Skip to content

Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus

Short name DUALTM IX

NCTNCT02773368 (opens ClinicalTrials.gov in a new tab)Other idNN9068-4229Other id2015-001596-48Other idU1111-1168-9343Other idREec-2016-2248
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States, Argentina, Canada, Finland, Hungary, India, Russia, Slovakia, Slovenia, Spain, Switzerland

Start
23 May 2016
Primary completion
26 Sept 2017
Completion
23 Oct 2017
First posted
16 May 2016 (estimated)
Last update posted
11 Aug 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
201620172018
  1. Ph 3

    DUALTM IX

    NCT02773368

    23 May 2016 to 23 Oct 2017

Registry summary

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

This trial is conducted globally. The aim of this trial is comparing glycaemic control and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) as add-on therapy to SGLT2i (sodium-glucose cotransporter 2 inhibitors) in subjects with type 2 diabetes mellitus.

Interventions

  • insulin degludec/liraglutideDrug
  • insulin glargineDrug

Arms2

  • Experimental

    IDegLira

  • Active comparator

    IGlar

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HbA1c (Glycosylated Haemoglobin)

    Time frame · Week 0, Week 26

    Registry description

    The mean change from baseline (week 0) in HbA1c values evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.

Secondary outcomes(20)

  1. Change in Body Weight

    Time frame · Week 0, Week 26

    Registry description

    The mean change from baseline (week 0) in body weight evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.

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

    Time frame · Week 0-26

    Registry description

    Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe (subjects who were not able to self-treat) and/or BG confirmed by a plasma glucose values \<3.1 mmol/L (56 mg/dL) with accompanied symptoms consistent with hypoglycaemia.

  3. Insulin Dose, Total Daily Dose (U)

    Time frame · After 26 weeks

    Registry description

    Actual daily total insulin dose (Units) was evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.

  4. Change in Fasting Plasma Glucose (FPG)

    Time frame · Week 0, Week 26

    Registry description

    Change from baseline (week 0) in FPG was evaluated after 26 weeks of randomised treatment.

  5. Number of Treatment-emergent Adverse Events

    Time frame · Week 0-26

    Registry description

    Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 26. TEAE was defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.

  6. Responder (Yes/No) for HbA1c Below 7.0%

    Time frame · After 26 weeks

    Registry description

    The proportion of subjects achieving pre-defined HbA1c targets \<7.0% after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.

  7. Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain

    Time frame · After 26 weeks

    Registry description

    The proportion of subjects achieving pre-defined HbA1c targets \<7.0% without weight gain after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.

  8. Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

    Time frame · After 26 weeks

    Registry description

    The proportion of subjects achieving pre-defined HbA1c targets \<7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.

  9. Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain

    Time frame · After 26 weeks

    Registry description

    The proportion of subjects achieving pre-defined HbA1c targets \<7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment and without weight gain. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.

  10. Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5%

    Time frame · After 26 weeks

    Registry description

    The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5% after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.

  11. Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain

    Time frame · After 26 weeks

    Registry description

    The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5% without weight gain after 26 weeks of randomised treatment. The results are based on retrieved data at week 26 for subjects who prematurely discontinued the trial product.

  12. Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

    Time frame · After 26 weeks

    Registry description

    The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5%without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.

  13. Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain

    Time frame · After 26 weeks

    Registry description

    The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5%without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment and without weight gain. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.

  14. Change From Baseline After 26 Weeks in Waist Circumference

    Time frame · After 26 weeks

    Registry description

    Mean change from baseline in waist circumference after 26 weeks of randomised treatment.

  15. Change From Baseline in Fasting Lipid Profile: Cholesterol

    Time frame · After 26 weeks

    Registry description

    The values of total cholesterol from fasting lipid profile after 26 weeks of randomised treatment.

  16. Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol)

    Time frame · After 26 weeks

    Registry description

    The values of LDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.

  17. Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol)

    Time frame · After 26 weeks

    Registry description

    The values of HDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.

  18. Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol)

    Time frame · After 26 weeks

    Registry description

    The values of VLDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.

  19. Change From Baseline in Fasting Lipid Profile: Triglycerides

    Time frame · After 26 weeks

    Registry description

    The values of triglycerides from fasting lipid profile after 26 weeks of randomised treatment.

  20. Change From Baseline in Fasting Lipid Profile: Free Fatty Acids

    Time frame · After 26 weeks

    Registry description

    The values of free fatty acids from fasting lipid profile after 26 weeks of randomised treatment.

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 (Glycosylated Haemoglobin)

GroupValue (Percentage of glycosylated haemoglobin)Spread
IDegLira8.200.93
IGlar8.361.08
Secondary and other outcome results(7)
Secondary outcomeMean· Week 0, Week 26

Change in Body Weight

GroupValue (kg)Spread
IDegLira89.317.6
IGlar87.217.2
Secondary outcomeNumber· Week 0-26

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

GroupValue (Number of episodes)
IDegLira38
IGlar95
Secondary outcomeMean· After 26 weeks

Insulin Dose, Total Daily Dose (U)

GroupValue (Units (U))Spread
IDegLira36.213.4
IGlar53.526.1
Secondary outcomeMean· Week 0, Week 26

Change in Fasting Plasma Glucose (FPG)

GroupValue (mmol/ L)Spread
IDegLira9.512.69
IGlar9.572.40
Secondary outcomeNumber· Week 0-26

Number of Treatment-emergent Adverse Events

GroupValue (Number of events)
IDegLira450
IGlar386
Secondary outcomeNumber· After 26 weeks

Responder (Yes/No) for HbA1c Below 7.0%

GroupValue (Participants)
IDegLira167
IGlar144
Secondary outcomeNumber· After 26 weeks

Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain

GroupValue (Participants)
IDegLira91
IGlar38

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
IDegLiraSubjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72 - 90 mg/dL\]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.0 / 2096 / 20949 / 209
IGlarSubjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72 - 90 mg/dL\]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern.0 / 2107 / 21045 / 210

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.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2019

8 results

Superior efficacy of insulin degludec/liraglutide versus insulin glargine U100 as add-on to sodium-glucose co-transporter-2 inhibitor therapy: A randomized clinical trial in people with uncontrolled type 2 diabetes.

Philis-Tsimikas et al. 2019Diabetes, obesity & metabolismcited by 56

PMID 30761720PMC6593861DOI 10.1111/dom.13666PUB-30761720

Free to read · publisher termsCC BY-NC8 results
Read at sourceSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent - Subjects diagnosed (clinically) with type 2 diabetes mellitus - HbA1c 7.0-11.0% \[53-97 mmol/mol\] (both inclusive) by central laboratory analysis - Body mass index (BMI) equal to or above 20 kg/m\^2 and below 40 kg/m\^2 - Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as well as prior insulin treatment for gestational diabetes - A stable daily dose for at least 90 days prior to the day of screening of any SGLT2i in monotherapy or in combination with metformin ± DPP4i ± pioglitazone. Use of pioglitazone is not allowed in subjects treated with dapagliflozin Exclusion Criteria: - Receipt of any investigational medicinal product within 90 days prior to screening - Use of any OADs (other than SGLT2i in monotherapy or in combination with metformin or DPP4i or pioglitazone as described in the inclusion criteria) within 90 days prior to the day of screening - Use of glucagon-like peptide-1 (GLP-1) receptor agonist (e.g., exenatide or liraglutide) within 90 days prior to the day of screening - Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g., diabetes ketoacidosis) in the previous 90 days prior to the day of the screening - Subjects presently classified as being in NYHA (New York Heart Association) Class III or IV1 - Renal impairment estimated Glomerular Filtration Rate 60 mL/min/1.73 m2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Impaired liver function, defined as ALT (alanine aminotransferase) equal to or above 2.5 times upper normal limit at screening - Known or suspected hypersensitivity to trial product(s) or related products

PepBank is a research reference. Talk to a doctor before you use any peptide.