Rosiglitazone RECORD study: glucose control outcomes at 18 months

Area of Science:

• Endocrinology
• Metabolic Diseases
• Pharmacology

Background:

• Type 2 diabetes management requires effective glucose control.
• Combination therapies are often necessary to achieve target HbA1c levels.
• Evaluating new drug combinations is crucial for optimizing patient outcomes.

Purpose of the Study:

• To compare the efficacy of rosiglitazone combination therapy versus standard metformin and sulphonylurea combination therapy in managing Type 2 diabetes.
• To assess glucose control, specifically HbA1c levels, over an 18-month period.
• To evaluate secondary outcomes including insulin sensitivity, C-reactive protein levels, and body weight changes.

Main Methods:

• A multicentre, parallel-group study (RECORD) enrolled participants with HbA1c between 7.1-9.0% on maximal metformin or sulphonylurea.
• Participants were randomized to add-on rosiglitazone or sulphonylurea (if on metformin), or rosiglitazone or metformin (if on sulphonylurea).
• Glycaemic control was managed to HbA1c ≤7.0% via dose titration, with a primary outcome assessed against a non-inferiority margin of 0.4% for HbA1c.

Main Results:

• Rosiglitazone combination therapy demonstrated non-inferiority to metformin + sulphonylurea in reducing HbA1c over 18 months.
• Improvements in homeostasis model assessment insulin sensitivity and C-reactive protein were significantly greater with rosiglitazone.
• Rosiglitazone was associated with significantly greater body weight gain compared to both metformin and sulphonylurea.

Conclusions:

• Rosiglitazone in combination with metformin or sulphonylurea provides comparable glucose-lowering efficacy to the standard metformin + sulphonylurea combination in Type 2 diabetes.
• The combination of rosiglitazone offers additional benefits in improving insulin sensitivity and reducing inflammation.
• Clinicians should consider the increased risk of weight gain when prescribing rosiglitazone-based combination therapy.