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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. United Kingdom Prospective Diabetes Study Group.

Abstract

BACKGROUND

Uncertainty exists about the suitability of oral hypoglycemic drugs and insulin therapy for patients with newly diagnosed type 2 diabetes.

OBJECTIVE

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

DESIGN

Multicenter, randomized, controlled trial.

SETTING

Outpatient diabetes clinics of 15 hospitals in the United Kingdom.

INTERVENTION

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

PATIENTS

458 patients with newly diagnosed type 2 diabetes that could not be controlled with diet and had hyperglycemic symptoms or fasting plasma glucose levels greater than 15 mmol/L during the initial 3 months of diet therapy (primary diet failure group) and 1620 patients in whom disease was controlled by diet therapy and who had fasting plasma glucose levels of 6 to 15 mmol/L and no hyperglycemic symptoms while receiving diet therapy alone.

MEASUREMENTS

Fasting plasma levels of glucose and insulin, hemoglobin A1c concentrations, body weight, and therapy required.

RESULTS

Compared with the diet-controlled group, the primary diet failure group was younger and less obese and had more retinopathy, lower fasting plasma insulin levels, and reduced beta-cell function. At 6 years, patients allocated to insulin had lower fasting plasma glucose levels than did patients allocated to oral agents, but hemoglobin A1c concentrations were similar. Forty-eight percent (95% CI, 37% to 58%) of patients in the primary diet failure group maintained hemoglobin A1c concentrations less than 0.08. By 6 years, 51% of patients (CI, 42% to 62%) allocated to ultralente insulin required additional short-acting insulin and 66% of patients (CI, 58% to 73%) allocated to sulfonylurea required additional therapy with metformin or insulin to control symptoms and maintain fasting plasma glucose levels less than 15 mmol/L. Patients allocated to insulin gained more weight and had more hypoglycemic attacks than did patients allocated to sulfonylurea. Obese patients allocated to metformin gained the least weight and had the fewest hypoglycemic attacks. For all therapies, control achieved at 6 years was worse in the primary diet failure group than in the diet-controlled group.

CONCLUSIONS

Because initial insulin therapy induced more hypoglycemic reactions and weight gain without necessarily providing better control, it may be reasonable to start with oral agents and change to insulin if goals for glycemic levels are not achieved.

Links

  • Publisher Full Text
  • Source

    Annals of internal medicine 128:3 1998 Feb 01 pg 165-75

    MeSH

    Adult
    Aged
    Blood Glucose
    Combined Modality Therapy
    Diabetes Mellitus, Type 2
    Female
    Follow-Up Studies
    Glycated Hemoglobin A
    Humans
    Hypoglycemia
    Hypoglycemic Agents
    Insulin
    Male
    Metformin
    Middle Aged
    Obesity
    Prospective Studies
    Statistics as Topic
    Sulfonylurea Compounds
    United Kingdom

    Pub Type(s)

    Clinical Trial
    Comparative Study
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't
    Research Support, U.S. Gov't, P.H.S.

    Language

    eng

    PubMed ID

    9454524

    Citation

    "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. United Kingdom Prospective Diabetes Study Group." Annals of Internal Medicine, vol. 128, no. 3, 1998, pp. 165-75.
    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. United Kingdom Prospective Diabetes Study Group. Ann Intern Med. 1998;128(3):165-75.
    (1998). 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. United Kingdom Prospective Diabetes Study Group. Annals of Internal Medicine, 128(3), pp. 165-75.
    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. United Kingdom Prospective Diabetes Study Group. Ann Intern Med. 1998 Feb 1;128(3):165-75. PubMed PMID: 9454524.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - 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. United Kingdom Prospective Diabetes Study Group. PY - 1998/2/7/pubmed PY - 1998/2/7/medline PY - 1998/2/7/entrez SP - 165 EP - 75 JF - Annals of internal medicine JO - Ann. Intern. Med. VL - 128 IS - 3 N2 - BACKGROUND: Uncertainty exists about the suitability of oral hypoglycemic drugs and insulin therapy for patients with newly diagnosed type 2 diabetes. OBJECTIVE: To assess and compare response to sulfonylurea, insulin, or metformin over 6 years in patients with newly diagnosed type 2 diabetes in whom disease could and could not be controlled with diet therapy alone. DESIGN: Multicenter, randomized, controlled trial. SETTING: Outpatient diabetes clinics of 15 hospitals in the United Kingdom. INTERVENTION: Sulfonylurea (chlorpropamide or glyburide), insulin, or metformin (if patients were obese). PATIENTS: 458 patients with newly diagnosed type 2 diabetes that could not be controlled with diet and had hyperglycemic symptoms or fasting plasma glucose levels greater than 15 mmol/L during the initial 3 months of diet therapy (primary diet failure group) and 1620 patients in whom disease was controlled by diet therapy and who had fasting plasma glucose levels of 6 to 15 mmol/L and no hyperglycemic symptoms while receiving diet therapy alone. MEASUREMENTS: Fasting plasma levels of glucose and insulin, hemoglobin A1c concentrations, body weight, and therapy required. RESULTS: Compared with the diet-controlled group, the primary diet failure group was younger and less obese and had more retinopathy, lower fasting plasma insulin levels, and reduced beta-cell function. At 6 years, patients allocated to insulin had lower fasting plasma glucose levels than did patients allocated to oral agents, but hemoglobin A1c concentrations were similar. Forty-eight percent (95% CI, 37% to 58%) of patients in the primary diet failure group maintained hemoglobin A1c concentrations less than 0.08. By 6 years, 51% of patients (CI, 42% to 62%) allocated to ultralente insulin required additional short-acting insulin and 66% of patients (CI, 58% to 73%) allocated to sulfonylurea required additional therapy with metformin or insulin to control symptoms and maintain fasting plasma glucose levels less than 15 mmol/L. Patients allocated to insulin gained more weight and had more hypoglycemic attacks than did patients allocated to sulfonylurea. Obese patients allocated to metformin gained the least weight and had the fewest hypoglycemic attacks. For all therapies, control achieved at 6 years was worse in the primary diet failure group than in the diet-controlled group. CONCLUSIONS: Because initial insulin therapy induced more hypoglycemic reactions and weight gain without necessarily providing better control, it may be reasonable to start with oral agents and change to insulin if goals for glycemic levels are not achieved. SN - 0003-4819 UR - https://www.unboundmedicine.com/medline/citation/9454524/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__United_Kingdom_Prospective_Diabetes_Study_Group_ L2 - https://www.annals.org/article.aspx?volume=128&issue=3&page=165 DB - PRIME DP - Unbound Medicine ER -