ADA:Treatment
with a Sustained Release Formulation of GLP-1
Induces
Weight Loss in Patients with Type 2 Diabetes.
The
human incretin hormone GLP-1 has several antidiabetic actions which
have been demonstrated in patients with type 2 diabetes: Strictly
glucose-dependant stimulation of insulin secretion, suppression of
glucagon levels, delay of gastric emptying, and weight loss.
Since
native GLP-1 is rapidly degraded by the peptidase DPP IV, a sustained
release formulation of a DPP IV resistant analogue, LY307161SR, was
developed for single daily administration.
In
this study, 24 patients with Type 2 diabetes (age: 58+/-1.5 y; weight:
90.9+/-2.1 kg; BMI: 30.2 +/-0.6 kg/m2;
HbA1c: 7.3+/-0.1 %; on diet (16), metformin (7), or metformin plus
sulfonylurea participated in a single blind dose-escalation study.
Patients received LY307161 SR treatment as a single injection prior to
breakfast with either 2.5 mg or 3.5 mg for 6 days. In a third group a
dose of 4.5 mg was given for 21 days.
Treatment
with LY307161 SR was well tolerated.. Once daily administration of
LY307161 SR resulted in sustained drug concentrations for the duration
of the 24 hour dosing interval. LY307161 plasma concentrations after
once daily dosing for 6 days were approximately 3-fold higher than
single dose values. Mean average LY307161 concentrations ranged from
370 to 620 pg/mL across the entire dose range.
Fasting
glucose was lowered by 19, 24, and 15% and 2 hour post prandial
glucose peaks were reduced by 26, 37, and 27% in the 2.5, 3.5, and 4.5
mg dosing groups, respectively, compared to pre-treatment values.
No
hypoglycemia was observed. Body weight was lowered at all doses. Six
day treatment with 2.5 and 3.5 mg/d resulted in 1.1+/-0.7kg (1.2%) and
1+/-0.7 kg (1%) weight loss respectively. Following 4.5 mg/d for 21
days patients had lost 2.1+/-0.5 kg (2.3%) body weight, indicating a
continuous weight reducing effect..
LY307161
SR may offer a unique new treatment for patients with type 2 diabetes
that combines the benefits of weight loss with improved glycemic
control. American
Diabetes Association's 62nd Annual Scientific Sessions
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