Primary outcome
What ADJUNCT TWO measured first
| Liraglutide 0.6 mgn=189 | Liraglutide 1.2 mgn=176 | Liraglutide 1.8 mgn=170 | Liraglutide Placebon=190 |
|---|---|---|---|
| -0.23(0.744) | -0.23(0.731) | -0.32(0.73) | 0.01(0.674) |
Phase 3 · Liraglutide
ADJUNCT TWO trial results
A 26-weeks Randomised, Insulin Capped, Placebo-controlled, Double-blind, Parallel Group, Multinational, Multi-centre Trial
Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percent (%) glycosylated haemoglobin), Week 0, Week 26. Liraglutide 0.6 mg: -0.23; Liraglutide 1.2 mg: -0.23; Liraglutide 1.8 mg: -0.32; Liraglutide Placebo: 0.01.
- Participants
- 835
- Status
- completed
- Completed
- 2015-04
- Sponsor
- Novo Nordisk A/S
As posted on ClinicalTrials.gov (NCT02098395), updated at source Feb 9, 2017. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in ADJUNCT TWO
Percent of participants affected, From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26).. The most common events the registry lists.
| Event | Liraglutide 0.6 mg | Liraglutide 1.2 mg | Liraglutide 1.8 mg | Liraglutide Placebo |
|---|---|---|---|---|
| Any serious event | 9.5% | 10% | 6.8% | 6.8% |
| Nausea | 32.2% | 46.4% | 49.5% | 16.5% |
| Decreased appetite | 10% | 19.1% | 24.3% | 4.4% |
| Nasopharyngitis | 20.9% | 19.1% | 22.8% | 22.3% |
| Vomiting | 9% | 13.9% | 17% | 3.4% |
| Diarrhoea | 6.6% | 12% | 14.6% | 8.3% |
| Headache | 7.6% | 12.4% | 14.6% | 14.6% |
| Upper respiratory tract infection | 6.6% | 5.3% | 5.3% | 12.1% |
| Dyspepsia | 3.8% | 9.1% | 11.7% | 0.5% |
| Constipation | 2.8% | 11% | 6.8% | 4.4% |
| Fatigue | 6.2% | 8.1% | 10.7% | 1.5% |
| Influenza | 7.1% | 8.6% | 8.7% | 8.3% |
| Abdominal pain upper | 3.8% | 3.8% | 6.8% | 2.4% |
| Back pain | 1.4% | 2.4% | 3.9% | 6.8% |
| Oropharyngeal pain | 4.7% | 1.9% | 6.8% | 2.9% |
| Abdominal discomfort | 1.4% | 6.7% | 3.4% | 2.9% |
| Hyperglycaemia | 4.7% | 6.2% | 5.8% | 1.9% |
| Gastroenteritis | 2.8% | 5.3% | 3.9% | 2.9% |
| Sinusitis | 3.3% | 5.3% | 1.5% | 1.9% |
Secondary outcomes
What else it measured
| Liraglutide 0.6 mgn=184 | Liraglutide 1.2 mgn=171 | Liraglutide 1.8 mgn=170 | Liraglutide Placebon=180 |
|---|---|---|---|
| -2.37(3.015) | -4.03(3.677) | -5.1(3.787) | -0.26(2.782) |
| Liraglutide 0.6 mgn=211 | Liraglutide 1.2 mgn=209 | Liraglutide 1.8 mgn=206 | Liraglutide Placebon=206 |
|---|---|---|---|
| 1437 | 1943 | 1490 | 1567 |
The trial
How ADJUNCT TWO was run
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.
- Liraglutide 1.8 mg + insulin
- Liraglutide 1.2 mg + insulin
- Liraglutide 0.6 mg + insulin
- Liraglutide placebo 0.3 ml + insulin
- Liraglutide placebo 0.2 ml + insulin
- Liraglutide placebo 0.1 ml + insulin
Who could join the trial
Inclusion Criteria: * Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * Male or female, aged equal to or greater than 18 years at the time of signing informed consent * Type 1 diabetes mellitus (as diagnosed clinically) 12 months or longer prior to Visit 1 (i.e. screening) * Treatment with basal bolus or CSII (continuous subcutaneous insulin infusion, insulin pump) treatment 6 months or longer prior to Visit 1 (i.e. screening) * Stable insulin treatment 3 months or longer prior to Visit 1 (i.e. screening), as judged and documented by the investigator * HbA1c 7.0-10.0 percent (Diabetes Control and Complications Trial (DCCT)), both inclusive, by central laboratory analysis (Visit 1, screening) corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC)) Exclusion Criteria: * Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPPIV) inhibitors * Use of any medication, which in the investigator's opinion could interfere with the glycaemic control (e.g. systemic corticosteroids, pramlintide (Symlin®)) or affect the subject's safety. Premix insulin is not allowed * Known proliferative retinopathy or maculopathy requiring acute treatment * Severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator * Uncontrolled/untreated blood pressure at screening (Visit 1) (after resting for 5 minutes) while sitting greater than 160 mmHg for systolic or greater than 100 mmHg for diastolic (repeated measurement at Visit 2 (prior to performing the trial related activities) is allowed to exclude white-coat hypertension) * History of acute or chronic pancreatitis * Screening (Visit 1) calcitonin value equal to or greater than 50 ng/L
Published papers
Papers from ADJUNCT TWO
- 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.
- 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.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.