MD Conference Express - ENDO 2015 - (Page 14)
ClINICAl TrIAl HIGHlIGHTS
placebo responders (69.2% vs 44.4%, respectively) than in
liraglutide and placebo nonresponders (67.2% vs 39.6%,
respectively). Responders had lower rates of AEs leading
to withdrawal (liraglutide, 4.5%; placebo, 0.9%). In nonresponders, the figures were 17% for liraglutide vs 4.8% for
placebo.
Liraglutide responders had greater improvements
than nonresponders across a range of efficacy outcomes.
Overall, weight loss ≥ 5% was achieved in a higher proportion of patients on liraglutide, 3 mg, with a stronger
effect among responders. The rates of AEs were largely
equivalent in responders and nonresponders.
A mean weight loss of 11.7% was achieved by patients
who were overweight or obese without diabetes and
responded to liraglutide. The weight loss responders
in both treatment groups also had improved glycemic,
cardiometabolic, and health-related quality-of-life outcomes. The SCALE-Obesity and Prediabetes trial showed
that liraglutide is a safe and effective weight loss option
in the study population.
Significant HbA1c Reduction
With Empagliflozin/
Linagliptin Combination
Written by Rita Buckley
One tablet of empagliflozin and linagliptin significantly
reduced HbA1c in patients with type 2 diabetes. Andrew
J. Lewin, MD, National Research Institute, Los Angeles,
California, USA, and colleagues conducted a randomized, double-blind, parallel-group, phase 3 study, the
Safety and Efficacy of the Combination of Empagliflozin
and Linagliptin Compared to Linagliptin Alone Over
24 Weeks in Patients With Type 2 Diabetes study
[Lewin A et al. Diabetes Care. 2015].
Empagliflozin reduces renal glucose reabsorption,
thereby increasing urinary glucose excretion. This leads to
a decline in plasma glucose levels in an insulin-independent
manner [Heise T et al. Diabetes Obes Metab. 2013].
Linagliptin prevents the inactivation of incretin peptides,
such as glucagon-like peptide-1 (GLP-1), stimulates insulin
release, and inhibits glucagon secretion [Gallwitz B. Diabetes
Metab Syndr Obes. 2013]. Each drug is an FDA-approved
treatment for patients with type 2 diabetes. As compared
with the single agent treatment groups, those treated with
the dual combination achieved lower A1c levels.
Efficacy was evaluated in 667 patients who had not
received antihyperglycemic therapy for ≥ 12 weeks. Their
mean (standard deviation) age was 54.6 (10.2) years;
mean weight was 87.9 (20.1) kg; average body mass index
was 31.6 (5.6) kg/m2; and mean HbA1c level was 8.02%
14
May 2015
(0.96). Baseline characteristics were balanced between
treatment groups.
Patients were randomized (1:1:1:1:1) to receive empagliflozin 25 mg/linagliptin 5 mg as a fixed-dose combination (FDC) tablet; empagliflozin 10 mg/linagliptin 5 mg
as an FDC tablet; empagliflozin 25 mg; empagliflozin
10 mg; or linagliptin 5 mg for 52 weeks. The primary end
point was the change from baseline in HbA1c at week 24.
At week 24, reductions from baseline in HbA1c were significantly greater for empagliflozin 25 mg/linagliptin 5 mg
compared with linagliptin 5 mg (P < .001), but not compared
with empagliflozin 25 mg (P < .179), and were significantly
greater for empagliflozin 10 mg/linagliptin 5 mg compared
with individual doses (P < .001 for both). At week 24, 55.4%
of patients with baseline HbA1c ≥ 7% reached HbA1c < 7% with
empagliflozin 25 mg/linagliptin 5 mg; 62.3% did so with
empagliflozin 10 mg/linagliptin 5 mg; 41.5% with empagliflozin 25 mg; 38.8% with empagliflozin 10 mg; and 32.3%
with linagliptin 5 mg. Efficacy was maintained at week 52.
The proportion of patients with adverse events over
this time was similar across groups (68.9% to 81.5%),
with no confirmed hypoglycemic adverse events in either
combination group. Empagliflozin/linagliptin was welltolerated, with an overall safety profile similar to those of
the individual drugs.
This was the first randomized controlled trial to evaluate the efficacy and safety of the initial combination of
a sodium-glucose cotransporter 2 (SGLT2) inhibitor
(empagliflozin) and a DPP-4 inhibitor (linagliptin) in
patients with type 2 diabetes.
ATL1103 Effective in Reducing IGF-1
Levels in Patients With Acromegaly
Written by Jill Shuman
Acromegaly is a chronic disorder resulting from excessive
secretion of growth hormone, with a resulting increase
in the production of the hormone known as insulinlike
growth factor 1 (IGF-1). ATL1103 is a second-generation
antisense drug designed to silence growth hormone
receptor expression, thereby reducing levels of IGF-1 in
the blood. It is currently under investigation as a potential treatment for diseases associated with excessive
growth hormone action, such as acromegaly [Störmann S,
Schopohl J. Expert Opin Emerg Drugs. 2014].
Peter J. Trainer, MD, The Christie National Health
Service Foundation Trust, Manchester, United Kingdom,
reported primary efficacy results from the phase 2
clinical trial of ATL1103 in patients with acromegaly
[2012-003147-30]. The ATL1103 phase 2 trial was a randomized, open-label, multicenter, parallel group study
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Contents
MD Conference Express - ENDO 2015
MD Conference Express - ENDO 2015 - (Page Cover1)
MD Conference Express - ENDO 2015 - (Page Cover2)
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MD Conference Express - ENDO 2015 - Contents (Page 1)
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