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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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)

Short name DUAL™ II China

NCTNCT03175120 (opens ClinicalTrials.gov in a new tab)Other idNN9068-4166Other idU1111-1154-6732Other idCTR20060909
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
453 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
2 countries

China, Hong Kong

Start
26 May 2017
Primary completion
5 Mar 2019
Completion
4 Apr 2019
First posted
5 Jun 2017
Last update posted
19 Mar 2020
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2017201820192020
  1. Ph 3

    DUAL™ II China

    NCT03175120

    26 May 2017 to 4 Apr 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Insulin degludec/liraglutideDrug
  • Insulin degludecDrug

Arms2

  • Experimental

    Insulin degludec/liraglutide

  • Active comparator

    Insulin degludec

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HbA1c

    Time frame · Week 0, week 26

    Registry description

    Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 26 is presented.

Secondary outcomes(20)

  1. Change in Body Weight

    Time frame · Week 0, week 26

    Registry description

    Change in body weight from baseline (week 0) to week 26 is presented.

  2. Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes

    Time frame · Up to 26 weeks

    Registry description

    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.

  3. Change in Fasting Plasma Glucose (FPG)

    Time frame · Week 0, week 26

    Registry description

    Change in FPG from baseline (week 0) to week 26 is presented.

  4. Change in Waist Circumference

    Time frame · Week 0, week 26

    Registry description

    Change in waist circumference from baseline (week 0) to week 26 is presented.

  5. Change in Mean of the 9-point Self-measured Plasma Glucose (SMPG) Profile

    Time frame · Week 0, week 26

    Registry description

    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.

  6. Change in SMPG-mean Post Prandial Increments

    Time frame · Week 0, week 26

    Registry description

    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.

  7. Insulin Dose

    Time frame · Week 26

    Registry description

    The mean of actual daily total insulin dose after 26 weeks of treatment is presented.

  8. SMPG-9-point Profile (Individual Points in the Profile)

    Time frame · Week 26

    Registry description

    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.

  9. Change in Fasting High-density Lipoprotein (HDL) Cholesterol- Ratio to Baseline

    Time frame · Week 0, week 26

    Registry description

    Change in fasting HDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.

  10. Change in Fasting Low-density Lipoprotein (LDL) Cholesterol- Ratio to Baseline

    Time frame · Week 0, week 26

    Registry description

    Change in fasting LDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.

  11. Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline

    Time frame · Week 0, week 26

    Registry description

    Change in fasting VLDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.

  12. Change in Fasting Total Cholesterol- Ratio to Baseline

    Time frame · Week 0, week 26

    Registry description

    Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.

  13. Change in Fasting Triglycerides- Ratio to Baseline

    Time frame · Week 0, week 26

    Registry description

    Change in fasting triglycerides (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.

  14. Change in Fasting Free Fatty Acids- Ratio to Baseline

    Time frame · Week 0, week 26

    Registry description

    Change in fasting free fatty acids (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.

  15. Change in Fasting C-peptide- Ratio to Baseline

    Time frame · Week 0, week 26

    Registry description

    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.

  16. Change in Fasting Insulin- Ratio to Baseline

    Time frame · Week 0, week 26

    Registry description

    Change in fasting insulin (measured in picomoles per liter (pmol/L)) from baseline (week 0) to week 26 is presented as ratio to baseline.

  17. Change in Fasting Glucagon- Ratio to Baseline

    Time frame · Week 0, week 26

    Registry description

    Change in fasting glucagon (measured in picograms per milliliter (pg/mL)) from baseline (week 0) to week 26 is presented as ratio to baseline.

  18. Change in HOMA-B (Beta-cell Function)- Ratio to Baseline

    Time frame · Week 0, week 26

    Registry description

    Change in HOMA-B from baseline (week 0) to week 26 is presented as ratio to baseline.

  19. Participants Who Achieved HbA1c < 7.0%, ADA Target (Yes/no)

    Time frame · Week 26

    Registry description

    Participants who achieved HbA1c \< 7.0%, ADA target (yes/no) is presented.

  20. Participants Who Achieved HbA1c ≤ 6.5%, American Association of Clinical Endocrinologists (AACE) Target (Yes/no)

    Time frame · Week 26

    Registry description

    Participants who achieved HbA1c ≤ 6.5%, AACE target (yes/no) is presented.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Week 0, week 26

Change in HbA1c

GroupValue (Percentage point of HbA1c)Spread
Insulin Degludec/Liraglutide-1.931.14
Insulin Degludec-1.061.19
Secondary and other outcome results(7)
Secondary outcomeMean· Week 0, week 26

Change in Body Weight

GroupValue (Kilogram (kg))Spread
Insulin Degludec/Liraglutide-0.73.0
Insulin Degludec0.52.7
Secondary outcomeNumber· Up to 26 weeks

Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes

GroupValue (Episodes)
Insulin Degludec/Liraglutide38
Insulin Degludec36
Secondary outcomeMean· Week 0, week 26

Change in Fasting Plasma Glucose (FPG)

GroupValue (mmol/L)Spread
Insulin Degludec/Liraglutide-3.573.00
Insulin Degludec-2.823.15
Secondary outcomeMean· Week 0, week 26

Change in Waist Circumference

GroupValue (Centimeter (cm))Spread
Insulin Degludec/Liraglutide-0.44.3
Insulin Degludec0.73.3
Secondary outcomeMean· Week 0, week 26

Change in Mean of the 9-point Self-measured Plasma Glucose (SMPG) Profile

GroupValue (mmol/L)Spread
Insulin Degludec/Liraglutide-3.352.63
Insulin Degludec-2.312.61
Secondary outcomeMean· Week 0, week 26

Change in SMPG-mean Post Prandial Increments

GroupValue (mmol/L)Spread
Insulin Degludec/Liraglutide0.082.19
Insulin Degludec0.282.71
Secondary outcomeMean· Week 26

Insulin Dose

GroupValue (Units of insulin (U))Spread
Insulin Degludec/Liraglutide34.611.1
Insulin Degludec37.910.8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Insulin Degludec/LiraglutideParticipants were to receive Insulin degludec/liraglutide (IDegLira) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) values. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.0 / 30113 / 301113 / 301
Insulin DegludecParticipants were to receive Insulin degludec (IDeg) subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 16 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG values. The maximum dose was 50 units IDeg.0 / 1517 / 15143 / 151

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

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