What DUAL III measured first
| Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)n=292 | Liraglutide or Exenatide + OADsn=146 |
|---|---|
| -1.32(0.05) | -0.37(0.07) |
The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy (DUAL™ III -GLP-1 Switch)
Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2) (percentage of glycosylated haemoglobin), Week 0, week 26. Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs): -1.32; Liraglutide or Exenatide + OADs: -0.37.
As posted on ClinicalTrials.gov (NCT01676116), updated at source Jan 3, 2019. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)n=292 | Liraglutide or Exenatide + OADsn=146 |
|---|---|
| -1.32(0.05) | -0.37(0.07) |
Percent of participants affected, Adverse events from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (week 27) are reported.. The most common events the registry lists.
| Event | Insulin Degludec/Liraglutide +OADs | Liraglutide or Exenatide + OADs |
|---|---|---|
| Any serious event | 3.1% | 2.1% |
| Nasopharyngitis | 8.9% | 13.1% |
| Lipase increased | 10% | 4.8% |
| Headache | 9.3% | 6.2% |
| Upper respiratory tract infection | 6.2% | 5.5% |
| Diarrhoea | 4.5% | 5.5% |
| Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)n=292 | Liraglutide or Exenatide + OADsn=146 |
|---|---|
| 75.3 | 35.6 |
| Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)n=292 | Liraglutide or Exenatide + OADsn=146 |
|---|---|
| 63 | 22.6 |
| Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)n=292 | Liraglutide or Exenatide + OADsn=146 |
|---|---|
| 2(3.9) | -0.8(3.0) |
| Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)n=285 | Liraglutide or Exenatide + OADsn=145 |
|---|---|
| -2.98(2.28) | -0.6(2.74) |
| Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)n=291 | Liraglutide or Exenatide + OADsn=145 |
|---|---|
| 281.7 | 12.1 |
| Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)n=291 | Liraglutide or Exenatide + OADsn=145 |
|---|---|
| 410.1 | 364.3 |
| Measure | Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)n=290 | Liraglutide or Exenatide + OADsn=146 |
|---|---|---|
| TRIM-D Treatment Burden Score | 10.8(18.8) | 5.7(19.3) |
| TRIM-D Daily Life Score | 6.3(18.4) | 0.8(18.2) |
| TRIM-D Diabetes Management Score | 10.9(21.3) | 4.1(19.8) |
| TRIM-D Compliance Score | 8.9(17.3) | 4.3(15.9) |
| TRIM-D Psychological Health Score | 7.3(14.7) | 1.4(16.5) |
| TRIM-D Total Score | 8.7(12) | 3.1(12.2) |
| Measure | Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)n=290 | Liraglutide or Exenatide + OADsn=146 |
|---|---|---|
| Treatment satisfaction scale total | 3.1(5.6) | 1.1(5.0) |
| Hyperglycaemia | -1.8(2.1) | -0.6(1.9) |
| Hypoglycaemia | 0.2(1.7) | -0.1(1.5) |
This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like peptide-1 (GLP-1) receptor agonist and OAD therapy.
Inclusion Criteria: * Subjects with type 2 diabetes mellitus * Glycosylated haemoglobin (HbA1c) 7.0-9.0% (53-75 mmol/mol) (both inclusive) * Treatment with daily GLP-1 receptor agonist at maximum dose according to local label (i.e. 1.8 mg once daily (OD) Victoza® (liraglutide) or 10 microgram twice daily (BID) Byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg OD Victoza® (liraglutide) or 5 microgram BID Byetta® (exenatide)) in combination with a stable daily dose of metformin (equal to or above 1500 mg or documented maximum tolerated dose) for 90 days or more prior to screening visit (Visit 1) * BMI (body mass index) equal to or below 40 kg/m\^2 Exclusion Criteria: * Any use of oral anti-diabetic drugs (OADs) (except for metformin, pioglitazone and sulphonylurea) for 90 days or less prior to screening visit (Visit 1) * Use of any drug (except metformin,pioglitazone, sulphonylurea and GLP-1 receptor agonist) which in the Investigator's opinion could interfere with the blood glucose level (e.g. systemic corticosteroids) * Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator) * Screening calcitonin equal to or above 50 ng/l * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) * Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary, carotid or peripheral artery revascularisation procedures * Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigator's opinion * Subjects with a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the type 2 diabetes mellitus), neurological, genitourinary or haematological system that in the opinion of the Investigator may confound the results of the trial or pose additional risk in administering trial products * History of chronic pancreatitis or idiopathic acute pancreatitis
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.