Insulin-Based Versus Triple Oral Therapy for Newly Diagnosed Type 2 Diabetes

OBJECTIVE Early use of insulin after diagnosis of type 2 diabetes is met with resistance because of associated weight gain, hypoglycemia, and fear of decreased compliance and quality of life (QoL). RESEARCH DESIGN AND METHODS In treatment-naive patients with newly diagnosed type 2 diabetes, insulin and metformin were initiated for a 3-month lead-in period, then patients were randomly assigned to insulin and metformin (insulin group) or metformin, pioglitazone, and glyburide (oral group) for 36 months. Hypoglycemic events, compliance, A1C, weight, QoL, and treatment satisfaction were assessed. RESULTS Of 29 patients randomly assigned into each group, 83% (insulin group) and 72% (oral group) completed this 3-year study. At study completion, A1C was 6.1 ± 0.6% (insulin group) versus 6.0 ± 0.8% (oral group). Weight increased similarly in both groups (P = 0.09) by 4.47 kg (95% CI 0.89–8.04 kg) (insulin group) and 7.15 kg (95% CI 4.18–10.13 kg) (orals group). Hypoglycemic events did not differ between groups (mild 0.51 event/person-month in the insulin group vs. 0.68 event/person-month in the orals group, P = 0.18 and severe 0.04 event/person-year in the insulin group vs. 0.09 event/person-year in the orals group, P = 0.53). Compliance, QoL, and treatment satisfaction were similar between groups, with 100% of patients randomly assigned to insulin willing to continue such treatment. CONCLUSIONS When compared with a clinically equivalent treatment regimen, insulin-based therapy is effective and 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.

[1]  D. Nathan.  Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy: A Consensus Statement of the American Diabetes Association and the European Association for the Study of Diabetes , 2009, Diabetes Care.

[2]  P. Raskin,et al.  Insulin as Initial Therapy in Type 2 Diabetes , 2007, Journal of Investigative Medicine.

[3]  B. Zinman,et al.  Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. , 2006, The New England journal of medicine.

[4]  Zulekha Hamid,et al.  Triple Therapy in Type 2 Diabetes: Insulin Glargine or Rosiglitazone Added to Combination Therapy of Sulfonylurea Plus Metformin in Insulin-Naïve Patients , 2006, Diabetes Care.

[5]  J. Rosenstock.  Triple Therapy in Type 2 Diabetes: Insulin Glargine or Rosiglitazone Added to Combination Therapy of Sulfonylurea Plus Metformin in Insulin-Naïve Patients , 2006, Diabetes Care.

[6]  R. Rubin,et al.  Resistance to insulin therapy among patients and providers: results of the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) study. , 2005, Diabetes care.

[7]  Ray Burke,et al.  A clinical trial of continuous subcutaneous insulin infusion versus multiple daily injections in older adults with type 2 diabetes. , 2005, Diabetes care.

[8]  J. Weng,et al.  Induction of long-term glycemic control in newly diagnosed type 2 diabetic patients is associated with improvement of beta-cell function. , 2004, Diabetes care.

[9]  S. Schwartz,et al.  Insulin 70/30 mix plus metformin versus triple oral therapy in the treatment of type 2 diabetes after failure of two oral drugs: efficacy, safety, and cost analysis. , 2003, Diabetes care.

[10]  G. Sundkvist,et al.  Beneficial effects of insulin versus sulphonylurea on insulin secretion and metabolic control in recently diagnosed type 2 diabetic patients. , 2003, Diabetes care.

[11]  John M. Lachin,et al.  Sustained effect of intensive treatment of type 1 diabetes mellitus on development and progression of diabetic nephropathy: the Epidemiology of Diabetes Interventions and Complications (EDIC) study. , 2003, JAMA.

[12]  D. Leroith.  Beta-cell dysfunction and insulin resistance in type 2 diabetes: role of metabolic and genetic abnormalities. , 2002, The American journal of medicine.

[13]  M. Korytkowski,et al.  When oral agents fail: practical barriers to starting insulin , 2002, International Journal of Obesity.

[14]  V. Grill,et al.  A rapid increase in β‐cell function by multiple insulin injections in type 2 diabetic patients is not further enhanced by prolonging treatment , 2002, Journal of internal medicine.

[15]  Rury R Holman,et al.  Sulfonylurea inadequacy: efficacy of addition of insulin over 6 years in patients with type 2 diabetes in the U.K. Prospective Diabetes Study (UKPDS 57). , 2002, Diabetes care.

[16]  M. Shichiri,et al.  Long-term results of the Kumamoto Study on optimal diabetes control in type 2 diabetic patients. , 2000, Diabetes care.

[17]  D L Patrick,et al.  Development and validation of the Diabetes Quality of Life Clinical Trial Questionnaire. , 1999, Medical care.

[18]  R. Holman,et al.  Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. , 1998 .

[19]  B. Glaser,et al.  Induction of Long-Term Glycemic Control in Newly Diagnosed Type 2 Diabetic Patients by Transient Intensive Insulin Treatment , 1997, Diabetes Care.

[20]  J. Levy,et al.  U.K. Prospective Diabetes Study 16: Overview of 6 Years' Therapy of Type II Diabetes: A Progressive Disease , 1995, Diabetes.

[21]  D. Rogers,et al.  The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus , 1994 .

[22]  Clare Bradley,et al.  Handbook of Psychology and Diabetes : A Guide to Psychological Measurement in Diabetes Research and Practice , 1994 .

[23]  S. Genuth,et al.  The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. , 1993, The New England journal of medicine.

[24]  J. Leahy,et al.  β-Cell Dysfunction Induced by Chronic Hyperglycemia: Current Ideas on Mechanism of Impaired Glucose-Induced Insulin Secretion , 1992, Diabetes Care.

[25]  J. Leahy,et al.  Beta-cell dysfunction induced by chronic hyperglycemia. Current ideas on mechanism of impaired glucose-induced insulin secretion. , 1992, Diabetes care.