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

Summary

This trial is conducted in Africa, Europe and North America. The purpose of the trial is to investigate the efficacy and safety of liraglutide adjunct to insulin treatment in type 1 diabetes.

Timeline

Start

2014-05

Primary completion

2015-04

Completion

2015-04

Outcome

Met primary endpoint

registry Liraglutide 1.8 mg vs Liraglutide Placebo; p < 0.0001; Mean Difference (Final Values) -0.35 (95% CI -0.5 to -0.2); Mixed Models Analysis NCT02098395 ↗

registry Liraglutide 1.2 mg vs Liraglutide Placebo; p = 0.0021; Mean Difference (Final Values) -0.23 (95% CI -0.38 to -0.08); Mixed Models Analysis NCT02098395 ↗

registry Liraglutide 0.6 mg vs Liraglutide Placebo; p = 0.0011; Mean Difference (Final Values) -0.24 (95% CI -0.39 to -0.1); Mixed Models Analysis NCT02098395 ↗

Publications

• Results Ahren B, Hirsch IB, Pieber TR, Mathieu C, Gomez-Peralta F, Hansen TK, Philotheou A, Birch S, Christiansen E, Jensen TJ, Buse JB; ADJUNCT TWO Investigators. Efficacy and Safety of Liraglutide Added to Capped Insulin Treatment in Subjects With Type 1 Diabetes: The ADJUNCT TWO Randomized Trial. Diabetes Care. 2016 Oct;39(10):1693-701. doi: 10.2337/dc16-0690. Epub 2016 Aug 4.
• Results Hoogenhout M, Malcolm-Smith S. Theory of mind predicts severity level in autism. Autism. 2017 Feb;21(2):242-252. doi: 10.1177/1362361316636758. Epub 2016 Aug 19.
• 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