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Phase 3 Completed N=453 Randomized Double-blind Treatment

A Trial Comparing 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 Oral Antidiabetic Drug (OAD)

Source: ClinicalTrials.gov NCT03175120 ↗
Enrolled (actual)
453
Serious AEs
4.4%
Results posted
Mar 2020
Primary outcomePrimary: Change in HbA1c — -1.93; -1.06 Percentage point of HbA1c — p=<.0001
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in HbA1c
-1.93; -1.06 <.0001 sig
SECONDARY
Change in Body Weight
-0.7; 0.5
SECONDARY
Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes
38; 36
SECONDARY
Change in Fasting Plasma Glucose (FPG)
-3.57; -2.82
SECONDARY
Change in Waist Circumference
-0.4; 0.7
SECONDARY
Change in Mean of the 9-point Self-measured Plasma Glucose (SMPG) Profile
-3.35; -2.31
SECONDARY
Change in SMPG-mean Post Prandial Increments
0.08; 0.28
SECONDARY
Insulin Dose
34.6; 37.9
SECONDARY
SMPG-9-point Profile (Individual Points in the Profile)
5.48; 5.88; 9.51; 10.50; 6.93; 8.17
SECONDARY
Change in Fasting High-density Lipoprotein (HDL) Cholesterol- Ratio to Baseline
1.00; 1.03
SECONDARY
Change in Fasting Low-density Lipoprotein (LDL) Cholesterol- Ratio to Baseline
0.89; 0.95
SECONDARY
Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline
0.92; 0.93
SECONDARY
Change in Fasting Total Cholesterol- Ratio to Baseline
0.92; 0.97
SECONDARY
Change in Fasting Triglycerides- Ratio to Baseline
0.91; 0.92
SECONDARY
Change in Fasting Free Fatty Acids- Ratio to Baseline
0.65; 0.64
SECONDARY
Change in Fasting C-peptide- Ratio to Baseline
0.64; 0.52
SECONDARY
Change in Fasting Insulin- Ratio to Baseline
0.63; 0.50
SECONDARY
Change in Fasting Glucagon- Ratio to Baseline
1.01; 1.09
SECONDARY
Change in HOMA-B (Beta-cell Function)- Ratio to Baseline
1.47; 0.99
SECONDARY
Participants Who Achieved HbA1c < 7.0%, ADA Target (Yes/no)
151; 23; 138; 115
SECONDARY
Participants Who Achieved HbA1c ≤ 6.5%, American Association of Clinical Endocrinologists (AACE) Target (Yes/no)
96; 10; 193; 128
SECONDARY
Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero
98; 7; 204; 144
SECONDARY
Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero
59; 3; 243; 148
SECONDARY
Participants Who Achieved HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes
148; 22; 154; 129
SECONDARY
Participants Who Achieved HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes
93; 9; 209; 142
SECONDARY
Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero and Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes
94; 7; 208; 144
SECONDARY
Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero and Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes
58; 3; 244; 148
SECONDARY
Number of Treatment-emergent Adverse Events (TEAEs)
641; 230
SECONDARY
Number of Treatment-emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes
9; 8
SECONDARY
Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
23; 21
SECONDARY
Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
7; 7
SECONDARY
Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition
1099; 680
SECONDARY
Change in Physical Examination
299; 149; 1; 0; 1; 2
SECONDARY
Eye Examination
167; 87; 34; 15; 100; 49
SECONDARY
Change in Electrocardiogram (ECG)
175; 90; 76; 41; 50; 20
SECONDARY
Change in Pulse
5.7; 1.3
SECONDARY
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
-3.5; -0.5; 0.1; -0.4
SECONDARY
Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
10.45; 2.69; 16.97; -0.35; 3.32; 6.99
SECONDARY
Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea
0.01; -0.01; -0.00; -0.01; -0.03; -0.11
SECONDARY
Change in Albumin
0.05; 0.02
SECONDARY
Change in Total Bilirubin
-0.30; -0.54
SECONDARY
Change in Creatinine
0.44; -0.32
SECONDARY
Change in Total Protein
0.08; 0.03
SECONDARY
Change in Haematological Parameter- Haematocrit
-0.07; -0.12
SECONDARY
Change in Haematological Parameter- Haemoglobin
-0.08; -0.09
SECONDARY
Change in Haematological Parameter- Leukocytes and Thrombocytes
0.32; 0.31; 14.13; 12.19
SECONDARY
Change in Haematological Parameter- Erythrocytes
-0.06; -0.05
SECONDARY
Change in Haematological Parameter- Basophils
0.00; 0.01
SECONDARY
Change in Haematological Parameter- Eosinophils
-0.15; -0.25
SECONDARY
Change in Haematological Parameter- Lymphocytes
-1.00; -0.82
SECONDARY
Change in Haematological Parameter- Monocytes
-0.19; -0.06
SECONDARY
Change in Haematological Parameter- Neutrophils
1.34; 0.99
SECONDARY
Change in Calcitonin
0; 0; 293; 149; 8; 2
SECONDARY
Urinalysis (Erythrocytes, Protein, Glucose and Ketones)
258; 121; 33; 22; 3; 4
SECONDARY
Anti-insulin Degludec Specific Antibodies
0.25; 0.13
SECONDARY
Antibodies Cross-reacting to Human Insulin
9.07; 8.64
SECONDARY
Total Insulin Antibodies
9.31; 8.77
SECONDARY
Occurrence of Anti-liraglutide Antibodies (Yes/no)
24; 264
SECONDARY
Occurrence of Anti-liraglutide Antibodies Cross Reacting Native Glucagon-like Peptide-1 (GLP-1)
6
SECONDARY
Occurrence of Neutralising Liraglutide Antibodies
SECONDARY
Occurrence of Neutralising Liraglutide Antibodies Cross Reacting Native GLP-1

Eligibility Criteria

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 defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months prior to screening and/or planned coronary, carotid or peripheral artery revascularisation procedures - Severe uncontrolled treated or untreated hypertension (systolic blood pressure above or equal to 180 mm Hg or diastolic blood pressure above or equal to 100 mm Hg) - Proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment - History of pancreatitis (acute or chronic)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03175120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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