A Study to Determine the Safety and Efficacy of Albiglutide in Patients With Type 2 Diabetes
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00838916
Collaborator
(none)
779
338
2
50.9
2.3
0
Study Details
Study Description
Brief Summary
A study 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
:
779 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-label, Parallel-group, Multicenter Study to Determine the Efficacy and Long-term Safety of Albiglutide Compared With Insulin in Subjects With Type 2 Diabetes Mellitus.
Study Start Date
:
Feb 1, 2009
Actual Primary Completion Date
:
Jan 1, 2012
Actual Study Completion Date
:
May 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: albiglutide weekly injection albiglutide weekly subcutaneous injection |
Biological: albiglutide
albiglutide weekly injection
|
| Active Comparator: insulin glargine insulin glargine daily injection |
Drug: insulin glargine
insulin glargine
|
Outcome Measures
Primary Outcome Measures
- 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 + current antidiabetic therapy. Difference of least squares means (albiglutide - insulin glargine) 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 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 + current antidiabetic therapy.
- Change From Baseline in Fasting Plasma Glucose (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.
- 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 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 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.
- 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 prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy.
- 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.
- Change From Baseline in Glucose Profile Measured by 24-hour Area Under Curve (AUC) at Week 52 [Baseline and Week 52]
A 24-hour glucose profile was collected at Baseline and Week 52 at a subset of sites in a subset of participants per treatment group using the continuous glucose monitoring device. Glucose measurements were obtained at 5 minute increments in the 24-hour period. The area under the curve (AUC) was determined using the trapezoidal method on the measurements obtained during the first 24 hours of continuous monitoring. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. The Baseline value is the last non-missing value before the start of treatment.
- Albiglutide Plasma Concentrations at Week 8 and Week 24 [Weeks 8 and 24]
Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post-dose, Week 24 pre-dose and Week 24 post-dose. All participants receiving albiglutide were initiated on a 30 mg weekly dosing regimen; however, beginning at Week 4, uptitration of albiglutide was allowed based on glycemic response. As such, albiglutide plasma concentrations achieved at each sampling time represent a mixed population of participants receiving either 30 mg or 50 mg weekly for various durations.
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 within <6 weeks post-partum
-
current symptomatic heart failure (NYHA Class III-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 | Dothan | Alabama | United States | 36301 |
| 5 | GSK Investigational Site | Hueytown | Alabama | United States | 35023 |
| 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 | 85224 |
| 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 | 85032 |
| 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 | Little Rock | Arkansas | United States | 72205 |
| 20 | GSK Investigational Site | Searcy | Arkansas | United States | 72143 |
| 21 | GSK Investigational Site | Buena Park | California | United States | 90620 |
| 22 | GSK Investigational Site | Cathedral City | California | United States | 92234 |
| 23 | GSK Investigational Site | Chino | California | United States | 91710 |
| 24 | GSK Investigational Site | Chula Vista | California | United States | 91911 |
| 25 | GSK Investigational Site | Commerce | California | United States | 90040 |
| 26 | GSK Investigational Site | Escondido | California | United States | 92026 |
| 27 | GSK Investigational Site | Foothill Ranch | California | United States | 92610 |
| 28 | GSK Investigational Site | Fountain Valley | California | United States | 92708 |
| 29 | GSK Investigational Site | Fresno | California | United States | 93720 |
| 30 | GSK Investigational Site | Fullerton | California | United States | 92835 |
| 31 | GSK Investigational Site | Huntington Beach | California | United States | 92646 |
| 32 | GSK Investigational Site | Huntington Beach | California | United States | 92648 |
| 33 | GSK Investigational Site | Irvine | California | United States | 92618 |
| 34 | GSK Investigational Site | La Jolla | California | United States | 92037 |
| 35 | GSK Investigational Site | LaJolla | California | United States | 92037 |
| 36 | GSK Investigational Site | Lakewood | California | United States | 90712 |
| 37 | GSK Investigational Site | Loma Linda | California | United States | 92354 |
| 38 | GSK Investigational Site | Long Beach | California | United States | 90806 |
| 39 | GSK Investigational Site | Los Alamitos | California | United States | 90720 |
| 40 | GSK Investigational Site | Los Angeles | California | United States | 90017 |
| 41 | GSK Investigational Site | Los Angeles | California | United States | 90022 |
| 42 | GSK Investigational Site | Los Angeles | California | United States | 90025 |
| 43 | GSK Investigational Site | Mission Viejo | California | United States | 92691 |
| 44 | GSK Investigational Site | Northridge | California | United States | 91325 |
| 45 | GSK Investigational Site | Palm Desert | California | United States | 92260 |
| 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 | 95821 |
| 49 | GSK Investigational Site | Sacramento | California | United States | 95825 |
| 50 | GSK Investigational Site | San Diego | California | United States | 92117 |
| 51 | GSK Investigational Site | San Diego | California | United States | 92120 |
| 52 | GSK Investigational Site | San Diego | California | United States | 92128 |
| 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 | Vista | California | United States | 92083 |
| 59 | GSK Investigational Site | West Hills | California | United States | 91307 |
| 60 | GSK Investigational Site | Denver | Colorado | United States | 80209 |
| 61 | GSK Investigational Site | New Britain | Connecticut | United States | 06050 |
| 62 | GSK Investigational Site | Trumbull | Connecticut | United States | 06611 |
| 63 | GSK Investigational Site | Waterbury | Connecticut | United States | 06708 |
| 64 | GSK Investigational Site | Middletown | Delaware | United States | 19709 |
| 65 | GSK Investigational Site | Boynton Beach | Florida | United States | 33426 |
| 66 | GSK Investigational Site | Boynton Beach | Florida | United States | 33437 |
| 67 | GSK Investigational Site | Clearwater | Florida | United States | 33756 |
| 68 | GSK Investigational Site | Clearwater | Florida | United States | 33765 |
| 69 | GSK Investigational Site | Cocoa | Florida | United States | 32927 |
| 70 | GSK Investigational Site | Cutler Bay | Florida | United States | 33189 |
| 71 | GSK Investigational Site | Deerfield Beach | Florida | United States | 33442 |
| 72 | GSK Investigational Site | Delray Beach | Florida | United States | 33445 |
| 73 | GSK Investigational Site | Edgewater | Florida | United States | 32132 |
| 74 | GSK Investigational Site | Fort Lauderdale | Florida | United States | 33316 |
| 75 | GSK Investigational Site | Gainesville | Florida | United States | 32605 |
| 76 | GSK Investigational Site | Hallandale Beach | Florida | United States | 33009 |
| 77 | GSK Investigational Site | Hialeah | Florida | United States | 33012 |
| 78 | GSK Investigational Site | Hialeah | Florida | United States | 33013 |
| 79 | GSK Investigational Site | Hollywood | Florida | United States | 33023 |
| 80 | GSK Investigational Site | Jacksonville | Florida | United States | 32205 |
| 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 | Plantation | Florida | United States | 33317 |
| 93 | GSK Investigational Site | Ponte Verda | Florida | United States | 32081 |
| 94 | GSK Investigational Site | St. Cloud | Florida | United States | 34769 |
| 95 | GSK Investigational Site | St. Petersburg | Florida | United States | 33709 |
| 96 | GSK Investigational Site | Tampa | Florida | United States | 33603 |
| 97 | GSK Investigational Site | West Palm Beach | Florida | United States | 33401 |
| 98 | GSK Investigational Site | Atlanta | Georgia | United States | 30308 |
| 99 | GSK Investigational Site | Atlanta | Georgia | United States | 30309 |
| 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 | Honolulu | Hawaii | United States | 96813 |
| 112 | GSK Investigational Site | Honolulu | Hawaii | United States | 96814 |
| 113 | GSK Investigational Site | Boise | Idaho | United States | 83702 |
| 114 | GSK Investigational Site | Idaho Falls | Idaho | United States | 83404 |
| 115 | GSK Investigational Site | Aurora | Illinois | United States | 60504 |
| 116 | GSK Investigational Site | Chicago | Illinois | United States | 60607 |
| 117 | GSK Investigational Site | Evergreen Park | Illinois | United States | 60805 |
| 118 | GSK Investigational Site | Gurnee | Illinois | United States | 60031 |
| 119 | GSK Investigational Site | La Grange | Illinois | United States | 60525 |
| 120 | GSK Investigational Site | Naperville | Illinois | United States | 60564 |
| 121 | GSK Investigational Site | Peoria | Illinois | United States | 61602 |
| 122 | GSK Investigational Site | Avon | Indiana | United States | 46123 |
| 123 | GSK Investigational Site | Evansville | Indiana | United States | 47714 |
| 124 | GSK Investigational Site | Fishers | Indiana | United States | 46037 |
| 125 | GSK Investigational Site | Indianapolis | Indiana | United States | 46254 |
| 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 | Wichita | Kansas | United States | 67211 |
| 140 | GSK Investigational Site | Fort Mitchell | Kentucky | United States | 41017 |
| 141 | GSK Investigational Site | Lexington | Kentucky | United States | 40503 |
| 142 | GSK Investigational Site | Lexington | Kentucky | United States | 40504 |
| 143 | GSK Investigational Site | Louisville | Kentucky | United States | 40202 |
| 144 | GSK Investigational Site | Madisonville | Kentucky | United States | 42431 |
| 145 | GSK Investigational Site | Paducah | Kentucky | United States | 42003 |
| 146 | GSK Investigational Site | Covington | Louisiana | United States | 70433 |
| 147 | GSK Investigational Site | Lake Charles | Louisiana | United States | 70601 |
| 148 | GSK Investigational Site | Shreveport | Louisiana | United States | 71101 |
| 149 | GSK Investigational Site | Shreveport | Louisiana | United States | 71115 |
| 150 | GSK Investigational Site | Baltimore | Maryland | United States | 21237 |
| 151 | GSK Investigational Site | Hyattsville | Maryland | United States | 20782 |
| 152 | GSK Investigational Site | Oxon Hill | Maryland | United States | 20745 |
| 153 | GSK Investigational Site | Haverhill | Massachusetts | United States | 01830 |
| 154 | GSK Investigational Site | Bay City | Michigan | United States | 48706 |
| 155 | GSK Investigational Site | Benzonia | Michigan | United States | 49616 |
| 156 | GSK Investigational Site | Bloomfield Hills | Michigan | United States | 48302 |
| 157 | GSK Investigational Site | Cadillac | Michigan | United States | 49601 |
| 158 | GSK Investigational Site | Dearborn | Michigan | United States | 48124 |
| 159 | GSK Investigational Site | Interlochen | Michigan | United States | 49643 |
| 160 | GSK Investigational Site | Kalamazoo | Michigan | United States | 49009 |
| 161 | GSK Investigational Site | Kalamazoo | Michigan | United States | 49048 |
| 162 | GSK Investigational Site | St Clair Shores | Michigan | United States | 48081 |
| 163 | GSK Investigational Site | Brooklyn Center | Minnesota | United States | 55430 |
| 164 | GSK Investigational Site | Gulfport | Mississippi | United States | 39501 |
| 165 | GSK Investigational Site | Picayune | Mississippi | United States | 39466 |
| 166 | GSK Investigational Site | Rolling Fork | Mississippi | United States | 39159 |
| 167 | GSK Investigational Site | Chesterfield | Missouri | United States | 63017 |
| 168 | GSK Investigational Site | Jefferson City | Missouri | United States | 65109 |
| 169 | GSK Investigational Site | Kansas City | Missouri | United States | 64106 |
| 170 | GSK Investigational Site | Kansas City | Missouri | United States | |
| 171 | GSK Investigational Site | St. Louis | Missouri | United States | 63108 |
| 172 | GSK Investigational Site | St. Louis | Missouri | United States | 63117 |
| 173 | GSK Investigational Site | West Plains | Missouri | United States | 65775 |
| 174 | GSK Investigational Site | Butte | Montana | United States | 59701 |
| 175 | GSK Investigational Site | Great Falls | Montana | United States | 59405 |
| 176 | GSK Investigational Site | Broken Bow | Nebraska | United States | 68822 |
| 177 | GSK Investigational Site | Lincoln | Nebraska | United States | 68516 |
| 178 | GSK Investigational Site | Omaha | Nebraska | United States | 68124 |
| 179 | GSK Investigational Site | Omaha | Nebraska | United States | 68131 |
| 180 | GSK Investigational Site | Omaha | Nebraska | United States | 68134 |
| 181 | GSK Investigational Site | Las Vegas | Nevada | United States | 89102 |
| 182 | GSK Investigational Site | Las Vegas | Nevada | United States | 89103 |
| 183 | GSK Investigational Site | Las Vegas | Nevada | United States | 89106 |
| 184 | GSK Investigational Site | Las Vegas | Nevada | United States | 89128 |
| 185 | GSK Investigational Site | Las Vegas | Nevada | United States | 89130 |
| 186 | GSK Investigational Site | Berlin | New Jersey | United States | 08009 |
| 187 | GSK Investigational Site | Elizabeth | New Jersey | United States | 07202 |
| 188 | GSK Investigational Site | Haddon Heights | New Jersey | United States | 08035 |
| 189 | GSK Investigational Site | Hainesport | New Jersey | United States | 08036 |
| 190 | GSK Investigational Site | New Brunswick | New Jersey | United States | 08903 |
| 191 | GSK Investigational Site | Stratford | New Jersey | United States | 08084 |
| 192 | GSK Investigational Site | Albuquerque | New Mexico | United States | 87106 |
| 193 | GSK Investigational Site | New York | New York | United States | 10022 |
| 194 | GSK Investigational Site | North Massapequa | New York | United States | 11758 |
| 195 | GSK Investigational Site | Syracuse | New York | United States | 13210 |
| 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 | Fayetteville | North Carolina | United States | 28304 |
| 200 | GSK Investigational Site | Greensboro | North Carolina | United States | 27405 |
| 201 | GSK Investigational Site | Hickory | North Carolina | United States | 28601 |
| 202 | GSK Investigational Site | Lenoir | North Carolina | United States | 28645 |
| 203 | GSK Investigational Site | Mint HIll | North Carolina | United States | 28227 |
| 204 | GSK Investigational Site | Morehead City | North Carolina | United States | 28557 |
| 205 | GSK Investigational Site | Shelby | North Carolina | United States | 28150 |
| 206 | GSK Investigational Site | Tabor City | North Carolina | United States | 28463 |
| 207 | GSK Investigational Site | Akron | Ohio | United States | 44320 |
| 208 | GSK Investigational Site | Canal Fulton | Ohio | United States | 44614 |
| 209 | GSK Investigational Site | Cincinnati | Ohio | United States | 45227 |
| 210 | GSK Investigational Site | Cincinnati | Ohio | United States | 45245 |
| 211 | GSK Investigational Site | Cleveland | Ohio | United States | 44122 |
| 212 | GSK Investigational Site | Columbus | Ohio | United States | 43212 |
| 213 | GSK Investigational Site | Columbus | Ohio | United States | 43213 |
| 214 | GSK Investigational Site | Dayton | Ohio | United States | 45432 |
| 215 | GSK Investigational Site | Dayton | Ohio | United States | 45439 |
| 216 | GSK Investigational Site | Kettering | Ohio | United States | 45429 |
| 217 | GSK Investigational Site | Mason | Ohio | United States | 45040 |
| 218 | GSK Investigational Site | Maumee | Ohio | United States | 43537-9402 |
| 219 | GSK Investigational Site | Thornville | Ohio | United States | 43076 |
| 220 | GSK Investigational Site | Zanesville | Ohio | United States | 43701 |
| 221 | GSK Investigational Site | Oklahoma City | Oklahoma | United States | 73103 |
| 222 | GSK Investigational Site | Oklahoma City | Oklahoma | United States | 73116 |
| 223 | GSK Investigational Site | Tulsa | Oklahoma | United States | 74104 |
| 224 | GSK Investigational Site | Tulsa | Oklahoma | United States | 74136 |
| 225 | GSK Investigational Site | Ashland | Oregon | United States | 97520 |
| 226 | GSK Investigational Site | Bensalem | Pennsylvania | United States | 19020 |
| 227 | GSK Investigational Site | Carlisle | Pennsylvania | United States | 17013 |
| 228 | GSK Investigational Site | Downington | Pennsylvania | United States | 19335 |
| 229 | GSK Investigational Site | Harrisburg | Pennsylvania | United States | 17112 |
| 230 | GSK Investigational Site | Landsdale | Pennsylvania | United States | 19446 |
| 231 | GSK Investigational Site | Pittsburgh | Pennsylvania | United States | 15243 |
| 232 | GSK Investigational Site | Tipton | Pennsylvania | United States | 16684 |
| 233 | GSK Investigational Site | Uniontown | Pennsylvania | United States | 15401 |
| 234 | GSK Investigational Site | East Providence | Rhode Island | United States | 02914 |
| 235 | GSK Investigational Site | Columbia | South Carolina | United States | 29201 |
| 236 | GSK Investigational Site | Greenville | South Carolina | United States | 29601 |
| 237 | GSK Investigational Site | Greenville | South Carolina | United States | 29615 |
| 238 | GSK Investigational Site | Greer | South Carolina | United States | 29651 |
| 239 | GSK Investigational Site | Manning | South Carolina | United States | 29102 |
| 240 | GSK Investigational Site | Murrells Inlet | South Carolina | United States | 29576 |
| 241 | GSK Investigational Site | North Myrtle Beach | South Carolina | United States | 29582 |
| 242 | GSK Investigational Site | Orangeburg | South Carolina | United States | 29115 |
| 243 | GSK Investigational Site | Simpsonville | South Carolina | United States | 29681 |
| 244 | GSK Investigational Site | Taylors | South Carolina | United States | 29687 |
| 245 | GSK Investigational Site | Bristol | Tennessee | United States | 37620 |
| 246 | GSK Investigational Site | Chattanooga | Tennessee | United States | 37421 |
| 247 | GSK Investigational Site | Clarksville | Tennessee | United States | 37043 |
| 248 | GSK Investigational Site | Columbia | Tennessee | United States | 38401 |
| 249 | GSK Investigational Site | Fayetteville | Tennessee | United States | 37334 |
| 250 | GSK Investigational Site | Johnson City | Tennessee | United States | 37604 |
| 251 | GSK Investigational Site | McKenzie | Tennessee | United States | 38201 |
| 252 | GSK Investigational Site | Nashville | Tennessee | United States | 37203 |
| 253 | GSK Investigational Site | Tullahoma | Tennessee | United States | 37398 |
| 254 | GSK Investigational Site | Arlington | Texas | United States | 76012 |
| 255 | GSK Investigational Site | Bedford | Texas | United States | 76201 |
| 256 | GSK Investigational Site | Cleburne | Texas | United States | 76033 |
| 257 | GSK Investigational Site | Corpus Christi | Texas | United States | 78404 |
| 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 | Dallas | Texas | United States | 75246 |
| 263 | GSK Investigational Site | Dallas | Texas | United States | 75251 |
| 264 | GSK Investigational Site | Deer Park | Texas | United States | 77536 |
| 265 | GSK Investigational Site | El Paso | Texas | United States | 79925 |
| 266 | GSK Investigational Site | Fort Worth | Texas | United States | 76104 |
| 267 | GSK Investigational Site | Fort Worth | Texas | United States | 76135 |
| 268 | GSK Investigational Site | Houston | Texas | United States | 77024 |
| 269 | GSK Investigational Site | Houston | Texas | United States | 77027 |
| 270 | GSK Investigational Site | Houston | Texas | United States | 77030 |
| 271 | GSK Investigational Site | Houston | Texas | United States | 77034 |
| 272 | GSK Investigational Site | Houston | Texas | United States | 77036 |
| 273 | GSK Investigational Site | Houston | Texas | United States | 77055 |
| 274 | GSK Investigational Site | Houston | Texas | United States | 77058 |
| 275 | GSK Investigational Site | Houston | Texas | United States | 77070 |
| 276 | GSK Investigational Site | Houston | Texas | United States | 77074 |
| 277 | GSK Investigational Site | Houston | Texas | United States | 77094 |
| 278 | GSK Investigational Site | Hurst | Texas | United States | 76054 |
| 279 | GSK Investigational Site | Katy | Texas | United States | 77450 |
| 280 | GSK Investigational Site | Lake Jackson | Texas | United States | 77566 |
| 281 | GSK Investigational Site | Lewisville | Texas | United States | 75067 |
| 282 | GSK Investigational Site | Midland | Texas | United States | 79705 |
| 283 | GSK Investigational Site | North Richland Hills | Texas | United States | 76180 |
| 284 | GSK Investigational Site | Odessa | Texas | United States | 79761 |
| 285 | GSK Investigational Site | San Antonio | Texas | United States | 78205 |
| 286 | GSK Investigational Site | San Antonio | Texas | United States | 78215 |
| 287 | GSK Investigational Site | San Antonio | Texas | United States | 78217 |
| 288 | GSK Investigational Site | San Antonio | Texas | United States | 78218 |
| 289 | GSK Investigational Site | San Antonio | Texas | United States | 78224 |
| 290 | GSK Investigational Site | San Antonio | Texas | United States | 78229 |
| 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 | Bountiful | Utah | United States | 84010 |
| 296 | GSK Investigational Site | Murray | Utah | United States | 84123 |
| 297 | GSK Investigational Site | Orem | Utah | United States | 84058 |
| 298 | GSK Investigational Site | Salt Lake City | Utah | United States | 84120 |
| 299 | GSK Investigational Site | West Jordan | Utah | United States | 84088 |
| 300 | GSK Investigational Site | West Valley City | Utah | United States | 84120 |
| 301 | GSK Investigational Site | South Burlington | Vermont | United States | 05403 |
| 302 | GSK Investigational Site | Burke | Virginia | United States | 22015 |
| 303 | GSK Investigational Site | Hampton | Virginia | United States | 23666 |
| 304 | GSK Investigational Site | Manassas | Virginia | United States | 20110 |
| 305 | GSK Investigational Site | Richmond | Virginia | United States | 23294 |
| 306 | GSK Investigational Site | Suffolk | Virginia | United States | 23434 |
| 307 | GSK Investigational Site | Weber City | Virginia | United States | 24290 |
| 308 | GSK Investigational Site | Renton | Washington | United States | 98057 |
| 309 | GSK Investigational Site | Richland | Washington | United States | 99352 |
| 310 | GSK Investigational Site | Selah | Washington | United States | 98942 |
| 311 | GSK Investigational Site | Spokane | Washington | United States | 99208 |
| 312 | GSK Investigational Site | Spokane | Washington | United States | 99216 |
| 313 | GSK Investigational Site | Tacoma | Washington | United States | 98405 |
| 314 | GSK Investigational Site | Lewisburg | West Virginia | United States | 24901 |
| 315 | GSK Investigational Site | Milwaukee | Wisconsin | United States | 53226 |
| 316 | GSK Investigational Site | Arkhangelsk | Russian Federation | 163045 | |
| 317 | GSK Investigational Site | Irkutsk | Russian Federation | 664003 | |
| 318 | GSK Investigational Site | Nizhniy Novgorod | Russian Federation | 603126 | |
| 319 | GSK Investigational Site | Saratov | Russian Federation | 410030 | |
| 320 | GSK Investigational Site | Smolensk | Russian Federation | 214019 | |
| 321 | GSK Investigational Site | Yaroslavl | Russian Federation | 150062 | |
| 322 | GSK Investigational Site | Port Elizabeth | Eastern Cape | South Africa | 6014 |
| 323 | GSK Investigational Site | Johannesburg | Gauteng | South Africa | 01820 |
| 324 | GSK Investigational Site | Johannesburg | Gauteng | South Africa | 2013 |
| 325 | GSK Investigational Site | Lenasia | Gauteng | South Africa | 1827 |
| 326 | GSK Investigational Site | Parktown | Gauteng | South Africa | 2193 |
| 327 | GSK Investigational Site | Pretoria | Gauteng | South Africa | 00083 |
| 328 | GSK Investigational Site | Phoenix | KwaZulu- Natal | South Africa | 4068 |
| 329 | GSK Investigational Site | Somerset West | Western Province | South Africa | 7129 |
| 330 | GSK Investigational Site | Cape Town | South Africa | 7530 | |
| 331 | GSK Investigational Site | Kempton Park | South Africa | 1619 | |
| 332 | GSK Investigational Site | Parow | South Africa | 7505 | |
| 333 | GSK Investigational Site | Blackpool | Lancashire | United Kingdom | FY4 3AD |
| 334 | GSK Investigational Site | Sunbury-on-Thames | Middlesex | United Kingdom | TW16 6RH |
| 335 | GSK Investigational Site | Port Glasgow | Renfrewshire | United Kingdom | PA14 6HW |
| 336 | GSK Investigational Site | Coventry | West Midlands | United Kingdom | CV2 2DX |
| 337 | GSK Investigational Site | Liverpool | United Kingdom | L9 7AL | |
| 338 | 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:
NCT00838916
Other Study ID Numbers:
- 112754
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
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Participants (par.) who met eligibility criteria and completed a 4 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 1060 par. were screened; 779 par. were randomized, and 745 par. received >=1 treatment dose. |
| Arm/Group Title | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Arm/Group Description | Participants received albiglutide 30 milligrams (mg) weekly (with 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 or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. | Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. |
| Period Title: Treatment Period (156 Weeks) | ||
| STARTED | 504 | 241 |
| COMPLETED | 308 | 164 |
| NOT COMPLETED | 196 | 77 |
| Period Title: Treatment Period (156 Weeks) | ||
| STARTED | 504 | 241 |
| COMPLETED | 408 | 190 |
| NOT COMPLETED | 96 | 51 |
Baseline Characteristics
| Arm/Group Title | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea | Total |
|---|---|---|---|
| Arm/Group Description | Participants received albiglutide 30 milligrams (mg) weekly (with 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 or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. | Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. | Total of all reporting groups |
| Overall Participants | 504 | 241 | 745 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
55.8
(9.33)
|
54.7
(9.75)
|
55.5
(9.48)
|
| Gender (Count of Participants) | |||
| Female |
218
43.3%
|
109
45.2%
|
327
43.9%
|
| Male |
286
56.7%
|
132
54.8%
|
418
56.1%
|
| Race/Ethnicity, Customized (Number) [Number] | |||
| African American/African Heritage |
130
25.8%
|
64
26.6%
|
194
26%
|
| American Indian or Alaskan Native |
3
0.6%
|
1
0.4%
|
4
0.5%
|
| Asian - Central/South Asian Heritage |
7
1.4%
|
5
2.1%
|
12
1.6%
|
| Asian - East Asian Heritage |
2
0.4%
|
1
0.4%
|
3
0.4%
|
| Asian - Japanese Heritage |
0
0%
|
1
0.4%
|
1
0.1%
|
| Asian - South East Asian Heritage |
16
3.2%
|
8
3.3%
|
24
3.2%
|
| Native Hawaiian or Other Pacific Islander |
1
0.2%
|
0
0%
|
1
0.1%
|
| White - Arabic/North African Heritage |
7
1.4%
|
2
0.8%
|
9
1.2%
|
| White - White/Caucasian/European Heritage |
342
67.9%
|
158
65.6%
|
500
67.1%
|
| Other - Central American Indian |
1
0.2%
|
0
0%
|
1
0.1%
|
| Other - Hispanic |
0
0%
|
1
0.4%
|
1
0.1%
|
| Other - Mexican |
1
0.2%
|
0
0%
|
1
0.1%
|
Outcome Measures
| 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 + current antidiabetic therapy. Difference of least squares means (albiglutide - insulin glargine) 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 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 | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Arm/Group Description | Participants received albiglutide 30 milligrams (mg) weekly (with 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 or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. | Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. |
| Measure Participants | 493 | 238 |
| Least Squares Mean (Standard Error) [Percentage of HbA1c in the blood] |
-0.67
(0.044)
|
-0.79
(0.064)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Albiglutide 30 mg + Metformin +/- Sulfonylurea, Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| 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 | 0.11 | |
| Confidence Interval |
(2-Sided) 95% -0.04 to 0.27 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Albiglutide 30 mg + Metformin +/- Sulfonylurea, Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | To test whether the difference of least square means (albiglutide - insulin glargine) is equal to the pre-specified non-inferiority margin of 0.3% | |
| Statistical Test of Hypothesis | p-Value | 0.0086 |
| Comments | p-value is for non-inferiority testing of albiglutide versus insulin glargine | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Albiglutide 30 mg + Metformin +/- Sulfonylurea, Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1463 |
| Comments | p-value is for superiority testing of albiglutide versus insulin glargine | |
| 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 - insulin glargine) is equal to zero. | |
| 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 |
|---|
| ITT Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed. |
| Arm/Group Title | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Arm/Group Description | Participants received albiglutide 30 milligrams (mg) weekly (with 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 or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. | Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. |
| Measure Participants | 123 | 88 |
| Mean (Standard Deviation) [Percentage of HbA1c in the blood] |
-0.83
(0.980)
|
-1.00
(0.922)
|
| 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 + current antidiabetic therapy. |
| 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 | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Arm/Group Description | Participants received albiglutide 30 milligrams (mg) weekly (with 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 or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. | Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. |
| Measure Participants | 494 | 238 |
| Least Squares Mean (Standard Error) [Millimoles per liter (mmol/L)] |
-0.87
(0.127)
|
-2.06
(0.184)
|
| Title | Change From Baseline in Fasting Plasma Glucose (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. |
| Time Frame | Baseline and Week 156 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. |
| Arm/Group Title | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Arm/Group Description | Participants received albiglutide 30 milligrams (mg) weekly (with 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 or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. | Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. |
| Measure Participants | 119 | 86 |
| Mean (Standard Deviation) [Millimoles per liter (mmol/L)] |
-0.83
(2.803)
|
-2.19
(3.420)
|
| 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 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 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 | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Arm/Group Description | Participants received albiglutide 30 milligrams (mg) weekly (with 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 or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. | Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. |
| Measure Participants | 493 | 238 |
| HbA1c <6.5% |
54
10.7%
|
25
10.4%
|
| HbA1c <7% |
156
31%
|
78
32.4%
|
| HbA1c <7.5% |
268
53.2%
|
135
56%
|
| 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 par. 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 | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Arm/Group Description | Participants received albiglutide 30 milligrams (mg) weekly (with 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 or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. | Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. |
| Measure Participants | 123 | 88 |
| HbA1c <6.5% |
33
6.5%
|
18
7.5%
|
| HbA1c <7% |
59
11.7%
|
46
19.1%
|
| HbA1c <7.5% |
85
16.9%
|
71
29.5%
|
| 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. Only those participants with a value at Baseline and at the specified visit were analyzed. |
| Arm/Group Title | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Arm/Group Description | Participants received albiglutide 30 milligrams (mg) weekly (with 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 or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. | Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. |
| Measure Participants | 496 | 239 |
| Median (95% Confidence Interval) [Weeks] |
107.57
|
NA
|
| 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 prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy. |
| 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 | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Arm/Group Description | Participants received albiglutide 30 milligrams (mg) weekly (with 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 or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. | Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. |
| Measure Participants | 495 | 238 |
| Least Squares Mean (Standard Error) [Kilograms] |
-1.05
(0.171)
|
1.56
(0.247)
|
| 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. |
| 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. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. |
| Arm/Group Title | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Arm/Group Description | Participants received albiglutide 30 milligrams (mg) weekly (with 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 or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. | Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. |
| Measure Participants | 122 | 89 |
| Mean (Standard Deviation) [Kilograms] |
-3.47
(6.300)
|
0.90
(4.890)
|
| Title | Change From Baseline in Glucose Profile Measured by 24-hour Area Under Curve (AUC) at Week 52 |
|---|---|
| Description | A 24-hour glucose profile was collected at Baseline and Week 52 at a subset of sites in a subset of participants per treatment group using the continuous glucose monitoring device. Glucose measurements were obtained at 5 minute increments in the 24-hour period. The area under the curve (AUC) was determined using the trapezoidal method on the measurements obtained during the first 24 hours of continuous monitoring. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. The Baseline value is the last non-missing value before the start of treatment. |
| Time Frame | Baseline and Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Glucose Profile Substudy Population: all participants who participated in the 24-hour glucose profile substudy . Only those participants with a value at Baseline and Week 52 were analyzed. |
| Arm/Group Title | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Arm/Group Description | Participants received albiglutide 30 milligrams (mg) weekly (with 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 or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. | Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. |
| Measure Participants | 13 | 9 |
| Mean (Standard Deviation) [Millimoles per hour per liter (mmol.h/L)] |
0.457
(2.9898)
|
-1.657
(1.9453)
|
| Title | Albiglutide Plasma Concentrations at Week 8 and Week 24 |
|---|---|
| Description | Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post-dose, Week 24 pre-dose and Week 24 post-dose. All participants receiving albiglutide were initiated on a 30 mg weekly dosing regimen; however, beginning at Week 4, uptitration of albiglutide was allowed based on glycemic response. As such, albiglutide plasma concentrations achieved at each sampling time represent a mixed population of participants receiving either 30 mg or 50 mg weekly for various durations. |
| Time Frame | Weeks 8 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population. Only those participants with a PK sample available for analysis at the indicated time points were analyzed. |
| Arm/Group Title | Albiglutide 30 mg + Metformin +/- Sulfonylurea |
|---|---|
| Arm/Group Description | Participants received albiglutide 30 milligrams (mg) weekly (with 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 or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. |
| Measure Participants | 459 |
| Week 8, Pre-dose, n=408 |
1642.83
(892.570)
|
| Week 8, Post-dose, n=398 |
1911.35
(966.180)
|
| Week 24, Pre-dose, n=416 |
2159.30
(1211.714)
|
| Week 24, Post-dose, n=401 |
2748.15
(1503.945)
|
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 | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea | ||
| Arm/Group Description | Participants received albiglutide 30 milligrams (mg) weekly (with 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 or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. | Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period. | ||
All Cause Mortality |
||||
| Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 92/504 (18.3%) | 46/241 (19.1%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 3/504 (0.6%) | 0/241 (0%) | ||
| Idiopathic thrombocytopenic purpura | 1/504 (0.2%) | 0/241 (0%) | ||
| Iron deficiency anaemia | 1/504 (0.2%) | 0/241 (0%) | ||
| Cardiac disorders | ||||
| Coronary artery disease | 5/504 (1%) | 2/241 (0.8%) | ||
| Acute myocardial infarction | 3/504 (0.6%) | 2/241 (0.8%) | ||
| Angina unstable | 2/504 (0.4%) | 3/241 (1.2%) | ||
| Cardiac failure congestive | 2/504 (0.4%) | 2/241 (0.8%) | ||
| Atrial fibrillation | 3/504 (0.6%) | 0/241 (0%) | ||
| Myocardial infarction | 3/504 (0.6%) | 0/241 (0%) | ||
| Acute coronary syndrome | 1/504 (0.2%) | 1/241 (0.4%) | ||
| Angina pectoris | 0/504 (0%) | 1/241 (0.4%) | ||
| Arteriosclerosis coronary artery | 1/504 (0.2%) | 0/241 (0%) | ||
| Atrial flutter | 1/504 (0.2%) | 0/241 (0%) | ||
| Bradycardia | 1/504 (0.2%) | 0/241 (0%) | ||
| Cardiomyopathy | 0/504 (0%) | 1/241 (0.4%) | ||
| Conduction disorder | 1/504 (0.2%) | 0/241 (0%) | ||
| Coronary artery insufficiency | 0/504 (0%) | 1/241 (0.4%) | ||
| Sinus bradycardia | 1/504 (0.2%) | 0/241 (0%) | ||
| Ventricular tachycardia | 1/504 (0.2%) | 0/241 (0%) | ||
| Eye disorders | ||||
| Cataract | 0/504 (0%) | 1/241 (0.4%) | ||
| Retinal detachment | 1/504 (0.2%) | 0/241 (0%) | ||
| Gastrointestinal disorders | ||||
| Lower gastrointestinal haemorrhage | 2/504 (0.4%) | 0/241 (0%) | ||
| Abdominal hernia | 1/504 (0.2%) | 0/241 (0%) | ||
| Abdominal pain upper | 1/504 (0.2%) | 0/241 (0%) | ||
| Ascites | 0/504 (0%) | 1/241 (0.4%) | ||
| Diarrhoea | 1/504 (0.2%) | 0/241 (0%) | ||
| Gastrointestinal haemorrhage | 1/504 (0.2%) | 0/241 (0%) | ||
| Gastrooesophageal reflux disease | 0/504 (0%) | 1/241 (0.4%) | ||
| Haemorrhoids | 0/504 (0%) | 1/241 (0.4%) | ||
| Pancreatitis | 1/504 (0.2%) | 0/241 (0%) | ||
| Peptic ulcer | 0/504 (0%) | 1/241 (0.4%) | ||
| Umbilical hernia | 0/504 (0%) | 1/241 (0.4%) | ||
| General disorders | ||||
| Chest pain | 5/504 (1%) | 4/241 (1.7%) | ||
| Non-cardiac chest pain | 4/504 (0.8%) | 0/241 (0%) | ||
| Death | 2/504 (0.4%) | 1/241 (0.4%) | ||
| Device leakage | 1/504 (0.2%) | 0/241 (0%) | ||
| Generalised oedema | 0/504 (0%) | 1/241 (0.4%) | ||
| Sudden cardiac death | 0/504 (0%) | 1/241 (0.4%) | ||
| Hepatobiliary disorders | ||||
| Cholecystitis Acute | 0/504 (0%) | 3/241 (1.2%) | ||
| Cholelithiasis | 1/504 (0.2%) | 0/241 (0%) | ||
| Hepatitis | 0/504 (0%) | 1/241 (0.4%) | ||
| Immune system disorders | ||||
| Anaphylactic reaction | 1/504 (0.2%) | 0/241 (0%) | ||
| Infections and infestations | ||||
| Pneumonia | 4/504 (0.8%) | 0/241 (0%) | ||
| Bronchitis | 3/504 (0.6%) | 0/241 (0%) | ||
| Cellulitis | 1/504 (0.2%) | 2/241 (0.8%) | ||
| Osteomyelitis | 3/504 (0.6%) | 0/241 (0%) | ||
| Diverticulitis | 0/504 (0%) | 2/241 (0.8%) | ||
| Lobar pneumonia | 2/504 (0.4%) | 0/241 (0%) | ||
| Urinary tract infection | 0/504 (0%) | 2/241 (0.8%) | ||
| Appendicitis | 1/504 (0.2%) | 0/241 (0%) | ||
| Arthritis bacterial | 1/504 (0.2%) | 0/241 (0%) | ||
| Bacterial pyelonephritis | 1/504 (0.2%) | 0/241 (0%) | ||
| Bronchopneumonia | 1/504 (0.2%) | 0/241 (0%) | ||
| Epiglottitis | 1/504 (0.2%) | 0/241 (0%) | ||
| Eye abscess | 1/504 (0.2%) | 0/241 (0%) | ||
| Gangrene | 1/504 (0.2%) | 0/241 (0%) | ||
| Gastroenteritis | 1/504 (0.2%) | 0/241 (0%) | ||
| Hepatitis B | 1/504 (0.2%) | 0/241 (0%) | ||
| Localised infection | 1/504 (0.2%) | 0/241 (0%) | ||
| Perirectal abscess | 1/504 (0.2%) | 0/241 (0%) | ||
| Pyelonephritis | 0/504 (0%) | 1/241 (0.4%) | ||
| Staphylococcal infection | 1/504 (0.2%) | 0/241 (0%) | ||
| Tracheobronchitis | 1/504 (0.2%) | 0/241 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Arterial injury | 1/504 (0.2%) | 0/241 (0%) | ||
| Femur fracture | 1/504 (0.2%) | 0/241 (0%) | ||
| Gastroenteritis radiation | 1/504 (0.2%) | 0/241 (0%) | ||
| Heat stroke | 1/504 (0.2%) | 0/241 (0%) | ||
| Hip fracture | 1/504 (0.2%) | 0/241 (0%) | ||
| Meniscus lesion | 1/504 (0.2%) | 0/241 (0%) | ||
| Road traffic accident | 1/504 (0.2%) | 0/241 (0%) | ||
| Seroma | 0/504 (0%) | 1/241 (0.4%) | ||
| Skeletal injury | 0/504 (0%) | 1/241 (0.4%) | ||
| Toxicity to various agents | 1/504 (0.2%) | 0/241 (0%) | ||
| Wound dehiscence | 1/504 (0.2%) | 0/241 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Hypoglycaemia | 1/504 (0.2%) | 2/241 (0.8%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Osteoarthritis | 2/504 (0.4%) | 3/241 (1.2%) | ||
| Arthritis | 0/504 (0%) | 2/241 (0.8%) | ||
| Cervical spinal stenosis | 1/504 (0.2%) | 1/241 (0.4%) | ||
| Intervertebral disc protrusion | 2/504 (0.4%) | 0/241 (0%) | ||
| Bursitis | 0/504 (0%) | 1/241 (0.4%) | ||
| Neuropathic arthropathy | 0/504 (0%) | 1/241 (0.4%) | ||
| Pathological fracture | 1/504 (0.2%) | 0/241 (0%) | ||
| Periarthritis | 1/504 (0.2%) | 0/241 (0%) | ||
| Rotator cuff syndrome | 0/504 (0%) | 1/241 (0.4%) | ||
| Spondylolisthesis | 1/504 (0.2%) | 0/241 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Acute myeloid leukaemia | 2/504 (0.4%) | 0/241 (0%) | ||
| Breast cancer | 1/504 (0.2%) | 1/241 (0.4%) | ||
| Endometrial cancer | 0/504 (0%) | 1/241 (0.4%) | ||
| Lung adenocarcinoma metastatic | 1/504 (0.2%) | 0/241 (0%) | ||
| Lung neoplasm | 1/504 (0.2%) | 0/241 (0%) | ||
| Lung neoplasm malignant | 0/504 (0%) | 1/241 (0.4%) | ||
| Lung squamous cell carcinoma stage unspecified | 1/504 (0.2%) | 0/241 (0%) | ||
| Meningioma | 1/504 (0.2%) | 0/241 (0%) | ||
| Myelodysplastic syndrome | 1/504 (0.2%) | 0/241 (0%) | ||
| Oesophageal carcinoma | 1/504 (0.2%) | 0/241 (0%) | ||
| Prostate cancer | 1/504 (0.2%) | 0/241 (0%) | ||
| Sarcoma | 0/504 (0%) | 1/241 (0.4%) | ||
| Nervous system disorders | ||||
| Cerebrovascular accident | 2/504 (0.4%) | 0/241 (0%) | ||
| Transient ischaemic attack | 2/504 (0.4%) | 0/241 (0%) | ||
| Migraine | 1/504 (0.2%) | 0/241 (0%) | ||
| Neuropathy peripheral | 0/504 (0%) | 1/241 (0.4%) | ||
| Syncope | 1/504 (0.2%) | 0/241 (0%) | ||
| Psychiatric disorders | ||||
| Depression | 2/504 (0.4%) | 0/241 (0%) | ||
| Confusional state | 1/504 (0.2%) | 0/241 (0%) | ||
| Schizophrenia | 0/504 (0%) | 1/241 (0.4%) | ||
| Renal and urinary disorders | ||||
| Calculus urinary | 2/504 (0.4%) | 0/241 (0%) | ||
| Hydronephrosis | 2/504 (0.4%) | 0/241 (0%) | ||
| Nephrolithiasis | 1/504 (0.2%) | 1/241 (0.4%) | ||
| Renal failure acute | 1/504 (0.2%) | 1/241 (0.4%) | ||
| Calculus ureteric | 1/504 (0.2%) | 0/241 (0%) | ||
| Reproductive system and breast disorders | ||||
| Dysfunctional uterine bleeding | 0/504 (0%) | 1/241 (0.4%) | ||
| Menorrhagia | 1/504 (0.2%) | 0/241 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 2/504 (0.4%) | 0/241 (0%) | ||
| Acute respiratory failure | 1/504 (0.2%) | 0/241 (0%) | ||
| Bronchospasm | 1/504 (0.2%) | 0/241 (0%) | ||
| Chronic obstructive pulmonary disease | 1/504 (0.2%) | 0/241 (0%) | ||
| Dyspnoea | 0/504 (0%) | 1/241 (0.4%) | ||
| Pneumothorax | 0/504 (0%) | 1/241 (0.4%) | ||
| Pulmonary embolism | 1/504 (0.2%) | 0/241 (0%) | ||
| Pulmonary hypertension | 0/504 (0%) | 1/241 (0.4%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Diabetic foot | 0/504 (0%) | 1/241 (0.4%) | ||
| Vascular disorders | ||||
| Deep vein thrombosis | 1/504 (0.2%) | 0/241 (0%) | ||
| Diabetic vascular disorder | 1/504 (0.2%) | 0/241 (0%) | ||
| Haematoma | 0/504 (0%) | 1/241 (0.4%) | ||
| Haemorrhage | 1/504 (0.2%) | 0/241 (0%) | ||
| Hypertension | 0/504 (0%) | 1/241 (0.4%) | ||
| Hypotension | 0/504 (0%) | 1/241 (0.4%) | ||
| Peripheral ischaemia | 1/504 (0.2%) | 0/241 (0%) | ||
| Peripheral vascular disorder | 0/504 (0%) | 1/241 (0.4%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 429/504 (85.1%) | 199/241 (82.6%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 14/504 (2.8%) | 12/241 (5%) | ||
| Cardiac disorders | ||||
| Palpitations | 3/504 (0.6%) | 5/241 (2.1%) | ||
| Ear and labyrinth disorders | ||||
| Vertigo | 11/504 (2.2%) | 6/241 (2.5%) | ||
| Eye disorders | ||||
| Cataract | 28/504 (5.6%) | 13/241 (5.4%) | ||
| Diabetic retinopathy | 18/504 (3.6%) | 10/241 (4.1%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 67/504 (13.3%) | 18/241 (7.5%) | ||
| Diarrhoea | 55/504 (10.9%) | 19/241 (7.9%) | ||
| Constipation | 29/504 (5.8%) | 4/241 (1.7%) | ||
| Vomiting | 27/504 (5.4%) | 13/241 (5.4%) | ||
| Dyspepsia | 21/504 (4.2%) | 7/241 (2.9%) | ||
| Gastrooesophageal reflux disease | 15/504 (3%) | 6/241 (2.5%) | ||
| Abdominal pain | 14/504 (2.8%) | 8/241 (3.3%) | ||
| Toothache | 5/504 (1%) | 5/241 (2.1%) | ||
| General disorders | ||||
| Injection site reaction | 50/504 (9.9%) | 8/241 (3.3%) | ||
| Oedema peripheral | 30/504 (6%) | 15/241 (6.2%) | ||
| Injection site haematoma | 24/504 (4.8%) | 20/241 (8.3%) | ||
| Fatigue | 21/504 (4.2%) | 3/241 (1.2%) | ||
| Injection site erythema | 14/504 (2.8%) | 0/241 (0%) | ||
| Chest pain | 5/504 (1%) | 8/241 (3.3%) | ||
| Pyrexia | 5/504 (1%) | 7/241 (2.9%) | ||
| Pain | 4/504 (0.8%) | 6/241 (2.5%) | ||
| Immune system disorders | ||||
| Seasonal allergy | 11/504 (2.2%) | 6/241 (2.5%) | ||
| Infections and infestations | ||||
| Upper respiratory tract infection | 83/504 (16.5%) | 37/241 (15.4%) | ||
| Nasopharyngitis | 55/504 (10.9%) | 24/241 (10%) | ||
| Sinusitis | 50/504 (9.9%) | 23/241 (9.5%) | ||
| Urinary tract infection | 47/504 (9.3%) | 21/241 (8.7%) | ||
| Bronchitis | 44/504 (8.7%) | 27/241 (11.2%) | ||
| Influenza | 38/504 (7.5%) | 22/241 (9.1%) | ||
| Gastroenteritis | 19/504 (3.8%) | 6/241 (2.5%) | ||
| Cellulitis | 15/504 (3%) | 7/241 (2.9%) | ||
| Pneumonia | 12/504 (2.4%) | 5/241 (2.1%) | ||
| Onychomycosis | 12/504 (2.4%) | 2/241 (0.8%) | ||
| Tooth abscess | 11/504 (2.2%) | 4/241 (1.7%) | ||
| Tinea pedis | 11/504 (2.2%) | 1/241 (0.4%) | ||
| Pharyngitis | 10/504 (2%) | 6/241 (2.5%) | ||
| Cystitis | 5/504 (1%) | 5/241 (2.1%) | ||
| Injury, poisoning and procedural complications | ||||
| Muscle strain | 10/504 (2%) | 8/241 (3.3%) | ||
| Ligament sprain | 10/504 (2%) | 5/241 (2.1%) | ||
| Contusion | 7/504 (1.4%) | 9/241 (3.7%) | ||
| Investigations | ||||
| Weight increased | 6/504 (1.2%) | 5/241 (2.1%) | ||
| Metabolism and nutrition disorders | ||||
| Hypoglycaemia | 187/504 (37.1%) | 117/241 (48.5%) | ||
| Decreased appetite | 14/504 (2.8%) | 4/241 (1.7%) | ||
| Dyslipidaemia | 12/504 (2.4%) | 7/241 (2.9%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 50/504 (9.9%) | 17/241 (7.1%) | ||
| Back pain | 37/504 (7.3%) | 20/241 (8.3%) | ||
| Pain in extremity | 25/504 (5%) | 17/241 (7.1%) | ||
| Osteoarthritis | 21/504 (4.2%) | 9/241 (3.7%) | ||
| Muscle spasms | 19/504 (3.8%) | 6/241 (2.5%) | ||
| Musculoskeletal pain | 17/504 (3.4%) | 19/241 (7.9%) | ||
| Arthritis | 11/504 (2.2%) | 2/241 (0.8%) | ||
| Myalgia | 9/504 (1.8%) | 6/241 (2.5%) | ||
| Rotator cuff syndrome | 4/504 (0.8%) | 6/241 (2.5%) | ||
| Spinal osteoarthritis | 3/504 (0.6%) | 5/241 (2.1%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Basal cell carcinoma | 3/504 (0.6%) | 5/241 (2.1%) | ||
| Nervous system disorders | ||||
| Headache | 46/504 (9.1%) | 20/241 (8.3%) | ||
| Dizziness | 30/504 (6%) | 8/241 (3.3%) | ||
| Diabetic neuropathy | 26/504 (5.2%) | 15/241 (6.2%) | ||
| Carpal tunnel syndrome | 4/504 (0.8%) | 6/241 (2.5%) | ||
| Psychiatric disorders | ||||
| Anxiety | 22/504 (4.4%) | 13/241 (5.4%) | ||
| Depression | 14/504 (2.8%) | 7/241 (2.9%) | ||
| Insomnia | 13/504 (2.6%) | 13/241 (5.4%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 39/504 (7.7%) | 29/241 (12%) | ||
| Oropharyngeal pain | 16/504 (3.2%) | 7/241 (2.9%) | ||
| Asthma | 12/504 (2.4%) | 5/241 (2.1%) | ||
| Nasal congestion | 11/504 (2.2%) | 1/241 (0.4%) | ||
| Sinus congestion | 9/504 (1.8%) | 7/241 (2.9%) | ||
| Dyspnoea | 7/504 (1.4%) | 10/241 (4.1%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Rash | 15/504 (3%) | 10/241 (4.1%) | ||
| Dermatitis contact | 9/504 (1.8%) | 5/241 (2.1%) | ||
| Hyperkeratosis | 5/504 (1%) | 5/241 (2.1%) | ||
| Vascular disorders | ||||
| Hypertension | 67/504 (13.3%) | 29/241 (12%) | ||
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 |
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00838916
Other Study ID Numbers:
- 112754
First Posted:
Feb 9, 2009
Last Update Posted:
Jan 9, 2017
Last Verified:
Nov 1, 2016