Trial · NCT00386100
A Type 2 Diabetes Study of the Longer-Term Glycemic Effect of AVANDAMET vs. Metformin
NCT00386100, Phase 4, Completed, GlaxoSmithKline; results first posted 2011-04-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Type 2 Diabetes Study of the Longer-Term Glycemic Effect of AVANDAMET vs. Metformin. Trials, record NCT00386100. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00386100
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Type 2 Diabetes Study of the Longer-Term Glycemic Effect of AVANDAMET vs. Metformin
- NCT number
- NCT00386100
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 688 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
Avandamet 6 mg/1500 mg (ttd), Avandamet 4 mg/1000 mg (ttd), Avandamet 2 mg/500 mg (ttd), Avandamet 8 mg/ 2000 mg (ttd), Metformin 500 mg (ttd), Metformin 1000 mg (ttd), Metformin 1500 mg (ttd), Metformin 2000 mg (ttd)
- First posted
- 2006-10-11
- Last updated
- 2016-11-23
- Results first posted
- 2011-04-05
- Limitations and caveats
Ten participants who started the study and were randomized did not receive any study medication (6 participants in the metformin arm and 4 participants in the avandamet arm). These participants are not included in any of the analysis populations.
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in HbA1c at Week 80 | Baseline and Week 80 | Blood was taken for serum HbA1c measurements. Change from baseline was calculated as the Week 80 value minus the baseline value. Last observation carried forward (LOCF) was not used for this analysis. |
| Secondary | Mean Change From Baseline in HbA1c at Week 80 | Baseline and Week 80 | Blood was taken for serum Hb1AC measurements. Change from baseline was calculated as the Week 80 value minus the baseline value, with LOCF from Week 32 for withdrawn participants or missing values. |
| Secondary | Number of Participants Achieving HbA1c <=6.5% and <7% at Week 80 | Week 80 | Blood was taken for serum Hb1AC measurements. Hb1AC responders were described as participants having achieved Hb1AC \<=6% and \<7% at Week 80 with LOCF from Week 32. |
| Secondary | Change in Fasting Plasma Glucose (FPG) From Baseline at Week 80 | Baseline and Week 80 | Blood was taken for serum FPG measurements. Change from baseline was calculated as the Week 80 value minus the baseline value. |
| Secondary | Change From Baseline in FPG at Week 80 | Baseline and Week 80 | Blood was taken for serum FPG measurements. Change from baseline was calculated as the Week 80 value minus the baseline value with LOCF from Week 32 for withdrawn participants or missing values. |
| Secondary | Number of Participants Achieving FPG <=6 mmol/L (110 mg/dL) and <=7 mmol/L (126 mg/dL) at Week 80 | Week 80 | Blood was taken for serum FPG measurements. FPG responders were described as participants having achieved FPG \<=6 mmol/L (110 mg/dL) and \<7 mmol/L (126 mg/dL) Hb1AC at Week 80 with LOCF from Week 32. |
| Secondary | Number of Participants Achieving Treatment Failure | Randomization to treatment failure (up to Week 80) | Treatment failure was defined as an HbA1c level \>= 7% after Week 32 or withdrawal due to insufficient therapeutic effect (ITE) at any time. |
| Secondary | Percent Change From Baseline in Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Triglycerides at Week 80 | Baseline and Week 80 | Blood was taken for measurement of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. Percent change from baseline at Week 80 was based on log transformed data. Geometric mean, GM; standard error, SE. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest. |
| Secondary | Percent Change From Baseline in Adiponectin at Week 80 (United States [US] and Mexico Subset of Participants ) | Baseline and Week 80 | Blood was taken for measurement of adiponectin. Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only. |
| Secondary | Percent Change From Baseline in C-reactive Protein (CRP) at Week 80 (US and Mexico Subset of Participants) | Baseline and Week 80 | Blood was taken for measurement of CRP. Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Mean Change From Baseline in HbA1c at Week 80 | Baseline and Week 80 | Week 32 Evaluable Population with LOCF: a subset of the ITT Population with LOCF starting at Week 32. Only participants with assessment(s) at Week 32 or later were included in this population. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed. | percent change | MEAN |
| PRIMARY | Change From Baseline in HbA1c at Week 80 | Baseline and Week 80 | Intent-to-Treat (ITT) Population: all participants who were randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value. Only evaluable participants, defined as the number of participants with a baseline and at least one post baseline assessment, were analyzed. | percent change | MEAN |
| SECONDARY | Number of Participants Achieving HbA1c <=6.5% and <7% at Week 80 | Week 80 | Week 32 Evaluable Population with LOCF. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed. | participants | NUMBER |
| SECONDARY | Change in Fasting Plasma Glucose (FPG) From Baseline at Week 80 | Baseline and Week 80 | ITT Population. Only evaluable participants, defined as the number of participants with a baseline and at least one post baseline assessment, were analyzed. Last observation carried forward (LOCF) was not used for this analysis. | millimoles per Liter (mmol/l) | MEAN |
| SECONDARY | Change From Baseline in FPG at Week 80 | Baseline and Week 80 | Week 32 Evaluable Population with LOCF. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed. | mmol/l | MEAN |
| SECONDARY | Number of Participants Achieving FPG <=6 mmol/L (110 mg/dL) and <=7 mmol/L (126 mg/dL) at Week 80 | Week 80 | Week 32 Evaluable Population with LOCF. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed. | participants | NUMBER |
| SECONDARY | Number of Participants Achieving Treatment Failure | Randomization to treatment failure (up to Week 80) | ITT Population. Only evaluable participants, defined as the number of subjects with a baseline and at least one post baseline assessment, were analyzed. Last observation carried forward (LOCF) was not used for this analysis | participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Triglycerides at Week 80 | Baseline and Week 80 | Week 32 evaluable population with LOCF from Week 32. n is the number of evaluable participants, which is defined as the number of participants with a value at baseline and at the specified visit for the parameter of interest. | percent change | NUMBER |
| SECONDARY | Percent Change From Baseline in Adiponectin at Week 80 (United States [US] and Mexico Subset of Participants ) | Baseline and Week 80 | Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as the number of participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed. | percent change | NUMBER |
| SECONDARY | Percent Change From Baseline in C-reactive Protein (CRP) at Week 80 (US and Mexico Subset of Participants) | Baseline and Week 80 | Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as the number of participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed. | percent change | NUMBER |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group778
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in HbA1c at Week 80 | Metformin | Baseline | 8.59 | Standard Deviation 0.898 | percent change |
| Mean Change From Baseline in HbA1c at Week 80 | Avandamet | Baseline | 8.66 | Standard Deviation 0.954 | percent change |
| Mean Change From Baseline in HbA1c at Week 80 | Metformin | Change from Baseline | -1.42 | Standard Deviation 0.070 | percent change |
| Mean Change From Baseline in HbA1c at Week 80 | Avandamet | Change from Baseline | -1.91 | Standard Deviation 0.069 | percent change |
| Change From Baseline in HbA1c at Week 80 | Metformin | Baseline | 8.64 | Standard Error 0.053 | percent change |
| Change From Baseline in HbA1c at Week 80 | Avandamet | Baseline | 8.64 | Standard Error 0.055 | percent change |
| Change From Baseline in HbA1c at Week 80 | Metformin | Change from Baseline | -1.36 | Standard Error 0.073 | percent change |
| Change From Baseline in HbA1c at Week 80 | Avandamet | Change from Baseline | -1.85 | Standard Error 0.070 | percent change |
| Number of Participants Achieving HbA1c <=6.5% and <7% at Week 80 | Metformin | <=6.5% | 97 | participants | |
| Number of Participants Achieving HbA1c <=6.5% and <7% at Week 80 | Avandamet | <=6.5% | 128 | participants |
1 to 10 of 778Source ClinicalTrials.gov
See all 778 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Metformin | 340 | |
| Overall Study | STARTED | Avandamet | 348 | |
| Overall Study | COMPLETED | Metformin | 186 | |
| Overall Study | COMPLETED | Avandamet | 217 | |
| Overall Study | NOT COMPLETED | Metformin | 154 | |
| Overall Study | NOT COMPLETED | Avandamet | 131 |
Source ClinicalTrials.gov
Adverse events126
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 | Diarrhoea | Gastrointestinal disorders | Metformin | 63 | 334 | |
| other | Diarrhoea | Gastrointestinal disorders | Avandamet | 41 | 344 | |
| other | Nausea | Gastrointestinal disorders | Metformin | 30 | 334 | |
| other | Nausea | Gastrointestinal disorders | Avandamet | 31 | 344 | |
| other | Upper respiratort tract infection | Infections and infestations | Metformin | 30 | 334 | |
| other | Upper respiratort tract infection | Infections and infestations | Avandamet | 22 | 344 | |
| other | Headache | Nervous system disorders | Metformin | 26 | 334 | |
| other | Headache | Nervous system disorders | Avandamet | 19 | 344 | |
| other | Nasopharyngitis | Infections and infestations | Metformin | 26 | 334 | |
| other | Nasopharyngitis | Infections and infestations | Avandamet | 18 | 344 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metformin | ||
| Total, all-cause mortality | Avandamet | ||
| Total, other adverse events | Metformin | 159 | 334 |
| Total, other adverse events | Avandamet | 145 | 344 |
| Total, serious adverse events | Metformin | 27 | 334 |
| Total, serious adverse events | Avandamet | 28 | 344 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21682834 | BACKGROUND |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Metformin vs Avandamet: Number of Participants Achieving Treatment Failure | Trial comparisons |
| Metformin vs Avandamet: serious adverse events | Trial comparisons |
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/NCT00386100
GET https://conductscience.org/api/trials/v1/NCT00386100/registered?page=2