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  • Variables associated with HbA1c and weight reductions when adding liraglutide to multiple daily insulin injections in persons with type 2 diabetes (MDI Liraglutide trial 3)

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Clinical Care/Education/Nutrition
Variables associated with HbA1c and weight reductions when adding liraglutide to multiple daily insulin injections in persons with type 2 diabetes (MDI Liraglutide trial 3)
  1. Sofia Dahlqvist1,
  2. Elsa Ahlén1,2,3,
  3. Karin Filipsson4,5,
  4. Thomas Gustafsson6,
  5. Irl B Hirsch7,
  6. Jaakko Tuomilehto8,9,10,
  7. Henrik Imberg11,12,
  8. Bo Ahrén4,
  9. Stig Attvall3,
  10. Marcus Lind1,3
  1. 1Department of Medicine, NU Hospital Group, Uddevalla, Sweden
  2. 2Värnamo Hospital, Värnamo, Sweden
  3. 3Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden
  4. 4Department of Clinical Sciences Lund, Lund University, Lund, Sweden
  5. 5Department of Endocrinology, Skåne University Hospital, Scania, Sweden
  6. 6Department of Clinical Chemistry, Karolinska University Hospital, Stockholm, Sweden
  7. 7Division of Metabolism, Endocrinology, and Nutrition, University of Washington, Seattle, Washington, USA
  8. 8Department of Chronic Disease Prevention, National Institute for Health and Welfare, Helsinki, Finland
  9. 9Diabetes Research Group, King Abdulaziz University, Jeddah, Saudi Arabia
  10. 10Research Division, Dasman Diabetes Institute, Dasman, Kuwait
  11. 11Statistiska Konsultgruppen, Gothenburg, Sweden
  12. 12Department of Mathematical Sciences, Chalmers University of Technology and University of Gothenburg, Gothenburg, Sweden
  1. Correspondence to Sofia Dahlqvist; sofia.dahlqvist{at}hotmail.com

Abstract

Objective To evaluate variables associated with hemoglobin A1c (HbA1c) and weight reduction when adding liraglutide to persons with type 2 diabetes treated with multiple daily insulin injections (MDI).

Research design and methods This was a reanalysis of a previous trial where 124 patients were enrolled in a double-blind, placebo-controlled, multicenter randomized trial carried out over 24 weeks. Predictors for effect on change in HbA1c and weight were analyzed within the treatment group and with concurrent interaction analyses. Correlation analyses for change in HbA1c and weight from baseline to week 24 were made.

Results The mean age at baseline was 63.7 years, 64.8% were men, the mean number of insulin injections was 4.4 per day, the mean daily insulin dose was 105 units and the mean HbA1c was 74.5 mmol/mol (9.0%). The mean HbA1c and weight reductions were 12.3 mmol/mol (1.13%; P<0.001) and 3.8 kg (P<0.001) greater in liraglutide than placebo-treated persons. There was no significant predictor for greater effect on HbA1c that existed in all analyses (univariate, multivariate and interaction analyses against controls). For a greater weight reduction when adding liraglutide, a lower HbA1c level at baseline was a predictor (liraglutide group P=0.002, P=0.020 for liraglutide group vs placebo). During follow-up in the liraglutide group, no significant correlation was found between change in weight and change in HbA1c (r=0.09, P=0.46), whereas a correlation existed between weight and insulin dose reduction (r=0.44, P<0.001).

Conclusion Weight reduction becomes greater when adding liraglutide in patients with type 2 diabetes treated with MDI who had a lower HbA1c level compared with those with a higher HbA1c level. There was no correlation between reductions in HbA1c and weight when liraglutide was added, that is, different patient groups responded with HbA1c and weight reductions.

Trial registration number EudraCT nr: 2012-001941-42.

  • liraglutide
  • predictive variables
  • HbA1c
  • weight

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjdrc-2017-000464

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    Footnotes

    • Contributors ML, SA, JT and IH designed the study. SD, KF and ML were involved in carrying out the study. HI analyzed the data, and all authors took part in interpreting the data. SD and EA wrote the first draft of the manuscript. All authors revised the manuscript and approved the final version.

    • Funding The current study was an investigator-initiated trial, where Novo Nordisk provided financial support and study drugs but had no role in the design or execution of the trial; the interpretation, analysis or publication of data; or the decision to submit the written report. NordicInfu Care provided continuous glucose monitoring systems.

    • Competing interests SD’s institution received grants from Novo Nordisk during the conduct of the study. KF has been a consultant or speaker for Novo Nordisk, Eli Lilly and Boehringer Ingelheim. IH has been a consultant for Abbott Diabetes Care, Adocia, Intarcia, Roche, Bigfoot and Valeritas. JT has received grants from Bayer Pharma, Boehringer Ingelheim, Merck Serono and MSD outside the submitted work, and has acted as a consultant, advisory board member or speaker for Merck Serono, Orion Pharma, Renova and MSD, and is a share owner in Orion Pharma. BA has received lecture fees from Novartis, Merck, Sanofi and Novo Nordisk, and has received grants from Novartis and Merck outside the submitted work. ML’s institution received grants from Novo Nordisk during the conduct of the study. ML has received honoraria or been a consultant for AstraZeneca, Eli Lilly and Novo Nordisk, participated in advisory boards for Novo Nordisk and received research grants from AstraZeneca and Dexcom outside the submitted work.

    • Patient consent Obtained.

    • Ethics approval The trial was approved by the ethics committee of the University of Gothenburg, Gothenburg, Sweden (diary no 956–12).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement The relevant anonymized patient-level data are available on reasonable request from the senior author (lind.marcus@telia.com).