Insulin-Based versus Triple Oral Therapy for Newly-Diagnosed Type 2 Diabetes: Which is Better?

  1. Ildiko Lingvay, MD, MPH, MSCS (Ildiko.lingvay{at}*,
  2. Jaime L. Legendre, BS*,
  3. Polina F. Kaloyanova, MD*,
  4. Song Zhang, PhD,
  5. Beverley Adams-Huet, MS* and
  6. Philip Raskin, MD*
  1. University of Texas Southwestern Medical Center at Dallas; 5323 Harry Hines Blvd.; Dallas, TX 75390; *Department of Internal Medicine/Division of Endocrinology
  2. †Department of Clinical Sciences


    Objectives: Early use of insulin following diagnosis of type 2 diabetes is met with resistance due to associated weight gain, hypoglycemia, and fear of decreased compliance and quality of life (QoL).

    Research Design and Methods: Treatment naïve patients with newly-diagnosed type 2 diabetes were initiated on insulin and metformin for a 3-month lead-in period, then randomized to insulin and metformin (insulin group) or metformin, pioglitazone, and glyburide (orals group) for 36 months. Hypoglycemic events, compliance, HbA1c, weight, QoL, and treatment satisfaction were assessed.

    Results: Of 29 patients randomized into each group, 83% (insulin group) and 72% (orals group) completed this 3-year study. At study completion, HbA1c was 6.1±0.6% (insulin group) versus 6.0±0.8% (orals group). Weight increased similarly in both groups (P=0.09), by 4.47kg (95% CI 0.89–8.04kg) (insulin group) and 7.15kg (95% CI 4.18–10.13kg) (orals group). Hypoglycemic events did not differ between groups, both mild (0.51 events/person-month in the insulin group vs. 0.68 events/person-month in the orals group - P=0.18) and severe (0.04 events/person-year in the insulin group vs. 0.09 events/person-year in the orals group - P=0.53). Compliance, QoL, and treatment satisfaction were similar between groups, with 100% of patients randomized to insulin willing to continue such treatment.

    Conclusions: When compared with a clinically equivalent treatment regimen, insulin-based therapy is effective, did not cause greater weight gain or hypoglycemia, nor decrease compliance, treatment satisfaction, or QoL. Insulin is safe, well-accepted, and effective for ongoing treatment of patients with newly-diagnosed type 2 diabetes.


      • Received April 3, 2009.
      • Accepted June 29, 2009.