Health economic benefits and quality of life during improved glycemic control in patients with type 2 diabetes mellitus: a randomized, controlled, double-blind trial

JAMA. 1998 Nov 4;280(17):1490-6. doi: 10.1001/jama.280.17.1490.

Abstract

Context: Although the long-term health benefits of good glycemic control in patients with diabetes are well documented, shorter-term quality of life (QOL) and economic savings generally have been reported to be minimal or absent.

Objective: To examine short-term outcomes of glycemic control in type 2 diabetes mellitus (DM).

Design: Double-blind, randomized, placebo-controlled, parallel trial.

Setting: Sixty-two sites in the United States.

Participants: A total of 569 male and female volunteers with type 2 DM.

Intervention: After a 3-week, single-blind placebo-washout period, participants were randomized to diet and titration with either 5 to 20 mg of glipizide gastrointestinal therapeutic system (GITS) (n = 377) or placebo (n = 192) for 12 weeks.

Main outcome measures: Change from baseline in glucose and hemoglobin A1c (HbA1c) levels and symptom distress, QOL, and health economic indicators by questionnaires and diaries.

Results: After 12 weeks, mean (+/-SE) HbA1c and fasting blood glucose levels decreased with active therapy (glipizide GITS) vs placebo (7.5% 0.1% vs 9.3%+/-0.1% and 7.0+/-0.1 mmol/L [126+/-2 mg/dL] vs 9.3+/-0.2 mmol/L [168+/-4 mg/ dL], respectively; P<.001). Quality-of-life treatment differences (SD units) for symptom distress (+0.59; P<.001), general perceived health (+0.36; P= .004), cognitive functioning (+0.34; P=.005), and the overall visual analog scale (VAS) (+0.24; P=.04) were significantly more favorable for active therapy. Subscales of acuity (+0.38; P=.002), VAS emotional health (+0.35; P=.003), general health (+0.27; P=.01), sleep (+0.26; P=.04), depression (+0.25; P=.05), disorientation and detachment (+0.23; P= .05), and vitality (+0.22; P=.04) were most affected. Favorable health economic outcomes for glipizide GITS included higher retained employment (97% vs 85%; P<.001), greater productive capacity (99% vs 87%; P<.001), less absenteeism (losses = $24 vs $115 per worker per month; P<.001), fewer bed-days (losses = $1539 vs $1843 per 1000 person-days; P=.05), and fewer restricted-activity days (losses = $2660 vs $4275 per 1000 person-days; P=.01).

Conclusions: Improved glycemic control of type 2 DM is associated with substantial short-term symptomatic, QOL, and health economic benefits.

Publication types

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

MeSH terms

  • Absenteeism
  • Adult
  • Aged
  • Aged, 80 and over
  • Blood Glucose / metabolism
  • Cost of Illness*
  • Diabetes Mellitus, Type 2 / economics*
  • Diabetes Mellitus, Type 2 / therapy*
  • Double-Blind Method
  • Female
  • Glipizide / administration & dosage
  • Glipizide / therapeutic use*
  • Humans
  • Hypoglycemic Agents / administration & dosage
  • Hypoglycemic Agents / therapeutic use*
  • Male
  • Middle Aged
  • Quality of Life*
  • Self-Assessment
  • Surveys and Questionnaires
  • United States

Substances

  • Blood Glucose
  • Hypoglycemic Agents
  • Glipizide