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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Trial Comparing Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs)

Short name DUAL™ I China

NCTNCT03172494 (opens ClinicalTrials.gov in a new tab)Other idNN9068-4148Other idU1111-1154-6671Other idCTR20170004
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
720 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
26 May 2017
Primary completion
14 Jun 2019
Completion
13 Jul 2019
First posted
1 Jun 2017
Last update posted
14 Dec 2022
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™ I China

    NCT03172494

    26 May 2017 to 13 Jul 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 efficacy of insulin degludec/liraglutide in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus inadequately controlled on oral antidiabetic agents

Interventions

  • Insulin degludec/liraglutideDrug
  • Insulin degludecDrug
  • LiraglutideDrug

Arms3

  • Experimental

    Insulin degludec/liraglutide

  • Active comparator

    Insulin degludec

  • Active comparator

    Liraglutide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HbA1c

    Time frame · Week 0, week 26

    Registry description

    Change in HbA1c from baseline (week 0) after 26 weeks of treatment 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) after 26 weeks of treatment is presented.

  2. Number of Treatment Emergent Severe or BG Confirmed Hypoglycaemic Episodes

    Time frame · Weeks 0-26

    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 blood glucose (BG) confirmed by a plasma glucose (PG) 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. The number of episodes are represented as rates. The observed rates of treatment-emergent severe or BG confirmed hypoglycaemic episodes per patient years of exposure (PYE) (number of episodes divided by PYE multiplied by 100) during 26 weeks of treatment are presented.

  3. Insulin Dose

    Time frame · Week 26

    Registry description

    The actual daily total insulin dose after 26 weeks of treatment is presented. This outcome measure is only applicable for Insulin degludec/liraglutide and Insulin degludec treatment arms.

  4. Participants Who Achieved HbA1c < 7.0%, American Diabetes Association (ADA) Target (Yes/no)

    Time frame · Week 26

    Registry description

    Number of participants who achieved ADA HbA1c target (HbA1c \< 7.0%) (yes/no) after 26 weeks of treatment are presented.

  5. Participants Who Achieved HbA1c ≤ 6.5%, International Diabetes Federation (IDF) Target (Yes/no)

    Time frame · Week 26

    Registry description

    Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment are presented.

  6. Participants Who Achieved HbA1c <7.0% and Change in Body Weight From Baseline Below or Equal to Zero

    Time frame · Week 26

    Registry description

    Number of participants who achieved ADA HbA1c target (HbA1c \< 7.0%) (yes/no) and change from baseline in body weight below or equal to zero after 26 weeks are presented. Missing values are imputed by LOCF.

  7. Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero

    Time frame · Week 26

    Registry description

    Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) and change from baseline in body weight below or equal to zero after 26 weeks are presented. Missing values are imputed by LOCF.

  8. Participants Who Achieved HbA1c < 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes

    Time frame · Week 26

    Registry description

    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 PG 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. Number of participants who achieved ADA HbA1c target (HbA1c \<7.0%) (yes/no) after 26 weeks of treatment and without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment are presented. Missing values are imputed by LOCF.

  9. Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Hypoglycaemic Episodes

    Time frame · Week 26

    Registry description

    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 PG 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. Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment and without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment are presented. Missing values are imputed by LOCF.

  10. Participants Who Achieved HbA1c < 7.0% Without Severe or BG Confirmed Episodes, and Change From Baseline in Body Weight Below or Equal to Zero.

    Time frame · Week 26

    Registry description

    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 PG 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. Number of participants who achieved ADA HbA1c target (HbA1c \< 7.0%) (yes/no) after 26 weeks of treatment without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment and with change from baseline in body weight below or equal to zero are presented. Missing values are imputed by LOCF.

  11. Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Episodes and Change From Baseline in Body Weight Below or Equal to Zero.

    Time frame · Week 26

    Registry description

    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 PG 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. Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment and with change from baseline in body weight below or equal to zero are presented. Missing values are imputed by LOCF.

  12. Change in Fasting Plasma Glucose (FPG)

    Time frame · Week 0, week 26

    Registry description

    Change from baseline (week 0) in FPG after 26 weeks of treatment is presented.

  13. Change in Waist Circumferance

    Time frame · Week 0, week 26

    Registry description

    Change from baseline (week 0) in waist circumferance after 26 weeks of treatment is presented.

  14. 9-point SMPG Profile

    Time frame · Week 26

    Registry description

    Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). 9-point SMPG values at 26 weeks of treatment are presented.

  15. Change in Mean of 9-point SMPG Profile

    Time frame · Week 0, week 26

    Registry description

    Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, 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.

  16. Change in Mean Post-prandial Plasma Glucose (PG) Increments

    Time frame · Week 0, week 26

    Registry description

    Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). Post-prandial SMPG increments from before meal to 90 minutes after for breakfast, lunch and dinner were calculated. The mean increment over all meals was derived as the mean of all available meal increments. Change from baseline (week 0) in post-prandial SMPG increments for all meals after 26 weeks of treatment is presented.

  17. 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.

  18. Change in Fasting Human Insulin - Ratio to Baseline

    Time frame · Week 0, week 26

    Registry description

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

  19. 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.

  20. Change in HOMA-B (Beta Cell Function)- Ratio to Baseline

    Time frame · Week 0, week 26

    Registry description

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

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 points of HbA1c)Spread
Insulin Degludec/Liraglutide-1.710.88
Insulin Degludec-1.200.99
Liraglutide-1.160.89
Secondary and other outcome results(7)
Secondary outcomeMean· Week 0, week 26

Change in Body Weight

GroupValue (Kilogram (Kg))Spread
Insulin Degludec/Liraglutide0.22.7
Insulin Degludec1.32.7
Liraglutide-2.52.7
Secondary outcomeNumber· Weeks 0-26

Number of Treatment Emergent Severe or BG Confirmed Hypoglycaemic Episodes

GroupValue ((Number of episodes/PYE)*100)
Insulin Degludec/Liraglutide23.94
Insulin Degludec17.01
Liraglutide3.60
Secondary outcomeMean· Week 26

Insulin Dose

GroupValue (Units of insulin (U))Spread
Insulin Degludec/Liraglutide24.811.9
Insulin Degludec30.114.4
Secondary outcomeCount of participants· Week 26

Participants Who Achieved HbA1c < 7.0%, American Diabetes Association (ADA) Target (Yes/no)

GroupValue (Participants)
Insulin Degludec/Liraglutide272
Insulin Degludec83
Liraglutide80
Secondary outcomeCount of participants· Week 26

Participants Who Achieved HbA1c ≤ 6.5%, International Diabetes Federation (IDF) Target (Yes/no)

GroupValue (Participants)
Insulin Degludec/Liraglutide201
Insulin Degludec48
Liraglutide41
Secondary outcomeCount of participants· Week 26

Participants Who Achieved HbA1c <7.0% and Change in Body Weight From Baseline Below or Equal to Zero

GroupValue (Participants)
Insulin Degludec/Liraglutide147
Insulin Degludec34
Liraglutide74
Secondary outcomeCount of participants· Week 26

Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero

GroupValue (Participants)
Insulin Degludec/Liraglutide111
Insulin Degludec21
Liraglutide37

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 subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide) initially. The dose was then adjusted twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) target of 4.0-5.0 mmol/L. The maximum dose was 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). One dose step corresponded to 1 unit insulin degludec per 0.036 mg liraglutide.0 / 35814 / 358161 / 358
Insulin DegludecParticipants were to receive Insulin degludec subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 10 units insulin degludec initially. The dose was then adjusted twice weekly based on pre-breakfast SMPG target of 4.0-5.0 mmol/L. There was no maximum dose for Insulin degludec.0 / 1757 / 17555 / 175
LiraglutideParticipants were to receive liraglutide subcutaneous injection once daily in combination with metformin for 26 weeks. Participants received 0.6 mg initially. The dose was then escalated in weekly increments of 0.6 mg to reach a target dose of 1.8 mg. Liraglutide dose of 1.8 mg/day was continued for the remaining period of treatment."0 / 18014 / 18098 / 180

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

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2022

Corrected

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.

Wang et al. 2022Journal of diabetescited by 16

PMID 35762390PMC9366571DOI 10.1111/1753-0407.13286PUB-35762390

CC BY
Download PDFRead the notice

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 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)

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