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Basal insulin peglispro delivers HbA1c reductions, ALT and liver fat elevations

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BOSTON – Basal insulin peglispro reduced HbA1c more frequently than insulin glargine in patients with type 2 diabetes, according to results of three phase 3 clinical trials reported at the American Diabetes Association’s 75th Scientific Sessions.

In addition, the ADA’s recommended HbA1c target of less than 7% was reached by more patients with insulin peglispro than with insulin glargine.

Melanie Davies

Insulin peglispro was also associated with an elevation in the liver enzyme alanine aminotransferase (ALT) and increased liver fat.

Overview of IMAGINE 2, 4, 5

In the 52-week noninferiority IMAGINE 2 trial, Melanie Davies, MD, of the University of Leicester, U.K., and colleagues from other institutions, randomly assigned patients with type 2 diabetes who had not previously used insulin but were prescribed oral antidiabetes medications to evening insulin peglispro (n = 1,003) or insulin glargine (n = 535).

In the 26-week treat-to-target IMAGINE 4 trial, Thomas Blevins, MD, of the University of Texas at Austin, and colleagues from other institutions, randomly assigned patients with type 2 diabetes with HbA1c between 7% and 12% taking at least 1 insulin injection per day to either basal insulin peglispro (n = 691) or insulin glargine (n = 678). Patients could also take metformin.

Thomas Belvins

In the 52-week noninferiority, open-label IMAGINE 5 trial, John B. Buse, MD, of the University of North Carolina School of Medicine, and colleagues at other institutions, randomly assigned patients with type 2 diabetes with HbA1c levels of no more than 9%, who were prescribed basal insulin alone or up to three oral antidiabetes medications, to basal insulin peglispro (n = 307) or insulin glargine (n = 159).

Effect on HbA1c levels

In all three studies, patients assigned insulin peglispro had lower HbA1c compared with insulin glargine (at week 52 in IMAGINE 2: 6.9% vs. 7.2%, P < .001; at week 26 in IMAGINE 4: 6.8% vs. 7%, P < .001; at week 52 in IMAGINE 5: 6.8% vs. 7.2%, P < .001). Significantly more patients reached the HbA1c target of less than 7% in the insulin peglispro groups compared with insulin glargine groups (at week 52 in IMAGINE 2: 58% vs. 43%, P < .001; at week 26 in IMAGINE 4: 63% vs. 53%, P < .001; at week 52 in IMAGINE 5: 64% vs. 46%, P < .001).

Patients assigned insulin peglispro in IMAGINE 2 and IMAGINE 4 gained less weight compared with patients assigned insulin glargine (at week 52 in IMAGINE 2: 2.4 kg vs. 2.6 kg, P = .046; at week 26 in IMAGINE 4: 1.3 kg vs. 2.2 kg, P < .001).

John B. Buse

Effect on liver function

In all studies, patients taking insulin peglispro had an increase in ALT compared with those assigned insulin glargine; more insulin peglispro patients also had ALT at least 3 times the upper levels of normal (at week 52 in IMAGINE 2: 2.3% vs. 0.6%, P = .012; at week 26 in IMAGINE 4: 1.9% vs. 0.9%, P = .16; at week 52 in IMAGINE 5: 2.3% vs. 0%, P = .101), with no cases of Hy’s law.

Liver fat content, measured by MRI, was higher in patients assigned insulin peglispro compared with insulin glargine in all studies.

“[Patients] with [type 2] diabetes moving onto insulin [peglispro] showed some clear patient-related advantages,” Davies told Endocrine Today. “Better glycemic control as shown by HBA1c, fasting glucose and self-monitoring glucose levels at some times of the day before meals, more patients getting to an HbA1 c goal of less than 7%, lower weight gain compared to insulin glargine — which is an important consideration in our patients. ... Having this combination of benefits for patients is highly valuable.” – by Jill Rollet

Reference s :

Blevins, T, et al. Abstract 985-P.

Buse, JBB, et al. Abstract 984-P.

Davies MJ, et al. Abstract 93-OR.

All presented at: American Diabetes Association’s 75th Scientific Sessions; June 5-9, 2015; Boston.

Disclosure: Blevins reports financial relationships with AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceutical Companies of Johnson & Johnson, Mylan, Merck & Co., Novo Nordisk Inc. and Sanofi U.S. Buse reports financial relationships with Andromeda, AstraZeneca, Boehringer Ingelheim GmbH, Bristol-Myers Squibb Company, Elcelyx Therapeutics, Inc., Eli Lilly and Company, GI Dynamics, Inc., GlaxoSmithKline, Halozyme Therapeutics, F. Hoffmann-La Roche, Ltd., Intarcia Therapeutics, Inc., Johnson & Johnson, Lexicon, LipoScience, Inc., Medtronic, Inc., Merck & Co., Inc., Metabolon, Inc., Metavention, Novo Nordisk A/S, Orexigen Therapeutics, Inc., Osiris Therapeutics, Inc., Pfizer Inc., PhaseBio Pharmaceuticals, Inc., Quest Diagnostics, Rhythm Pharmaceuticals, Sanofi, Spherix Inc., Takeda, ToleRx, TransTech Pharma, LLC. Davies reports financial relationships with AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck Sharp & Dohme, Mitsubishi Tanabe Pharma Corporation, Novo Nordisk and Sanofi-Aventis.