Phase 3
Completed N=1,398
The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes
Diabetes · Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT01836523 ↗
Enrolled (actual)
1,398
Serious AEs
9.9%
Results posted
Mar 2017
Primary outcomePrimary: Change From Baseline in HbA1c (Glycosylated Haemoglobin) — -0.45; -0.50; -0.54; -0.34 percentage of glycosylated haemoglobin
◆ Published Evidence
Highly cited
329citations · ~33 / year
Efficacy and Safety of Liraglutide Added to Insulin Treatment in Type 1 Diabetes: The ADJUNCT ONE Treat-To-Target Randomized Trial.
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.
Linked Publications (3)
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Efficacy and Safety of Liraglutide Added to Insulin Treatment in Type 1 Diabetes: The ADJUNCT ONE Treat-To-Target Randomized Trial.
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Efficacy and safety of liraglutide in type 1 diabetes by baseline characteristics in the ADJUNCT ONE and ADJUNCT TWO randomized controlled trials.
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Determinants of Liraglutide Treatment Discontinuation in Type 1 Diabetes: A Post Hoc Analysis of ADJUNCT ONE and ADJUNCT TWO Randomized Placebo-Controlled Clinical Studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c (Glycosylated Haemoglobin) |
-0.45; -0.50; -0.54; -0.34 | — |
| PRIMARY Change From Baseline in Body Weight |
-1.34; -2.73; -4.02; 0.94 | <0.0001 sig |
| PRIMARY Change From Baseline in Total Daily Insulin Dose |
1.04; 0.98; 0.95; 1.04 | <0.0001 sig |
| SECONDARY Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes |
4954; 4602; 4614; 3654 | 0.0081 sig |
Eligibility Criteria
Inclusion Criteria
- - Informed consent obtained
- - Type 1 diabetes mellitus for 12 months or longer
- - Basal bolus or CSII (Continuous Subcutaneous Insulin Infusion, insulin pump) treatment for 6 months or longer
- - Stable insulin treatment for the last 3 months prior to Screening, as judged and documented by the investigator
- - HbA1c 7.0-10% (Diabetes Control and Complications Trial (DCCT)), both inclusive, (corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC))
- - Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, complete trial related questionnaires, diaries, self-monitoring of plasma glucose, self titration of insulin and attend all scheduled visits
Exclusion Criteria
- - Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPP-4) inhibitors
- - Use of any medication, which in the investigator's opinion could interfere with the glycaemic control 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 above 160 mmHg for systolic or above 100 mmHg for diastolic
- - History of acute or chronic pancreatitis
- - Screening calcitonin value equal to or above 50 ng/L
- - Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2 (MEN2)
- - Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
Data sourced from ClinicalTrials.gov (NCT01836523) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.