Trial · NCT00131664
Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin (AVALANCHE™ Study)
NCT00131664, Phase 3, Completed, Canadian Heart Research Centre; results first posted 2013-04-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin (AVALANCHE™ Study). Trials, record NCT00131664. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00131664
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin (AVALANCHE™ Study)
- NCT number
- NCT00131664
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 391 participants, actual
- Lead sponsor
- Canadian Heart Research Centre
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Avandamet, Avandia and Amaryl, Metformin
- First posted
- 2005-08-19
- Last updated
- 2013-04-17
- Results first posted
- 2013-04-17
- Limitations and caveats
The LOCF used in the ITT population for withdrawn subjects or missing values was analyzed as per protocol. The 3 treatment groups used throughout the results section were the numbers where the patients were originally randomized to.
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in A1C at Month 6 | Baseline and Month 6 | Change from baseline was calculated as the Month 6 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values. |
| Secondary | Mean Change From Baseline in A1C at Month 4 | Baseline and Month 4 | Change from baseline was calculated as the Month 4 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values. |
| Secondary | Mean Change From Baseline in A1C at Month 12 | Baseline and Month 12 | Change from baseline was calculated as the Month 12 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values. |
| Secondary | Number of Subjects Achieving A1C Target at Month 4 | Month 4 | A1C responders were described as subjects having achieved A1C less than 7 percent at Month 4, with LOCF from Month 2. |
| Secondary | Number of Subjects Achieving A1C Target at Month 6 | Month 6 | A1C responders were described as subjects having achieved A1C less than 7 percent at Month 6, with LOCF from Month 2. |
| Secondary | Number of Subjects Achieving A1C Target at Month 12 | Month 12 | A1C responders were described as subjects having achieved A1C less than 7 percent at Month 12 with LOCF from Month 2. |
| Secondary | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 4 | Baseline and Month 4 | Change from baseline was calculated as the Month 4 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values. |
| Secondary | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6 | Baseline and Month 6 | Change from baseline was calculated as the Month 6 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values. |
| Secondary | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12 | Baseline and Month 12 | Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 2 for withdrawn subjects or missing values. |
| Secondary | Number of Subjects Achieving FPG Target at Month 4 | Month 4 | FPG responders were described as subjects having achieved FPG less than 7 mmol/L at Month 4 with LOCF from Month 2. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in A1C at Month 6 | Baseline and Month 6 | Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with a value at baseline and at Month 6 were analyzed. | percent | MEAN |
| SECONDARY | Mean Change From Baseline in A1C at Month 4 | Baseline and Month 4 | Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 4 were analyzed. | percent | MEAN |
| SECONDARY | Mean Change From Baseline in A1C at Month 12 | Baseline and Month 12 | Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 12 were analyzed. | percent | MEAN |
| SECONDARY | Number of Subjects Achieving A1C Target at Month 4 | Month 4 | Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 4 were analyzed. | participants | NUMBER |
| SECONDARY | Number of Subjects Achieving A1C Target at Month 6 | Month 6 | Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline Month 6 were analyzed. | participants | NUMBER |
| SECONDARY | Number of Subjects Achieving A1C Target at Month 12 | Month 12 | Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 12 were analyzed. | participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 4 | Baseline and Month 4 | Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 4 were analyzed. | millimoles per litre (mmol/L) | MEAN |
| SECONDARY | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6 | Baseline and Month 6 | Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed. | millimoles per litre (mmol/L) | MEAN |
| SECONDARY | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12 | Baseline and Month 12 | Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed. | millimoles per litre (mmol/L) | MEAN |
| SECONDARY | Number of Subjects Achieving FPG Target at Month 4 | Month 4 | Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 4 were analyzed. | participants | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group57
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 A1C at Month 6 | Avandia and Amaryl | Baseline | 8.14 | Standard Error 0.095 | percent |
| Mean Change From Baseline in A1C at Month 6 | Avandamet | Baseline | 7.96 | Standard Error 0.076 | percent |
| Mean Change From Baseline in A1C at Month 6 | Metformin | Baseline | 7.90 | Standard Error 0.085 | percent |
| Mean Change From Baseline in A1C at Month 6 | Avandia and Amaryl | Change from baseline | -1.61 | Standard Error 0.108 | percent |
| Mean Change From Baseline in A1C at Month 6 | Avandamet | Change from baseline | -1.39 | Standard Error 0.081 | percent |
| Mean Change From Baseline in A1C at Month 6 | Metformin | Change from baseline | -1.02 | Standard Error 0.092 | percent |
| Mean Change From Baseline in A1C at Month 4 | Avandia and Amaryl | -1.44 | Standard Error 0.099 | percent | |
| Mean Change From Baseline in A1C at Month 4 | Avandamet | -1.28 | Standard Error 0.083 | percent | |
| Mean Change From Baseline in A1C at Month 4 | Metformin | -0.94 | Standard Error 0.097 | percent | |
| Mean Change From Baseline in A1C at Month 12 | Avandia and Amaryl | -1.50 | Standard Error 0.115 | percent |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Period (First 6 Months) | STARTED | Avandia and Amaryl | 136 | |
| First Period (First 6 Months) | STARTED | Avandamet | 135 | |
| First Period (First 6 Months) | STARTED | Metformin | 120 | |
| First Period (First 6 Months) | STARTED | Avandia, Amaryl and Metformin | 0 | |
| First Period (First 6 Months) | STARTED | Avandamet and Amaryl | 0 | |
| First Period (First 6 Months) | STARTED | Metformin and Amaryl | 0 | |
| First Period (First 6 Months) | COMPLETED | Avandia and Amaryl | 111 | |
| First Period (First 6 Months) | COMPLETED | Avandamet | 117 | |
| First Period (First 6 Months) | COMPLETED | Metformin | 104 | |
| First Period (First 6 Months) | COMPLETED | Avandia, Amaryl and Metformin | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events3
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 | Fracture | Musculoskeletal and connective tissue disorders | Avandia and Amaryl | 2 | 136 | 2 |
| other | Fracture | Musculoskeletal and connective tissue disorders | Avandamet | 3 | 117 | 3 |
| other | Fracture | Musculoskeletal and connective tissue disorders | Metformin | 0 | 104 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Avandia and Amaryl | ||
| Total, all-cause mortality | Avandamet | ||
| Total, all-cause mortality | Metformin | ||
| Total, other adverse events | Avandia and Amaryl | 2 | 136 |
| Total, other adverse events | Avandamet | 3 | 117 |
| Total, other adverse events | Metformin | 0 | 104 |
| Total, serious adverse events | Avandia and Amaryl | 0 | 136 |
| Total, serious adverse events | Avandamet | 0 | 135 |
| Total, serious adverse events | Metformin | 0 | 120 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00131664
GET https://conductscience.org/api/trials/v1/NCT00131664/results?page=2