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Emerging Treatments and Technologies

Glucagon-Like Peptide-1 Infusion Must Be Maintained for 24 h/day to Obtain Acceptable Glycemia in Type 2 Diabetic Patients Who Are Poorly Controlled on Sulphonylurea Treatment

  1. Jens Larsen, MD1,
  2. Birgitte Hylleberg, MSC2,
  3. Kevin Ng, MD3 and
  4. Peter Damsbo, MD1
  1. 1Clinical Development, Diabetes, and
  2. 2Clinical Statistics, Novo Nordisk A/S, Bagsvaerd, Denmark
  3. 3Division of Clinical Pharmacology, University of Miami School of Medicine, Miami, Florida
    Diabetes Care 2001 Aug; 24(8): 1416-1421. https://doi.org/10.2337/diacare.24.8.1416
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      Figure 1—

      24-h plasma glucose profiles for the five groups on day 7. - -⋄- -, placebo group; —▪—, GLP-1 4 ng · kg–1 · min–1 16-h group; —▴—, GLP-1 8 ng · kg–1 · min–1 16-h group; —⧫—, GLP-1 4 ng · kg–1 · min–1 24-h group; —×—, GLP-1 8 ng · kg–1 · min–1 24-h group.

    • Figure 2—
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      Figure 2—

      The left column shows the 24-h plasma glucose profiles on day 0 (□) and on day 7 (▪) for the placebo group and the four active treatment regimens. The curves in the center column represent the corresponding insulin profiles and the curves in the right column represent the glucagon profiles. The bars are SEM.

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    • Table 1—

      Patient characteristics at baseline

      CharacteristicsPlacebo groupGLP-1 4 ng · kg–1 · min–1 16-h groupGLP-1 8 ng · kg–1 · min–1 16-h groupGLP-1 4 ng · kg–1 · min–1 24-h groupGLP-1 8 ng · kg–1 · min–1 24-h group
      n88888
      Female/male (n)1/72/65/33/54/4
      Age range (years)37–6943–6242–6650–6752–68
      Weight range (kg)61–9967–11068–10862–9975–117
      Height range (cm)163–183157–180147–180148–178155–183
      HbA1c (%)9.8 ± 2.69.9 ± 1.99.5 ± 2.38.8 ± 2.210.1 ± 1.4
      FPG (mmol/l)12.7 ± 1.713.5 ± 2.514.2 ± 4.112.5 ± 3.715.9 ± 4.2
      • Data are means ± SD unless otherwise indicated.

    • Table 2—

      24-h mean values and changes from baseline for glucose, insulin, and glucagons

      Placebo groupGLP-1 4 ng · kg–1 · min–1 16-h groupGLP-1 8 ng · kg–1 · min–1 16-h groupGLP-1 4 ng · kg–1 · min–1 24-h groupGLP-1 8 ng · kg–1 · min–1 24-h group
      Glucose (mmol/l)
       Baseline15.315.214.817.218.3
       Change (day 1)−0.2−3.2*−4.4*−4.7*−6.6*†
       Change (day 4)+1.1−3.4*−3.7*−4.6*−10.9*†
       Change (day 7)+1.3−3.9*−4.7*−5.2*−7.7*†
      Insulin (μU/ml)
       Baseline3754493630
       Change−3+3−5−7−7
      Glucagon (pg/ml)
       Baseline84107118115114
       Change+6−7−30‡−24‡−30‡
      • Compared with placebo,

      • *

        ↵* P < 0.001; compared with other active treatments,

      • †

        ↵† P < 0.05; compared with placebo,

      • ‡

        ↵‡ P < 0.05.

    • Table 3—

      Overall AE with a rate of occurrence in two or more patients

      Placebo groupGLP-1 4 ng · kg–1 · min–1 16-h groupGLP-1 8 ng · kg–1 · min–1 16-h groupGLP-1 4 ng · kg–1 · min–1 24-h groupGLP-1 8 ng · kg–1 · min–1 24-h group
      Patients with at least one event65747
      Total number of unique events141421729
      Cellulitis20012
      Fever11002
      Chills01001
      Headache32223
      Injection site reaction20002
      Abdominal pain22201
      Back pain00103
      Diarrhea00101
      Dyspepsia00322
      Nausea12404
      Vomiting12313
      Dizziness01301
      Tremor01001
      • Data are n.

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    Diabetes Care: 24 (8)

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    August 2001, 24(8)
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    Glucagon-Like Peptide-1 Infusion Must Be Maintained for 24 h/day to Obtain Acceptable Glycemia in Type 2 Diabetic Patients Who Are Poorly Controlled on Sulphonylurea Treatment
    Jens Larsen, Birgitte Hylleberg, Kevin Ng, Peter Damsbo
    Diabetes Care Aug 2001, 24 (8) 1416-1421; DOI: 10.2337/diacare.24.8.1416

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    Glucagon-Like Peptide-1 Infusion Must Be Maintained for 24 h/day to Obtain Acceptable Glycemia in Type 2 Diabetic Patients Who Are Poorly Controlled on Sulphonylurea Treatment
    Jens Larsen, Birgitte Hylleberg, Kevin Ng, Peter Damsbo
    Diabetes Care Aug 2001, 24 (8) 1416-1421; DOI: 10.2337/diacare.24.8.1416
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