United Kingdom Prospective Diabetes Study 24: A 6-Year, Randomized, Controlled Trial Comparing Sulfonylurea, Insulin, and Metformin Therapy in Patients with Newly Diagnosed Type 2 Diabetes That Could Not Be Controlled with Diet Therapy

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ARTICLE

United Kingdom Prospective Diabetes Study 24: A 6-Year, Randomized, Controlled Trial Comparing Sulfonylurea, Insulin, and Metformin Therapy in Patients with Newly Diagnosed Type 2 Diabetes That Could Not Be Controlled with Diet Therapy

1 February 1998 | Volume 128 Issue 3 | Pages 165-175

Background: Uncertainty exists about the suitability of oralhypoglycemic drugs and insulin therapy for patients with newlydiagnosed type 2 diabetes.

Objective: To assess and compare response to sulfonylurea,insulin, or metformin over 6 years in patients with newly diagnosedtype 2 diabetes in whom disease could and could not be controlledwith diet therapy alone.

Design: Multicenter, randomized, controlled trial.

Setting: Outpatient diabetes clinics of 15 hospitals in theUnited Kingdom.

Intervention: Sulfonylurea (chlorpropamide or glyburide), insulin,or metformin (if patients were obese).

Patients: 458 patients with newly diagnosed type 2 diabetesthat could not be controlled with diet and had hyperglycemicsymptoms or fasting plasma glucose levels greater than 15 mmol/Lduring the initial 3 months of diet therapy (primary diet failuregroup) and 1620 patients in whom disease was controlled by diettherapy and who had fasting plasma glucose levels of 6 to 15mmol/L and no hyperglycemic symptoms while receiving diet therapyalone.

Measurements: Fasting plasma levels of glucose and insulin,hemoglobin A_1c concentrations, body weight, and therapy required.

Results: Compared with the diet-controlled group, the primarydiet failure group was younger and less obese and had more retinopathy,lower fasting plasma insulin levels, and reduced ß-cellfunction. At 6 years, patients allocated to insulin had lowerfasting plasma glucose levels than did patients allocated tooral agents, but hemoglobin A_1c concentrations were similar.Forty-eight percent (95% CI, 37% to 58%) of patients in theprimary diet failure group maintained hemoglobin A_1c concentrationsless than 0.08. By 6 years, 51% of patients (CI, 42% to 62%)allocated to ultralente insulin required additional short-actinginsulin and 66% of patients (CI, 58% to 73%) allocated to sulfonylurearequired additional therapy with metformin or insulin to controlsymptoms and maintain fasting plasma glucose levels less than15 mmol/L. Patients allocated to insulin gained more weightand had more hypoglycemic attacks than did patients allocatedto sulfonylurea. Obese patients allocated to metformin gainedthe least weight and had the fewest hypoglycemic attacks. Forall therapies, control achieved at 6 years was worse in theprimary diet failure group than in the diet-controlled group.

Conclusions: Because initial insulin therapy induced more hypoglycemicreactions and weight gain without necessarily providing bettercontrol, it may be reasonable to start with oral agents andchange to insulin if goals for glycemic levels are not achieved.

Author and Article Information

United Kingdom Prospective Diabetes Study Group.

From Radcliffe Infirmary, Oxford, United Kingdom.

For participants in the United Kingdom Prospective DiabetesStudy Group, see Appendix.

Acknowledgments: The authors thank the patients and the NationalHealth Serviceand non-National Health Service staff at the centersfor their cooperation.

Grant Support: By grants from the United Kingdom Medical ResearchCouncil; the British Diabetic Association; the United KingdomDepartment of Health; The National Eye Institute (5 U10 EY07049-11)and The National Institute of Diabetes and Digestive and KidneyDiseases (2 R01 DK33152-07), National Institutes of Health;The British Heart Foundation; The Health Promotion ResearchTrust; The Clothworkers' Foundation; Charles Wolfson CharitableTrust; The Alan and Babette Sainsbury Trust; and The OxfordUniversity Medical Research Fund Committee.

Requests for Reprints: United Kingdom Prospective DiabetesStudy Group, Diabetes Research Laboratories, Radcliffe Infirmary,Woodstock Road, Oxford OX2 6HE, United Kingdom.

Current Author Addresses: Drs. Wright, Cull, Holman, and Turner:United Kingdom Prospective Diabetes Study Group, Diabetes ResearchLaboratories, Radcliffe Infirmary, Woodstock Road, Oxford OX26HE, United Kingdom.

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