Choosing an Insulin Regimen for Patients With Type 2 Diabetes

STUDY

Holman RR, Thorne KI, Farmer AJ, Davies MJ, Keenan JF, Paul S, Levy JC; 4-T Study Group: Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes.

SUMMARY

Design. A randomized controlled trial comparing three insulin regimens: biphasic insulin aspart twice daily, prandial insulin aspart three times daily, or basal insulin detemir once daily (with the option of twice daily if needed).

Subjects. Participants included 708 patients (64% male) ≥ 18 years of age (mean age 61.7 years) with type 2 diabetes, hemoglobin A_1c (A1C) levels of 7.0-10.0% on maximally tolerated doses of sulfonylurea and metformin, who were willing to inject insulin and perform self-monitoring of blood glucose. Patients with BMI > 40 kg/m², taking thiazolidinediones, or who had been diagnosed with retinopathy or nephropathy were excluded.

Methods. Participants were recruited from 58 clinical centers in the United Kingdom and Ireland and randomized centrally. Participants assigned to each group were managed according to a regimen-specific trial algorithm that estimated starting insulin dose. Patients were then seen at 2, 6, 12, 24, 38, and 52 weeks with interim phone contact and were …