The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes. A 52-week Randomised, Treat-to-target, Placebo-controlled, Double Blinded, Parallel Group, Multinational, Multi-centre Trial
Change From Baseline in HbA1c (Glycosylated Haemoglobin) (percentage of glycosylated haemoglobin), Week 0, week 52. Liraglutide 0.6 mg: -0.45; Liraglutide 1.2 mg: -0.50; Liraglutide 1.8 mg: -0.54; Placebo: -0.34.
As posted on ClinicalTrials.gov (NCT01836523), updated at source Mar 6, 2017. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| Liraglutide 0.6 mgn=334 | Liraglutide 1.2 mgn=312 | Liraglutide 1.8 mgn=305 | Placebon=324 |
|---|---|---|---|
| -0.45(0.741) | -0.50(0.767) | -0.54(0.729) | -0.34(0.707) |
| Liraglutide 0.6 mgn=324 | Liraglutide 1.2 mgn=300 | Liraglutide 1.8 mgn=298 | Placebon=311 |
|---|---|---|---|
| -1.34(4.183) | -2.73(4.524) | -4.02(4.873) | 0.94(3.828) |
| Liraglutide 0.6 mgn=337 | Liraglutide 1.2 mgn=328 | Liraglutide 1.8 mgn=331 | Placebon=341 |
|---|---|---|---|
| 1.04(23.75) | 0.98(26.66) | 0.95(24.21) | 1.04(26.69) |
Percent of participants affected, Up to 52 weeks. The most common events the registry lists.
| Event | Liraglutide 0.6 mg | Liraglutide 1.2 mg | Liraglutide 1.8 mg | Placebo |
|---|---|---|---|---|
| Any serious event | 10% | 10.3% | 8.4% | 10.9% |
| Nausea | 32% | 40.5% | 49.6% | 12.1% |
| Nasopharyngitis | 30% | 23.3% | 23.9% | 24.4% |
| Diarrhoea | 11.7% | 14.4% | 18.4% | 10.9% |
| Vomiting | 6.9% | 12.6% | 18.4% | 6% |
| Decreased appetite | 8.9% | 12.4% | 18.4% | 1.7% |
| Headache | 16% | 13.2% | 14.1% | 11.5% |
| Upper respiratory tract infection | 9.4% | 6.6% | 12.4% | 11.5% |
| Dyspepsia | 7.4% | 7.8% | 11% | 2.3% |
| Abdominal pain | 5.7% | 4.6% | 8.4% | 2.3% |
| Gastroenteritis | 6% | 4.3% | 8.4% | 4.3% |
| Influenza | 8.3% | 4.9% | 7.2% | 6.9% |
| Oropharyngeal pain | 4.3% | 6.3% | 8.1% | 3.7% |
| Constipation | 4.9% | 8% | 7.5% | 2.6% |
| Hypoglycaemia | 7.4% | 3.7% | 5.8% | 6.9% |
| Sinusitis | 6.9% | 4.9% | 4.6% | 6% |
| Fatigue | 4.9% | 6.3% | 5.2% | 4.6% |
| Hyperglycaemia | 4.9% | 4.9% | 6.3% | 4.9% |
| Back pain | 4.3% | 6.3% | 5.2% | 4.6% |
| Cough | 4% | 2% | 2.9% | 6% |
| Urinary tract infection | 5.1% | 4% | 5.8% | 3.2% |
| Gastroenteritis viral | 3.4% | 1.7% | 5.2% | 2.3% |
| Liraglutide 0.6 mgn=350 | Liraglutide 1.2 mgn=348 | Liraglutide 1.8 mgn=347 | Placebon=348 |
|---|---|---|---|
| 4954 | 4602 | 4614 | 3654 |
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.
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)
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.