Carotid Artery Thickness Data from a Sitagliptin Diabetes Trial

442 participants with type 2 diabetes were included in a primary analysis comparing carotid artery intima-media thickness (IMT) between a sitagliptin group and a conventional therapy group over 24 months. The dataset originates from the PROLOGUE randomized controlled trial, which used a multicenter PROBE design to evaluate the cardiovascular effects of the DPP-4 inhibitor sitagliptin. Key outcomes include IMT measurements and HbA1c levels at follow-up.

Use Cases

• Analyze the relationship between HbA1c level and common carotid artery IMT measurements across treatment groups.
• Compare the progression of carotid IMT between the sitagliptin and conventional therapy groups over the 24-month follow-up period.
• Investigate adverse event rates, such as episodes of serious hypoglycemia, recorded only in the conventional therapy group.

Strengths

• Data from a randomized controlled trial with 463 enrolled participants, providing a structured comparison framework.
• Carotid ultrasound parameters were measured in a core laboratory, ensuring standardized assessment of IMT.
• Includes 24 months of follow-up data with key clinical metrics like HbA1c level and IMT.

Limitations

• Carotid IMT was used as a surrogate marker for atherosclerosis, limiting direct interpretation of cardiovascular outcomes.
• The trial was not placebo-controlled and used an open-label design, which can introduce bias.
• The dataset is focused on a specific drug (sitagliptin) and patient population (T2DM with 6.2% ≤ HbA1c < 9.4%), limiting generalizability.

Provenance

Source

Dryad, from the PROLOGUE randomized controlled trial.

Collection Method

Multicenter prospective, randomized, open label, blinded endpoint (PROBE) study with carotid ultrasound performed at medical centers and core laboratory analysis.

Time Range

24-month follow-up period.

Freshness

Last updated in June 2020.

Geography

Data collected from participating medical centers in Japan (inferred from trial registry UMIN).