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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avandamet | Active Comparator | Avandamet 2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months |
|
| 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 |
|
| Metformin | Active Comparator | Metformin 500 mg twice daily titration up to 1000 mg twice daily over 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avandamet | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Month 4 |
| Mean Change From Baseline in A1C at Month 12 |
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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:
Signed informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| robert josse, md | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canadian Heart Research Centre | Toronto | Ontario | m5b 2p9 | Canada |
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| Label | URL |
|---|---|
| coordinating centre web site | View source |
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This open-label, prospective, randomized multi-centre study included naïve or recently treated type 2 diabetes mellitus (T2DM) patients. Recently treated patients (up to 3 years on single therapy of a low to moderate dose of Glyburide or Amaryl™ or Metformin) entered the study after a 2-week wash-out period.
391 patients were randomized from 49 Canadian sites of General Practitioners and Community Endocrinologists during an 8 month recruitment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Avandia and Amaryl | Avandia™ + Amaryl™ Arm: at month 2 initial dose of 4 mg + 1 mg once daily (OD) was titrated up to 8 mg + 1 mg OD; at month 4 it was further titrated up to 8 mg + 2 mg OD. |
| FG001 | Avandamet | Avandamet™ Arm: at month 2 the initial dose of 2 mg / 500 mg twice daily (BID) was titrated up to 4 mg / 500 mg BID; at month 4 it was be further titrated up to 4 mg / 1000 mg BID. |
| FG002 | Metformin | Metformin Arm: initial dose of 500 mg twice daily (BID) was titrated up to 850 mg BID at month 2. At month 4, it was further titrated up to 1000 mg BID. |
| FG003 | Avandia, Amaryl and Metformin | Avandia™ + Amaryl™ Arm: At month 6, if patients not achieving A1C target of less than 7 received additional specified drug therapy. Metformin was added and titrated up to 1000 mg twice daily (BID) maximum dose for an additional 6 months. |
| FG004 | Avandamet and Amaryl | Avandamet™ Arm: At month 6, if patients not achieving A1C target of less than 7 received additional specified drug therapy. Amaryl™ was added and titrated up to 4 mg once daily maximum dose for an additional 6 months |
| FG005 | Metformin and Amaryl | Metformin Arm: At month 6, if patients not achieving A1C target of less than 7 received additional specified drug therapy. Amaryl™ was added and titrated up to 4 mg once daily maximum dose for an additional 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Period (First 6 Months) |
|
| ||||||||||||||||||
| Second Period (Additional Drug Added) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Avandia and Amaryl | 4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months |
| BG001 | Avandamet | 2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Error | percent | Baseline and Month 6 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Avandia and Amaryl | Avandia™ + Amaryl™ Arm: at month 2 initial dose of 4 mg +1 mg OD was titrated up to 8 mg + 1 mg OD; at month 4 it was further titrated up to 8 mg / 2 mg OD. At month 6, patients not achieving target received additional specified drug therapy: Metformin was added and titrated up to 1000 mg BID maximum dose for an additional 6 months. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Fractures were all wrist or ankle. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Josse | Dr. Anatoly Langer, Chair CHRC, Canadian Heart Research Centre | 416-977-8010 | langera@chrc.net |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C471074 | rosiglitazone-metformin combination |
| D000077154 | Rosiglitazone |
| D008687 | Metformin |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
| Avandia and Amaryl | Drug | 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. |
|
|
| Metformin | Drug | 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 |
|
|
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Death |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Adverse Event |
|
| Clinically significant lab abnormalities |
|
| Administrative reasons |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Metformin | 500 mg twice daily titration up to 1000 mg twice daily over 6 months |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months |
| OG002 | Metformin | 500 mg twice daily titration up to 1000 mg twice daily over 6 months |
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Error | percent | Baseline and Month 4 |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Error | percent | Baseline and Month 12 |
|
|
|
| Secondary | 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. | 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. | Posted | Number | participants | Month 4 |
|
|
|
| Secondary | 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. | 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. | Posted | Number | participants | Month 6 |
|
|
|
| Secondary | 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. | 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. | Posted | Number | participants | Month 12 |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Error | millimoles per litre (mmol/L) | Baseline and Month 4 |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Error | millimoles per litre (mmol/L) | Baseline and Month 6 |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Error | millimoles per litre (mmol/L) | Baseline and Month 12 |
|
|
|
| Secondary | 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. | 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. | Posted | Number | participants | Month 4 |
|
|
|
| Secondary | 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. | 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. | Posted | Number | participants | Month 6 |
|
|
|
| Secondary | 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. | 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. | Posted | Number | participants | Month 12 |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Error | percent | Baseline and Month 6 |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Error | percent | Baseline and Month 12 |
|
|
|
| Secondary | 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. | All Primary and secondary endpoints were calculated on the Intent to Treat (ITT) population where each patient had at least one dose of the medication and at least one valid observation. Missing values were carried forward (using Last Observation Carried Forward method) except for the calculation of the composite variables. | Posted | Mean | Standard Error | milligram per decilitre (mg/dL) | Baseline and Month 6 |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Month 12 |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Error | microgram per millilitre (µg/mL) | Baseline and Month 6 |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Error | µg/mL | Baseline and Month 12 |
|
|
|
| 0 |
| 136 |
| 2 |
| 136 |
| EG001 | Avandamet | Avandamet™ Arm: at month 2 the initial dose of 2 mg / 500 mg BID was titrated up to 4 mg / 500 mg BID; at month 4 it was be further titrated up to 4 mg / 1000 mg BID. At month 6, patients not achieving target received additional specified drug therapy Amaryl™ was added and titrated up to 4 mg OD maximum dose for an additional 6 months | 0 | 135 | 3 | 117 |
| EG002 | Metformin | Metformin Arm: initial dose of 500 mg BID was titrated up to 850 mg BID at month 2. At month 4, it was further titrated up to 1000 mg BID. At month 6 (visit 6), patients not achieving target received additional specified drug therapy: Amaryl™ was added and titrated up to 4 mg OD maximum dose for an additional 6 months. | 0 | 120 | 0 | 104 |
|
Not provided
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| D004700 | Endocrine System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |