DiabetesPhase 3DUAL™ II ChinaNCT03175120
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)
A Phase 3 study testing Insulin degludec/liraglutide and Insulin degludec in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 37 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- Insulin degludec/liraglutide and Insulin degludec
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 453 participants
- Where
- 37 sitesin 2 countries
- Study dates
- 26 May 2017to 4 Apr 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Trial locations and contacts
37 sites in 2 countries.
37 sites in 2 countries
China36 sites
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100071
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100088
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100730
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100853
Novo Nordisk Investigational Site
Changchun, Jilin, 130021
Novo Nordisk Investigational Site
Changchun, Jilin, 130033
Novo Nordisk Investigational Site
Changzhou, Jiangsu, 213003
Novo Nordisk Investigational Site
Chongqing, Chongqing Municipality, 404000
Novo Nordisk Investigational Site
Dalian, Liaoning, 116011
Novo Nordisk Investigational Site
Fuzhou, Fujian, 350001
Novo Nordisk Investigational Site
Guangzhou, Guangdong, 510120
Novo Nordisk Investigational Site
Guangzhou, Guangdong, 510515
Novo Nordisk Investigational Site
Harbin, Heilongjiang, 150001
Novo Nordisk Investigational Site
Hefei, Anhui, 230001
Novo Nordisk Investigational Site
Hefei, Anhui, 230061
Novo Nordisk Investigational Site
Hengshui, Hebei, 053000
Novo Nordisk Investigational Site
Hohhot, Inner Mongolia, 010020
Novo Nordisk Investigational Site
Hohhot, Inner Mongolia, 010050
Novo Nordisk Investigational Site
Kunming, Yunnan, 650101
Novo Nordisk Investigational Site
Nanchang, Jiangxi, 330006
Novo Nordisk Investigational Site
Nanjing, Jiangsu, 210011
Novo Nordisk Investigational Site
Nanjing, Jiangsu, 210012
Novo Nordisk Investigational Site
Nanjing, Jiangsu, 210029
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200040
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200072
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200240
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 201199
Novo Nordisk Investigational Site
Shijiazhuang, Hebei, 050000
Novo Nordisk Investigational Site
Siping, Jilin, 136000
Novo Nordisk Investigational Site
Taiyuan, Shanxi, 030001
Novo Nordisk Investigational Site
Tangshan, Hebei, 063000
Novo Nordisk Investigational Site
Tianjin, Tianjin Municipality, 300052
Novo Nordisk Investigational Site
Xi'an, Shaanxi, 710061
Novo Nordisk Investigational Site
Yinchuan, Ningxia, 750004
Novo Nordisk Investigational Site
Yueyang, Hunan, 414000
Novo Nordisk Investigational Site
Zhenjiang, Jiangsu, 212001
About this study
Official title: 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
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
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- Insulin degludec/liraglutide, Insulin degludec
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin degludec/liraglutideDrug
Administered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks.
Insulin degludecDrug
Administered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Insulin degludec/liraglutide | Experimental | Not described Receives: Drug: Insulin degludec/liraglutide |
| Insulin degludec | Active comparator | Not described Receives: Drug: Insulin degludec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 26 is presented.
Measured: Week 0, week 26
Secondary outcomes (60)
Change in Body Weight
Change in body weight from baseline (week 0) to week 26 is presented.
Measured: Week 0, week 26
Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes
Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 millimoles per liter (mmol/L) with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed hypoglycaemic episodes during 26 weeks of treatment is presented.
Measured: Up to 26 weeks
Change in Fasting Plasma Glucose (FPG)
Change in FPG from baseline (week 0) to week 26 is presented.
Measured: Week 0, week 26
Change in Waist Circumference
Change in waist circumference from baseline (week 0) to week 26 is presented.
Measured: Week 0, week 26
Change in Mean of the 9-point Self-measured Plasma Glucose (SMPG) Profile
Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. The mean of profile is defined as the area under the profile divided by measurement time and is calculated using the trapezoidal method. Change in mean of the 9-point SMPG profile from baseline (week 0) to week 26 is presented.
Measured: Week 0, week 26
Change in SMPG-mean Post Prandial Increments
Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean postprandial increment over all meals from baseline (week 0) to week 26 is presented.
Measured: Week 0, week 26
Insulin Dose
The mean of actual daily total insulin dose after 26 weeks of treatment is presented.
Measured: Week 26
SMPG-9-point Profile (Individual Points in the Profile)
Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. SMPG-9-point profile (individual points in the profile) at week 26 is presented.
Measured: Week 26
Change in Fasting High-density Lipoprotein (HDL) Cholesterol- Ratio to Baseline
Change in fasting HDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.
Measured: Week 0, week 26
Change in Fasting Low-density Lipoprotein (LDL) Cholesterol- Ratio to Baseline
Change in fasting LDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.
Measured: Week 0, week 26
Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline
Change in fasting VLDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.
Measured: Week 0, week 26
Change in Fasting Total Cholesterol- Ratio to Baseline
Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.
Measured: Week 0, week 26
Change in Fasting Triglycerides- Ratio to Baseline
Change in fasting triglycerides (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.
Measured: Week 0, week 26
Change in Fasting Free Fatty Acids- Ratio to Baseline
Change in fasting free fatty acids (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.
Measured: Week 0, week 26
Change in Fasting C-peptide- Ratio to Baseline
Change in fasting C-peptide (measured in nanomoles per liter (nmol/L)) from baseline (week 0) to week 26 is presented as ratio to baseline.
Measured: Week 0, week 26
Change in Fasting Insulin- Ratio to Baseline
Change in fasting insulin (measured in picomoles per liter (pmol/L)) from baseline (week 0) to week 26 is presented as ratio to baseline.
Measured: Week 0, week 26
Change in Fasting Glucagon- Ratio to Baseline
Change in fasting glucagon (measured in picograms per milliliter (pg/mL)) from baseline (week 0) to week 26 is presented as ratio to baseline.
Measured: Week 0, week 26
Change in HOMA-B (Beta-cell Function)- Ratio to Baseline
Change in HOMA-B from baseline (week 0) to week 26 is presented as ratio to baseline.
Measured: Week 0, week 26
Participants Who Achieved HbA1c < 7.0%, ADA Target (Yes/no)
Participants who achieved HbA1c < 7.0%, ADA target (yes/no) is presented.
Measured: Week 26
Participants Who Achieved HbA1c ≤ 6.5%, American Association of Clinical Endocrinologists (AACE) Target (Yes/no)
Participants who achieved HbA1c ≤ 6.5%, AACE target (yes/no) is presented.
Measured: Week 26
Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero
Participants who achieved HbA1c < 7.0% and change from baseline in body weight below or equal to zero is presented.
Measured: Week 26
Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero
Participants who achieved HbA1c ≤ 6.5% and change from baseline in body weight below or equal to zero is presented.
Measured: Week 26
Participants Who Achieved HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes
Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Participants who achieved HbA1c < 7.0% at week 26 without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented.
Measured: Week 26
Participants Who Achieved HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes
Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Participants who achieved HbA1c ≤ 6.5% at week 26 without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented.
Measured: Week 26
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
Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. 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 during the last 12 weeks of treatment is presented.
Measured: Week 26
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
Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. 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 during the last 12 weeks of treatment is presented.
Measured: Week 26
Number of Treatment-emergent Adverse Events (TEAEs)
A TEAE was defined as an adverse event with onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.
Measured: Weeks 0-27
Number of Treatment-emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes
Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 a.m. both inclusive. Number of treatment-emergent nocturnal severe or BG confirmed hypoglycaemic episodes is presented.
Measured: Weeks 0-27
Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes is presented.
Measured: Weeks 0-27
Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 a.m. both inclusive. Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes is presented.
Measured: Weeks 0-27
Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition
Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent hypoglycaemic episodes according to ADA definition is presented.
Measured: Weeks 0-27
Change in Physical Examination
Physical examination parameters are categorised as cardiovascular system; central and peripheral nervous system; gastrointestinal system including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin and thyroid gland. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at week -2 and week 26 is presented.
Measured: Week -2, week 26
Eye Examination
Dilated fundoscopy or fundus photography was performed by the investigator at week -2 and week 26. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at week -2 and week 26 were presented.
Measured: Week -2, week 26
Change in Electrocardiogram (ECG)
The ECG was assessed by the investigator at baseline (week -2) and week 26 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 26 were presented.
Measured: Week -2, week 26
Change in Pulse
Change in pulse from baseline (week 0) to week 26 is presented.
Measured: Week 0, week 26
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
Change in blood pressure (systolic and diastolic blood pressure) from baseline (week 0) to week 26 is presented.
Measured: Week 0, week 26
Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
Change in amylase, lipase, creatinine kinase, ALT, AST, ALP from baseline (week 0) to week 26 is presented.
Measured: Week 0, week 26
Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea
Change in calcium (total), albumin corrected calcium, potassium, sodium, urea from baseline (week 0) to week 26 is presented.
Measured: Week 0, week 26
Change in Albumin
Change in albumin from baseline (week 0) to week 26 is presented.
Measured: Week 0, week 26
Change in Total Bilirubin
Change in total bilirubin from baseline (week 0) to week 26 is presented.
Measured: Week 0, week 26
Change in Creatinine
Change in creatinine from baseline (week 0) to week 26 is presented.
Measured: Week 0, week 26
Change in Total Protein
Change in total protein from baseline (week 0) to week 26 is presented.
Measured: Week 0, week 26
Change in Haematological Parameter- Haematocrit
Change in haematocrit from baseline (week 0) to week 26 is presented.
Measured: Week 0, week 26
Change in Haematological Parameter- Haemoglobin
Change in haemoglobin from baseline (week 0) to week 26 is presented.
Measured: Week 0, week 26
Change in Haematological Parameter- Leukocytes and Thrombocytes
Change in leukocytes and thrombocytes from baseline (week 0) to week 26 is presented.
Measured: Week 0, week 26
Change in Haematological Parameter- Erythrocytes
Change in erythrocytes from baseline (week 0) to week 26 is presented.
Measured: Week 0, week 26
Change in Haematological Parameter- Basophils
Change in basophils from baseline (week 0) to week 26 is presented.
Measured: Week 0, week 26
Change in Haematological Parameter- Eosinophils
Change in eosinophils from baseline (week 0) to week 26 is presented.
Measured: Week 0, week 26
Change in Haematological Parameter- Lymphocytes
Change in lymphocytes from baseline (week 0) to week 26 is presented.
Measured: Week 0, week 26
Change in Haematological Parameter- Monocytes
Change in monocytes from baseline (week 0) to week 26 is presented.
Measured: Week 0, week 26
Change in Haematological Parameter- Neutrophils
Change in neutrophils from baseline (week 0) to week 26 is presented.
Measured: Week 0, week 26
Change in Calcitonin
Calcitonin levels were measured and were categorised as low, normal or high. Number of participants in each category at week 0 and week 26 were presented.
Measured: Week 0, week 26
Urinalysis (Erythrocytes, Protein, Glucose and Ketones)
The urinalysis was the measurements of protein, glucose, erythrocytes and ketones at week 0 and week 26 and categorised as negative, trace, 1+, 2+ and 3+. Number of participants in each category at week 0 and week 26 are presented.
Measured: Week 0, week 26
Anti-insulin Degludec Specific Antibodies
Serum samples were analysed for the presence of anti-insulin degludec specific antibodies. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T).
Measured: Week 27
Antibodies Cross-reacting to Human Insulin
Serum samples were analysed for the presence of antibodies cross-reacting to human insulin. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T).
Measured: Week 27
Total Insulin Antibodies
Serum samples were analysed for the presence of total insulin antibodies. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T).
Measured: Week 27
Occurrence of Anti-liraglutide Antibodies (Yes/no)
This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with anti-liraglutide antibodies at week 27 are presented.
Measured: Week 27
Occurrence of Anti-liraglutide Antibodies Cross Reacting Native Glucagon-like Peptide-1 (GLP-1)
This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with anti-liraglutide antibodies cross reacting native GLP-1 at week 27 are presented.
Measured: Week 27
Occurrence of Neutralising Liraglutide Antibodies
This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with neutralising liraglutide antibodies at week 27 are presented.
Measured: Week 27
Occurrence of Neutralising Liraglutide Antibodies Cross Reacting Native GLP-1
This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with neutralising liraglutide antibodies cross reacting native GLP-1 at week 27 are presented.
Measured: Week 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start26 May 2017
- Primary completion5 Mar 2019
- Study completion4 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR,1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175120
- Sponsor's protocol ID
- NN9068-4166
- Other IDs
- U1111-1154-6732, CTR20060909
- Acronym
- DUAL™ II China
- Status last verified
- Mar 2020
- First submitted
- 24 May 2017
- Last updated
- 19 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03175120
- Acronym / sponsor ID
- DUAL™ II China / NN9068-4166
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 26 May 2017 (actual)
- Primary completion
- 5 Mar 2019 (actual)
- Study completion
- 4 Apr 2019 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Posted 19 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin degludec/liraglutide | Experimental | Drug: Insulin degludec/liraglutide |
| Insulin degludec | Active comparator | Drug: Insulin degludec |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin degludec/liraglutideAdministered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks. | Drug | Insulin degludec/liraglutide |
| Insulin degludecAdministered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks. | Drug | Insulin degludec |
Primary outcome
Change in HbA1c
Time frame: Week 0, week 26
Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 26 is presented.
60 secondary outcomes
Change in Body Weight
Time frame: Week 0, week 26
Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes
Time frame: Up to 26 weeks
Change in Fasting Plasma Glucose (FPG)
Time frame: Week 0, week 26
Change in Waist Circumference
Time frame: Week 0, week 26
Change in Mean of the 9-point Self-measured Plasma Glucose (SMPG) Profile
Time frame: Week 0, week 26
Change in SMPG-mean Post Prandial Increments
Time frame: Week 0, week 26
Insulin Dose
Time frame: Week 26
SMPG-9-point Profile (Individual Points in the Profile)
Time frame: Week 26
Change in Fasting High-density Lipoprotein (HDL) Cholesterol- Ratio to Baseline
Time frame: Week 0, week 26
Change in Fasting Low-density Lipoprotein (LDL) Cholesterol- Ratio to Baseline
Time frame: Week 0, week 26
Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline
Time frame: Week 0, week 26
Change in Fasting Total Cholesterol- Ratio to Baseline
Time frame: Week 0, week 26
Change in Fasting Triglycerides- Ratio to Baseline
Time frame: Week 0, week 26
Change in Fasting Free Fatty Acids- Ratio to Baseline
Time frame: Week 0, week 26
Change in Fasting C-peptide- Ratio to Baseline
Time frame: Week 0, week 26
Change in Fasting Insulin- Ratio to Baseline
Time frame: Week 0, week 26
Change in Fasting Glucagon- Ratio to Baseline
Time frame: Week 0, week 26
Change in HOMA-B (Beta-cell Function)- Ratio to Baseline
Time frame: Week 0, week 26
Participants Who Achieved HbA1c < 7.0%, ADA Target (Yes/no)
Time frame: Week 26
Participants Who Achieved HbA1c ≤ 6.5%, American Association of Clinical Endocrinologists (AACE) Target (Yes/no)
Time frame: Week 26
Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero
Time frame: Week 26
Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero
Time frame: Week 26
Participants Who Achieved HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes
Time frame: Week 26
Participants Who Achieved HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes
Time frame: Week 26
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
Time frame: Week 26
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
Time frame: Week 26
Number of Treatment-emergent Adverse Events (TEAEs)
Time frame: Weeks 0-27
Number of Treatment-emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes
Time frame: Weeks 0-27
Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Time frame: Weeks 0-27
Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Time frame: Weeks 0-27
Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition
Time frame: Weeks 0-27
Change in Physical Examination
Time frame: Week -2, week 26
Eye Examination
Time frame: Week -2, week 26
Change in Electrocardiogram (ECG)
Time frame: Week -2, week 26
Change in Pulse
Time frame: Week 0, week 26
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
Time frame: Week 0, week 26
Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)
Time frame: Week 0, week 26
Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea
Time frame: Week 0, week 26
Change in Albumin
Time frame: Week 0, week 26
Change in Total Bilirubin
Time frame: Week 0, week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR,1452) study director
Novo Nordisk A/S
37 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin degludec/liraglutide and Insulin degludec in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 37 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: Week 0, week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.