Dose response of continuous subcutaneous infusion of recombinant glucagon-like peptide-1 in combination with metformin and sulphonylurea over 12 weeks in patients with type 2 diabetes mellitus

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AIMS: Any differences observed between natural glucagon-like peptide-1 (GLP-1) and studies obtained with analogues might call for renewed considerations concerning the use and design of such analogues. Thus, we aimed to evaluate the dose-response relationship of recombinant glucagon-like peptide-1 (7-36) amide (rGLP-1) administered by continuous subcutaneous infusion (CSCI) in subjects with type 2 diabetes.

METHODS: We compared the efficacy and safety of three doses of recombinant GLP-1, ranging from 1.25 to 5.0 pmol/kg/min (pkm) and placebo, given by continuous subcutaneous infusion over 3 months in combination with metformin and sulphonylurea (SU), to lower haemoglobin A1c (HbA1c), fasting plasma glucose and weight in 95 type 2 diabetes patients with inadequate glycaemic control.

RESULTS: The mean decreases in HbA1c at endpoint (week 12) were significantly greater for all three rGLP-1 dose groups when each was compared with the placebo group, with the greatest decrease occurring in the 5.0 pkm dose group (-1.3%, s.d. ± 0.18, p < 0.001). (-26.0 mg (p =" 0.04).</p" (s.d. ± 1.3) 1.25 pkm 1.8 kg 5.0 pkm all baseline body by decrease decreases dl, dose endpoint fasting for from glucose greater greatest group group, groups in mean occurring only p =" 0.02)." placebo plasma reduced rglp-1 s.d. ± 8.5, significantly than the three to was weight were with>

CONCLUSIONS: Administration of rGLP-1 by CSCI over a 12-week period in combination with metformin and an SU had a dose dependent effect in lowering HbA1c and fasting plasma glucose. However, administration of rGLP-1 by CSCI may be less effective with respect to lowering of body weight compared with the daily and once weekly analogues.

OriginalsprogEngelsk
TidsskriftDiabetes, Obesity and Metabolism
Vol/bind16
Udgave nummer5
Sider (fra-til)451-6
Antal sider6
ISSN1462-8902
DOI
StatusUdgivet - maj 2014

ID: 117418257