TITLE:
Safety and Efficacy of Combination Therapy with Insulin Glargine and Oral Hypoglycaemic Agents Including DPP-4 Inhibitors in Japanese T2DM Patients: ALOHA 2 Study, a Post-Marketing Surveillance for Lantus®
AUTHORS:
Masayuki Kobayashi, Shoko Tsukube, Yukio Ikeda, Yujin Shuto
KEYWORDS:
ALOHA 2, Insulin Glargine, Patient-Reported Outcomes, Post-Marketing Surveillance Study, Type 2 Diabetes
JOURNAL NAME:
Journal of Diabetes Mellitus,
Vol.4 No.4,
October
16,
2014
ABSTRACT: Aims: In the Add-on Lantus®to Oral Hypoglycaemic Agents 2 (ALOHA
2) Study in Japanese adults with type 2 diabetes mellitus (T2DM), data on the
safety and efficacy of combination therapy with insulin glargine (Lantus®)
and oral anti-hyperglycaemic drugs (OADs) including dipeptidyl peptidase-4
(DPP-4) inhibitors in a real-life setting were collected and analyzed. Methods:
This postmarketing surveillance was a prospective, observational, 24-week study
that complied with the pharmaceutical affairs law and the ministerial ordinance
of “Good Post-Marketing Study Practice (GPSP)” in Japan. Safety, efficacy and
patient-reported outcomes (PROs); patients’ satisfaction with treatment (DTSQs
and DTSQc) and patients’ self-reported health (EQ-5D and EQ-VAS) of combination
therapy of insulin glargine and OADs were evaluated. Results: A total of 2,630
patients were enrolled. Of the 2,602 patients in the safety analysis
population, 161 patients experienced 175 cases of adverse drug reactions, and
the major adverse drug reaction was hypoglycaemia (140 patients, 5.38%). Out of
those with hypoglycaemia, 11 patients (0.42%) had severe hypoglycaemia and the
incidence rate (episodes per patient-year) was 0.019. Basal supported oral
therapy (BOT) with insulin glargine substantially reduced the HbA1c, FPG and 2
hour-PPG levels for 24 weeks by -1.61%, -54.4 mg/dL and -74.5 mg/dL
respectively. The mean weight was increased, however the change was +0.50 kg.
In addition, the treatment satisfaction scores of DTSQs (mean treatment satisfaction
score increased 3.6 from baseline to last observation) and DTSQc, EQ-5D index
scores and EQ-VAS scores were significantly improved. Conclusion: Insulin
glargine and OADs combination therapy was suggested to be effective and well
tolerated. Patients’ satisfaction with treatment and their self-reported health
improved in spite of the addition of injections to oral agents. The combination
therapy of insulin glargine and OADs including DPP-4 inhibitors is likely to be
considered an important therapeutic option in the diabetic patients.