What DUAL I Japan measured first
| Insulin Degludec/Liraglutiden=275 | Insulin Degludecn=271 | Liraglutiden=273 |
|---|---|---|
| -2.42(1.04) | -1.80(1.02) | -1.80(0.92) |
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus
Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Non-inferiority of IDegLira vs IDeg and Superiority of IDegLira vs Lira (Percentage of HbA1c), Week 0, Week 52. Insulin Degludec/Liraglutide: -2.42; Insulin Degludec: -1.80; Liraglutide: -1.80.
As posted on ClinicalTrials.gov (NCT02607306), updated at source Apr 9, 2021. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| Insulin Degludec/Liraglutiden=275 | Insulin Degludecn=271 | Liraglutiden=273 |
|---|---|---|
| -2.42(1.04) | -1.80(1.02) | -1.80(0.92) |
Percent of participants affected, Week 0 (randomisation) to week 52 (end of treatment) and 7 days after end of treatment.. The most common events the registry lists.
| Event | Insulin Degludec/Liraglutide | Insulin Degludec | Liraglutide |
|---|---|---|---|
| Any serious event | 6.2% | 4.8% | 5.1% |
| Viral upper respiratory tract infection | 38.5% | 33.6% | 34.4% |
| Constipation | 9.8% | 4.4% | 13.9% |
| Diarrhoea | 5.5% | 4.4% | 8.8% |
| Nausea | 3.3% | 1.8% | 8.4% |
| Weight increased | 1.5% | 7% | 0.4% |
| Diabetic retinopathy | 6.2% | 4.4% | 4% |
| Eczema | 5.8% | 2.2% | 3.3% |
| Headache | 2.5% | 2.6% | 5.5% |
| Influenza | 5.5% | 3.3% | 3.3% |
| Lipase increased | 2.2% | 0% | 5.5% |
| Pharyngitis | 4% | 5.5% | 3.3% |
| Insulin Degludec/Liraglutiden=275 | Insulin Degludecn=271 | Liraglutiden=273 |
|---|---|---|
| 2.9(3.2) | 4.1(4.3) | -1.0(3.4) |
| Insulin Degludec/Liraglutiden=275 | Insulin Degludecn=271 | Liraglutiden=273 |
|---|---|---|
| 467 | 869 | 13 |
| Insulin Degludec/Liraglutiden=275 | Insulin Degludecn=271 | Liraglutiden=273 |
|---|---|---|
| -2.42(1.04) | -1.80(1.02) | -1.80(0.92) |
| Insulin Degludec/Liraglutiden=275 | Insulin Degludecn=271 | Liraglutiden=272 |
|---|---|---|
| -4.08(2.47) | -3.97(2.56) | -2.62(1.95) |
| Insulin Degludec/Liraglutiden=275 | Insulin Degludecn=271 |
|---|---|
| 27.7(14.8) | 34.8(26.0) |
| Measure | Insulin Degludec/Liraglutiden=275 | Insulin Degludecn=271 | Liraglutiden=273 |
|---|---|---|---|
| Yes | 245 | 189 | 208 |
| No | 30 | 82 | 65 |
| Measure | Insulin Degludec/Liraglutiden=275 | Insulin Degludecn=271 | Liraglutiden=273 |
|---|---|---|---|
| Yes | 44 | 22 | 142 |
| No | 231 | 249 | 131 |
| Measure | Insulin Degludec/Liraglutiden=270 | Insulin Degludecn=265 | Liraglutiden=271 |
|---|---|---|---|
| Yes | 227 | 169 | 206 |
| No | 43 | 96 | 65 |
| Measure | Insulin Degludec/Liraglutiden=270 | Insulin Degludecn=265 | Liraglutiden=271 |
|---|---|---|---|
| Yes | 37 | 22 | 141 |
| No | 233 | 243 | 130 |
| Measure | Insulin Degludec/Liraglutiden=275 | Insulin Degludecn=271 | Liraglutiden=273 |
|---|---|---|---|
| Yes | 213 | 134 | 171 |
| No | 62 | 137 | 102 |
| Measure | Insulin Degludec/Liraglutiden=275 | Insulin Degludecn=271 | Liraglutiden=273 |
|---|---|---|---|
| Yes | 41 | 17 | 126 |
| No | 234 | 254 | 147 |
| Measure | Insulin Degludec/Liraglutiden=270 | Insulin Degludecn=265 | Liraglutiden=271 |
|---|---|---|---|
| Yes | 198 | 123 | 170 |
| No | 72 | 142 | 101 |
This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide, insulin degludec and liraglutide in Japanese subjects with type 2 diabetes mellitus.
Inclusion Criteria: * Male or female Japanese subjects, age at least 20 years at the time of signing informed consent * Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening * HbA1c (glycosylated haemoglobin) 7.0-11.0 % (both inclusive) by central laboratory analysis, with the aim of a median of 8.3%. When approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c below or equal to 8.3%; or when approximately 50% of the randomised subjects have a HbA1c below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3% * Body-mass index (BMI) above or equal to 20 kg/m\^2 * Subjects on stable therapy with one OAD (defined as unchanged medication and unchanged dose) for at least 60 days (metformin, a-GI, TZD, SU, SGLT2i or glinide) prior to screening according to approved Japanese labelling Exclusion Criteria: * Previous treatment with insulin (except for short-term treatment in connection with intercurrent illness including gestational diabetes) * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before screening * Anticipated initiation or change in concomitant medications in excess of 14 days known to affect weight or glucose metabolism * Impaired liver function, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal to or above 2.5 times upper limit of normal * Renal impairment estimated Glomerular Filtration Rate (eGFR) below 60mL/min/1.73m\^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) * Screening calcitonin equal to or above 50 ng/L * History of pancreatitis (acute or chronic) * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2) * Subjects presently classified as being in New York Heart Association (NYHA) Class IV
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.