Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00838903

Collaborator

(none)

1,049

Enrollment

386

Locations

Arms

49.9

Duration (Months)

2.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if albiglutide is safe and effective in the treatment of type 2 diabetes.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Biological: albiglutide Drug: sitagliptin Drug: glimepiride Drug: metformin Biological: placebo albiglutide Drug: placebo sitagliptin Drug: placebo glimepiride	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1049 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 When Used in Combination With Metformin Compared With Metformin Plus Sitagliptin, Metformin Plus Glimepiride, and Metformin Plus Placebo 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
Experimental: albiglutide + metformin Albiglutide + metformin + placebo sitagliptin + placebo glimepiride	Biological: albiglutide albiglutide Drug: metformin Metformin Drug: placebo sitagliptin placebo to match sitagliptin Drug: placebo glimepiride placebo to match glimepiride
Active Comparator: sitagliptin + metformin Sitagliptin + metformin + placebo albiglutide + placebo glimepiride	Drug: sitagliptin sitagliptin Drug: metformin Metformin Biological: placebo albiglutide placebo to match albiglutide Drug: placebo glimepiride placebo to match glimepiride
Active Comparator: glimepiride + metformin Glimepiride + metformin + placebo albiglutide + placebo sitagliptin	Drug: glimepiride Glimepiride Drug: metformin Metformin Biological: placebo albiglutide placebo to match albiglutide Drug: placebo sitagliptin placebo to match sitagliptin
Active Comparator: metformin + placebo Metformin + placebo albiglutide + placebo sitagliptin + placebo glimepiride	Drug: metformin Metformin Biological: placebo albiglutide placebo to match albiglutide Drug: placebo sitagliptin placebo to match sitagliptin Drug: placebo glimepiride placebo to match glimepiride

Outcome Measures

Primary Outcome Measures

Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104 [Baseline and Week 104]
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 104 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. Difference of least squares means (albiglutide - placebo, albiglutide - sitagliptin, albiglutide - glimepiride) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline 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.

Secondary Outcome Measures

Change From Baseline in HbA1c at Week 156 [Baseline 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. 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 .
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104 [Baseline and Week 104]
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.
Change From Baseline in FPG at Week 156 [Baseline 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.
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104 [Week 104]
The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed.
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 achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed.
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 hyperglycemic 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 week
Change From Baseline in Body Weight at Week 104 [Baseline and Week 104]
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 prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region.
Change From Baseline in Body Weight at Week 156 [Baseline 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:

Inclusion Criteria:

type 2 diabetes
BMI 20-45kg/m2 inclusive

Exclusion Criteria:

females who are pregnant, lactating or <6 weeks post-partum
current symptomatic heart failure (NYHA Class III or IV)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Birmingham	Alabama	United States	35235
2	GSK Investigational Site	Birmingham	Alabama	United States	35242
3	GSK Investigational Site	Dothan	Alabama	United States	36301
4	GSK Investigational Site	Hueytown	Alabama	United States	35023
5	GSK Investigational Site	Mobile	Alabama	United States	36617
6	GSK Investigational Site	Tuscaloosa	Alabama	United States	35406
7	GSK Investigational Site	Chandler	Arizona	United States	85224
8	GSK Investigational Site	Gilbert	Arizona	United States	85295
9	GSK Investigational Site	Green Valley	Arizona	United States	85614
10	GSK Investigational Site	Phoenix	Arizona	United States	85023
11	GSK Investigational Site	Phoenix	Arizona	United States	85028
12	GSK Investigational Site	Phoenix	Arizona	United States	85051
13	GSK Investigational Site	Tucson	Arizona	United States	85712
14	GSK Investigational Site	Tucson	Arizona	United States	85745
15	GSK Investigational Site	Bull Shoals	Arkansas	United States	72619
16	GSK Investigational Site	Harrisburg	Arkansas	United States	72432
17	GSK Investigational Site	Hot Springs	Arkansas	United States	71913
18	GSK Investigational Site	Jonesboro	Arkansas	United States	72401
19	GSK Investigational Site	Searcy	Arkansas	United States	72143
20	GSK Investigational Site	Buena Park	California	United States	90620
21	GSK Investigational Site	Carmichael	California	United States	95608
22	GSK Investigational Site	Chino	California	United States	91710
23	GSK Investigational Site	Chula Vista	California	United States	91910
24	GSK Investigational Site	Escondido	California	United States	92026
25	GSK Investigational Site	Foothill Ranch	California	United States	92610
26	GSK Investigational Site	Fountain Valley	California	United States	92708
27	GSK Investigational Site	Fresno	California	United States	93720
28	GSK Investigational Site	Huntington Beach	California	United States	92646
29	GSK Investigational Site	Indio	California	United States	92201
30	GSK Investigational Site	LaJolla	California	United States	92037
31	GSK Investigational Site	Lakewood	California	United States	90712
32	GSK Investigational Site	Loma Linda	California	United States	92354
33	GSK Investigational Site	Long Beach	California	United States	90806
34	GSK Investigational Site	Los Alamitos	California	United States	90720
35	GSK Investigational Site	Los Angeles	California	United States	90017
36	GSK Investigational Site	Los Angeles	California	United States	90022
37	GSK Investigational Site	Los Angeles	California	United States	90025
38	GSK Investigational Site	Mission Viejo	California	United States	92691
39	GSK Investigational Site	Northridge	California	United States	91325
40	GSK Investigational Site	Palm Desert	California	United States	92260
41	GSK Investigational Site	Pasadena	California	United States	91105
42	GSK Investigational Site	Poway	California	United States	92064
43	GSK Investigational Site	Riverside	California	United States	92506
44	GSK Investigational Site	Sacramento	California	United States	95821
45	GSK Investigational Site	Sacramento	California	United States	95825
46	GSK Investigational Site	San Diego	California	United States	92117
47	GSK Investigational Site	San Diego	California	United States	92120
48	GSK Investigational Site	Santa Ana	California	United States	92701
49	GSK Investigational Site	Satna Monica	California	United States	90404
50	GSK Investigational Site	Spring Valley	California	United States	91978
51	GSK Investigational Site	Tarzana	California	United States	91356
52	GSK Investigational Site	Victorville	California	United States	92395
53	GSK Investigational Site	Vista	California	United States	92083
54	GSK Investigational Site	Walnut Creek	California	United States	94598
55	GSK Investigational Site	West Hills	California	United States	91307
56	GSK Investigational Site	Arvada	Colorado	United States	80005
57	GSK Investigational Site	New Britain	Connecticut	United States	06050
58	GSK Investigational Site	Trumbull	Connecticut	United States	06611
59	GSK Investigational Site	Waterbury	Connecticut	United States	06708
60	GSK Investigational Site	Middletown	Delaware	United States	19709
61	GSK Investigational Site	Boynton Beach	Florida	United States	33426
62	GSK Investigational Site	Boynton Beach	Florida	United States	33437
63	GSK Investigational Site	Clearwater	Florida	United States	33756
64	GSK Investigational Site	Clearwater	Florida	United States	33765
65	GSK Investigational Site	Cocoa	Florida	United States	32927
66	GSK Investigational Site	Cutler Bay	Florida	United States	33189
67	GSK Investigational Site	Deerfield Beach	Florida	United States	33442
68	GSK Investigational Site	Delray Beach	Florida	United States	33445
69	GSK Investigational Site	Fort Lauderdale	Florida	United States	33316
70	GSK Investigational Site	Gainesville	Florida	United States	32605
71	GSK Investigational Site	Hallandale Beach	Florida	United States	33009
72	GSK Investigational Site	Hialeah	Florida	United States	33012
73	GSK Investigational Site	Hialeah	Florida	United States	33013
74	GSK Investigational Site	Hollywood	Florida	United States	33023
75	GSK Investigational Site	Lauderdale Lakes	Florida	United States	33319
76	GSK Investigational Site	Marianna	Florida	United States	32446
77	GSK Investigational Site	Miami	Florida	United States	33135
78	GSK Investigational Site	Miami	Florida	United States	33156
79	GSK Investigational Site	North Miami	Florida	United States	33161
80	GSK Investigational Site	Ocala	Florida	United States	34471
81	GSK Investigational Site	Orlando	Florida	United States	32822
82	GSK Investigational Site	Ormond Beach	Florida	United States	32174
83	GSK Investigational Site	Oviedo	Florida	United States	32765
84	GSK Investigational Site	Panama City	Florida	United States	32401
85	GSK Investigational Site	Pembroke Pines	Florida	United States	33026
86	GSK Investigational Site	Pembroke Pines	Florida	United States	33027
87	GSK Investigational Site	Plantation	Florida	United States	33317
88	GSK Investigational Site	Ponte Vedra Beach	Florida	United States	32081
89	GSK Investigational Site	St. Cloud	Florida	United States	34769
90	GSK Investigational Site	St. Petersburg	Florida	United States	33709
91	GSK Investigational Site	Tampa	Florida	United States	33603
92	GSK Investigational Site	West Palm Beach	Florida	United States	33401
93	GSK Investigational Site	Atlanta	Georgia	United States	30135
94	GSK Investigational Site	Atlanta	Georgia	United States	30308
95	GSK Investigational Site	Atlanta	Georgia	United States	30312
96	GSK Investigational Site	Atlanta	Georgia	United States	30328
97	GSK Investigational Site	Atlanta	Georgia	United States	30342
98	GSK Investigational Site	Blue Ridge	Georgia	United States	30513
99	GSK Investigational Site	Columbus	Georgia	United States	31904
100	GSK Investigational Site	Decatur	Georgia	United States	30032
101	GSK Investigational Site	Savannah	Georgia	United States	31406
102	GSK Investigational Site	Snellville	Georgia	United States	30078
103	GSK Investigational Site	Stone Mountain	Georgia	United States	30088
104	GSK Investigational Site	Tucker	Georgia	United States	30084
105	GSK Investigational Site	Honolulu	Hawaii	United States	96813
106	GSK Investigational Site	Honolulu	Hawaii	United States	96814
107	GSK Investigational Site	Idaho Falls	Idaho	United States	83404
108	GSK Investigational Site	Aurora	Illinois	United States	60504
109	GSK Investigational Site	Chicago	Illinois	United States	60607
110	GSK Investigational Site	Evergreen Park	Illinois	United States	60805
111	GSK Investigational Site	La Grange	Illinois	United States	60525
112	GSK Investigational Site	Naperville	Illinois	United States	60564
113	GSK Investigational Site	Peoria	Illinois	United States	61602
114	GSK Investigational Site	Fishers	Indiana	United States	46037
115	GSK Investigational Site	Indianapolis	Indiana	United States	46254
116	GSK Investigational Site	La Porte	Indiana	United States	46350
117	GSK Investigational Site	Muncie	Indiana	United States	47304
118	GSK Investigational Site	South Bend	Indiana	United States	46614
119	GSK Investigational Site	Council Bluffs	Iowa	United States	51501
120	GSK Investigational Site	Des Moines	Iowa	United States	50314
121	GSK Investigational Site	Dubuque	Iowa	United States	52001
122	GSK Investigational Site	Iowa City	Iowa	United States	52243
123	GSK Investigational Site	Waterloo	Iowa	United States	50701
124	GSK Investigational Site	Arkansas City	Kansas	United States	67005
125	GSK Investigational Site	Mission	Kansas	United States	66202
126	GSK Investigational Site	Newton	Kansas	United States	67114
127	GSK Investigational Site	Overland Park	Kansas	United States	66211
128	GSK Investigational Site	Topeka	Kansas	United States	66606
129	GSK Investigational Site	Wichita	Kansas	United States	67211
130	GSK Investigational Site	Crescent Springs	Kentucky	United States	41017
131	GSK Investigational Site	Lexington	Kentucky	United States	40503
132	GSK Investigational Site	Lexington	Kentucky	United States	40504
133	GSK Investigational Site	Louisville	Kentucky	United States	40202
134	GSK Investigational Site	Madisonville	Kentucky	United States	42431
135	GSK Investigational Site	Paducah	Kentucky	United States	42003
136	GSK Investigational Site	Covington	Louisiana	United States	70433
137	GSK Investigational Site	Lake Charles	Louisiana	United States	70601
138	GSK Investigational Site	Shreveport	Louisiana	United States	71101
139	GSK Investigational Site	Shreveport	Louisiana	United States	71115
140	GSK Investigational Site	Baltimore	Maryland	United States	21237
141	GSK Investigational Site	Hyattsville	Maryland	United States	20782
142	GSK Investigational Site	Oxon Hill	Maryland	United States	20745
143	GSK Investigational Site	Haverhill	Massachusetts	United States	01830
144	GSK Investigational Site	Bay City	Michigan	United States	48706
145	GSK Investigational Site	Benzonia	Michigan	United States	49616
146	GSK Investigational Site	Cadillac	Michigan	United States	49601
147	GSK Investigational Site	Dearborn	Michigan	United States	48124
148	GSK Investigational Site	Interlochen	Michigan	United States	49643
149	GSK Investigational Site	Kalamazoo	Michigan	United States	49009
150	GSK Investigational Site	Kalamazoo	Michigan	United States	49048
151	GSK Investigational Site	St Clair Shores	Michigan	United States	48081
152	GSK Investigational Site	Gulfport	Mississippi	United States	39501
153	GSK Investigational Site	Picayune	Mississippi	United States	39466
154	GSK Investigational Site	Rolling Fork	Mississippi	United States	39159
155	GSK Investigational Site	Chesterfield	Missouri	United States	63017
156	GSK Investigational Site	Jefferson City	Missouri	United States	65109
157	GSK Investigational Site	Kansas City	Missouri	United States	64106
158	GSK Investigational Site	Kansas City	Missouri	United States
159	GSK Investigational Site	Springfield	Missouri	United States	65807
160	GSK Investigational Site	St. Louis	Missouri	United States	63117
161	GSK Investigational Site	St. Louis	Missouri	United States	63141
162	GSK Investigational Site	West Plains	Missouri	United States	65775
163	GSK Investigational Site	Billings	Montana	United States	59102
164	GSK Investigational Site	Butte	Montana	United States	59701
165	GSK Investigational Site	Great Falls	Montana	United States	59405
166	GSK Investigational Site	Broken Bow	Nebraska	United States	68822
167	GSK Investigational Site	Lincoln	Nebraska	United States	68516
168	GSK Investigational Site	Omaha	Nebraska	United States	68124
169	GSK Investigational Site	Omaha	Nebraska	United States	68131
170	GSK Investigational Site	Omaha	Nebraska	United States	68134
171	GSK Investigational Site	Las Vegas	Nevada	United States	89102-4509
172	GSK Investigational Site	Las Vegas	Nevada	United States	89102
173	GSK Investigational Site	Las Vegas	Nevada	United States	89103
174	GSK Investigational Site	Las Vegas	Nevada	United States	89106
175	GSK Investigational Site	Las Vegas	Nevada	United States	89128
176	GSK Investigational Site	Berlin	New Jersey	United States	08009
177	GSK Investigational Site	Elizabeth	New Jersey	United States	07202
178	GSK Investigational Site	Haddon Heights	New Jersey	United States	08035
179	GSK Investigational Site	Hainesport	New Jersey	United States	08036
180	GSK Investigational Site	New Brunswick	New Jersey	United States	08903
181	GSK Investigational Site	Stratford	New Jersey	United States	08084
182	GSK Investigational Site	Albuquerque	New Mexico	United States	87106
183	GSK Investigational Site	New York	New York	United States	10022
184	GSK Investigational Site	North Massapequa	New York	United States	11758
185	GSK Investigational Site	Syracuse	New York	United States	13210
186	GSK Investigational Site	Asheboro	North Carolina	United States	27203
187	GSK Investigational Site	Asheville	North Carolina	United States	28803
188	GSK Investigational Site	Burlington	North Carolina	United States	27215
189	GSK Investigational Site	Calabash	North Carolina	United States	28467
190	GSK Investigational Site	Chadbourn	North Carolina	United States	28431
191	GSK Investigational Site	Durham	North Carolina	United States	27710
192	GSK Investigational Site	Fayetteville	North Carolina	United States	28304
193	GSK Investigational Site	Greensboro	North Carolina	United States	27405
194	GSK Investigational Site	Hickory	North Carolina	United States	28601
195	GSK Investigational Site	Huntersville	North Carolina	United States	28078
196	GSK Investigational Site	Lenoir	North Carolina	United States	28645
197	GSK Investigational Site	Mint HIll	North Carolina	United States	28227
198	GSK Investigational Site	Morehead City	North Carolina	United States	28557
199	GSK Investigational Site	Shelby	North Carolina	United States	28150
200	GSK Investigational Site	Tabor City	North Carolina	United States	28463
201	GSK Investigational Site	Grand Forks	North Dakota	United States	58201
202	GSK Investigational Site	Akron	Ohio	United States	44320
203	GSK Investigational Site	Canal Fulton	Ohio	United States	44614
204	GSK Investigational Site	Cincinnati	Ohio	United States	45211
205	GSK Investigational Site	Cincinnati	Ohio	United States	45219
206	GSK Investigational Site	Cincinnati	Ohio	United States	45227
207	GSK Investigational Site	Cincinnati	Ohio	United States	45245
208	GSK Investigational Site	Cleveland	Ohio	United States	44122
209	GSK Investigational Site	Columbus	Ohio	United States	43212
210	GSK Investigational Site	Columbus	Ohio	United States	43213
211	GSK Investigational Site	Dayton	Ohio	United States	45432
212	GSK Investigational Site	Dayton	Ohio	United States	45439
213	GSK Investigational Site	Kettering	Ohio	United States	45429
214	GSK Investigational Site	Mason	Ohio	United States	45040
215	GSK Investigational Site	Maumee	Ohio	United States	43537-9402
216	GSK Investigational Site	Thornville	Ohio	United States	43076
217	GSK Investigational Site	Zanesville	Ohio	United States	43701
218	GSK Investigational Site	Oklahoma City	Oklahoma	United States	73103
219	GSK Investigational Site	Tulsa	Oklahoma	United States	74104
220	GSK Investigational Site	Tulsa	Oklahoma	United States	74135
221	GSK Investigational Site	Tulsa	Oklahoma	United States	74136
222	GSK Investigational Site	Ashland	Oregon	United States	97520
223	GSK Investigational Site	Bensalem	Pennsylvania	United States	19020
224	GSK Investigational Site	Carlisle	Pennsylvania	United States	17013
225	GSK Investigational Site	Downington	Pennsylvania	United States	19335
226	GSK Investigational Site	Feasterville	Pennsylvania	United States	19053
227	GSK Investigational Site	Harrisburg	Pennsylvania	United States	17112
228	GSK Investigational Site	Landsdale	Pennsylvania	United States	19446
229	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15243
230	GSK Investigational Site	Tipton	Pennsylvania	United States	16684
231	GSK Investigational Site	Uniontown	Pennsylvania	United States	15401
232	GSK Investigational Site	Cumberland	Rhode Island	United States	02864
233	GSK Investigational Site	East Providence	Rhode Island	United States	02914
234	GSK Investigational Site	Columbia	South Carolina	United States	29201
235	GSK Investigational Site	Greenville	South Carolina	United States	29601
236	GSK Investigational Site	Greenville	South Carolina	United States	29615
237	GSK Investigational Site	Greer	South Carolina	United States	29651
238	GSK Investigational Site	Manning	South Carolina	United States	29102
239	GSK Investigational Site	Murrells Inlet	South Carolina	United States	29576
240	GSK Investigational Site	North Myrtle Beach	South Carolina	United States	29582
241	GSK Investigational Site	Orangeburg	South Carolina	United States	29115
242	GSK Investigational Site	Simpsonville	South Carolina	United States	29681
243	GSK Investigational Site	Taylors	South Carolina	United States	29687
244	GSK Investigational Site	Bristol	Tennessee	United States	37620
245	GSK Investigational Site	Chattanooga	Tennessee	United States	37421
246	GSK Investigational Site	Clarksville	Tennessee	United States	37043
247	GSK Investigational Site	Columbia	Tennessee	United States	38401
248	GSK Investigational Site	Fayetteville	Tennessee	United States	37334
249	GSK Investigational Site	Germantown	Tennessee	United States	38138
250	GSK Investigational Site	Johnson City	Tennessee	United States	37604
251	GSK Investigational Site	McKenzie	Tennessee	United States	38201
252	GSK Investigational Site	Memphis	Tennessee	United States	38125
253	GSK Investigational Site	Nashville	Tennessee	United States	37203
254	GSK Investigational Site	Tullahoma	Tennessee	United States	37398
255	GSK Investigational Site	Arlington	Texas	United States	76012
256	GSK Investigational Site	Bedford	Texas	United States	76201
257	GSK Investigational Site	Cleburne	Texas	United States	76033
258	GSK Investigational Site	Corpus Christi	Texas	United States	78414
259	GSK Investigational Site	Dallas	Texas	United States	75224
260	GSK Investigational Site	Dallas	Texas	United States	75230
261	GSK Investigational Site	Dallas	Texas	United States	75235
262	GSK Investigational Site	Deer Park	Texas	United States	77536
263	GSK Investigational Site	El Paso	Texas	United States	79925
264	GSK Investigational Site	Fort Worth	Texas	United States	76104
265	GSK Investigational Site	Fort Worth	Texas	United States	76135
266	GSK Investigational Site	Houston	Texas	United States	77024
267	GSK Investigational Site	Houston	Texas	United States	77027
268	GSK Investigational Site	Houston	Texas	United States	77030
269	GSK Investigational Site	Houston	Texas	United States	77034
270	GSK Investigational Site	Houston	Texas	United States	77036
271	GSK Investigational Site	Houston	Texas	United States	77055
272	GSK Investigational Site	Houston	Texas	United States	77058
273	GSK Investigational Site	Houston	Texas	United States	77069
274	GSK Investigational Site	Houston	Texas	United States	77070
275	GSK Investigational Site	Houston	Texas	United States	77074
276	GSK Investigational Site	Houston	Texas	United States	77094
277	GSK Investigational Site	Hurst	Texas	United States	76054
278	GSK Investigational Site	Katy	Texas	United States	77450
279	GSK Investigational Site	Lake Jackson	Texas	United States	77566
280	GSK Investigational Site	Lewisville	Texas	United States	75067
281	GSK Investigational Site	Midland	Texas	United States	79707
282	GSK Investigational Site	North Richland Hills	Texas	United States	76180
283	GSK Investigational Site	Odessa	Texas	United States	79761
284	GSK Investigational Site	San Antonio	Texas	United States	78205
285	GSK Investigational Site	San Antonio	Texas	United States	78215
286	GSK Investigational Site	San Antonio	Texas	United States	78217
287	GSK Investigational Site	San Antonio	Texas	United States	78218
288	GSK Investigational Site	San Antonio	Texas	United States	78224
289	GSK Investigational Site	San Antonio	Texas	United States	78229
290	GSK Investigational Site	San Antonio	Texas	United States	78237
291	GSK Investigational Site	San Antonio	Texas	United States	78258
292	GSK Investigational Site	Schertz	Texas	United States	78154
293	GSK Investigational Site	Sugar Land	Texas	United States	77479
294	GSK Investigational Site	Sugarland	Texas	United States	77479
295	GSK Investigational Site	Temple	Texas	United States	76508
296	GSK Investigational Site	Bountiful	Utah	United States	84010
297	GSK Investigational Site	Orem	Utah	United States	84058
298	GSK Investigational Site	Salt Lake City	Utah	United States	84102
299	GSK Investigational Site	Salt Lake City	Utah	United States	84107
300	GSK Investigational Site	Salt Lake City	Utah	United States	84124
301	GSK Investigational Site	West Jordan	Utah	United States	84088
302	GSK Investigational Site	West Valley City	Utah	United States	84120
303	GSK Investigational Site	South Burlington	Vermont	United States	05403
304	GSK Investigational Site	Burke	Virginia	United States	22015
305	GSK Investigational Site	Hampton	Virginia	United States	23666
306	GSK Investigational Site	Manassas	Virginia	United States	20110
307	GSK Investigational Site	Norfolk	Virginia	United States	23502
308	GSK Investigational Site	Suffolk	Virginia	United States
309	GSK Investigational Site	Virgina Beach	Virginia	United States	23455
310	GSK Investigational Site	Weber City	Virginia	United States	24290
311	GSK Investigational Site	Federal Way	Washington	United States	98003
312	GSK Investigational Site	Richland	Washington	United States	99352
313	GSK Investigational Site	Selah	Washington	United States	98942
314	GSK Investigational Site	Spokane	Washington	United States	99208
315	GSK Investigational Site	Spokane	Washington	United States	99216
316	GSK Investigational Site	Lewisburg	West Virginia	United States	24901
317	GSK Investigational Site	Milwaukee	Wisconsin	United States	53226
318	GSK Investigational Site	Alabaster		Albania	35007
319	GSK Investigational Site	Villingen-Schwenningen	Baden-Wuerttemberg	Germany	78054
320	GSK Investigational Site	Kelkheim	Hessen	Germany	65779
321	GSK Investigational Site	Rotenburg	Hessen	Germany	36199
322	GSK Investigational Site	Bad Lauterberg	Niedersachsen	Germany	37431
323	GSK Investigational Site	Witten	Nordrhein-Westfalen	Germany	58455
324	GSK Investigational Site	Mainz	Rheinland-Pfalz	Germany	55116
325	GSK Investigational Site	Berlin		Germany	10115
326	GSK Investigational Site	Kwun Tong, Kowloon		Hong Kong
327	GSK Investigational Site	Shatin		Hong Kong
328	GSK Investigational Site	Tai Po,		Hong Kong
329	GSK Investigational Site	Tijuana	Baja California Norte	Mexico	22010
330	GSK Investigational Site	Torreon	Coahuila	Mexico	27000
331	GSK Investigational Site	Pachuca	Hidalgo	Mexico	42086
332	GSK Investigational Site	Guadalajara	Jalisco	Mexico	44670
333	GSK Investigational Site	Zapopan	Jalisco	Mexico	45200
334	GSK Investigational Site	Morelia	Michoacán	Mexico	C.P. 58249
335	GSK Investigational Site	Cuernavaca	Morelos	Mexico	62250
336	GSK Investigational Site	Merida	Yucatán	Mexico	97000
337	GSK Investigational Site	Distrito Federal		Mexico	06700
338	GSK Investigational Site	Durango		Mexico	34080
339	GSK Investigational Site	Guadalajara		Mexico	44600
340	GSK Investigational Site	Guadalajara		Mexico	44680
341	GSK Investigational Site	Mexico City		Mexico	03300
342	GSK Investigational Site	Mexico City		Mexico	11570
343	GSK Investigational Site	Nezahualcoyotl		Mexico	57170
344	GSK Investigational Site	Puebla		Mexico	72190
345	GSK Investigational Site	Callao	Lima	Peru	Callao 2
346	GSK Investigational Site	Ica		Peru	11
347	GSK Investigational Site	Lima		Peru	01
348	GSK Investigational Site	Lima		Peru	Lima 1
349	GSK Investigational Site	Piura		Peru
350	GSK Investigational Site	Cebu City		Philippines	6000
351	GSK Investigational Site	Quezon City		Philippines	1101
352	GSK Investigational Site	Quezon City		Philippines	1102
353	GSK Investigational Site	San Juan		Philippines	1500
354	GSK Investigational Site	Taytay Rizal		Philippines	1920
355	GSK Investigational Site	Arkhangelsk		Russian Federation	163045
356	GSK Investigational Site	Irkutsk		Russian Federation	664003
357	GSK Investigational Site	Moscow		Russian Federation	119034
358	GSK Investigational Site	Nizhniy Novgorod		Russian Federation	603126
359	GSK Investigational Site	Saratov		Russian Federation	410030
360	GSK Investigational Site	Smolensk		Russian Federation	214019
361	GSK Investigational Site	Yaroslavl		Russian Federation	150062
362	GSK Investigational Site	Port Elizabeth	Eastern Cape	South Africa	6014
363	GSK Investigational Site	Boksburg North	Gauteng	South Africa	1459
364	GSK Investigational Site	Johannesburg	Gauteng	South Africa	01820
365	GSK Investigational Site	Lenasia	Gauteng	South Africa	1827
366	GSK Investigational Site	Parktown	Gauteng	South Africa	2193
367	GSK Investigational Site	Pretoria	Gauteng	South Africa	00083
368	GSK Investigational Site	Durban	KwaZulu- Natal	South Africa	4000
369	GSK Investigational Site	Cape Town		South Africa	7530
370	GSK Investigational Site	Kempton Park		South Africa	1619
371	GSK Investigational Site	Parow		South Africa	7505
372	GSK Investigational Site	Somerset West		South Africa	07129
373	GSK Investigational Site	Soweto		South Africa	1111
374	GSK Investigational Site	Barcelona		Spain	08022
375	GSK Investigational Site	Sevilla		Spain	41003
376	GSK Investigational Site	Plymouth	Devon	United Kingdom	PL6 8BX
377	GSK Investigational Site	Canterbury	Kent	United Kingdom	CT1 3HX
378	GSK Investigational Site	Blackpool	Lancashire	United Kingdom	FY4 3AD
379	GSK Investigational Site	Liverpool	Merseyside	United Kingdom	L7 8XP
380	GSK Investigational Site	Sunbury-on-Thames	Middlesex	United Kingdom	TW16 6RH
381	GSK Investigational Site	Port Glasgow	Renfrewshire	United Kingdom	PA14 6HW
382	GSK Investigational Site	Coventry	West Midlands	United Kingdom	CV2 2DX
383	GSK Investigational Site	Glasgow		United Kingdom	G45 9AW
384	GSK Investigational Site	Hull		United Kingdom	HU3 2RW
385	GSK Investigational Site	Liverpool		United Kingdom	L9 7AL
386	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:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

None provided.

Responsible Party:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00838903

Other Study ID Numbers:

112753

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

Sitagliptin Phosphate

Glimepiride

rGLP-1 protein

Glucagon-Like Peptide 1

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail	Eligible participants (par.) entered a 2-week Screening Period, a 4-week Run-in/Stabilization Period, a 156-week Treatment Period, and a 8-week post-treatment Follow-up Period. A total of 1525 par. were screened, 1049 were randomized and 1012 par. received at least 1 dose of study treatment.

Arm/Group Title	Placebo Plus Metformin	Sitagliptin 100 mg Plus Metformin	Glimepiride 2 mg Plus Metformin	Albiglutide 30 mg Plus Metformin
Arm/Group Description	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Period Title: Treatment Period (156 Weeks)
STARTED	101	302	307	302
Missing Active Treatment Status	1	0	0	0
COMPLETED	55	190	191	192
NOT COMPLETED	46	112	116	110
Period Title: Treatment Period (156 Weeks)
STARTED	101	302	307	302
COMPLETED	75	237	243	244
NOT COMPLETED	26	65	64	58

Baseline Characteristics

Arm/Group Title	Placebo Plus Metformin	Sitagliptin 100 mg Plus Metformin	Glimepiride 2 mg Plus Metformin	Albiglutide 30 mg Plus Metformin	Total
Arm/Group Description	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Total of all reporting groups
Overall Participants	101	302	307	302	1012
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	56.1 (10.01)	54.3 (9.81)	54.4 (9.97)	54.3 (10.12)	54.5 (9.97)
Gender (Count of Participants)
Female	51 50.5%	163 54%	149 48.5%	167 55.3%	530 52.4%
Male	50 49.5%	139 46%	158 51.5%	135 44.7%	482 47.6%
Race/Ethnicity, Customized (Number) [Number]
African American/African Heritage	23 22.8%	35 11.6%	39 12.7%	53 17.5%	150 14.8%
American Indian or Alaskan Native	9 8.9%	22 7.3%	25 8.1%	17 5.6%	73 7.2%
Asian - Central/South Asian Heritage	1 1%	7 2.3%	3 1%	2 0.7%	13 1.3%
Asian - East Asian Heritage	0 0%	2 0.7%	3 1%	5 1.7%	10 1%
Asian - Japanese Heritage	1 1%	0 0%	1 0.3%	0 0%	2 0.2%
Asian - South East Asian Heritage	3 3%	11 3.6%	9 2.9%	11 3.6%	34 3.4%
Native Hawaiian or Other Pacific Islander	1 1%	0 0%	0 0%	1 0.3%	2 0.2%
White - Arabic/North African Heritage	0 0%	1 0.3%	9 2.9%	3 1%	13 1.3%
White - White/Caucasian/European Heritage	64 63.4%	225 74.5%	220 71.7%	214 70.9%	723 71.4%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104
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 104 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. Difference of least squares means (albiglutide - placebo, albiglutide - sitagliptin, albiglutide - glimepiride) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline 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.
Time Frame	Baseline and Week 104

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 104.

Arm/Group Title	Placebo Plus Metformin	Sitagliptin 100 mg Plus Metformin	Glimepiride 2 mg Plus Metformin	Albiglutide 30 mg Plus Metformin
Arm/Group Description	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Measure Participants	97	297	299	293
Least Squares Mean (Standard Error) [Percentage of HbA1c in the blood]	0.27 (0.113)	-0.28 (0.065)	-0.36 (0.064)	-0.63 (0.065)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo Plus Metformin, Albiglutide 30 mg Plus Metformin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.91
	Confidence Interval	(2-Sided) 95% -1.16 to -0.65
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Sitagliptin 100 mg Plus Metformin, Albiglutide 30 mg Plus Metformin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.35
	Confidence Interval	(2-Sided) 95% -0.53 to -0.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Glimepiride 2 mg Plus Metformin, Albiglutide 30 mg Plus Metformin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.27
	Confidence Interval	(2-Sided) 95% -0.45 to -0.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo Plus Metformin, Albiglutide 30 mg Plus Metformin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	The p-value is for superiority testing of albiglutide over placebo at 0.05 level.
	Method	t-test, 2 sided
	Comments	The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - placebo) is equal to zero

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Sitagliptin 100 mg Plus Metformin, Albiglutide 30 mg Plus Metformin
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	To test whether the difference of least square means (albiglutide - sitagliptin) is equal to the pre-specified non-inferiority margin of 0.3%.

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	The p-value is for non-inferiority testing of albiglutide versus sitagliptin at 0.0125 level.
	Method	t-test, 1 sided
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Glimepiride 2 mg Plus Metformin, Albiglutide 30 mg Plus Metformin
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	To test whether the difference of least square means (albiglutide - glimepiride) is equal to the pre-specified non-inferiority margin of 0.3%.

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	The p-value is for non-inferiority testing of albiglutide versus glimepiride at 0.0125 level.
	Method	t-test, 1 sided
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Sitagliptin 100 mg Plus Metformin, Albiglutide 30 mg Plus Metformin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0001
	Comments	The p-value is for superiority testing of albiglutide versus sitagliptin at 0.025 level.
	Method	t-test, 2 sided
	Comments	The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - sitagliptin) is equal to zero.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Glimepiride 2 mg Plus Metformin, Albiglutide 30 mg Plus Metformin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0033
	Comments	The p-value is for superiority testing of albiglutide versus glimepiride at 0.025 level.
	Method	t-test, 2 sided
	Comments	The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - glimepiride) is equal to zero.

2. Secondary Outcome

Title	Change From Baseline in HbA1c at 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. 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 and Week 156

Outcome Measure Data

Analysis Population Description
Intent-to-Treat (ITT) Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed.

Arm/Group Title	Placebo Plus Metformin	Sitagliptin 100 mg Plus Metformin	Glimepiride 2 mg Plus Metformin	Albiglutide 30 mg Plus Metformin
Arm/Group Description	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Measure Participants	16	88	102	115
Mean (Standard Deviation) [Percentage of HbA1c in the blood]	-0.46 (0.820)	-0.56 (1.160)	-0.59 (0.999)	-0.88 (0.959)

3. Secondary Outcome

Title	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104
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 104

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 104.

Arm/Group Title	Placebo Plus Metformin	Sitagliptin 100 mg Plus Metformin	Glimepiride 2 mg Plus Metformin	Albiglutide 30 mg Plus Metformin
Arm/Group Description	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Measure Participants	100	299	302	296
Least Squares Mean (Standard Error) [Millimoles per liter (mmol/L)]	0.55 (0.277)	-0.12 (0.160)	-0.41 (0.159)	-0.98 (0.161)

4. Secondary Outcome

Title	Change From Baseline in FPG at 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 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.

Arm/Group Title	Placebo Plus Metformin	Sitagliptin 100 mg Plus Metformin	Glimepiride 2 mg Plus Metformin	Albiglutide 30 mg Plus Metformin
Arm/Group Description	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Measure Participants	16	88	98	112
Mean (Standard Deviation) [Millimoles per liter (mmol/L)]	-0.11 (1.498)	-0.50 (2.519)	-0.71 (2.684)	-1.30 (2.602)

5. Secondary Outcome

Title	Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104
Description	The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed.
Time Frame	Week 104

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 104.

Arm/Group Title	Placebo Plus Metformin	Sitagliptin 100 mg Plus Metformin	Glimepiride 2 mg Plus Metformin	Albiglutide 30 mg Plus Metformin
Arm/Group Description	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Measure Participants	97	297	299	293
HbA1c <6.5%	7 6.9%	45 14.9%	40 13%	50 16.6%
HbA1c <7.0%	15 14.9%	94 31.1%	94 30.6%	113 37.4%
HbA1c <7.5%	27 26.7%	132 43.7%	147 47.9%	172 57%

6. 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 achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were 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.

Arm/Group Title	Placebo Plus Metformin	Sitagliptin 100 mg Plus Metformin	Glimepiride 2 mg Plus Metformin	Albiglutide 30 mg Plus Metformin
Arm/Group Description	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Measure Participants	16	88	102	115
HbA1c <6.5%	4 4%	23 7.6%	15 4.9%	31 10.3%
HbA1c <7.0%	7 6.9%	44 14.6%	44 14.3%	69 22.8%
HbA1c <7.5%	13 12.9%	69 22.8%	69 22.5%	90 29.8%

7. 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 hyperglycemic 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 week
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. Only those participants with a value at Baseline and at the specified visit were analyzed.

Arm/Group Title	Placebo Plus Metformin	Sitagliptin 100 mg Plus Metformin	Glimepiride 2 mg Plus Metformin	Albiglutide 30 mg Plus Metformin
Arm/Group Description	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Measure Participants	100	300	302	297
Median (95% Confidence Interval) [Weeks]	67.71	NA	NA	NA

8. Secondary Outcome

Title	Change From Baseline in Body Weight at Week 104
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 prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region.
Time Frame	Baseline and Week 104

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 104.

Arm/Group Title	Placebo Plus Metformin	Sitagliptin 100 mg Plus Metformin	Glimepiride 2 mg Plus Metformin	Albiglutide 30 mg Plus Metformin
Arm/Group Description	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Measure Participants	100	300	302	296
Least Squares Mean (Standard Error) [Kilograms]	-1.00 (0.411)	-0.86 (0.237)	1.17 (0.237)	-1.21 (0.239)

9. Secondary Outcome

Title	Change From Baseline in Body Weight at 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 and Week 156

Outcome Measure Data

Analysis Population Description
ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed.

Arm/Group Title	Placebo Plus Metformin	Sitagliptin 100 mg Plus Metformin	Glimepiride 2 mg Plus Metformin	Albiglutide 30 mg Plus Metformin
Arm/Group Description	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
Measure Participants	16	89	102	116
Mean (Standard Deviation) [Kilograms]	-3.61 (3.460)	-2.05 (4.109)	0.98 (4.760)	-2.31 (5.093)

Adverse Events

	Placebo Plus Metformin		Sitagliptin 100 mg Plus Metformin		Glimepiride 2 mg Plus Metformin		Albiglutide 30 mg Plus Metformin
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 Plus Metformin		Sitagliptin 100 mg Plus Metformin		Glimepiride 2 mg Plus Metformin		Albiglutide 30 mg Plus Metformin
Arm/Group Description	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.		Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.		Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.		Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo Plus Metformin		Sitagliptin 100 mg Plus Metformin		Glimepiride 2 mg Plus Metformin		Albiglutide 30 mg Plus Metformin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/101 (14.9%)		32/302 (10.6%)		36/307 (11.7%)		44/302 (14.6%)
Cardiac disorders
Acute myocardial infarction	1/101 (1%)		2/302 (0.7%)		1/307 (0.3%)		2/302 (0.7%)
Coronary artery disease	2/101 (2%)		1/302 (0.3%)		2/307 (0.7%)		1/302 (0.3%)
Myocardial infarction	1/101 (1%)		0/302 (0%)		1/307 (0.3%)		3/302 (1%)
Cardiac failure congestive	0/101 (0%)		1/302 (0.3%)		1/307 (0.3%)		2/302 (0.7%)
Angina pectoris	0/101 (0%)		0/302 (0%)		0/307 (0%)		2/302 (0.7%)
Angina unstable	1/101 (1%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Cardio-respiratory arrest	1/101 (1%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Arrhythmia	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Arteriospasm coronary	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Cardiac failure	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Coronary artery stenosis	0/101 (0%)		0/302 (0%)		1/307 (0.3%)		0/302 (0%)
Eye disorders
Retinal detachment	0/101 (0%)		1/302 (0.3%)		1/307 (0.3%)		0/302 (0%)
Dacryostenosis acquired	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Gastrointestinal disorders
Gastritis	0/101 (0%)		0/302 (0%)		0/307 (0%)		2/302 (0.7%)
Intestinal obstruction	0/101 (0%)		1/302 (0.3%)		1/307 (0.3%)		0/302 (0%)
Pancreatitis acute	0/101 (0%)		0/302 (0%)		1/307 (0.3%)		1/302 (0.3%)
Rectal haemorrhage	1/101 (1%)		0/302 (0%)		1/307 (0.3%)		0/302 (0%)
Abdominal pain	0/101 (0%)		0/302 (0%)		1/307 (0.3%)		0/302 (0%)
Colitis ischaemic	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Gastrointestinal haemorrhage	1/101 (1%)		0/302 (0%)		0/307 (0%)		0/302 (0%)
Gastrooesophageal reflux disease	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Lower gastrointestinal haemorrhage	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Oesophageal spasm	0/101 (0%)		0/302 (0%)		1/307 (0.3%)		0/302 (0%)
Small intestinal obstruction	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
General disorders
Chest pain	0/101 (0%)		1/302 (0.3%)		2/307 (0.7%)		4/302 (1.3%)
Non-cardiac chest pain	0/101 (0%)		1/302 (0.3%)		1/307 (0.3%)		0/302 (0%)
Death	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Device malfunction	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Hepatobiliary disorders
Cholecystitis acute	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		1/302 (0.3%)
Cholelithiasis	1/101 (1%)		0/302 (0%)		1/307 (0.3%)		0/302 (0%)
Bile duct stone	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Cholecystitis	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Immune system disorders
Hypersensitivity	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Infections and infestations
Pneumonia	1/101 (1%)		2/302 (0.7%)		1/307 (0.3%)		2/302 (0.7%)
Gastroenteritis	0/101 (0%)		1/302 (0.3%)		2/307 (0.7%)		1/302 (0.3%)
Appendicitis	0/101 (0%)		0/302 (0%)		0/307 (0%)		3/302 (1%)
Pyelonephritis acute	1/101 (1%)		1/302 (0.3%)		0/307 (0%)		1/302 (0.3%)
Cellulitis	0/101 (0%)		0/302 (0%)		2/307 (0.7%)		0/302 (0%)
Pyelonephritis	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		1/302 (0.3%)
Abscess limb	0/101 (0%)		0/302 (0%)		1/307 (0.3%)		0/302 (0%)
Arthritis bacterial	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Helicobacter infection	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Osteomyelitis	1/101 (1%)		0/302 (0%)		0/307 (0%)		0/302 (0%)
Pelvic abscess	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Post procedural cellulitis	0/101 (0%)		0/302 (0%)		1/307 (0.3%)		0/302 (0%)
Subcutaneous abscess	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Upper respiratory tract infection	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Urinary tract infection	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Viral infection	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Injury, poisoning and procedural complications
Coronary artery restenosis	0/101 (0%)		0/302 (0%)		1/307 (0.3%)		0/302 (0%)
Femur fracture	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Fibula fracture	0/101 (0%)		0/302 (0%)		1/307 (0.3%)		0/302 (0%)
Head injury	1/101 (1%)		0/302 (0%)		0/307 (0%)		0/302 (0%)
Intentional overdose	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Joint dislocation	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Ligament sprain	0/101 (0%)		0/302 (0%)		1/307 (0.3%)		0/302 (0%)
Spinal fracture	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Tibia fracture	0/101 (0%)		0/302 (0%)		1/307 (0.3%)		0/302 (0%)
Metabolism and nutrition disorders
Hyperglycaemia	0/101 (0%)		0/302 (0%)		0/307 (0%)		3/302 (1%)
Diabetes mellitus inadequate control	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Hypoglycaemia	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Hyponatraemia	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	1/101 (1%)		0/302 (0%)		2/307 (0.7%)		1/302 (0.3%)
Back pain	0/101 (0%)		0/302 (0%)		2/307 (0.7%)		0/302 (0%)
Spinal osteoarthritis	1/101 (1%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Arthralgia	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Arthritis	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Costochondritis	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Intervertebral disc protrusion	1/101 (1%)		0/302 (0%)		0/307 (0%)		0/302 (0%)
Musculoskeletal chest pain	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Myopathy	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Osteoporosis	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Scoliosis	0/101 (0%)		0/302 (0%)		1/307 (0.3%)		0/302 (0%)
Spondylolisthesis	1/101 (1%)		0/302 (0%)		0/307 (0%)		0/302 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer	0/101 (0%)		2/302 (0.7%)		0/307 (0%)		1/302 (0.3%)
B-cell lymphoma	0/101 (0%)		0/302 (0%)		2/307 (0.7%)		0/302 (0%)
Breast cancer	1/101 (1%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Lung cancer metastatic	0/101 (0%)		0/302 (0%)		2/307 (0.7%)		0/302 (0%)
Uterine cancer	0/101 (0%)		0/302 (0%)		1/307 (0.3%)		1/302 (0.3%)
Bladder cancer	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Breast cancer stage III	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Gastrointestinal cancer metastatic	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Hepatic cancer metastatic	0/101 (0%)		0/302 (0%)		1/307 (0.3%)		0/302 (0%)
Lung squamous cell carcinoma stage II	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Malignant melanoma	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Prostate cancer	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Prostate cancer metastatic	1/101 (1%)		0/302 (0%)		0/307 (0%)		0/302 (0%)
Rectal cancer	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Renal cancer	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Squamous cell carcinoma	0/101 (0%)		0/302 (0%)		1/307 (0.3%)		0/302 (0%)
Uterine leiomyoma	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Nervous system disorders
Cerebrovascular accident	1/101 (1%)		0/302 (0%)		0/307 (0%)		2/302 (0.7%)
Carotid artery stenosis	0/101 (0%)		0/302 (0%)		1/307 (0.3%)		0/302 (0%)
Complicated migraine	0/101 (0%)		0/302 (0%)		1/307 (0.3%)		0/302 (0%)
Convulsion	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Polyneuropathy	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Presyncope	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Subarachnoid haemorrhage	1/101 (1%)		0/302 (0%)		0/307 (0%)		0/302 (0%)
Syncope	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Transient ischaemic attack	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Viith nerve paralysis	1/101 (1%)		0/302 (0%)		0/307 (0%)		0/302 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous	0/101 (0%)		0/302 (0%)		1/307 (0.3%)		0/302 (0%)
Psychiatric disorders
Mental status changes	0/101 (0%)		0/302 (0%)		1/307 (0.3%)		0/302 (0%)
Suicidal ideation	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Renal and urinary disorders
Nephrolithiasis	0/101 (0%)		0/302 (0%)		1/307 (0.3%)		1/302 (0.3%)
Azotaemia	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Calculus ureteric	1/101 (1%)		0/302 (0%)		0/307 (0%)		0/302 (0%)
Reproductive system and breast disorders
Cervical Polyp	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Respiratory, thoracic and mediastinal disorders
Pleural effusion	0/101 (0%)		0/302 (0%)		1/307 (0.3%)		1/302 (0.3%)
Pulmonary embolism	0/101 (0%)		0/302 (0%)		0/307 (0%)		2/302 (0.7%)
Atelectasis	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Chronic obstructive pulmonary disease	0/101 (0%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Epistaxis	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Skin and subcutaneous tissue disorders
Angioedema	1/101 (1%)		0/302 (0%)		2/307 (0.7%)		0/302 (0%)
Vascular disorders
Peripheral vascular disorder	1/101 (1%)		1/302 (0.3%)		1/307 (0.3%)		0/302 (0%)
Deep vein thrombosis	0/101 (0%)		0/302 (0%)		0/307 (0%)		2/302 (0.7%)
Hypertension	1/101 (1%)		0/302 (0%)		0/307 (0%)		1/302 (0.3%)
Hypertensive crisis	1/101 (1%)		0/302 (0%)		0/307 (0%)		0/302 (0%)
Ischaemia	0/101 (0%)		1/302 (0.3%)		0/307 (0%)		0/302 (0%)
Other (Not Including Serious) Adverse Events
	Placebo Plus Metformin		Sitagliptin 100 mg Plus Metformin		Glimepiride 2 mg Plus Metformin		Albiglutide 30 mg Plus Metformin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	75/101 (74.3%)		229/302 (75.8%)		258/307 (84%)		242/302 (80.1%)
Blood and lymphatic system disorders
Anaemia	8/101 (7.9%)		14/302 (4.6%)		12/307 (3.9%)		14/302 (4.6%)
Ear and labyrinth disorders
Vertigo	3/101 (3%)		3/302 (1%)		1/307 (0.3%)		8/302 (2.6%)
Eye disorders
Diabetic retinopathy	2/101 (2%)		7/302 (2.3%)		14/307 (4.6%)		14/302 (4.6%)
Cataract	6/101 (5.9%)		12/302 (4%)		20/307 (6.5%)		13/302 (4.3%)
Conjunctivitis	0/101 (0%)		4/302 (1.3%)		7/307 (2.3%)		4/302 (1.3%)
Gastrointestinal disorders
Diarrhoea	11/101 (10.9%)		28/302 (9.3%)		31/307 (10.1%)		46/302 (15.2%)
Nausea	13/101 (12.9%)		22/302 (7.3%)		25/307 (8.1%)		37/302 (12.3%)
Vomiting	1/101 (1%)		14/302 (4.6%)		13/307 (4.2%)		22/302 (7.3%)
Constipation	14/101 (13.9%)		8/302 (2.6%)		13/307 (4.2%)		19/302 (6.3%)
Dyspepsia	2/101 (2%)		5/302 (1.7%)		8/307 (2.6%)		13/302 (4.3%)
Abdominal pain	0/101 (0%)		12/302 (4%)		8/307 (2.6%)		12/302 (4%)
Gastritis	4/101 (4%)		7/302 (2.3%)		7/307 (2.3%)		10/302 (3.3%)
Gastrooesophageal reflux disease	4/101 (4%)		10/302 (3.3%)		10/307 (3.3%)		7/302 (2.3%)
Abdominal pain upper	3/101 (3%)		6/302 (2%)		3/307 (1%)		4/302 (1.3%)
Flatulence	3/101 (3%)		1/302 (0.3%)		1/307 (0.3%)		4/302 (1.3%)
Dental caries	3/101 (3%)		7/302 (2.3%)		8/307 (2.6%)		2/302 (0.7%)
Abdominal discomfort	0/101 (0%)		7/302 (2.3%)		2/307 (0.7%)		1/302 (0.3%)
General disorders
Injection site reaction	2/101 (2%)		5/302 (1.7%)		9/307 (2.9%)		33/302 (10.9%)
Oedema peripheral	2/101 (2%)		10/302 (3.3%)		25/307 (8.1%)		13/302 (4.3%)
Injection site haematoma	2/101 (2%)		11/302 (3.6%)		11/307 (3.6%)		9/302 (3%)
Fatigue	4/101 (4%)		8/302 (2.6%)		6/307 (2%)		8/302 (2.6%)
Chest pain	3/101 (3%)		6/302 (2%)		5/307 (1.6%)		8/302 (2.6%)
Injection site erythema	1/101 (1%)		2/302 (0.7%)		3/307 (1%)		7/302 (2.3%)
Immune system disorders
Seasonal allergy	1/101 (1%)		3/302 (1%)		5/307 (1.6%)		8/302 (2.6%)
Infections and infestations
Upper respiratory tract infection	10/101 (9.9%)		33/302 (10.9%)		32/307 (10.4%)		58/302 (19.2%)
Urinary tract infection	11/101 (10.9%)		37/302 (12.3%)		35/307 (11.4%)		27/302 (8.9%)
Nasopharyngitis	9/101 (8.9%)		31/302 (10.3%)		30/307 (9.8%)		24/302 (7.9%)
Bronchitis	10/101 (9.9%)		26/302 (8.6%)		23/307 (7.5%)		24/302 (7.9%)
Influenza	7/101 (6.9%)		17/302 (5.6%)		25/307 (8.1%)		21/302 (7%)
Gastroenteritis	4/101 (4%)		16/302 (5.3%)		9/307 (2.9%)		19/302 (6.3%)
Pharyngitis	10/101 (9.9%)		22/302 (7.3%)		17/307 (5.5%)		17/302 (5.6%)
Sinusitis	5/101 (5%)		22/302 (7.3%)		22/307 (7.2%)		17/302 (5.6%)
Herpes zoster	1/101 (1%)		2/302 (0.7%)		5/307 (1.6%)		8/302 (2.6%)
Cellulitis	1/101 (1%)		7/302 (2.3%)		6/307 (2%)		7/302 (2.3%)
Pneumonia	1/101 (1%)		2/302 (0.7%)		7/307 (2.3%)		6/302 (2%)
Tooth abscess	6/101 (5.9%)		10/302 (3.3%)		7/307 (2.3%)		4/302 (1.3%)
Otitis media	1/101 (1%)		7/302 (2.3%)		2/307 (0.7%)		4/302 (1.3%)
Ear infection	3/101 (3%)		5/302 (1.7%)		6/307 (2%)		3/302 (1%)
Viral infection	1/101 (1%)		7/302 (2.3%)		4/307 (1.3%)		3/302 (1%)
Lower respiratory tract infection	4/101 (4%)		6/302 (2%)		1/307 (0.3%)		3/302 (1%)
Gastroenteritis viral	1/101 (1%)		7/302 (2.3%)		5/307 (1.6%)		1/302 (0.3%)
Injury, poisoning and procedural complications
Contusion	1/101 (1%)		3/302 (1%)		7/307 (2.3%)		8/302 (2.6%)
Excoriation	2/101 (2%)		2/302 (0.7%)		5/307 (1.6%)		7/302 (2.3%)
Muscle strain	4/101 (4%)		4/302 (1.3%)		9/307 (2.9%)		6/302 (2%)
Fall	1/101 (1%)		7/302 (2.3%)		0/307 (0%)		6/302 (2%)
Ligament sprain	2/101 (2%)		8/302 (2.6%)		9/307 (2.9%)		5/302 (1.7%)
Investigations
Weight Increased	1/101 (1%)		2/302 (0.7%)		7/307 (2.3%)		5/302 (1.7%)
Metabolism and nutrition disorders
Dyslipidaemia	4/101 (4%)		11/302 (3.6%)		5/307 (1.6%)		9/302 (3%)
Hypertriglyceridaemia	3/101 (3%)		8/302 (2.6%)		12/307 (3.9%)		8/302 (2.6%)
Hypercholesterolaemia	1/101 (1%)		4/302 (1.3%)		6/307 (2%)		7/302 (2.3%)
Gout	2/101 (2%)		3/302 (1%)		3/307 (1%)		7/302 (2.3%)
Hyperuricaemia	2/101 (2%)		4/302 (1.3%)		7/307 (2.3%)		3/302 (1%)
Musculoskeletal and connective tissue disorders
Arthralgia	8/101 (7.9%)		31/302 (10.3%)		28/307 (9.1%)		24/302 (7.9%)
Musculoskeletal pain	2/101 (2%)		11/302 (3.6%)		6/307 (2%)		20/302 (6.6%)
Back pain	9/101 (8.9%)		22/302 (7.3%)		19/307 (6.2%)		19/302 (6.3%)
Pain in extremity	6/101 (5.9%)		15/302 (5%)		21/307 (6.8%)		17/302 (5.6%)
Osteoarthritis	6/101 (5.9%)		11/302 (3.6%)		9/307 (2.9%)		10/302 (3.3%)
Muscle spasms	5/101 (5%)		8/302 (2.6%)		9/307 (2.9%)		10/302 (3.3%)
Arthritis	3/101 (3%)		5/302 (1.7%)		3/307 (1%)		7/302 (2.3%)
Myalgia	2/101 (2%)		7/302 (2.3%)		5/307 (1.6%)		6/302 (2%)
Tendonitis	2/101 (2%)		0/302 (0%)		7/307 (2.3%)		4/302 (1.3%)
Hypoglycaemia	18/101 (17.8%)		24/302 (7.9%)		102/307 (33.2%)		35/302 (11.6%)
Nervous system disorders
Headache	5/101 (5%)		26/302 (8.6%)		34/307 (11.1%)		22/302 (7.3%)
Dizziness	5/101 (5%)		13/302 (4.3%)		14/307 (4.6%)		10/302 (3.3%)
Neuropathy peripheral	1/101 (1%)		5/302 (1.7%)		7/307 (2.3%)		8/302 (2.6%)
Diabetic neuropathy	2/101 (2%)		5/302 (1.7%)		7/307 (2.3%)		5/302 (1.7%)
Paraesthesia	3/101 (3%)		3/302 (1%)		5/307 (1.6%)		4/302 (1.3%)
Sciatica	3/101 (3%)		1/302 (0.3%)		1/307 (0.3%)		2/302 (0.7%)
Amnesia	3/101 (3%)		0/302 (0%)		1/307 (0.3%)		1/302 (0.3%)
Psychiatric disorders
Depression	5/101 (5%)		9/302 (3%)		10/307 (3.3%)		15/302 (5%)
Insomnia	2/101 (2%)		6/302 (2%)		10/307 (3.3%)		12/302 (4%)
Anxiety	6/101 (5.9%)		6/302 (2%)		9/307 (2.9%)		8/302 (2.6%)
Reproductive system and breast disorders
Erectile Dysfunction	3/101 (3%)		4/302 (1.3%)		4/307 (1.3%)		6/302 (2%)
Respiratory, thoracic and mediastinal disorders
Cough	9/101 (8.9%)		24/302 (7.9%)		28/307 (9.1%)		26/302 (8.6%)
Oropharyngeal pain	1/101 (1%)		7/302 (2.3%)		16/307 (5.2%)		9/302 (3%)
Nasal congestion	1/101 (1%)		4/302 (1.3%)		10/307 (3.3%)		5/302 (1.7%)
Rhinitis allergic	2/101 (2%)		5/302 (1.7%)		9/307 (2.9%)		4/302 (1.3%)
Skin and subcutaneous tissue disorders
Rash	0/101 (0%)		8/302 (2.6%)		5/307 (1.6%)		10/302 (3.3%)
Hyperkeratosis	3/101 (3%)		0/302 (0%)		2/307 (0.7%)		0/302 (0%)
Vascular disorders
Hypertension	6/101 (5.9%)		28/302 (9.3%)		32/307 (10.4%)		32/302 (10.6%)

Limitations/Caveats

[Not Specified]

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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:

NCT00838903

Other Study ID Numbers:

112753

First Posted:

Feb 9, 2009

Last Update Posted:

Jan 9, 2017

Last Verified:

Nov 1, 2016

Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes

Study Details

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Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Statistical Analysis 4

Statistical Analysis 5

Statistical Analysis 6

Statistical Analysis 7

Statistical Analysis 8

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

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Other (Not Including Serious) Adverse Events

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