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Pharmacology & Therapeutics

Prevention of Type 2 Diabetes With Troglitazone in the Diabetes Prevention Program

  1. The Diabetes Prevention Program Research Group*
  1. From the George Washington University Biostatistics Center, Rockville, Maryland
  1. Address correspondence and reprint requests to The Biostatistics Center, George Washington University, 6110 Executive Blvd., Suite 750, Rockville, MD 20852. E-mail: dppmail{at}biostat.bsc.gwu.edu
Diabetes 2005 Apr; 54(4): 1150-1156. https://doi.org/10.2337/diabetes.54.4.1150
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  • FIG. 1.
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    FIG. 1.

    Mean values of body weight, waist circumference, and FPG and 2-h postload glucose concentrations in response to treatment. Sample sizes are shown in Table 2.

  • FIG. 2.
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    FIG. 2.

    A: Cumulative incidence of diabetes during the time when troglitazone was used, according to treatment assignment. B: Diabetes incidence rates (cases/100 person-years) with 95% CIs during the time when troglitazone was used, according to treatment assignment.

  • FIG. 3.
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    FIG. 3.

    A: Cumulative incidence of diabetes (%) from date of randomization in participants assigned to placebo or troglitazone. B: Cumulative incidence of diabetes (%) from date of discontinuation of troglitazone (4 June 1998) in participants assigned to placebo or troglitazone. C: Diabetes incidence rates (cases/100 person-years) from date of randomization, showing the date of discontinuation of troglitazone (4 June 1998), in participants assigned to placebo or troglitazone.

Tables

  • Figures
  • TABLE 1

    Adherence to study medication

    Treatment
    Placebo group
        M-placebo76%
        T-placebo77%
    Metformin group
        M-active72%
        T-placebo78%
    Troglitazone group
        M-placebo77%
        T-active83%
    • Data are percentages of participants taking ≥80% of study pills averaged throughout the study. M-placebo, placebo pill for metformin; M-active, active metformin pill; T-placebo, placebo pill for troglitazone; T-active, active troglitazone pill.

  • TABLE 2

    Body weight, waist circumference, and FPG and 2-h postload plasma glucose concentrations

    VariableTime (years)Placebo
    Metformin
    Troglitazone
    ILS
    nMeannMeannMeannMean
    Body weight (kg)0.058294.658794.558593.358995.5
    0.538494.538992.837895.238688.1
    1.018295.317293.319697.019189.7
    1.55897.65994.37298.05391.1
    Waist circumference (cm)0.0582105.6586105.0585104.3588106.1
    1.0180105.1172104.4197105.7191100.4
    FPG (mmol/l)0.05825.965875.965855.965895.98
    0.53885.973945.723835.633885.71
    1.01826.001725.801975.661905.75
    1.5586.27615.88725.74546.00
    2-h plasma glucose (mmol/l)0.05829.225879.195859.185899.19
    1.01748.791728.811968.031887.86
    • None of the variables differed significantly between treatment groups at baseline (time = 0). By repeated-measures ANOVA, the troglitazone group differed significantly from each of the others (P < 0.05 adjusted for three comparisons) for body weight and FPG. It differed significantly from the ILS group for waist circumference and from the placebo and metformin groups in 2-h plasma glucose. n, number of participants with the measurement at each time point. Conversion of units for glucose: 1 mg/dl = 0.05551 mmol/l.

  • TABLE 3

    Baseline and follow-up median values of serum insulin-related variables by treatment over time

    VariableTime (years)PlaceboMetforminTroglitazoneILSP difference among four treatments (Kruskal-Wallis)Placebo vs. troglitazoneMetformin vs. troglitazoneILS vs. troglitazone
    n172164187183
    Fasting insulin (pmol/l)01441381321320.58———
    113211190102<0.01††—
    Δ—***<0.01†——
    30-min insulin (pmol/l)05134984984740.72———
    1522447402408<0.01††—
    Δ—**—<0.01††—
    Sensitivity [1/fasting insulin 1,000/(pmol/l)]06.947.257.587.580.58———
    17.589.0211.119.80<0.01††—
    Δ—***<0.01†——
    Sensitivity {ISI 10,000/ [(pmol/l) × (mmol/l)]}011.812.012.312.50.64———
    113.215.419.917.0<0.01††—
    Δ—***<0.01††—
    Secretion {CIR (pmol/l)/ [(mmol/l)2]}010.19.059.589.060.19———
    110.38.4710.158.340.05———
    Δ————0.99———
    Secretion [IGR (pmol/l)/ (mmol/l)]0116.4102.1108.1101.50.24———
    1109.191.1103.291.40.03———
    Δ————0.43———
    • *

      * P < 0.05 for difference from baseline to 1 year (signed-rank test).

    • †

      † P < 0.05 compared with troglitazone (Wilcoxon test, adjusted for multiple comparisons, i.e., unadjusted P < 0.0167). Dash indicates no significant difference; n, number of participants with both baseline and 1-year measurements; Δ, test for difference between baseline and 1 year. Conversion of units: for insulin, 1 μU/ml = 6.0 pmol/l; for glucose, 1 mg/dl = 0.05551 mmol/l.

  • TABLE 4

    Adverse events by treatment assignment

    EventPlaceboMetforminTroglitazoneILS
    n582587585589
    CHF0 (0.0)1 (0.2)0 (0.0)1 (0.2)
    MI2 (0.3)0 (0.0)0 (0.0)2 (0.3)
    Anemia7 (1.2)5 (0.9)7 (1.2)4 (0.7)
    Edema31 (5.3)8 (1.4)27 (4.6)26 (4.4)
    LFT ≥321 (3.6)18 (3.1)25 (4.3)NA
    LFT ≥101 (0.2)0 (0.0)7 (1.2)NA
    • Data are n (%) of individuals in each randomization group experiencing at least one adverse event of the type specified. Liver function tests were not measured on the same schedule in the ILS group. CHF, congestive heart failure; MI, myocardial infarction; LFT ≥3, liver function test (either alanine aminotransferase or aspartate aminotransferase) ≥3 times the upper limit of normal; LFT ≥10, liver function test (either alanine aminotransferase or aspartate aminotransferase) ≥10 times the upper limit of normal; NA, not applicable.

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Prevention of Type 2 Diabetes With Troglitazone in the Diabetes Prevention Program
Diabetes Apr 2005, 54 (4) 1150-1156; DOI: 10.2337/diabetes.54.4.1150

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Prevention of Type 2 Diabetes With Troglitazone in the Diabetes Prevention Program
Diabetes Apr 2005, 54 (4) 1150-1156; DOI: 10.2337/diabetes.54.4.1150
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