Trial · NCT00838903
Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes
NCT00838903, Phase 3, Completed, GlaxoSmithKline; results first posted 2014-05-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes. Trials, record NCT00838903. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00838903
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes
- NCT number
- NCT00838903
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,049 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- albiglutide, sitagliptin, glimepiride, metformin, placebo albiglutide, placebo sitagliptin, placebo glimepiride
- First posted
- 2009-02-09
- Last updated
- 2017-01-09
- Results first posted
- 2014-05-16
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 104 | Baseline and Week 104 | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 104 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. Difference of least squares means (albiglutide - placebo, albiglutide - sitagliptin, albiglutide - glimepiride) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. |
| Secondary | 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 . |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104 | Baseline and Week 104 | The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region. |
| Secondary | Change From Baseline in FPG at Week 156 | Baseline and Week 156 | The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. |
| Secondary | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104 | Week 104 | The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of \<6.5%, \<7%, and \<7.5% at Week 52) were assessed. |
| 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 achieved the HbA1c treatment goal (i.e., HbA1c response levels of \<6.5%, \<7%, and \<7.5% at Week 156) were assessed. |
| 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 hyperglycemic rescue were as follows: FPG \>=280 milligrams/deciliter (mg/dL) between \>=Week 2 and \<Week 4; FPG \>=250 mg/dL between \>=Week 4 and \<Week 12; HbA1c \>=8.5% and a \<=0.5% reduction from Baseline between \>=Week 12 and \<Week 24; HbA1c \>=8.5% between \>=Week 24 and \<Week 48; HbA1c \>=8.0% between \>= Week 48 and \<Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in week |
| Secondary | Change From Baseline in Body Weight at Week 104 | Baseline and Week 104 | The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region. |
| Secondary | Change From Baseline in Body Weight at Week 156 | Baseline and Week 156 | The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. |
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 104 | Baseline and Week 104 | Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received \>=1 dose of study medication and who had a BL assessment and \>=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 104. | Percentage of HbA1c in the blood | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in HbA1c at Week 156 | Baseline and Week 156 | Intent-to-Treat (ITT) Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed. | Percentage of HbA1c in the blood | MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104 | Baseline and Week 104 | Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 104. | Millimoles per liter (mmol/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in FPG at Week 156 | Baseline and Week 156 | ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. | Millimoles per liter (mmol/L) | MEAN |
| SECONDARY | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104 | Week 104 | ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 104. | 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. | Participants | NUMBER |
| SECONDARY | Time to Hyperglycemia Rescue | From the start of study medication until the end of the treatment (up to Week 156) | ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed. | Weeks | MEDIAN |
| SECONDARY | Change From Baseline in Body Weight at Week 104 | Baseline and Week 104 | ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 104. | Kilograms | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Body Weight at Week 156 | Baseline and Week 156 | ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed. | Kilograms | MEAN |
Source ClinicalTrials.gov
Results by group52
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 104 | Placebo Plus Metformin | 0.27 | Standard Error 0.113 | Percentage of HbA1c in the blood | |
| Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104 | Sitagliptin 100 mg Plus Metformin | -0.28 | Standard Error 0.065 | Percentage of HbA1c in the blood | |
| Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104 | Glimepiride 2 mg Plus Metformin | -0.36 | Standard Error 0.064 | Percentage of HbA1c in the blood | |
| Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104 | Albiglutide 30 mg Plus Metformin | -0.63 | Standard Error 0.065 | Percentage of HbA1c in the blood | |
| Change From Baseline in HbA1c at Week 156 | Placebo Plus Metformin | -0.46 | Standard Deviation 0.820 | Percentage of HbA1c in the blood | |
| Change From Baseline in HbA1c at Week 156 | Sitagliptin 100 mg Plus Metformin | -0.56 | Standard Deviation 1.160 | Percentage of HbA1c in the blood | |
| Change From Baseline in HbA1c at Week 156 | Glimepiride 2 mg Plus Metformin | -0.59 | Standard Deviation 0.999 | Percentage of HbA1c in the blood | |
| Change From Baseline in HbA1c at Week 156 | Albiglutide 30 mg Plus Metformin | -0.88 | Standard Deviation 0.959 | Percentage of HbA1c in the blood | |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104 | Placebo Plus Metformin | 0.55 | Standard Error 0.277 | Millimoles per liter (mmol/L) | |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104 | Sitagliptin 100 mg Plus Metformin | -0.12 | Standard Error 0.160 | Millimoles per liter (mmol/L) |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period (156 Weeks) | STARTED | Placebo Plus Metformin | 101 | |
| Treatment Period (156 Weeks) | STARTED | Sitagliptin 100 mg Plus Metformin | 302 | |
| Treatment Period (156 Weeks) | STARTED | Glimepiride 2 mg Plus Metformin | 307 | |
| Treatment Period (156 Weeks) | STARTED | Albiglutide 30 mg Plus Metformin | 302 | |
| Treatment Period (156 Weeks) | Missing Active Treatment Status | Placebo Plus Metformin | 1 | |
| Treatment Period (156 Weeks) | Missing Active Treatment Status | Sitagliptin 100 mg Plus Metformin | 0 | |
| Treatment Period (156 Weeks) | Missing Active Treatment Status | Glimepiride 2 mg Plus Metformin | 0 | |
| Treatment Period (156 Weeks) | Missing Active Treatment Status | Albiglutide 30 mg Plus Metformin | 0 | |
| Treatment Period (156 Weeks) | COMPLETED | Placebo Plus Metformin | 55 | |
| Treatment Period (156 Weeks) | COMPLETED | Sitagliptin 100 mg Plus Metformin | 190 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events796
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 | Upper respiratory tract infection | Infections and infestations | Placebo Plus Metformin | 10 | 101 | |
| other | Upper respiratory tract infection | Infections and infestations | Sitagliptin 100 mg Plus Metformin | 33 | 302 | |
| other | Upper respiratory tract infection | Infections and infestations | Glimepiride 2 mg Plus Metformin | 32 | 307 | |
| other | Upper respiratory tract infection | Infections and infestations | Albiglutide 30 mg Plus Metformin | 58 | 302 | |
| other | Urinary tract infection | Infections and infestations | Placebo Plus Metformin | 11 | 101 | |
| other | Urinary tract infection | Infections and infestations | Sitagliptin 100 mg Plus Metformin | 37 | 302 | |
| other | Urinary tract infection | Infections and infestations | Glimepiride 2 mg Plus Metformin | 35 | 307 | |
| other | Urinary tract infection | Infections and infestations | Albiglutide 30 mg Plus Metformin | 27 | 302 | |
| other | Nasopharyngitis | Infections and infestations | Placebo Plus Metformin | 9 | 101 | |
| other | Nasopharyngitis | Infections and infestations | Sitagliptin 100 mg Plus Metformin | 31 | 302 |
1 to 10 of 796Source ClinicalTrials.gov
See all 796 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Plus Metformin | ||
| Total, all-cause mortality | Sitagliptin 100 mg Plus Metformin | ||
| Total, all-cause mortality | Glimepiride 2 mg Plus Metformin | ||
| Total, all-cause mortality | Albiglutide 30 mg Plus Metformin | ||
| Total, other adverse events | Placebo Plus Metformin | 75 | 101 |
| Total, other adverse events | Sitagliptin 100 mg Plus Metformin | 229 | 302 |
| Total, other adverse events | Glimepiride 2 mg Plus Metformin | 258 | 307 |
| Total, other adverse events | Albiglutide 30 mg Plus Metformin | 242 | 302 |
| Total, serious adverse events | Placebo Plus Metformin | 15 | 101 |
| Total, serious adverse events | Sitagliptin 100 mg Plus Metformin | 32 | 302 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28683300 | DERIVED |
Source PubMed
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.
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