Insulin Glargine 100 Units/mL Alone or in Combination with Short-Acting Insulin in the Management of Uncontrolled Type 2 Diabetes Mellitus: A Prospective Real-Life Study from Egypt (DIAMOND)

Abstract Background: Recent reports reveal growing evidence of the effectiveness of insulin glargine (Lantus®), a long-acting human insulin analogue, in the management of poorly con-trolled type 2 diabetes mellitus (T2DM). In the present real-life study.
Aim of the Study: To investigate the safety and efficacy of insulin glargine in treating patients with T2DM that are poorly controlled on oral anti-diabetic drugs (OADs).
Subjects and Methods: In this prospective observational study conducted in Egypt from 2014 to 2016, a total of 1008 people with poorly controlled T2DM were enrolled, and for whom the investigator decided to prescribe insulin glargine with or without short-acting insulin. The decision of adding-on OADs or short-acting insulin was left to the investigators to reflect the "in-practice" approach. Patients were followed up for six months and efficacy and safety outcomes were measured throughout the study period. The primary efficacy endpoint was the change in HbA1c levels from the baseline to the final visit. Results: At the end of follow-up, the mean HbA1c levels decreased significantly from 9.6±1.3% at the baseline to 7.3±0.9% (p<0.00 1). After three months of treatment, 10.2% of the patients achieved the targeted HbA1c £7%, and 1.6% of the patients achieved HbA1c £6.5%. At sixth months, 34.8% of the patients achieved the targeted HbA1c £7%, and 10.7% of the patients achieved HbA1c £6.5%. The differences between patients receiving insulin glargine, with or without OADs, and patients receiving insulin glargine plus short-acting insulin were not statistically significant (p>0.05). A total of 17 hypoglycemia events (11 categorized as serious) and one hyperglycemic event were recorded.
Conclusion: Under real-world clinical practice insulin glargine 100U/ml as add-on to OADs, or in combination with prandial insulin, demonstrated a good efficacy and safety profile in people with T2DM uncontrolled previous on OAD therapy.