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A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00839527
Collaborator
(none)
685
Enrollment
358
Locations
3
Arms
49.9
Duration (Months)
1.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
685 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo and Active-Controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide Administered in Combination With Metformin and Glimepiride Compared With Metformin Plus Glimepiride and Placebo and With Metformin Plus Glimepiride and Pioglitazone in Subjects With Type 2 Diabetes Mellitus
Study Start Date :
Feb 1, 2009
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: metformin + glimepiride + pioglitazone + albiglutide placebo

Metformin + glimepiride + pioglitazone + matching albiglutide placebo

Drug: placebo to match albiglutide
albiglutide matching placebo weekly subcutaneous injection

Drug: metformin
metformin

Drug: glimepiride
glimepiride

Drug: pioglitazone
pioglitazone
Experimental: metformin + glimepiride + pioglitazone placebo + albiglutide

Metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide

Biological: albiglutide
albiglutide weekly subcutaneous injection

Drug: metformin
metformin

Drug: glimepiride
glimepiride

Drug: placebo to match pioglitazone
pioglitazone matching placebo
Active Comparator: met + glimepiride + pioglitazone placebo + albiglutide placebo

metformin + open-label glimepiride + pioglitazone placebo + albiglutide placebo

Drug: placebo to match albiglutide
albiglutide matching placebo weekly subcutaneous injection

Drug: metformin
metformin

Drug: glimepiride
glimepiride

Drug: placebo to match pioglitazone
pioglitazone matching placebo

Outcome Measures

Primary Outcome Measures

  1. Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 [Baseline and Week 52]

    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. Nine par. with post-BL values obtained >14 days after the last dose or after hyperglycemic rescue were included in the analysis population but were not analyzed for this endpoint.

Secondary Outcome Measures

  1. Change From Baseline in HbA1c at Week 104 and Week 156 [Baseline, Week 104, and Week 156]

    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.

  2. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 [Baseline and Week 52]

    The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region.

  3. Change From Baseline in FPG at Week 104 and Week 156 [Baseline, Week 104, and Week 156]

    The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.

  4. Time to Hyperglycemia Rescue [From the start of study medication until the end of the treatment (up to Week 156)]

    Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.

  5. Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52 [Week 52]

    The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) was assessed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.

  6. Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 [Week 156]

    The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) was assessed.

  7. Change From Baseline in Body Weight at Week 52 [Baseline and Week 52]

    The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region.

  8. Change From Baseline in Body Weight at Week 104 and Week 156 [Baseline, Week 104, and Week 156]

    The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • type 2 diabetes

  • BMI 20-45kg/m2 inclusive

Exclusion Criteria:

  • females who are pregnant, lactating, or less than 6 weeks post-partum

  • current symptomatic heart failure (NYHA Class II-IV)

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Alabaster Alabama United States 35007
2 GSK Investigational Site Birmingham Alabama United States 35205
3 GSK Investigational Site Birmingham Alabama United States 35235
4 GSK Investigational Site Birmingham Alabama United States 35242
5 GSK Investigational Site Dothan Alabama United States 36301
6 GSK Investigational Site Mobile Alabama United States 36617
7 GSK Investigational Site Tuscaloosa Alabama United States 35406
8 GSK Investigational Site Chandler Arizona United States 85225
9 GSK Investigational Site Gilbert Arizona United States 85295
10 GSK Investigational Site Green Valley Arizona United States 85614
11 GSK Investigational Site Phoenix Arizona United States 85023
12 GSK Investigational Site Phoenix Arizona United States 85028
13 GSK Investigational Site Phoenix Arizona United States 85032
14 GSK Investigational Site Phoenix Arizona United States 85050
15 GSK Investigational Site Phoenix Arizona United States 85051
16 GSK Investigational Site Tucson Arizona United States 85712
17 GSK Investigational Site Tucson Arizona United States 85745
18 GSK Investigational Site Bull Shoals Arkansas United States 72619
19 GSK Investigational Site Harrisburg Arkansas United States 72432
20 GSK Investigational Site Hot Springs Arkansas United States 71913
21 GSK Investigational Site Jonesboro Arkansas United States 72401
22 GSK Investigational Site Searcy Arkansas United States 72143
23 GSK Investigational Site Buena Park California United States 90620
24 GSK Investigational Site Chino California United States 91710
25 GSK Investigational Site Chula Vista California United States 91910
26 GSK Investigational Site Commerce California United States 90040
27 GSK Investigational Site Escondido California United States 92026
28 GSK Investigational Site Foothill Ranch California United States 92610
29 GSK Investigational Site Fountain Valley California United States 92708
30 GSK Investigational Site Fresno California United States 93720
31 GSK Investigational Site Fullerton California United States 92835
32 GSK Investigational Site Huntington Beach California United States 92646
33 GSK Investigational Site Indio California United States 92201
34 GSK Investigational Site La Jolla California United States 92037
35 GSK Investigational Site Lakewood California United States 90712
36 GSK Investigational Site Loma Linda California United States 92354
37 GSK Investigational Site Long Beach California United States 90806
38 GSK Investigational Site Los Alamitos California United States 90720
39 GSK Investigational Site Los Angeles California United States 90017
40 GSK Investigational Site Los Angeles California United States 90022
41 GSK Investigational Site Los Angeles California United States 90025
42 GSK Investigational Site Mission Viejo California United States 92691
43 GSK Investigational Site Northridge California United States 91325
44 GSK Investigational Site Palm Desert California United States 92260
45 GSK Investigational Site Palm Springs California United States 92262
46 GSK Investigational Site Pasadena California United States 91105
47 GSK Investigational Site Riverside California United States 92506
48 GSK Investigational Site Sacramento California United States 95825
49 GSK Investigational Site Sacramento California United States 95831
50 GSK Investigational Site San Diego California United States 92117
51 GSK Investigational Site San Diego California United States 92120
52 GSK Investigational Site Santa Ana California United States 92701
53 GSK Investigational Site Satna Monica California United States 90404
54 GSK Investigational Site Spring Valley California United States 91978
55 GSK Investigational Site Tarzana California United States 91356
56 GSK Investigational Site Tustin California United States 92780
57 GSK Investigational Site Victorville California United States 92395
58 GSK Investigational Site Walnut Creek California United States 94598
59 GSK Investigational Site West Hills California United States 91307
60 GSK Investigational Site Arvada Colorado United States 80005
61 GSK Investigational Site Denver Colorado United States 80209
62 GSK Investigational Site New Britain Connecticut United States 06050
63 GSK Investigational Site Trumbull Connecticut United States 06611
64 GSK Investigational Site Waterbury Connecticut United States 06708
65 GSK Investigational Site Middletown Delaware United States 19709
66 GSK Investigational Site Boynton Beach Florida United States 33426
67 GSK Investigational Site Boynton Beach Florida United States 33437
68 GSK Investigational Site Clearwater Florida United States 33756
69 GSK Investigational Site Clearwater Florida United States 33765
70 GSK Investigational Site Cocoa Florida United States 32927
71 GSK Investigational Site Cutler Bay Florida United States 33189
72 GSK Investigational Site Deerfield Beach Florida United States 33442
73 GSK Investigational Site Delray Beach Florida United States 33445
74 GSK Investigational Site Edgewater Florida United States 32132
75 GSK Investigational Site Fort Lauderdale Florida United States 33316
76 GSK Investigational Site Gainesville Florida United States 32605
77 GSK Investigational Site Hallandale Beach Florida United States 33009
78 GSK Investigational Site Hialeah Florida United States 33012
79 GSK Investigational Site Hialeah Florida United States 33013
80 GSK Investigational Site Hollywood Florida United States 33023
81 GSK Investigational Site Lauderdale Lakes Florida United States 33319
82 GSK Investigational Site Marianna Florida United States 32446
83 GSK Investigational Site Miami Florida United States 33135
84 GSK Investigational Site Miami Florida United States 33156
85 GSK Investigational Site North Miami Florida United States 33161
86 GSK Investigational Site Ocala Florida United States 34471
87 GSK Investigational Site Orlando Florida United States 32822
88 GSK Investigational Site Ormond Beach Florida United States 32174
89 GSK Investigational Site Oviedo Florida United States 32765
90 GSK Investigational Site Panama City Florida United States 32401
91 GSK Investigational Site Pembroke Pines Florida United States 33026
92 GSK Investigational Site Pembroke Pines Florida United States 33027
93 GSK Investigational Site Plantation Florida United States 33317
94 GSK Investigational Site Ponte Verda Florida United States 32081
95 GSK Investigational Site St. Cloud Florida United States 34769
96 GSK Investigational Site St. Petersburg Florida United States 33709
97 GSK Investigational Site Tampa Florida United States 33603
98 GSK Investigational Site West Palm Beach Florida United States 33401
99 GSK Investigational Site Atlanta Georgia United States 30308
100 GSK Investigational Site Atlanta Georgia United States 30312
101 GSK Investigational Site Atlanta Georgia United States 30328
102 GSK Investigational Site Atlanta Georgia United States 30338
103 GSK Investigational Site Atlanta Georgia United States 30342
104 GSK Investigational Site Blue Ridge Georgia United States 30513
105 GSK Investigational Site Columbus Georgia United States 31904
106 GSK Investigational Site Decatur Georgia United States 30032
107 GSK Investigational Site Savannah Georgia United States 31406
108 GSK Investigational Site Savannah Georgia United States 31419
109 GSK Investigational Site Snellville Georgia United States 30078
110 GSK Investigational Site Stone Mountain Georgia United States 30088
111 GSK Investigational Site Tucker Georgia United States 30084
112 GSK Investigational Site Honolulu Hawaii United States 96813
113 GSK Investigational Site Honolulu Hawaii United States 96814
114 GSK Investigational Site Boise Idaho United States 83702
115 GSK Investigational Site Idaho Falls Idaho United States 83404
116 GSK Investigational Site Aurora Illinois United States 60504
117 GSK Investigational Site Chicago Illinois United States 60607
118 GSK Investigational Site Evergreen Park Illinois United States 60805
119 GSK Investigational Site Gurnee Illinois United States 60031
120 GSK Investigational Site La Grange Illinois United States 60525
121 GSK Investigational Site Naperville Illinois United States 60564
122 GSK Investigational Site Peoria Illinois United States 61602
123 GSK Investigational Site Avon Indiana United States 46123
124 GSK Investigational Site Evansville Indiana United States 47714
125 GSK Investigational Site Fishers Indiana United States 46037
126 GSK Investigational Site La Porte Indiana United States 46350
127 GSK Investigational Site Lafayette Indiana United States 47904
128 GSK Investigational Site South Bend Indiana United States 46614
129 GSK Investigational Site Council Bluffs Iowa United States 51501
130 GSK Investigational Site Des Moines Iowa United States 50314
131 GSK Investigational Site Dubuque Iowa United States 52001
132 GSK Investigational Site Iowa City Iowa United States 52243
133 GSK Investigational Site Waterloo Iowa United States 50701
134 GSK Investigational Site Arkansas City Kansas United States 67005
135 GSK Investigational Site Mission Kansas United States 66202
136 GSK Investigational Site Newton Kansas United States 67114
137 GSK Investigational Site Overland Park Kansas United States 66211
138 GSK Investigational Site Topeka Kansas United States 66606
139 GSK Investigational Site Fort Mitchell Kentucky United States 41017
140 GSK Investigational Site Lexington Kentucky United States 40503
141 GSK Investigational Site Lexington Kentucky United States 40504
142 GSK Investigational Site Madisonville Kentucky United States 42431
143 GSK Investigational Site Paducah Kentucky United States 42003
144 GSK Investigational Site Covington Louisiana United States 70433
145 GSK Investigational Site Lake Charles Louisiana United States 70601
146 GSK Investigational Site Shreveport Louisiana United States 71101
147 GSK Investigational Site Shreveport Louisiana United States 71115
148 GSK Investigational Site Baltimore Maryland United States 21237-3998
149 GSK Investigational Site Hyattsville Maryland United States 20782
150 GSK Investigational Site Oxon Hill Maryland United States 20745
151 GSK Investigational Site Haverhill Massachusetts United States 01830
152 GSK Investigational Site Bay City Michigan United States 48706
153 GSK Investigational Site Benzonia Michigan United States 49616
154 GSK Investigational Site Bloomfield Hills Michigan United States 48302
155 GSK Investigational Site Cadillac Michigan United States 49601
156 GSK Investigational Site Dearborn Michigan United States 48124
157 GSK Investigational Site Kalamazoo Michigan United States 49009
158 GSK Investigational Site Kalamazoo Michigan United States 49048
159 GSK Investigational Site St Clair Shores Michigan United States 48081
160 GSK Investigational Site Minneapolis Minnesota United States 55430
161 GSK Investigational Site Gulfport Mississippi United States 39501
162 GSK Investigational Site Picayune Mississippi United States 39466
163 GSK Investigational Site Rolling Fork Mississippi United States 39159
164 GSK Investigational Site Chesterfield Missouri United States 63017
165 GSK Investigational Site Jefferson City Missouri United States 65109
166 GSK Investigational Site Kansas City Missouri United States 64106
167 GSK Investigational Site Kansas City Missouri United States
168 GSK Investigational Site Springfield Missouri United States 65807
169 GSK Investigational Site St. Louis Missouri United States 63117
170 GSK Investigational Site St. Louis Missouri United States 63141
171 GSK Investigational Site West Plains Missouri United States 65775
172 GSK Investigational Site Billings Montana United States 59102
173 GSK Investigational Site Butte Montana United States 59701
174 GSK Investigational Site Great Falls Montana United States 59405
175 GSK Investigational Site Broken Bow Nebraska United States 68822
176 GSK Investigational Site Lincoln Nebraska United States 68516
177 GSK Investigational Site Omaha Nebraska United States 68124
178 GSK Investigational Site Omaha Nebraska United States 68131
179 GSK Investigational Site Omaha Nebraska United States 68134
180 GSK Investigational Site Las Vegas Nevada United States 89102
181 GSK Investigational Site Las Vegas Nevada United States 89104
182 GSK Investigational Site Las Vegas Nevada United States 89106
183 GSK Investigational Site Las Vegas Nevada United States 89128
184 GSK Investigational Site Las Vegas Nevada United States 89130
185 GSK Investigational Site Berlin New Jersey United States 08009
186 GSK Investigational Site Elizabeth New Jersey United States 07202
187 GSK Investigational Site Haddon Heights New Jersey United States 08035
188 GSK Investigational Site Hainesport New Jersey United States 08036
189 GSK Investigational Site New Brunswick New Jersey United States 08903
190 GSK Investigational Site Stratford New Jersey United States 08084
191 GSK Investigational Site Albuquerque New Mexico United States 87106
192 GSK Investigational Site New York New York United States 10022
193 GSK Investigational Site New York New York United States 10025
194 GSK Investigational Site North Massapequa New York United States 11758
195 GSK Investigational Site Asheboro North Carolina United States 27203
196 GSK Investigational Site Asheville North Carolina United States 28803
197 GSK Investigational Site Burlington North Carolina United States 27215
198 GSK Investigational Site Calabash North Carolina United States 28467
199 GSK Investigational Site Durham North Carolina United States 27710
200 GSK Investigational Site Fayetteville North Carolina United States 28304
201 GSK Investigational Site Greensboro North Carolina United States 27405
202 GSK Investigational Site Hickory North Carolina United States 28601
203 GSK Investigational Site Huntersville North Carolina United States 28078
204 GSK Investigational Site Lenoir North Carolina United States 28645
205 GSK Investigational Site Mint HIll North Carolina United States 28227
206 GSK Investigational Site Morehead City North Carolina United States 28557
207 GSK Investigational Site Shelby North Carolina United States 28150
208 GSK Investigational Site Tabor City North Carolina United States 28463
209 GSK Investigational Site Akron Ohio United States 44320
210 GSK Investigational Site Canal Fulton Ohio United States 44614
211 GSK Investigational Site Cincinnati Ohio United States 45211
212 GSK Investigational Site Cincinnati Ohio United States 45219
213 GSK Investigational Site Cincinnati Ohio United States 45227
214 GSK Investigational Site Cincinnati Ohio United States 45245
215 GSK Investigational Site Cleveland Ohio United States 44122
216 GSK Investigational Site Columbus Ohio United States 43212
217 GSK Investigational Site Columbus Ohio United States 43213
218 GSK Investigational Site Dayton Ohio United States 45432
219 GSK Investigational Site Dayton Ohio United States 45439
220 GSK Investigational Site Kettering Ohio United States 45429
221 GSK Investigational Site Mason Ohio United States 45040
222 GSK Investigational Site Maumee Ohio United States 43537-9402
223 GSK Investigational Site Thornville Ohio United States 43076
224 GSK Investigational Site Zanesville Ohio United States 43701
225 GSK Investigational Site Oklahoma City Oklahoma United States 73103
226 GSK Investigational Site Tulsa Oklahoma United States 74104
227 GSK Investigational Site Tulsa Oklahoma United States 74136
228 GSK Investigational Site Ashland Oregon United States 97520
229 GSK Investigational Site Bensalem Pennsylvania United States 19020
230 GSK Investigational Site Carlisle Pennsylvania United States 17013
231 GSK Investigational Site Downington Pennsylvania United States 19335
232 GSK Investigational Site Harrisburg Pennsylvania United States 17112
233 GSK Investigational Site Landsdale Pennsylvania United States 19446
234 GSK Investigational Site Melrose Park Pennsylvania United States 19027
235 GSK Investigational Site Tipton Pennsylvania United States 16684
236 GSK Investigational Site Uniontown Pennsylvania United States 15401
237 GSK Investigational Site Cumberland Rhode Island United States 02864
238 GSK Investigational Site East Providence Rhode Island United States 02914
239 GSK Investigational Site Columbia South Carolina United States 29201
240 GSK Investigational Site Greenville South Carolina United States 29601
241 GSK Investigational Site Greenville South Carolina United States 29615
242 GSK Investigational Site Greer South Carolina United States 29651
243 GSK Investigational Site Manning South Carolina United States 29102
244 GSK Investigational Site Murrells Inlet South Carolina United States 29576
245 GSK Investigational Site North Myrtle Beach South Carolina United States 29582
246 GSK Investigational Site Orangeburg South Carolina United States 29115
247 GSK Investigational Site Simpsonville South Carolina United States 29681
248 GSK Investigational Site Taylors South Carolina United States 29687
249 GSK Investigational Site Bristol Tennessee United States 37620
250 GSK Investigational Site Chattanooga Tennessee United States 37421
251 GSK Investigational Site Clarksville Tennessee United States 37043
252 GSK Investigational Site Columbia Tennessee United States 38401
253 GSK Investigational Site Fayetteville Tennessee United States 37334
254 GSK Investigational Site Germantown Tennessee United States 38138
255 GSK Investigational Site Johnson City Tennessee United States 37604
256 GSK Investigational Site McKenzie Tennessee United States 38201
257 GSK Investigational Site Memphis Tennessee United States 38125
258 GSK Investigational Site Nashville Tennessee United States 37203
259 GSK Investigational Site Tullahoma Tennessee United States 37398
260 GSK Investigational Site Arlington Texas United States 76012
261 GSK Investigational Site Bedford Texas United States 76201
262 GSK Investigational Site Cleburne Texas United States 76033
263 GSK Investigational Site Corpus Christi Texas United States 78404
264 GSK Investigational Site Corpus Christi Texas United States 78414
265 GSK Investigational Site Dallas Texas United States 75224
266 GSK Investigational Site Dallas Texas United States 75230
267 GSK Investigational Site Dallas Texas United States 75235
268 GSK Investigational Site Dallas Texas United States 75246
269 GSK Investigational Site Dallas Texas United States 75251
270 GSK Investigational Site Deer Park Texas United States 77536
271 GSK Investigational Site El Paso Texas United States 79925
272 GSK Investigational Site Fort Worth Texas United States 76104
273 GSK Investigational Site Fort Worth Texas United States 76135
274 GSK Investigational Site Houston Texas United States 77024
275 GSK Investigational Site Houston Texas United States 77030
276 GSK Investigational Site Houston Texas United States 77034
277 GSK Investigational Site Houston Texas United States 77036
278 GSK Investigational Site Houston Texas United States 77055
279 GSK Investigational Site Houston Texas United States 77058
280 GSK Investigational Site Houston Texas United States 77070
281 GSK Investigational Site Houston Texas United States 77074
282 GSK Investigational Site Hurst Texas United States 76054
283 GSK Investigational Site Katy Texas United States 77450
284 GSK Investigational Site Lake Jackson Texas United States 77566
285 GSK Investigational Site Lewisville Texas United States 75067
286 GSK Investigational Site Midland Texas United States 79707
287 GSK Investigational Site North Richland Hills Texas United States 76180
288 GSK Investigational Site Odessa Texas United States 79761
289 GSK Investigational Site San Antonio Texas United States 78215
290 GSK Investigational Site San Antonio Texas United States 78217
291 GSK Investigational Site San Antonio Texas United States 78218
292 GSK Investigational Site San Antonio Texas United States 78224
293 GSK Investigational Site San Antonio Texas United States 78229
294 GSK Investigational Site San Antonio Texas United States 78258
295 GSK Investigational Site Schertz Texas United States 78154
296 GSK Investigational Site Sugar Land Texas United States 77479
297 GSK Investigational Site Sugarland Texas United States 77479
298 GSK Investigational Site Temple Texas United States 76508
299 GSK Investigational Site Orem Utah United States 84058
300 GSK Investigational Site Salt Lake City Utah United States 84102
301 GSK Investigational Site Salt Lake City Utah United States 84107
302 GSK Investigational Site West Jordan Utah United States 84088
303 GSK Investigational Site West Valley City Utah United States 84120
304 GSK Investigational Site South Burlington Vermont United States 05403
305 GSK Investigational Site Burke Virginia United States 22015
306 GSK Investigational Site Hampton Virginia United States 23666
307 GSK Investigational Site Manassas Virginia United States 20110
308 GSK Investigational Site Norfolk Virginia United States 23502
309 GSK Investigational Site Richmond Virginia United States 23294
310 GSK Investigational Site Suffolk Virginia United States
311 GSK Investigational Site Virgina Beach Virginia United States 23455
312 GSK Investigational Site Weber City Virginia United States 24290
313 GSK Investigational Site Federal Way Washington United States 98003
314 GSK Investigational Site Renton Washington United States 98057
315 GSK Investigational Site Richland Washington United States 99352
316 GSK Investigational Site Selah Washington United States 98942
317 GSK Investigational Site Spokane Washington United States 99208
318 GSK Investigational Site Spokane Washington United States 99216
319 GSK Investigational Site Tacoma Washington United States 98405
320 GSK Investigational Site Lewisburg West Virginia United States 24901
321 GSK Investigational Site Milwaukee Wisconsin United States 53226
322 GSK Investigational Site Villingen-Schwenningen Baden-Wuerttemberg Germany 78054
323 GSK Investigational Site Kuenzing Bayern Germany 94550
324 GSK Investigational Site Kelkheim Hessen Germany 65779
325 GSK Investigational Site Rotenburg Hessen Germany 36199
326 GSK Investigational Site Bad Lauterberg Niedersachsen Germany 37431
327 GSK Investigational Site Mainz Rheinland-Pfalz Germany 55116
328 GSK Investigational Site Berlin Germany 10115
329 GSK Investigational Site Chaiwan Hong Kong
330 GSK Investigational Site Kwun Tong, Kowloon Hong Kong
331 GSK Investigational Site Shatin Hong Kong
332 GSK Investigational Site Tai Po, Hong Kong
333 GSK Investigational Site Aurangabad India 431001
334 GSK Investigational Site Bangalore India 560043
335 GSK Investigational Site Chennai India 600086
336 GSK Investigational Site Pune India 411 011
337 GSK Investigational Site Pune India 411011
338 GSK Investigational Site Callao Lima Peru Callao 2
339 GSK Investigational Site Ica Peru 11
340 GSK Investigational Site Lima Peru 01
341 GSK Investigational Site Lima Peru Lima 1
342 GSK Investigational Site Cebu City Philippines 6000
343 GSK Investigational Site Marikina City Philippines 1810
344 GSK Investigational Site Quezon City Philippines 1101
345 GSK Investigational Site Quezon City Philippines 1102
346 GSK Investigational Site San Juan Philippines 1500
347 GSK Investigational Site Taytay Rizal Philippines 1920
348 GSK Investigational Site Smolensk Russian Federation 214 019
349 GSK Investigational Site Yaroslavl Russian Federation 150062
350 GSK Investigational Site Alzira/Valencia Spain 46600
351 GSK Investigational Site Barcelona Spain 08022
352 GSK Investigational Site Madrid Spain 28034
353 GSK Investigational Site Palma de Mallorca Spain 07010
354 GSK Investigational Site Sevilla Spain 41003
355 GSK Investigational Site Blackpool Lancashire United Kingdom FY4 3AD
356 GSK Investigational Site Coventry West Midlands United Kingdom CV2 2DX
357 GSK Investigational Site Glasgow United Kingdom G45 9AW
358 GSK Investigational Site London United Kingdom SE1 9NH

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00839527
Other Study ID Numbers:
  • 112757
First Posted:
Feb 9, 2009
Last Update Posted:
Jan 9, 2017
Last Verified:
Nov 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
diabetes
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Metformin
Pioglitazone
Glimepiride
rGLP-1 protein
Glucagon-Like Peptide 1

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail Participants (par.) who met eligibility criteria and completed a 6- to 8-week Run-in/Stabilization Period were then randomized to a 156-week Treatment Period, followed by 8 weeks of post-treatment follow-up. A total of 992 par. were screened; 685 par. were randomized, and 663 par. received >=1 treatment dose.
Arm/Group Title Placebo + Metformin + Glimepiride Pioglitazone + Metformin + Glimepiride Albiglutide + Metformin + Glimepiride
Arm/Group Description Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
Period Title: Treatment Period (TP) (156 Weeks)
STARTED 115 277 271
COMPLETED 55 159 152
NOT COMPLETED 60 118 119
Period Title: Treatment Period (TP) (156 Weeks)
STARTED 114 273 266
COMPLETED 86 217 204
NOT COMPLETED 28 56 62

Baseline Characteristics

Arm/Group Title Placebo + Metformin + Glimepiride Pioglitazone + Metformin + Glimepiride Albiglutide + Metformin + Glimepiride Total
Arm/Group Description Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Total of all reporting groups
Overall Participants 115 277 271 663
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
55.7
(9.59)
55.7
(9.39)
54.5
(9.47)
55.2
(9.46)
Gender (Count of Participants)
Female
45
39.1%
129
46.6%
136
50.2%
310
46.8%
Male
70
60.9%
148
53.4%
135
49.8%
353
53.2%
Race/Ethnicity, Customized (Number) [Number]
African American/African Heritage
10
8.7%
24
8.7%
34
12.5%
68
10.3%
American Indian or Alaskan Native
9
7.8%
10
3.6%
22
8.1%
41
6.2%
Asian - Central/South Asian Heritage
6
5.2%
6
2.2%
8
3%
20
3%
Asian - East Asian Heritage
2
1.7%
8
2.9%
12
4.4%
22
3.3%
Asian - Japanese Heritage
0
0%
1
0.4%
2
0.7%
3
0.5%
Asian - South East Asian Heritage
7
6.1%
24
8.7%
14
5.2%
45
6.8%
Native Hawaiian or Other Pacific Islander
1
0.9%
1
0.4%
0
0%
2
0.3%
White - Arabic/North African Heritage
1
0.9%
2
0.7%
2
0.7%
5
0.8%
White - White/Caucasian/European Heritage
79
68.7%
201
72.6%
176
64.9%
456
68.8%
Mexican American
0
0%
0
0%
1
0.4%
1
0.2%

Outcome Measures

1. Primary Outcome
Title Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52
Description HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. Nine par. with post-BL values obtained >14 days after the last dose or after hyperglycemic rescue were included in the analysis population but were not analyzed for this endpoint.
Time Frame Baseline and Week 52

Outcome Measure Data

Analysis Population Description
Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 52.
Arm/Group Title Placebo + Metformin + Glimepiride Pioglitazone + Metformin + Glimepiride Albiglutide + Metformin + Glimepiride
Arm/Group Description Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
Measure Participants 115 268 265
Least Squares Mean (Standard Error) [Percentage of HbA1c in the blood]
0.33
(0.083)
-0.80
(0.055)
-0.55
(0.055)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Metformin + Glimepiride, Albiglutide + Metformin + Glimepiride
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.0001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.87
Confidence Interval (2-Sided) 95%
-1.07 to -0.68
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pioglitazone + Metformin + Glimepiride, Albiglutide + Metformin + Glimepiride
Comments
Type of Statistical Test Non-Inferiority or Equivalence
Comments The p-value is from a one-sided t-test testing at the 0.025 level of significance whether or not the difference of least square means (albiglutide - pioglitazone) is less than or equal to the pre-specified non-inferiority margin of 0.3%.
Statistical Test of Hypothesis p-Value 0.2685
Comments
Method t-test, 1 sided
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
0.10 to 0.40
Parameter Dispersion Type:
Value:
Estimation Comments
2. Secondary Outcome
Title Change From Baseline in HbA1c at Week 104 and Week 156
Description HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Time Frame Baseline, Week 104, and Week 156

Outcome Measure Data

Analysis Population Description
ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles).
Arm/Group Title Placebo + Metformin + Glimepiride Pioglitazone + Metformin + Glimepiride Albiglutide + Metformin + Glimepiride
Arm/Group Description Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
Measure Participants 12 130 104
Week 104, n=12, 130, 104
-0.32
(0.552)
-1.09
(1.119)
-0.76
(1.009)
Week 156, n=9, 89, 71
-0.10
(0.923)
-0.97
(1.063)
-0.46
(1.113)
3. Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Description The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region.
Time Frame Baseline and Week 52

Outcome Measure Data

Analysis Population Description
Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.
Arm/Group Title Placebo + Metformin + Glimepiride Pioglitazone + Metformin + Glimepiride Albiglutide + Metformin + Glimepiride
Arm/Group Description Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
Measure Participants 115 272 268
Least Squares Mean (Standard Error) [Millimoles per liter (mmol/L)]
0.64
(0.243)
-1.74
(0.158)
-0.69
(0.159)
4. Secondary Outcome
Title Change From Baseline in FPG at Week 104 and Week 156
Description The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Time Frame Baseline, Week 104, and Week 156

Outcome Measure Data

Analysis Population Description
ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles).
Arm/Group Title Placebo + Metformin + Glimepiride Pioglitazone + Metformin + Glimepiride Albiglutide + Metformin + Glimepiride
Arm/Group Description Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
Measure Participants 12 128 103
Week 104, n=12, 128, 103
0.43
(3.346)
-1.98
(3.471)
-0.99
(3.083)
Week 156, n=9, 88, 71
-0.50
(4.093)
-1.94
(3.127)
-0.88
(2.652)
5. Secondary Outcome
Title Time to Hyperglycemia Rescue
Description Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.
Time Frame From the start of study medication until the end of the treatment (up to Week 156)

Outcome Measure Data

Analysis Population Description
ITT Population
Arm/Group Title Placebo + Metformin + Glimepiride Pioglitazone + Metformin + Glimepiride Albiglutide + Metformin + Glimepiride
Arm/Group Description Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
Measure Participants 115 273 269
Median (95% Confidence Interval) [Weeks]
49.57
NA
137.71
6. Secondary Outcome
Title Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52
Description The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) was assessed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.
Time Frame Week 52

Outcome Measure Data

Analysis Population Description
ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed.
Arm/Group Title Placebo + Metformin + Glimepiride Pioglitazone + Metformin + Glimepiride Albiglutide + Metformin + Glimepiride
Arm/Group Description Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
Measure Participants 115 268 265
HbA1c <6.5%
4
3.5%
37
13.4%
27
10%
HbA1c <7.0%
10
8.7%
94
33.9%
79
29.2%
HbA1c <7.5%
19
16.5%
150
54.2%
126
46.5%
7. Secondary Outcome
Title Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156
Description The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) was assessed.
Time Frame Week 156

Outcome Measure Data

Analysis Population Description
ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Arm/Group Title Placebo + Metformin + Glimepiride Pioglitazone + Metformin + Glimepiride Albiglutide + Metformin + Glimepiride
Arm/Group Description Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
Measure Participants 9 89 71
HbA1c <6.5%
1
0.9%
23
8.3%
16
5.9%
HbA1c <7.0%
3
2.6%
44
15.9%
26
9.6%
HbA1c <7.5%
5
4.3%
68
24.5%
45
16.6%
8. Secondary Outcome
Title Change From Baseline in Body Weight at Week 52
Description The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region.
Time Frame Baseline and Week 52

Outcome Measure Data

Analysis Population Description
ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.
Arm/Group Title Placebo + Metformin + Glimepiride Pioglitazone + Metformin + Glimepiride Albiglutide + Metformin + Glimepiride
Arm/Group Description Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
Measure Participants 115 272 268
Least Squares Mean (Standard Error) [Kilograms]
-0.40
(0.362)
4.43
(0.235)
-0.42
(0.237)
9. Secondary Outcome
Title Change From Baseline in Body Weight at Week 104 and Week 156
Description The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Time Frame Baseline, Week 104, and Week 156

Outcome Measure Data

Analysis Population Description
ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles).
Arm/Group Title Placebo + Metformin + Glimepiride Pioglitazone + Metformin + Glimepiride Albiglutide + Metformin + Glimepiride
Arm/Group Description Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
Measure Participants 12 130 104
Week 104, n=12, 130, 104
-2.16
(3.603)
6.28
(6.189)
-0.90
(3.721)
Week 156, n=9, 90, 71
-4.47
(5.380)
6.52
(6.332)
-1.53
(3.880)

Adverse Events

Time Frame On-treatment serious adverse events (SAEs) and non-serious AEs, defined as those events that had a start date on or after the first day of study medication and within 56 days after the end of study medication (up to Week 156), are reported.
Adverse Event Reporting Description SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
Arm/Group Title Placebo + Metformin + Glimepiride Pioglitazone + Metformin + Glimepiride Albiglutide + Metformin + Glimepiride
Arm/Group Description Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period. Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
All Cause Mortality
Placebo + Metformin + Glimepiride Pioglitazone + Metformin + Glimepiride Albiglutide + Metformin + Glimepiride
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Placebo + Metformin + Glimepiride Pioglitazone + Metformin + Glimepiride Albiglutide + Metformin + Glimepiride
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 21/115 (18.3%) 48/277 (17.3%) 39/271 (14.4%)
Blood and lymphatic system disorders
Anaemia 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Lymphadenopathy 0/115 (0%) 0/277 (0%) 1/271 (0.4%)
Cardiac disorders
Coronary artery disease 0/115 (0%) 4/277 (1.4%) 3/271 (1.1%)
Cardiac failure congestive 1/115 (0.9%) 4/277 (1.4%) 0/271 (0%)
Angina unstable 1/115 (0.9%) 0/277 (0%) 3/271 (1.1%)
Acute myocardial infarction 1/115 (0.9%) 2/277 (0.7%) 0/271 (0%)
Sick sinus syndrome 0/115 (0%) 1/277 (0.4%) 2/271 (0.7%)
Atrial fibrillation 0/115 (0%) 1/277 (0.4%) 1/271 (0.4%)
Acute coronary syndrome 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Arteriosclerosis coronary 0/115 (0%) 0/277 (0%) 1/271 (0.4%)
Cardiac failure 1/115 (0.9%) 0/277 (0%) 0/271 (0%)
Myocardial infarction 0/115 (0%) 0/277 (0%) 1/271 (0.4%)
Eye disorders
Cataract 0/115 (0%) 1/277 (0.4%) 1/271 (0.4%)
Gastrointestinal disorders
Abdominal hernia 0/115 (0%) 0/277 (0%) 2/271 (0.7%)
Pancreatitis 0/115 (0%) 0/277 (0%) 2/271 (0.7%)
Small intestinal obstruction 0/115 (0%) 1/277 (0.4%) 1/271 (0.4%)
Abdominal pain 1/115 (0.9%) 0/277 (0%) 0/271 (0%)
Constipation 0/115 (0%) 0/277 (0%) 1/271 (0.4%)
Duodenal ulcer haemorrhage 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Retroperitoneal haemorrhage 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Sigmoiditis 0/115 (0%) 0/277 (0%) 1/271 (0.4%)
Vomiting 0/115 (0%) 0/277 (0%) 1/271 (0.4%)
General disorders
Chest pain 1/115 (0.9%) 4/277 (1.4%) 2/271 (0.7%)
Sudden death 0/115 (0%) 0/277 (0%) 1/271 (0.4%)
Infections and infestations
Pneumonia 2/115 (1.7%) 1/277 (0.4%) 2/271 (0.7%)
Cellulitis 2/115 (1.7%) 1/277 (0.4%) 0/271 (0%)
Diabetic foot infection 1/115 (0.9%) 0/277 (0%) 1/271 (0.4%)
Abscess 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Febrile infection 1/115 (0.9%) 0/277 (0%) 0/271 (0%)
Gangrene 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Gastroenteritis 0/115 (0%) 0/277 (0%) 1/271 (0.4%)
Gastroenteritis viral 1/115 (0.9%) 0/277 (0%) 0/271 (0%)
Infected bites 0/115 (0%) 0/277 (0%) 1/271 (0.4%)
Influenza 1/115 (0.9%) 0/277 (0%) 0/271 (0%)
Lobar pneumonia 1/115 (0.9%) 0/277 (0%) 0/271 (0%)
Localised infection 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Meningitis pneumococcal 1/115 (0.9%) 0/277 (0%) 0/271 (0%)
Pancreatitis viral 0/115 (0%) 0/277 (0%) 1/271 (0.4%)
Peritonitis 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Postoperative wound infection 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Septic shock 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Tracheobronchitis 0/115 (0%) 0/277 (0%) 1/271 (0.4%)
Injury, poisoning and procedural complications
Ankle fracture 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Overdose 0/115 (0%) 0/277 (0%) 1/271 (0.4%)
Road traffic accident 1/115 (0.9%) 0/277 (0%) 0/271 (0%)
Thoracic vertebral fracture 0/115 (0%) 0/277 (0%) 1/271 (0.4%)
Metabolism and nutrition disorders
Hypoglycaemia 1/115 (0.9%) 2/277 (0.7%) 0/271 (0%)
Fluid overload 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Gout 1/115 (0.9%) 0/277 (0%) 0/271 (0%)
Musculoskeletal and connective tissue disorders
Osteoarthritis 0/115 (0%) 1/277 (0.4%) 2/271 (0.7%)
Back pain 1/115 (0.9%) 1/277 (0.4%) 0/271 (0%)
Muscle spasms 0/115 (0%) 0/277 (0%) 1/271 (0.4%)
Musculoskeletal chest pain 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Musculoskeletal pain 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Spinal column stenosis 0/115 (0%) 0/277 (0%) 1/271 (0.4%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Bile duct cancer 0/115 (0%) 0/277 (0%) 1/271 (0.4%)
Bladder cancer 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Bladder neoplasm 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Breast cancer 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Endometrial cancer 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Lung neoplasm malignant 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Prostate cancer 1/115 (0.9%) 0/277 (0%) 0/271 (0%)
Rectal cancer 0/115 (0%) 0/277 (0%) 1/271 (0.4%)
Renal cancer 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Thyroid adenoma 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Thyroid cancer 1/115 (0.9%) 0/277 (0%) 0/271 (0%)
Uterine cancer 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Uterine leiomyoma 0/115 (0%) 0/277 (0%) 1/271 (0.4%)
Nervous system disorders
Cerebrovascular accident 1/115 (0.9%) 3/277 (1.1%) 0/271 (0%)
Carotid artery stenosis 0/115 (0%) 2/277 (0.7%) 0/271 (0%)
Transient ischaemic attack 0/115 (0%) 2/277 (0.7%) 0/271 (0%)
Haemorrhagic stroke 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Headache 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Hypertensive encephalopathy 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Hypoaesthesia 0/115 (0%) 0/277 (0%) 1/271 (0.4%)
Ischaemic stroke 1/115 (0.9%) 0/277 (0%) 0/271 (0%)
Metabolic encephalopathy 1/115 (0.9%) 0/277 (0%) 0/271 (0%)
Migraine 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Myelitis transverse 0/115 (0%) 0/277 (0%) 1/271 (0.4%)
Nerve compression 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Trigeminal neuralgia 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Vith nerve paralysis 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Psychiatric disorders
Bipolar disorder 0/115 (0%) 0/277 (0%) 1/271 (0.4%)
Major depression 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Panic disorder 0/115 (0%) 0/277 (0%) 1/271 (0.4%)
Suicidal ideation 0/115 (0%) 1/277 (0.4%) 0/271 (0%)
Renal and urinary disorders
Nephrolithiasis 3/115 (2.6%) 0/277 (0%) 0/271 (0%)
Glomerulonephritis acute 1/115 (0.9%) 0/277 (0%) 0/271 (0%)
Respiratory, thoracic and mediastinal disorders
Respiratory failure 1/115 (0.9%) 1/277 (0.4%) 0/271 (0%)
Pneumothorax 1/115 (0.9%) 0/277 (0%) 0/271 (0%)
Pulmonary embolism 1/115 (0.9%) 0/277 (0%) 0/271 (0%)
Vascular disorders
Hypertensive crisis 0/115 (0%) 0/277 (0%) 2/271 (0.7%)
Peripheral artery stenosis 0/115 (0%) 0/277 (0%) 1/271 (0.4%)
Other (Not Including Serious) Adverse Events
Placebo + Metformin + Glimepiride Pioglitazone + Metformin + Glimepiride Albiglutide + Metformin + Glimepiride
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 81/115 (70.4%) 228/277 (82.3%) 228/271 (84.1%)
Blood and lymphatic system disorders
Anaemia 4/115 (3.5%) 24/277 (8.7%) 13/271 (4.8%)
Leukocytosis 3/115 (2.6%) 0/277 (0%) 2/271 (0.7%)
Ear and labyrinth disorders
Vertigo 1/115 (0.9%) 7/277 (2.5%) 9/271 (3.3%)
Eye disorders
Diabetic retinopathy 3/115 (2.6%) 17/277 (6.1%) 10/271 (3.7%)
Cataract 3/115 (2.6%) 13/277 (4.7%) 8/271 (3%)
Gastrointestinal disorders
Diarrhoea 12/115 (10.4%) 23/277 (8.3%) 37/271 (13.7%)
Nausea 7/115 (6.1%) 20/277 (7.2%) 30/271 (11.1%)
Abdominal pain 2/115 (1.7%) 7/277 (2.5%) 17/271 (6.3%)
Constipation 7/115 (6.1%) 11/277 (4%) 14/271 (5.2%)
Gastrooesophageal reflux disease 3/115 (2.6%) 9/277 (3.2%) 12/271 (4.4%)
Dyspepsia 1/115 (0.9%) 2/277 (0.7%) 10/271 (3.7%)
Vomiting 4/115 (3.5%) 14/277 (5.1%) 6/271 (2.2%)
Abdominal pain upper 1/115 (0.9%) 7/277 (2.5%) 6/271 (2.2%)
Gastritis 3/115 (2.6%) 5/277 (1.8%) 5/271 (1.8%)
Toothache 1/115 (0.9%) 9/277 (3.2%) 4/271 (1.5%)
Abdominal distension 3/115 (2.6%) 4/277 (1.4%) 3/271 (1.1%)
General disorders
Injection site reaction 1/115 (0.9%) 8/277 (2.9%) 32/271 (11.8%)
Oedema peripheral 9/115 (7.8%) 41/277 (14.8%) 12/271 (4.4%)
Fatigue 6/115 (5.2%) 15/277 (5.4%) 8/271 (3%)
Chest pain 3/115 (2.6%) 4/277 (1.4%) 2/271 (0.7%)
Oedema 0/115 (0%) 8/277 (2.9%) 1/271 (0.4%)
Immune system disorders
Seasonal allergy 3/115 (2.6%) 4/277 (1.4%) 5/271 (1.8%)
Infections and infestations
Nasopharyngitis 16/115 (13.9%) 28/277 (10.1%) 43/271 (15.9%)
Upper respiratory tract infection 21/115 (18.3%) 50/277 (18.1%) 34/271 (12.5%)
Urinary tract infection 9/115 (7.8%) 31/277 (11.2%) 24/271 (8.9%)
Sinusitis 7/115 (6.1%) 16/277 (5.8%) 18/271 (6.6%)
Bronchitis 7/115 (6.1%) 25/277 (9%) 16/271 (5.9%)
Influenza 5/115 (4.3%) 10/277 (3.6%) 16/271 (5.9%)
Gastroenteritis 5/115 (4.3%) 10/277 (3.6%) 9/271 (3.3%)
Pharyngitis 5/115 (4.3%) 9/277 (3.2%) 8/271 (3%)
Gastroenteritis viral 2/115 (1.7%) 3/277 (1.1%) 6/271 (2.2%)
Furuncle 0/115 (0%) 2/277 (0.7%) 6/271 (2.2%)
Tooth abscess 4/115 (3.5%) 3/277 (1.1%) 5/271 (1.8%)
Herpes zoster 3/115 (2.6%) 1/277 (0.4%) 4/271 (1.5%)
Cellulitis 2/115 (1.7%) 13/277 (4.7%) 2/271 (0.7%)
Injury, poisoning and procedural complications
Ligament sprain 2/115 (1.7%) 4/277 (1.4%) 8/271 (3%)
Contusion 5/115 (4.3%) 8/277 (2.9%) 7/271 (2.6%)
Muscle strain 5/115 (4.3%) 6/277 (2.2%) 7/271 (2.6%)
Excoriation 6/115 (5.2%) 7/277 (2.5%) 4/271 (1.5%)
Procedural pain 1/115 (0.9%) 8/277 (2.9%) 3/271 (1.1%)
Rib Fracture 3/115 (2.6%) 1/277 (0.4%) 2/271 (0.7%)
Investigations
Cardiac murmur 0/115 (0%) 3/277 (1.1%) 6/271 (2.2%)
Gamma-glutamyltransferase increased 1/115 (0.9%) 1/277 (0.4%) 6/271 (2.2%)
Blood creatinine increased 1/115 (0.9%) 6/277 (2.2%) 1/271 (0.4%)
Weight increased 0/115 (0%) 21/277 (7.6%) 0/271 (0%)
Metabolism and nutrition disorders
Hypoglycaemia 28/115 (24.3%) 115/277 (41.5%) 84/271 (31%)
Dyslipidaemia 1/115 (0.9%) 4/277 (1.4%) 7/271 (2.6%)
Decreased appetite 3/115 (2.6%) 3/277 (1.1%) 5/271 (1.8%)
Hyperlipidaemia 3/115 (2.6%) 4/277 (1.4%) 4/271 (1.5%)
Musculoskeletal and connective tissue disorders
Arthralgia 9/115 (7.8%) 23/277 (8.3%) 26/271 (9.6%)
Back pain 8/115 (7%) 24/277 (8.7%) 24/271 (8.9%)
Pain in extremity 5/115 (4.3%) 14/277 (5.1%) 12/271 (4.4%)
Muscle spasms 3/115 (2.6%) 7/277 (2.5%) 12/271 (4.4%)
Musculoskeletal pain 6/115 (5.2%) 12/277 (4.3%) 11/271 (4.1%)
Osteoarthritis 2/115 (1.7%) 11/277 (4%) 8/271 (3%)
Tendonitis 3/115 (2.6%) 4/277 (1.4%) 5/271 (1.8%)
Myalgia 4/115 (3.5%) 8/277 (2.9%) 4/271 (1.5%)
Musculoskeletal chest pain 3/115 (2.6%) 4/277 (1.4%) 2/271 (0.7%)
Nervous system disorders
Headache 6/115 (5.2%) 25/277 (9%) 21/271 (7.7%)
Dizziness 6/115 (5.2%) 9/277 (3.2%) 16/271 (5.9%)
Neuropathy peripheral 1/115 (0.9%) 12/277 (4.3%) 13/271 (4.8%)
Hypoaesthesia 1/115 (0.9%) 7/277 (2.5%) 7/271 (2.6%)
Diabetic neuropathy 4/115 (3.5%) 4/277 (1.4%) 4/271 (1.5%)
Psychiatric disorders
Insomnia 2/115 (1.7%) 9/277 (3.2%) 11/271 (4.1%)
Anxiety 1/115 (0.9%) 7/277 (2.5%) 9/271 (3.3%)
Depression 3/115 (2.6%) 12/277 (4.3%) 5/271 (1.8%)
Reproductive system and breast disorders
Benign prostatic hyperplasia 4/115 (3.5%) 3/277 (1.1%) 2/271 (0.7%)
Respiratory, thoracic and mediastinal disorders
Cough 10/115 (8.7%) 19/277 (6.9%) 28/271 (10.3%)
Asthma 0/115 (0%) 2/277 (0.7%) 7/271 (2.6%)
Dyspnoea 2/115 (1.7%) 9/277 (3.2%) 5/271 (1.8%)
Rhinitis allergic 1/115 (0.9%) 6/277 (2.2%) 2/271 (0.7%)
Skin and subcutaneous tissue disorders
Rash 4/115 (3.5%) 9/277 (3.2%) 5/271 (1.8%)
Dermatitis Contact 1/115 (0.9%) 6/277 (2.2%) 2/271 (0.7%)
Dry Skin 3/115 (2.6%) 2/277 (0.7%) 2/271 (0.7%)
Vascular disorders
Hypertension 11/115 (9.6%) 27/277 (9.7%) 22/271 (8.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact

Name/Title GSK Response Center
Organization GlaxoSmithKline
Phone 866-435-7343
Email
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00839527
Other Study ID Numbers:
  • 112757
First Posted:
Feb 9, 2009
Last Update Posted:
Jan 9, 2017
Last Verified:
Nov 1, 2016