Insulin-based versus triple oral therapy for newly diagnosed type 2 diabetes: which is better?

Ildiko Lingvay, Jaime L Legendre, Polina F Kaloyanova, Song Zhang, Beverley Adams-Huet, Philip Raskin, Ildiko Lingvay, Jaime L Legendre, Polina F Kaloyanova, Song Zhang, Beverley Adams-Huet, Philip Raskin

Abstract

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.

Trial registration: ClinicalTrials.gov NCT00232583.

Figures

Figure 1
Figure 1
A1C (A), weight (B), and compliance (C) of the insulin treatment group (■) and the triple oral group (○) during the 36-month study. The results are reported as means ± SD.
Figure 2
Figure 2
Results of modified Diabetes Quality of Life Questionnaire in the insulin-treated group (■) and triple oral group (○). All patients were given the questionnaire to complete at randomization and at 6 and 18 months after randomization. Patients randomly assigned to oral hypoglycemic agents did not complete the two questions regarding insulin. The results are reported as means ± SD of the Likert scale score of 1–5. Both groups had improved scores with respect to social worries and a change toward stable current health perception over time. ANOVA, P

References

    1. 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 Lancet 1998;352:837–853
    1. Shichiri M, Kishikawa H, Ohkubo Y, Wake N: Long-term results of the Kumamoto study on optimal diabetes control in type 2 diabetic patients. Diabetes Care 2000;23(Suppl. 2):B21–B29
    1. 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. JAMA 2003;290:2159–2167
    1. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus: the Diabetes Control and Complications Trial Research Group N Engl J Med 1993;329:977–986
    1. Leahy JL, Bonner-Weir S, Weir GC: β-Cell dysfunction induced by chronic hyperglycemia: current ideas on mechanism of impaired glucose-induced insulin secretion. Diabetes Care 1992;15:442–455
    1. LeRoith D: β-Cell dysfunction and insulin resistance in type 2 diabetes: role of metabolic and genetic abnormalities. Am J Med 2002;113(Suppl. 6A):3S–11S
    1. UK Prospective Diabetes Study 16. Overview of 6 years' therapy of type II diabetes: a progressive disease. UK Prospective Diabetes Study Group Diabetes 1995;44:1249–1258
    1. Wright A, Burden AC, Paisey RB, Cull CA, Holman RR: Sulfonylurea inadequacy: efficacy of addition of insulin over 6 years in patients with type 2 diabetes in the UK Prospective Diabetes Study (UKPDS 57). Diabetes Care 2002;25:330–336
    1. Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B: 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. Diabetes Care 2009;32:193–203
    1. Alvarsson M, Sundkvist G, Lager I, Henricsson M, Berntorp K, Fernqvist-Forbes E, Steen L, Westermark G, Westermark P, Orn T, Grill V: Beneficial effects of insulin versus sulphonylurea on insulin secretion and metabolic control in recently diagnosed type 2 diabetic patients. Diabetes Care 2003;26:2231–2237
    1. Peyrot M, Rubin RR, Lauritzen T, Skovlund SE, Snoek FJ, Matthews DR, Landgraf R, Kleinebreil L: Resistance to insulin therapy among patients and providers: results of the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) study. Diabetes Care 2005;28:2673–2679
    1. Korytkowski M: When oral agents fail: practical barriers to starting insulin. Int J Obes Relat Metab Disord 2002;26(Suppl. 3):S18–S24.
    1. Rosenstock J, Sugimoto D, Strange P, Stewart JA, Soltes-Rak E, Dailey G: Triple therapy in type 2 diabetes: insulin glargine or rosiglitazone added to combination therapy of sulfonylurea plus metformin in insulin-naive patients. Diabetes Care 2006;29:554–559
    1. Schwartz S, Sievers R, Strange P, Lyness WH, Hollander P: 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. Diabetes Care 2003;26:2238–2243
    1. Ilkova H, Glaser B, Tunckale A, Bagriacik N, Cerasi E: Induction of long-term glycemic control in newly diagnosed type 2 diabetic patients by transient intensive insulin treatment. Diabetes Care 1997;20:1353–1356
    1. Karvestedt L, Andersson G, Efendic S, Grill V: A rapid increase in β-cell function by multiple insulin injections in type 2 diabetic patients is not further enhanced by prolonging treatment. J Intern Med 2002;251:307–316
    1. Lingvay I, Kaloyanova PF, Adams-Huet B, Salinas K, Raskin P: Insulin as initial therapy in type 2 diabetes: effective, safe, and well accepted. J Investig Med 2007;55:62–68
    1. Jacobson A: Diabetes quality of life measure. In Handbook of Psychology and Diabetes: A Guide to Psychological Measurement in Diabetes Research and Practice Bradley E. Ed. Chur, Switzerland, Harwood Academic Publishers, 1994, p. 65–87
    1. Shen W, Kotsanos JG, Huster WJ, Mathias SD, Andrejasich CM, Patrick DL: Development and validation of the Diabetes Quality of Life Clinical Trial Questionnaire. Med Care 1999;37:AS45–AS66
    1. Herman WH, Ilag LL, Johnson SL, Martin CL, Sinding J, Al Harthi A, Plunkett CD, LaPorte FB, Burke R, Brown MB, Halter JB, Raskin P: A clinical trial of continuous subcutaneous insulin infusion versus multiple daily injections in older adults with type 2 diabetes. Diabetes Care 2005;28:1568–1573
    1. Kahn SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP, Kravitz BG, Lachin JM, O'Neill MC, Zinman B, Viberti G: Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med 2006;355:2427–2443
    1. Li Y, Xu W, Liao Z, Yao B, Chen X, Huang Z, Hu G, Weng J: Induction of long-term glycemic control in newly diagnosed type 2 diabetic patients is associated with improvement of β-cell function. Diabetes Care 2004;27:2597–2602

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