Trial · NCT00839527
A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes
NCT00839527, Phase 3, Completed, GlaxoSmithKline; results first posted 2014-07-01
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes. Trials, record NCT00839527. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00839527
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes
- NCT number
- NCT00839527
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 685 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- placebo to match albiglutide, albiglutide, metformin, glimepiride, pioglitazone, placebo to match pioglitazone
- First posted
- 2009-02-09
- Last updated
- 2017-01-09
- Results first posted
- 2014-07-01
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 | Baseline and Week 52 | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. Nine par. with post-BL values obtained \>14 days after the last dose or after hyperglycemic rescue were included in the analysis population but were not analyzed for this endpoint. |
| Secondary | Change From Baseline in HbA1c at Week 104 and Week 156 | Baseline, Week 104, and Week 156 | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. |
| Secondary | 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. |
| Secondary | Change From Baseline in FPG at Week 104 and Week 156 | Baseline, Week 104, and Week 156 | The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. |
| Secondary | 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. |
| Secondary | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52 | Week 52 | The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of \<6.5%, \<7%, and \<7.5% at Week 52) was assessed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52. |
| Secondary | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 | Week 156 | The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of \<6.5%, \<7%, and \<7.5% at Week 156) was assessed. |
| Secondary | Change From Baseline in Body Weight at Week 52 | Baseline and Week 52 | The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region. |
| Secondary | Change From Baseline in Body Weight at Week 104 and Week 156 | Baseline, Week 104, and Week 156 | The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 | Baseline and Week 52 | 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. | Percentage of HbA1c in the blood | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in HbA1c at Week 104 and Week 156 | Baseline, Week 104, and Week 156 | ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles). | Percentage of HbA1c in the blood | MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 | Baseline and Week 52 | 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. | Millimoles per liter (mmol/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in FPG at Week 104 and Week 156 | Baseline, Week 104, and Week 156 | ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles). | Millimoles per liter (mmol/L) | MEAN |
| SECONDARY | Time to Hyperglycemia Rescue | From the start of study medication until the end of the treatment (up to Week 156) | ITT Population | Weeks | MEDIAN |
| SECONDARY | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52 | Week 52 | ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. | Participants | NUMBER |
| SECONDARY | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 | Week 156 | ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Body Weight at Week 52 | Baseline and Week 52 | 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. | Kilograms | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Body Weight at Week 104 and Week 156 | Baseline, Week 104, and Week 156 | ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles). | Kilograms | MEAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 | Placebo + Metformin + Glimepiride | 0.33 | Standard Error 0.083 | Percentage of HbA1c in the blood | |
| Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 | Pioglitazone + Metformin + Glimepiride | -0.80 | Standard Error 0.055 | Percentage of HbA1c in the blood | |
| Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 | Albiglutide + Metformin + Glimepiride | -0.55 | Standard Error 0.055 | Percentage of HbA1c in the blood | |
| Change From Baseline in HbA1c at Week 104 and Week 156 | Placebo + Metformin + Glimepiride | Week 104, n=12, 130, 104 | -0.32 | Standard Deviation 0.552 | Percentage of HbA1c in the blood |
| Change From Baseline in HbA1c at Week 104 and Week 156 | Pioglitazone + Metformin + Glimepiride | Week 104, n=12, 130, 104 | -1.09 | Standard Deviation 1.119 | Percentage of HbA1c in the blood |
| Change From Baseline in HbA1c at Week 104 and Week 156 | Albiglutide + Metformin + Glimepiride | Week 104, n=12, 130, 104 | -0.76 | Standard Deviation 1.009 | Percentage of HbA1c in the blood |
| Change From Baseline in HbA1c at Week 104 and Week 156 | Placebo + Metformin + Glimepiride | Week 156, n=9, 89, 71 | -0.10 | Standard Deviation 0.923 | Percentage of HbA1c in the blood |
| Change From Baseline in HbA1c at Week 104 and Week 156 | Pioglitazone + Metformin + Glimepiride | Week 156, n=9, 89, 71 | -0.97 | Standard Deviation 1.063 | Percentage of HbA1c in the blood |
| Change From Baseline in HbA1c at Week 104 and Week 156 | Albiglutide + Metformin + Glimepiride | Week 156, n=9, 89, 71 | -0.46 | Standard Deviation 1.113 | Percentage of HbA1c in the blood |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 | Placebo + Metformin + Glimepiride | 0.64 | Standard Error 0.243 | Millimoles per liter (mmol/L) |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period (TP) (156 Weeks) | STARTED | Placebo + Metformin + Glimepiride | 115 | |
| Treatment Period (TP) (156 Weeks) | STARTED | Pioglitazone + Metformin + Glimepiride | 277 | |
| Treatment Period (TP) (156 Weeks) | STARTED | Albiglutide + Metformin + Glimepiride | 271 | |
| Treatment Period (TP) (156 Weeks) | COMPLETED | Placebo + Metformin + Glimepiride | 55 | |
| Treatment Period (TP) (156 Weeks) | COMPLETED | Pioglitazone + Metformin + Glimepiride | 159 | |
| Treatment Period (TP) (156 Weeks) | COMPLETED | Albiglutide + Metformin + Glimepiride | 152 | |
| Treatment Period (TP) (156 Weeks) | NOT COMPLETED | Placebo + Metformin + Glimepiride | 60 | |
| Treatment Period (TP) (156 Weeks) | NOT COMPLETED | Pioglitazone + Metformin + Glimepiride | 118 | |
| Treatment Period (TP) (156 Weeks) | NOT COMPLETED | Albiglutide + Metformin + Glimepiride | 119 | |
| Follow-up Period (FUP) (8 Weeks) | STARTED | Placebo + Metformin + Glimepiride | 114 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events507
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Placebo + Metformin + Glimepiride | 16 | 115 | |
| other | Nasopharyngitis | Infections and infestations | Pioglitazone + Metformin + Glimepiride | 28 | 277 | |
| other | Nasopharyngitis | Infections and infestations | Albiglutide + Metformin + Glimepiride | 43 | 271 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo + Metformin + Glimepiride | 21 | 115 | |
| other | Upper respiratory tract infection | Infections and infestations | Pioglitazone + Metformin + Glimepiride | 50 | 277 | |
| other | Upper respiratory tract infection | Infections and infestations | Albiglutide + Metformin + Glimepiride | 34 | 271 | |
| other | Urinary tract infection | Infections and infestations | Placebo + Metformin + Glimepiride | 9 | 115 | |
| other | Urinary tract infection | Infections and infestations | Pioglitazone + Metformin + Glimepiride | 31 | 277 | |
| other | Urinary tract infection | Infections and infestations | Albiglutide + Metformin + Glimepiride | 24 | 271 | |
| other | Sinusitis | Infections and infestations | Placebo + Metformin + Glimepiride | 7 | 115 |
1 to 10 of 507Source ClinicalTrials.gov
See all 507 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo + Metformin + Glimepiride | ||
| Total, all-cause mortality | Pioglitazone + Metformin + Glimepiride | ||
| Total, all-cause mortality | Albiglutide + Metformin + Glimepiride | ||
| Total, other adverse events | Placebo + Metformin + Glimepiride | 81 | 115 |
| Total, other adverse events | Pioglitazone + Metformin + Glimepiride | 228 | 277 |
| Total, other adverse events | Albiglutide + Metformin + Glimepiride | 228 | 271 |
| Total, serious adverse events | Placebo + Metformin + Glimepiride | 21 | 115 |
| Total, serious adverse events | Pioglitazone + Metformin + Glimepiride | 48 | 277 |
| Total, serious adverse events | Albiglutide + Metformin + Glimepiride | 39 | 271 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00839527
GET https://conductscience.org/api/trials/v1/NCT00839527/results?page=2