- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00131664
Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin (AVALANCHE™ Study) (AVALANCHE)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, m5b 2p9
- Canadian Heart Research Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Avandamet
Avandamet 2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
|
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.
Other Names:
|
ACTIVE_COMPARATOR: Avandia and Amaryl
Avandia + Amaryl 4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
|
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.
Other Names:
|
ACTIVE_COMPARATOR: Metformin
Metformin 500 mg twice daily titration up to 1000 mg twice daily over 6 months
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and Month 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline in A1C at Month 4
Time Frame: 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.
|
Baseline and Month 4
|
Mean Change From Baseline in A1C at Month 12
Time Frame: 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.
|
Baseline and Month 12
|
Number of Subjects Achieving A1C Target at Month 4
Time Frame: Month 4
|
A1C responders were described as subjects having achieved A1C less than 7 percent at Month 4, with LOCF from Month 2.
|
Month 4
|
Number of Subjects Achieving A1C Target at Month 6
Time Frame: Month 6
|
A1C responders were described as subjects having achieved A1C less than 7 percent at Month 6, with LOCF from Month 2.
|
Month 6
|
Number of Subjects Achieving A1C Target at Month 12
Time Frame: Month 12
|
A1C responders were described as subjects having achieved A1C less than 7 percent at Month 12 with LOCF from Month 2.
|
Month 12
|
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 4
Time Frame: 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.
|
Baseline and Month 4
|
Mean Change From Baseline in Fasting Plasma Glucose (FPG) 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.
|
Baseline and Month 6
|
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12
Time Frame: 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.
|
Baseline and Month 12
|
Number of Subjects Achieving FPG Target at Month 4
Time Frame: Month 4
|
FPG responders were described as subjects having achieved FPG less than 7 mmol/L at Month 4 with LOCF from Month 2.
|
Month 4
|
Number of Subjects Achieving FPG Target at Month 6
Time Frame: Month 6
|
FPG responders were described as subjects having achieved FPG less than 7 mmol/L at Month 6 with LOCF from Month 2.
|
Month 6
|
Number of Subjects Achieving FPG Target at Month 12
Time Frame: Month 12
|
FPG responders were described as subjects having achieved FPG less than 7 mmol/L at Month 12 with LOCF from Month 2.
|
Month 12
|
Mean Change From Baseline in 5 Year UKPDS Risk Scores at Month 6
Time Frame: Baseline and 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. |
Baseline and Month 6
|
Mean Change From Baseline in 5 Year UKPDS Risk Scores at Month 12
Time Frame: Baseline and 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. |
Baseline and Month 12
|
Mean Change From Baseline in C-reactive Protein (CRP) at Month 6
Time Frame: Baseline and 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.
|
Baseline and Month 6
|
Mean Change From Baseline in C-reactive Protein (CRP) at Month 12
Time Frame: Baseline and 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.
|
Baseline and Month 12
|
Mean Change From Baseline in Adiponectin at Month 6
Time Frame: Baseline and 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.
|
Baseline and Month 6
|
Mean Change From Baseline in Adiponectin at Month 12
Time Frame: Baseline and 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.
|
Baseline and Month 12
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: robert josse, md, University of Toronto
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Enzyme Inhibitors
- Immunosuppressive Agents
- Immunologic Factors
- Metformin
- Rosiglitazone
- Maleic acid
- Glimepiride
Other Study ID Numbers
- AVM103436
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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