24-Hour Glycemia: Rosiglitazone Versus Glimepiride In Type 2 Diabetes - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Non-Insulin-Dependent Diabetes Mellitus
Interventions:	Drug: rosiglitazone-metformin fixed dose combination Drug: metformin + glimepiride

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Avandamet® (Rosiglitazone/Metformin)	Fixed-dose combination will be started at a dose of 4mg/day of Rosiglitazone (RSG) and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
Glimepiride/Metformin	Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern: from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal.

Description

Avandamet® (Rosiglitazone/Metformin)

Fixed-dose combination will be started at a dose of 4mg/day of Rosiglitazone (RSG) and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.

Glimepiride/Metformin

Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study

Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:

from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal
from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal
from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal
from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal.

Participant Flow: Overall Study

	Avandamet® (Rosiglitazone/Metformin)	Glimepiride/Metformin
STARTED	12	11
COMPLETED	12	9 ^[1]
NOT COMPLETED	0	2
Took Avandamet instead of Glim/Met	0	1
Did not receive any treatment	0	1

[1]	1 patient received by error avandamet treatment and 1 patient did not receive any treatment.

Baseline Characteristics

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Reporting Groups

	Description
Avandamet® (Rosiglitazone/Metformin)	Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
Glimepiride/Metformin	Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern: from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal.

Description

Avandamet® (Rosiglitazone/Metformin)

Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.

Glimepiride/Metformin

Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study

Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:

from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal
from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal
from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal
from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal.

Baseline Measures

	Avandamet® (Rosiglitazone/Metformin)	Glimepiride/Metformin	Total
Number of Participants [units: participants]	11	10	21
Age [units: years] Mean ± Standard Deviation	59 ± 10.3	62.2 ± 6.6	60.5 ± 8.7
Gender [units: Participants]
Female	5	2	7
Male	6	8	14
Body Mass Index (BMI) ^[1] [units: kg/m²] Mean ± Standard Deviation	32.2 ± 6.6	30.1 ± 4.8	31.2 ± 5.8
HbA1c ^[2] [units: percentage] Mean ± Standard Deviation	7.8 ± 0.51	7.8 ± 0.52	7.8 ± 0.50

[1]	BMI: A key index for relating a person's body weight to their height. The body mass index (BMI) is a person's weight in kilograms (kg) divided by their height in meters (m) squared.
[2]	HbA1c reflects the mean level of glycaemia over time.

Outcome Measures

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1. Primary:

Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment [ Time Frame: Baseline and 12 weeks ]

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2. Primary:

Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment [ Time Frame: Baseline and 12 weeks ]

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3. Secondary:

Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment [ Time Frame: Baseline and 12 weeks ]

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4. Secondary:

Episodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment [ Time Frame: Baseline and 12 weeks ]

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5. Secondary:

Duration of Hypoglycaemia (<80 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment [ Time Frame: Baseline and 12 weeks ]

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6. Secondary:

Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment [ Time Frame: Baseline and 12 weeks ]

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7. Secondary:

Duration of Hypoglycaemia (<60 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment [ Time Frame: Baseline and 12 weeks ]

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8. Secondary:

Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment [ Time Frame: Baseline and 12 weeks ]

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9. Secondary:

HbA1c (Glycosylated Hemoglobin) [ Time Frame: Baseline and 12 weeks ]

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10. Secondary:

8-Iso Prostaglandin F2α (8-iso PGF2α) Excretion Rate [ Time Frame: Baseline and 12 weeks ]

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11. Secondary:

Glycaemia According to CGMS (Nocturnal), mg/dL [ Time Frame: Baseline and 12 weeks ]

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12. Secondary:

Glycaemia According to CGMS (Diurnal), mg/dL [ Time Frame: Baseline and 12 weeks ]

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13. Secondary:

Glycaemia According to CGMS (Dawn), mg/dL [ Time Frame: Baseline and 12 weeks ]

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14. Secondary:

Glycaemia According to CGMS (Total Area Under the Curve (AUC) for Values Above 1 mg/dL), mg/dL [ Time Frame: Baseline and 12 weeks ]

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15. Secondary:

Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL [ Time Frame: Baseline and 12 weeks ]

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16. Secondary:

Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL [ Time Frame: Baseline and 12 weeks ]

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17. Secondary:

Glycaemia According to CGMS (MAGE), mg/dL [ Time Frame: Baseline and 12 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centres of a multi-centre trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00318656 History of Changes
Other Study ID Numbers:	104988, AVAF4003
Study First Received:	April 25, 2006
Results First Received:	October 17, 2008
Last Updated:	April 10, 2009
Health Authority:	France: Afssaps - French Health Products Safety Agency