What DUAL II China measured first
| Insulin Degludec/Liraglutiden=289 | Insulin Degludecn=138 |
|---|---|
| -1.93(1.14) | -1.06(1.19) |
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Therapy and Metformin With or Without One Other OAD
Change in HbA1c (Percentage point of HbA1c), Week 0, week 26. Insulin Degludec/Liraglutide: -1.93; Insulin Degludec: -1.06.
As posted on ClinicalTrials.gov (NCT03175120), updated at source Mar 19, 2020. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| Insulin Degludec/Liraglutiden=289 | Insulin Degludecn=138 |
|---|---|
| -1.93(1.14) | -1.06(1.19) |
Percent of participants affected, Weeks 0-30. The most common events the registry lists.
| Event | Insulin Degludec/Liraglutide | Insulin Degludec |
|---|---|---|
| Any serious event | 4.3% | 4.6% |
| Upper respiratory tract infection | 12.6% | 17.9% |
| Lipase increased | 12% | 2% |
| Diabetic retinopathy | 11.6% | 7.3% |
| Diarrhoea | 7.3% | 1.3% |
| Decreased appetite | 7% | 2% |
| Insulin Degludec/Liraglutiden=288 | Insulin Degludecn=139 |
|---|---|
| -0.7(3.0) | 0.5(2.7) |
| Insulin Degludec/Liraglutiden=301 | Insulin Degludecn=151 |
|---|---|
| 38 | 36 |
| Insulin Degludec/Liraglutiden=289 | Insulin Degludecn=139 |
|---|---|
| -3.57(3.00) | -2.82(3.15) |
| Insulin Degludec/Liraglutiden=288 | Insulin Degludecn=139 |
|---|---|
| -0.4(4.3) | 0.7(3.3) |
| Insulin Degludec/Liraglutiden=272 | Insulin Degludecn=133 |
|---|---|
| -3.35(2.63) | -2.31(2.61) |
| Insulin Degludec/Liraglutiden=280 | Insulin Degludecn=134 |
|---|---|
| 0.08(2.19) | 0.28(2.71) |
| Insulin Degludec/Liraglutiden=290 | Insulin Degludecn=139 |
|---|---|
| 34.6(11.1) | 37.9(10.8) |
| Measure | Insulin Degludec/Liraglutiden=302 | Insulin Degludecn=151 |
|---|---|---|
| Before breakfast | 5.48(1.06) | 5.88(1.30) |
| 90 minutes after start of breakfast | 9.51(2.66) | 10.50(2.45) |
| Before lunch | 6.93(2.10) | 8.17(3.19) |
| 90 minutes after start of lunch | 9.68(2.52) | 11.21(2.93) |
| Before main evening meal | 7.24(2.16) | 7.87(2.65) |
| 90 minutes after main evening meal | 9.87(2.53) | 10.86(2.46) |
| At bedtime | 8.57(2.52) | 9.52(2.61) |
| At 4:00 a.m. | 5.97(1.49) | 6.61(1.99) |
| Before breakfast the following day | 5.48(1.14) | 5.83(1.52) |
| Insulin Degludec/Liraglutiden=289 | Insulin Degludecn=139 |
|---|---|
| 1.00(17.5) | 1.03(15.9) |
| Insulin Degludec/Liraglutiden=284 | Insulin Degludecn=134 |
|---|---|
| 0.89(32.5) | 0.95(37.7) |
| Insulin Degludec/Liraglutiden=289 | Insulin Degludecn=139 |
|---|---|
| 0.92(55.2) | 0.93(49.1) |
| Insulin Degludec/Liraglutiden=289 | Insulin Degludecn=139 |
|---|---|
| 0.92(19.1) | 0.97(20.0) |
This trial is conducted in Asia. The aim of this trial is to confirm the superiority of insulin degludec/liraglutide versus insulin degludec in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus after 26 weeks of treatment
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 procedures to determine suitability for the trial - Male or female, age at least 18 years at the time of signing inform consent - Type 2 diabetes mellitus (clinically diagnosed) - HbA1c (glycosylated haemoglobin) above or equal to 7.5% by central laboratory analysis, with the aim of a median of 8.5%. When approximately 50% of the randomised subjects have an HbA1c above 8.5%, the remaining subjects randomised must have an HbA1c below or equal to 8.5% or when approximately 50% of the subjects randomised have an HbA1c below or equal to 8.5%, the remaining subjects randomised must have an HbA1c above 8.5% - Current treatment for at least 90 calendar days prior to screening with basal insulin plus metformin plus/minus α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones. Subjects should be on a stable dose for at least 60 calendar days prior to screening of: Basal insulin 20-50 units (U)/day (both inclusive) ( Individual fluctuations of plus/minus 5U during the 60 day period prior to the day of screening are acceptable.) on the day of screening in combination with: - Metformin (above or equal to 1500 mg or max tolerated dose) or - Metformin (above or equal to 1500 mg or max tolerated dose) and sulphonylureas (above or equal to half of the max approved dose according to local label) or - Metformin (above or equal to 1500 mg or max tolerated dose) and glinide (at least half of the max approved dose according to local label) or - Metformin (above or equal to 1500 mg or max tolerated dose) and α-glucosidase inhibitors (AGI) (at least half of the max approved dose according to local label) or - Metformin (above or equal to 1500 mg or max tolerated dose) and thiazolidinediones (at least half of the max approved dose according to local label) - Body mass index (BMI) above or equal to 24 kg/m\^2 Exclusion Criteria: Current use of any antidiabetic drug (except for basal insulin, metformin, α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones) or anticipated change in concomitant medication, that in the investigator´s opinion could interfere with glucose level (e.g. systemic corticosteroids) - Treatment with glucagon like peptide -1 receptor agonists, or dipeptidyl-peptidase-4 inhibitors or insulin (except for basal insulin) within 90 days prior to Visit 1 - Impaired liver function defined as alanine aminotransferase above or equal to 2.5 times upper normal range - Impaired renal function defined as serum-creatinine above or equal to 133 μmol/L for males and above or equal to 125 μmol/L for females, or as defined according to local contraindications for metformin Screening calcitonin above or equal to 50 ng/L - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) - Cardiac disorder...
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.