The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes

Summary

This trial is conducted globally. The aim of the trial is to confirm the efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes. The total trial duration per subject is approximately 58 weeks.

Timeline

Start

2013-11

Primary completion

2015-06

Completion

2015-06

Outcome

Mixed primary results

registry analysis (superiority or other test); Liraglutide 1.8 mg vs Placebo; p <0.0001; Treatment difference -4.90 (95% CI -5.65 to -4.16); Mixed Models Analysis NCT01836523 ↗

registry analysis (superiority or other test); Liraglutide 0.6 mg vs Placebo; p = 0.9615; Treatment ratio 1.00 (95% CI 0.96 to 1.04); Mixed Models Analysis NCT01836523 ↗

Publications

• Results Mathieu C, Zinman B, Hemmingsson JU, Woo V, Colman P, Christiansen E, Linder M, Bode B; ADJUNCT ONE Investigators. Efficacy and Safety of Liraglutide Added to Insulin Treatment in Type 1 Diabetes: The ADJUNCT ONE Treat-To-Target Randomized Trial. Diabetes Care. 2016 Oct;39(10):1702-10. doi: 10.2337/dc16-0691. Epub 2016 Aug 9.
• Shah VN, Agesen RM, Bardtrum L, Christiansen E, Snaith J, Greenfield JR. Determinants of Liraglutide Treatment Discontinuation in Type 1 Diabetes: A Post Hoc Analysis of ADJUNCT ONE and ADJUNCT TWO Randomized Placebo-Controlled Clinical Studies. J Diabetes Sci Technol. 2025 Mar;19(2):321-331. doi: 10.1177/19322968241305647. Epub 2024 Dec 24.
• Dejgaard TF, von Scholten BJ, Christiansen E, Kreiner FF, Bardtrum L, von Herrath M, Mathieu C, Madsbad S; ADJUNCT ONE and ADJUNCT TWO Investigators. Efficacy and safety of liraglutide in type 1 diabetes by baseline characteristics in the ADJUNCT ONE and ADJUNCT TWO randomized controlled trials. Diabetes Obes Metab. 2021 Dec;23(12):2752-2762. doi: 10.1111/dom.14532. Epub 2021 Sep 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Liraglutide	Peptide	0.6 mg	Subcutaneous
Subject	Liraglutide	Peptide	1.2 mg	Subcutaneous
Subject	Liraglutide	Peptide	1.8 mg	Subcutaneous

Indications