Phase 3
Completed N=720
A Trial Comparing Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs)
Source: ClinicalTrials.gov NCT03172494 ↗Enrolled (actual)
720
Serious AEs
4.9%
Results posted
Jul 2020
Primary outcomePrimary: Change in HbA1c — -1.71; -1.20; -1.16 Percentage points of HbA1c — p=<0.0001
◆ Published Evidence
Emerging
16citations · ~4 / year
DUAL I China: Improved glycemic control with IDegLira versus its individual components in a randomized trial with Chinese participants with type 2 diabetes uncontrolled on oral antidiabetic drugs.
Summary
This trial is conducted in Asia. The aim of this trial is to confirm the efficacy of insulin degludec/liraglutide in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus inadequately controlled on oral antidiabetic agents
Linked Publications
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DUAL I China: Improved glycemic control with IDegLira versus its individual components in a randomized trial with Chinese participants with type 2 diabetes uncontrolled on oral antidiabetic drugs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c |
-1.71; -1.20; -1.16 | <0.0001 sig |
| SECONDARY Change in Body Weight |
0.2; 1.3; -2.5 | — |
| SECONDARY Number of Treatment Emergent Severe or BG Confirmed Hypoglycaemic Episodes |
23.94; 17.01; 3.60 | — |
| SECONDARY Insulin Dose |
24.8; 30.1 | — |
| SECONDARY Participants Who Achieved HbA1c < 7.0%, American Diabetes Association (ADA) Target (Yes/no) |
272; 83; 80; 69; 84; 71 | — |
| SECONDARY Participants Who Achieved HbA1c ≤ 6.5%, International Diabetes Federation (IDF) Target (Yes/no) |
201; 48; 41; 140; 119; 110 | — |
| SECONDARY Participants Who Achieved HbA1c <7.0% and Change in Body Weight From Baseline Below or Equal to Zero |
147; 34; 74; 214; 145; 106 | — |
| SECONDARY Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero |
111; 21; 37; 250; 158; 143 | — |
| SECONDARY Participants Who Achieved HbA1c < 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes |
265; 80; 84; 96; 99; 96 | — |
| SECONDARY Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Hypoglycaemic Episodes |
195; 46; 43; 166; 133; 137 | — |
| SECONDARY Participants Who Achieved HbA1c < 7.0% Without Severe or BG Confirmed Episodes, and Change From Baseline in Body Weight Below or Equal to Zero. |
136; 33; 72; 225; 146; 108 | — |
| SECONDARY Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Episodes and Change From Baseline in Body Weight Below or Equal to Zero. |
103; 21; 36; 258; 158; 144 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) |
-3.64; -3.45; -1.86 | — |
| SECONDARY Change in Waist Circumferance |
-0.3; 1.2; -2.6 | — |
| SECONDARY 9-point SMPG Profile |
5.41; 5.66; 6.89; 8.97; 9.85; 10.04 | — |
| SECONDARY Change in Mean of 9-point SMPG Profile |
-3.17; -2.47; -2.13 | — |
| SECONDARY Change in Mean Post-prandial Plasma Glucose (PG) Increments |
-0.20; 0.09; -0.54 | — |
| SECONDARY Change in Fasting C-peptide - Ratio to Baseline |
0.54; 0.38; 0.98 | — |
| SECONDARY Change in Fasting Human Insulin - Ratio to Baseline |
0.53; 0.38; 1.04 | — |
| SECONDARY Change in Fasting Glucagon - Ratio to Baseline |
0.90; 0.95; 0.98 | — |
| SECONDARY Change in HOMA-B (Beta Cell Function)- Ratio to Baseline |
1.38; 0.94; 1.53 | — |
| SECONDARY Change in Fasting Total Cholesterol - Ratio to Baseline |
0.94; 0.99; 0.97 | — |
| SECONDARY Change in Fasting High Density Lipoprotein (HDL) Cholesterol- Ratio to Baseline |
1.01; 1.02; 1.03 | — |
| SECONDARY Change in Fasting Low Density Lipoprotein (LDL) Cholesterol- Ratio to Baseline |
0.92; 1.01; 0.96 | — |
| SECONDARY Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline |
0.90; 0.84; 0.92 | — |
| SECONDARY Change in Fasting Triglycerides - Ratio to Baseline. |
0.88; 0.82; 0.90 | — |
| SECONDARY Change in Fasting Free Fatty Acid - Ratio to Baseline |
0.55; 0.48; 0.80 | — |
| SECONDARY Number of Treatment-emergent Adverse Events (TEAE) |
410.82; 306.19; 541.00 | — |
| SECONDARY Number of Treatment Emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes. |
4.45; 4.54 | — |
| SECONDARY Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes. |
15.03; 9.07; 1.20 | — |
| SECONDARY Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes |
2.78; 3.40 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition |
668.55; 746.20; 37.19 | — |
| SECONDARY Change in Physical Examination |
353; 173; 180; 2; 2; 0 | — |
| SECONDARY Eye Examination |
222; 109; 110; 45; 14; 20 | — |
| SECONDARY Change in Electrocardiogram (ECG) |
223; 109; 108; 94; 46; 52 | — |
| SECONDARY Change in Pulse |
4.6; -0.1; 4.9 | — |
| SECONDARY Change in Blood Pressure (Systolic and Diastolic Blood Pressure) |
-3.5; -1.2; -3.3; -0.4; -0.7; 0.0 | — |
| SECONDARY Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum |
-2.0; -2.29; -0.48; -4.63; -6.17; -2.81 | — |
| SECONDARY Change in Biochemistry Parameters (Albumin Serum, Total Protein) |
-0.05; -0.09; 0.04; -0.08; -0.08; -0.01 | — |
| SECONDARY Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum |
-0.01; -0.02; -0.00; -0.00; -0.00; -0.01 | — |
| SECONDARY Change in Biochemistry Parameters: Total Bilirubin Serum, Creatinine Serum |
-0.78; -0.55; -1.16; 1.02; 1.36; -0.60 | — |
| SECONDARY Change in Haematological Parameter: Erythrocytes Blood |
-0.05; -0.00; -0.05 | — |
| SECONDARY Change in Haematological Parameter: Haematocrits |
-0.56; -0.49; -0.42 | — |
| SECONDARY Change in Haemotological Parameter- Eosinophils |
-0.06; 0.19; 0.11 | — |
| SECONDARY Change in Haematological Parameter - Neutrophils |
0.57; 0.18; -0.53 | — |
| SECONDARY Change in Haematological Parameter: Basophils |
-0.02; -0.01; -0.03 | — |
| SECONDARY Change in Haemotological Parameter- Monocytes |
-0.03; 0.01; 0.05 | — |
| SECONDARY Change in Haematological Parameter - Lymphocytes |
-0.46; -0.38; 0.40 | — |
| SECONDARY Change in Haematology: Haemoglobin Blood |
-0.10; -0.06; -0.05 | — |
| SECONDARY Change in Haematologcal Parameter: Leukocytes |
0.25; 0.23; -0.01 | — |
| SECONDARY Change in Haematological Parameter: Thrombocytes |
8.19; 8.32; 4.32 | — |
| SECONDARY Change in Calcitonin |
0; 0; 0; 351; 172; 178 | — |
| SECONDARY Urinalysis (Protein, Glucose, Erythrocytes and Ketones) |
299; 153; 156; 36; 16; 16 | — |
| SECONDARY Occurence of Anti-insulin Degludec Specific Antibodies |
0.22; 0.12 | — |
| SECONDARY Occurence of Antibodies Cross-reacting to Human Insulin |
6.61; 2.99 | — |
| SECONDARY Occurence of Total Insulin Antibodies |
6.83; 3.11 | — |
| SECONDARY Occurence of Anti-liraglutide Antibodies |
45; 40; 287; 120 | — |
| SECONDARY Occurence of Antibodies Cross-reacting to Native Glucagon-like Peptide (GLP-1) |
6; 3 | — |
| SECONDARY Occurence of Neutralising Liraglutide Antibodies |
9; 8 | — |
| SECONDARY Occurence of Neutralising Antibodies Cross-reacting to Native GLP-1 |
0; 0 | — |
| SECONDARY Serum Concentrations of Insulin Degludec |
3583; 4133 | — |
| SECONDARY Plasma Concentration of Liraglutide |
9963; 21602 | — |
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 activities to determine suitability for the trial
- Type 2 diabetes mellitus (clinically diagnosed)
- Male or female, age at least 18 years at the time of signing informed consent
- HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis, with the aim of a median of8.3%. When approximately 50% of the randomised subjects have an HbA1c above 8.3%, the remaining subjects randomised must have an HbA1c below or equal to 8.3%; or when approximately 50% of the randomised subjects have an HbA1c below or equal to 8.3%, the remaining subjects randomised must have an HbA1c above 8.3%
- Current treatment for at least 90 calendar days prior to screening with metformin plus/minus one other OAD: α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones. For above or equal to 60 calendar days prior to screening subjects should be on a stable dose of:
- 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 glinides (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 α-glucosidase inhibitors (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 thiazolidinediones (above or equal to half of the max approved dose according to local label)
Exclusion Criteria
- Treatment with insulin (except for short-term treatment at the discretion of the investigator)
- Treatment with glucagon-like-peptide-1 receptor agonists or dipeptidyl-peptidase-4 inhibitors within 90 days prior to screening
- 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 mmHg or diastolic blood pressure above or equal to 100 mmHg
- Proliferative retinopathy or maculopathy (macular oedema), requiring acute treatment
- History of pancreatitis (acute or chronic)
Data sourced from ClinicalTrials.gov (NCT03172494) and the linked publication. 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.