mg: 5 (3) Dose Level 3 6mg/1500mg: 23 (15) 1500mg: 13 (9) 8mg: 12 (8) 5

6 Dose Level 4 8mg/2000mg: 112 (74) 2000mg: 123 (82) 8mg: 134 (86) Mean final dose (mg) 7.2 / Safety Results: An on therapy adverse event (AE) or serious adverse event (SAE) was defined as an AE reported between the first day of double-blind study medication until two days after the last date of double-blind study medication. Most Frequent Adverse Events On-Therapy n (%) n (%) n (%) Subjects with any AE(s), n(%) 126 (81) 113 (73) 125 (79) Nausea/vomiting 1 25 (16) 20 (13) 13 (8) Diarrhea 22 (14) 32 (21) 11 (7) Headache 17 (11) 18 (12) 16 (10) Dyspepsia 15 (10) 12 (8) 14 (9) Upper respiratory tract infection 14 (9) 11 (7) 13 (8) Dizziness 12 (8) 4 (3) 8 (5) Edema 2 10 (6) 4 (3) 11 (7) Nasopharyngitis 10 (6) 7 (5) 7 (4) Abdominal pain 8 (5) 10 (6) 11 (7) Arthralgia 8 (5) 4 (3) 11 (7) Flatulence 8 (5) 4 (3) 6 (4) Loose stools 7 (5) 9 (6) 2 (1) Constipation 7 (5) 6 (4) 10 (6) Abdominal pain upper 6 (4) 8 (5) 8 (5) Gastroenteritis 3 (2) 5 (3) 4 (3) Hypertension 3 (2) 5 (3) 4 (3) Influenza 2 (1) 3 (2) 10 (6) Terms for nausea and vomiting were combined. Terms for edema peripheral, edema, generalized edema and pitting edema were combined. Serious Adverse Events - On-Therapy n (%) [n considered by the investigator to be related to study medication] MET RSG RSG/MET Subjects with non-fatal SAEs, n (%) 5 (3) 5 (3) 5 (3) n (%) [related] n (%) [related] n (%) [related] Non-cardiac chest pain 1 (<1) [0] 0 1 (<1) [0] Appendicitis 1 (<1) [0] 0 0 Pneumonia 1 (<1) [0] 0 0 Atrial fibrillation 1 (<1) [0] 0 0 Uterine leiomyoma 1 (<1) [0] 0 0 Joint dislocation 1 (<1) [0] 0 0 Angina pectoris 0 1 (<1) [0] 0 Corneal ulcer 0 1 (<1) [0] 0 B-cell lymphoma 0 1 (<1) [0] 0 Deep vein thrombosis 0 1 (<1) [0] 0 Pulmonary embolism 0 1 (<1) [0] 0 Congenital anomaly 0 1 (<1) [0] 0 Cellulitis (<1) [0] Diverticulitis (<1) [0] Mycardial infarction (<1) [0] Dyspnea (<1) [0] Pancreatitis acute (<1) [0] Hypovolemia (<1) [0] Subjects with fatal SAEs, n (%)

7 Conclusion: See publication below. Publications: Chou H., et. al.; Rosiglitazone and metformin fixed-dose combination provides superior glycaemic control compared to metformin and rosiglitazone monotherapies, and was well tolerated in drug-naïve patients with T2DM [poster]; European Association for the Study of Diabetes, September 2005, Athens, Greece. Date Updated: 22-Aug

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