Type 2 Diabetes MellitusPhase 3AVALANCHENCT00131664
Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin (AVALANCHE™ Study)
A Phase 3 study testing Avandamet, Avandia and Amaryl and Metformin in people with Type 2 Diabetes Mellitus, run by Canadian Heart Research Centre at 1 site in Canada.
Trial summary
The incidence of type 2 diabetes is on the increase. According to recent Canadian Diabetes Association guidelines glucose control, based on the A1C measurement, needs to be achieved within a 6-12 month period of time after the initial diagnosis of type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Avandamet, Avandia and Amaryl and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 391 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2005to Jan 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes patients
- 18 - 75 years old
- Type 2 diabetes mellitus (DM) drug naïve or on submaximal oral monotherapy < 3 years
- A1C criteria at screening:
- 7.1-10% for drug naïve patients after failure of diet control and life-style modification
- 7.1 - 9% on single therapy (e.g. not more 10 mg of Glyburide or 4 mg of Amaryl™ or 1000mg of Metformin) who will start after 2 weeks wash-out. During wash out the following will be done: i) diet and life style modification ii) Angiotensin converting enzyme inhibitor (ACE), aspirin (80 mg), and statin if appropriate
- Signed informed consent
Who cannot join
- Type 1 diabetes
- Subjects currently treated with insulin
- Subject treated for previous 3 month with any thiazolidinedione (TZD)
- Evidence of clinically significant concomitant illnesses which are not controlled by medication and/or may limit participation in the study as judged by the investigator
- Subjects who have hypersensitivity to any components of study drugs
- Participation in a clinical trial and/or intake of an investigational drug within 30 days prior to screening.
Show all 12Show fewer
- Pregnant or nursing females
- Females of childbearing potential who are not on adequate birth control
- Liver enzymes (Alanine Aminotransferase (ALT) > 2.5 times upper limit of normal)
- Renal impairment: serum creatinine ≥ 136umol/L (males) and ≥ 124 umol/L (females)
- Congestive Heart Failure (CHF class III/IV)
- Weight >160 kg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin: A 48-week Randomized, Open-label, Multicentre Phase IIIB Study to Compare the Effectiveness of Combination Therapy to Monotherapy in Type 2 Diabetes Mellitus Patients
The incidence of type 2 diabetes is on the increase. According to recent Canadian Diabetes Association guidelines glucose control, based on the A1C measurement, needs to be achieved within a 6-12 month period of time after the initial diagnosis of type 2 diabetes. The guidelines on the use of antihyperglycemic agents identify the potential benefits of sub-maximal oral combination therapy in order to achieve more rapid and improved glycemic control compared with higher dose monotherapy. Furthermore, many patients on prolonged oral antihyperglycemic monotherapy who then start on combination therapy may not achieve the required target glycemic control. Indeed early initiation of combination therapies may be necessary to achieve and maintain glycemic targets because of the progressive deterioration of pancreatic β cell function and glycemic control.
Read the detailed description
AvandametTM combines two oral antihyperglycemic agents, rosiglitazone maleate and metformin hydrochloride, with different but complementary mechanisms of action to improve glycemic control while reducing circulating insulin levels in patients with type 2 diabetes. AvandiaTM and AmarylTM combine two antidiabetic agents, rosiglitazone maleate and glimepiride. Glimepiride is an effective antihyperglycemic agent which has a low incidence of hypoglycemia, symptomatic hypoglycemia, severe hypoglycemia, and confirmed hypoglycemia. Subjects in this study who are inadequately controlled on diet, exercise and a submaximal dose of metformin or sulfonylurea (SU) will be randomized to either a combination of metformin plus rosiglitazone (AvandametTM) or a combination of AvandiaTM + AmarylTM or a Metformin monotherapy arm. As per the Canadian Diabetes Association (CDA) guidelines, their fasting plasma glucose and A1C to be 7 (mmol/L / percent) or less throughout the study. If the subject does not achieve the target then either AvandametTM or AvandiaTM and AmarylTM or Metformin will be up-titrated in an effort to reach this CDA recommended target. This study will attempt to demonstrate that the either combination arm of rosiglitazone plus metformin (AvandametTM) or the other combination arm of AvandiaTM + AmarylTM will provide greater glycemic control while avoiding the side-effects associated with the use of maximal dose metformin.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Avandamet, Avandia and Amaryl, Metformin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvandametDrug
Also called rosiglitazone maleate and metformin hydrochloride, Avandamet 2 mg / 500 mg, Avandamet 4 mg / 500 mg, Avandamet 4 mg / 1000 mg
Avandamet 2 / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily compared to Avandia 4 mg and Amaryl 1 mg once daily over 6 months or compared to Metformin 500 mg twice daily up to 1000 mg over 6 months.
Avandia and AmarylDrug
Also called rosiglitazone maleate and glimepiride, Avandia (rosiglitazone maleate) 4 mg, Avandia (rosiglitazone maleate) 8 mg, Amaryl (glimepiride) 1 mg
Avandia 4 mg and Amaryl 1 mg once daily compared to Avandamet 2 / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily, or compared to Metformin 500 mg twice daily up to 1000 mg over 6 months.
MetforminDrug
Also called Metformin 500 mg, Metformin 850 mg
Metformin 500 mg twice daily up to 1000 mg over 6 months compared to Avandia 4 mg and Amaryl 1 mg once daily or compared to Avandamet 2 / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Avandamet | Active comparator | Avandamet 2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months Receives: Drug: Avandamet |
| Avandia and Amaryl | Active comparator | Avandia + Amaryl 4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months Receives: Drug: Avandia and Amaryl |
| Metformin | Active comparator | Metformin 500 mg twice daily titration up to 1000 mg twice daily over 6 months Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in A1C at 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.
Measured: Baseline and Month 6
Secondary outcomes (17)
Mean Change From Baseline in A1C at 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.
Measured: Baseline and Month 4
Mean Change From Baseline in A1C at 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.
Measured: Baseline and Month 12
Number of Subjects Achieving A1C Target at Month 4
A1C responders were described as subjects having achieved A1C less than 7 percent at Month 4, with LOCF from Month 2.
Measured: Month 4
Number of Subjects Achieving A1C Target at Month 6
A1C responders were described as subjects having achieved A1C less than 7 percent at Month 6, with LOCF from Month 2.
Measured: Month 6
Number of Subjects Achieving A1C Target at Month 12
A1C responders were described as subjects having achieved A1C less than 7 percent at Month 12 with LOCF from Month 2.
Measured: Month 12
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at 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.
Measured: Baseline and Month 4
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at 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.
Measured: Baseline and Month 6
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at 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.
Measured: Baseline and Month 12
Number of Subjects Achieving FPG Target at Month 4
FPG responders were described as subjects having achieved FPG less than 7 mmol/L at Month 4 with LOCF from Month 2.
Measured: Month 4
Number of Subjects Achieving FPG Target at Month 6
FPG responders were described as subjects having achieved FPG less than 7 mmol/L at Month 6 with LOCF from Month 2.
Measured: Month 6
Number of Subjects Achieving FPG Target at Month 12
FPG responders were described as subjects having achieved FPG less than 7 mmol/L at Month 12 with LOCF from Month 2.
Measured: Month 12
Mean Change From Baseline in 5 Year UKPDS Risk Scores at Month 6
Change from baseline was calculated as the Month 6 value minus the baseline value, with LOCF from Month 2. The UKPDS (United Kingdom Prospective Diabetes Study) risk engine calculated was based on 5 years risk using gender, race, age at diagnosis of diabetes, duration of diabetes, smoking status, A1C, systolic blood pressure and total cholesterol to high-density lipoprotein (HDL) ratio at a specified visit.
The UKPDS cardiovascular disease (CVD) risk engine is used to estimate the risk of having coronary heart disease in type II diabetes according to the UKPDS model. The possible risk scores can range from 0 to 100% and hence lower scores would predict a person is less likely to have an event.
Measured: Baseline and Month 6
Mean Change From Baseline in 5 Year UKPDS Risk Scores at Month 12
Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 2. The UKPDS (U.K. Prospective Diabetes Study) risk engine calculated was based on 5 years risk using gender, race, age at diagnosis of diabetes, duration of diabetes, smoking status, A1C, systolic blood pressure and total cholesterol to HDL ratio at a specified visit.
The UKPDS cardiovascular disease (CVD) risk engine is used to estimate the risk of having coronary heart disease in type II diabetes according to the UKPDS model. The possible risk scores can range from 0 to 100% and hence lower scores would predict a person is less likely to have an event.
Measured: Baseline and Month 12
Mean Change From Baseline in C-reactive Protein (CRP) at Month 6
Change from baseline was calculated as the Month 6 value minus the baseline value. LOCF was not used for this analysis. CRP was only done at baseline, months 6 and 8. The test was optional and performed only by participating sites.
Measured: Baseline and Month 6
Mean Change From Baseline in C-reactive Protein (CRP) at Month 12
Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 6. CRP was only done at baseline, months 6 and 12. The test was optional and performed only by participating sites.
Measured: Baseline and Month 12
Mean Change From Baseline in Adiponectin at Month 6
Change from baseline was calculated as the Month 6 value minus the baseline value. LOCF was not used for this analysis. Adiponectin was only done at baseline, months 6 and 12. The test was optional and performed only by participating sites.
Measured: Baseline and Month 6
Mean Change From Baseline in Adiponectin at Month 12
Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 6. Adiponectin was only done at baseline, months 6 and 12. The test was optional and performed only by participating sites.
Measured: Baseline and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2005 (estimated)
- Study startSep 2005
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Heart Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Dr. Anatoly Langer, Canadian Heart Research Centre
- Investigators
- robert josse, md, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131664
- Sponsor's protocol ID
- AVM103436
- Acronym
- AVALANCHE
- Status last verified
- Apr 2013
- First submitted
- 17 Aug 2005
- Last updated
- 17 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin: A 48-week Randomized, Open-label, Multicentre Phase IIIB Study to Compare the Effectiveness of Combination Therapy to Monotherapy in Type 2 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT00131664
- Acronym / sponsor ID
- AVALANCHE / AVM103436
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- Canadian Heart Research CentreUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Sep 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 19 Aug 2005 (estimated)
- Results
- Posted 17 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The incidence of type 2 diabetes is on the increase. According to recent Canadian Diabetes Association guidelines glucose control, based on the A1C measurement, needs to be achieved within a 6-12 month period of time after the initial diagnosis of type 2 diabetes. The guidelines on the use of antihyperglycemic agents identify the potential benefits of sub-maximal oral combination therapy in order to achieve more rapid and improved glycemic control compared with higher dose monotherapy. Furthermore, many patients on prolonged oral antihyperglycemic monotherapy who then start on combination therapy may not achieve the required target glycemic control. Indeed early initiation of combination therapies may be necessary to achieve and maintain glycemic targets because of the progressive deterioration of pancreatic β cell function and glycemic control.
Detailed description
AvandametTM combines two oral antihyperglycemic agents, rosiglitazone maleate and metformin hydrochloride, with different but complementary mechanisms of action to improve glycemic control while reducing circulating insulin levels in patients with type 2 diabetes. AvandiaTM and AmarylTM combine two antidiabetic agents, rosiglitazone maleate and glimepiride. Glimepiride is an effective antihyperglycemic agent which has a low incidence of hypoglycemia, symptomatic hypoglycemia, severe hypoglycemia, and confirmed hypoglycemia. Subjects in this study who are inadequately controlled on diet, exercise and a submaximal dose of metformin or sulfonylurea (SU) will be randomized to either a combination of metformin plus rosiglitazone (AvandametTM) or a combination of AvandiaTM + AmarylTM or a Metformin monotherapy arm. As per the Canadian Diabetes Association (CDA) guidelines, their fasting plasma glucose and A1C to be 7 (mmol/L / percent) or less throughout the study. If the subject does not achieve the target then either AvandametTM or AvandiaTM and AmarylTM or Metformin will be up-titrated in an effort to reach this CDA recommended target. This study will attempt to demonstrate that the either combination arm of rosiglitazone plus metformin (AvandametTM) or the other combination arm of AvandiaTM + AmarylTM will provide greater glycemic control while avoiding the side-effects associated with the use of maximal dose metformin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Avandamet | Active comparator | Drug: AvandametAvandamet 2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months |
| Avandia and Amaryl | Active comparator | Drug: Avandia and AmarylAvandia + Amaryl 4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months |
| Metformin | Active comparator | Drug: MetforminMetformin 500 mg twice daily titration up to 1000 mg twice daily over 6 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Type 2 diabetes patients
- 18 - 75 years old
- Type 2 diabetes mellitus (DM) drug naïve or on submaximal oral monotherapy < 3 years
- A1C criteria at screening:
- Signed informed consent
Key exclusion criteria (12 listed)
- Type 1 diabetes
- Subjects currently treated with insulin
- Subject treated for previous 3 month with any thiazolidinedione (TZD)
- Evidence of clinically significant concomitant illnesses which are not controlled by medication and/or may limit participation in the study as judged by the investigator
- Subjects who have hypersensitivity to any components of study drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvandametAlso: rosiglitazone maleate and metformin hydrochloride, Avandamet 2 mg / 500 mg, Avandamet 4 mg / 500 mg, Avandamet 4 mg / 1000 mgAvandamet 2 / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily compared to Avandia 4 mg and Amaryl 1 mg once daily over 6 months or compared to Metformin 500 mg twice daily up to 1000 mg over 6 months. | Drug | Avandamet |
| Avandia and AmarylAlso: rosiglitazone maleate and glimepiride, Avandia (rosiglitazone maleate) 4 mg, Avandia (rosiglitazone maleate) 8 mg, Amaryl (glimepiride) 1 mgAvandia 4 mg and Amaryl 1 mg once daily compared to Avandamet 2 / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily, or compared to Metformin 500 mg twice daily up to 1000 mg over 6 months. | Drug | Avandia and Amaryl |
| MetforminAlso: Metformin 500 mg, Metformin 850 mgMetformin 500 mg twice daily up to 1000 mg over 6 months compared to Avandia 4 mg and Amaryl 1 mg once daily or compared to Avandamet 2 / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily | Drug | Metformin |
Primary outcome
Mean Change From Baseline in A1C at Month 6
Time frame: 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.
17 secondary outcomes
Mean Change From Baseline in A1C at Month 4
Time frame: Baseline and Month 4
Mean Change From Baseline in A1C at Month 12
Time frame: Baseline and Month 12
Number of Subjects Achieving A1C Target at Month 4
Time frame: Month 4
Number of Subjects Achieving A1C Target at Month 6
Time frame: Month 6
Number of Subjects Achieving A1C Target at Month 12
Time frame: Month 12
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 4
Time frame: Baseline and Month 4
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6
Time frame: Baseline and Month 6
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12
Time frame: Baseline and Month 12
Number of Subjects Achieving FPG Target at Month 4
Time frame: Month 4
Number of Subjects Achieving FPG Target at Month 6
Time frame: Month 6
Number of Subjects Achieving FPG Target at Month 12
Time frame: Month 12
Mean Change From Baseline in 5 Year UKPDS Risk Scores at Month 6
Time frame: Baseline and Month 6
Mean Change From Baseline in 5 Year UKPDS Risk Scores at Month 12
Time frame: Baseline and Month 12
Mean Change From Baseline in C-reactive Protein (CRP) at Month 6
Time frame: Baseline and Month 6
Mean Change From Baseline in C-reactive Protein (CRP) at Month 12
Time frame: Baseline and Month 12
Mean Change From Baseline in Adiponectin at Month 6
Time frame: Baseline and Month 6
Mean Change From Baseline in Adiponectin at Month 12
Time frame: Baseline and Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- coordinating centre web siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
robert josse, md principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Avandamet, Avandia and Amaryl and Metformin in people with Type 2 Diabetes Mellitus, run by Canadian Heart Research Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in A1C at Month 6 (time frame: Baseline and Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2013.