Phase 3 · Liraglutide

DUAL II China trial results

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.

Participants
453
Status
completed
Completed
2019-04-04
Sponsor
Novo Nordisk A/S

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.

Primary outcome

What DUAL II China measured first

Change in HbA1cPercentage point of HbA1c · Week 0, week 26 · mean
Insulin Degludec/Liraglutiden=289Insulin Degludecn=138
-1.93(1.14)-1.06(1.19)
Side effects by arm

Side effects in DUAL II China

Percent of participants affected, Weeks 0-30. The most common events the registry lists.

EventInsulin Degludec/LiraglutideInsulin Degludec
Any serious event4.3%4.6%
Upper respiratory tract infection12.6%17.9%
Lipase increased12%2%
Diabetic retinopathy11.6%7.3%
Diarrhoea7.3%1.3%
Decreased appetite7%2%
Secondary outcomes

What else it measured

Change in Body WeightKilogram (kg) · Week 0, week 26 · mean
Insulin Degludec/Liraglutiden=288Insulin Degludecn=139
-0.7(3.0)0.5(2.7)
Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic EpisodesEpisodes · Up to 26 weeks · number
Insulin Degludec/Liraglutiden=301Insulin Degludecn=151
3836
Change in Fasting Plasma Glucose (FPG)mmol/L · Week 0, week 26 · mean
Insulin Degludec/Liraglutiden=289Insulin Degludecn=139
-3.57(3.00)-2.82(3.15)
Change in Waist CircumferenceCentimeter (cm) · Week 0, week 26 · mean
Insulin Degludec/Liraglutiden=288Insulin Degludecn=139
-0.4(4.3)0.7(3.3)
Change in Mean of the 9-point Self-measured Plasma Glucose (SMPG) Profilemmol/L · Week 0, week 26 · mean
Insulin Degludec/Liraglutiden=272Insulin Degludecn=133
-3.35(2.63)-2.31(2.61)
Change in SMPG-mean Post Prandial Incrementsmmol/L · Week 0, week 26 · mean
Insulin Degludec/Liraglutiden=280Insulin Degludecn=134
0.08(2.19)0.28(2.71)
Insulin DoseUnits of insulin (U) · Week 26 · mean
Insulin Degludec/Liraglutiden=290Insulin Degludecn=139
34.6(11.1)37.9(10.8)
SMPG-9-point Profile (Individual Points in the Profile)mmol/L · Week 26 · mean
MeasureInsulin Degludec/Liraglutiden=302Insulin Degludecn=151
Before breakfast5.48(1.06)5.88(1.30)
90 minutes after start of breakfast9.51(2.66)10.50(2.45)
Before lunch6.93(2.10)8.17(3.19)
90 minutes after start of lunch9.68(2.52)11.21(2.93)
Before main evening meal7.24(2.16)7.87(2.65)
90 minutes after main evening meal9.87(2.53)10.86(2.46)
At bedtime8.57(2.52)9.52(2.61)
At 4:00 a.m.5.97(1.49)6.61(1.99)
Before breakfast the following day5.48(1.14)5.83(1.52)
Change in Fasting High-density Lipoprotein (HDL) Cholesterol- Ratio to BaselineRatio of HDL cholesterol · Week 0, week 26 · geometric mean
Insulin Degludec/Liraglutiden=289Insulin Degludecn=139
1.00(17.5)1.03(15.9)
Change in Fasting Low-density Lipoprotein (LDL) Cholesterol- Ratio to BaselineRatio of LDL cholesterol · Week 0, week 26 · geometric mean
Insulin Degludec/Liraglutiden=284Insulin Degludecn=134
0.89(32.5)0.95(37.7)
Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to BaselineRatio of VLDL cholesterol · Week 0, week 26 · geometric mean
Insulin Degludec/Liraglutiden=289Insulin Degludecn=139
0.92(55.2)0.93(49.1)
Change in Fasting Total Cholesterol- Ratio to BaselineRatio of total cholesterol · Week 0, week 26 · geometric mean
Insulin Degludec/Liraglutiden=289Insulin Degludecn=139
0.92(19.1)0.97(20.0)
The trial

How DUAL II China was run

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

  • Insulin degludec/liraglutide
  • Insulin degludec
Who could join the trial

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.

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