DiabetesPhase 3DUALTM IXNCT02773368
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
A Phase 3 study testing insulin degludec/liraglutide and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 88 sites in 11 countries.
Trial summary
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. 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 glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 88 sitesin 11 countries
- Study dates
- 23 May 2016to 23 Oct 2017
- 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: - 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
Trial locations and contacts
88 sites in 11 countries.
88 sites in 11 countries
United States24 sites
Novo Nordisk Investigational Site
Albany, New York, 12206
Novo Nordisk Investigational Site
Austin, Texas, 78731
Novo Nordisk Investigational Site
Avon, Indiana, 46123
Novo Nordisk Investigational Site
Boynton Beach, Florida, 33472
Novo Nordisk Investigational Site
Bristol, Tennessee, 37620-7352
Novo Nordisk Investigational Site
Chiefland, Florida, 32626
Novo Nordisk Investigational Site
Glendale, Arizona, 85308
Novo Nordisk Investigational Site
Greer, South Carolina, 29651
Novo Nordisk Investigational Site
Houston, Texas, 77081
Novo Nordisk Investigational Site
Kenosha, Wisconsin, 53144
Novo Nordisk Investigational Site
La Jolla, California, 92037
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89118
Novo Nordisk Investigational Site
Longview, Texas, 75605
Novo Nordisk Investigational Site
Mason, Ohio, 45040-6815
Novo Nordisk Investigational Site
Mission Viejo, California, 92691
Novo Nordisk Investigational Site
Northridge, California, 91325
Novo Nordisk Investigational Site
Palm Springs, California, 92262
Novo Nordisk Investigational Site
Rockville, Maryland, 20852
Novo Nordisk Investigational Site
San Antonio, Texas, 78228-3419
Novo Nordisk Investigational Site
San Ramon, California, 94583
Novo Nordisk Investigational Site
Skokie, Illinois, 60077
Novo Nordisk Investigational Site
Teaneck, New Jersey, 07666
Novo Nordisk Investigational Site
West Seneca, New York, 14224
Novo Nordisk Investigational Site
Whiteville, North Carolina, 28472
India10 sites
Novo Nordisk Investigational Site
Bhopal, Madhya Pradesh, 462037
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, 600029
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, 600086
Novo Nordisk Investigational Site
Hyderbad, Andhra Pradesh, 500 012
Novo Nordisk Investigational Site
Jaipur, Rajasthan, 302004
Novo Nordisk Investigational Site
Kolkata, West Bengal, 700054
Novo Nordisk Investigational Site
Ludhiana, Punjab, 141001
Novo Nordisk Investigational Site
New Delhi, 110001
Novo Nordisk Investigational Site
Pune, Maharashtra, 411040
Novo Nordisk Investigational Site
Varanasi, Uttar Pradesh, 221105
Switzerland8 sites
Novo Nordisk Investigational Site
Baden, 5400
Novo Nordisk Investigational Site
Geneva, 1211
Novo Nordisk Investigational Site
Lucerne, 6000
Novo Nordisk Investigational Site
Olten, 4600
Novo Nordisk Investigational Site
Schaffhausen, 8208
Novo Nordisk Investigational Site
Winterthur, 8400
Novo Nordisk Investigational Site
Zollikerberg, 8125
Novo Nordisk Investigational Site
Zurich, 8091
Russia7 sites
Novo Nordisk Investigational Site
Barnaul, 656043
Novo Nordisk Investigational Site
Moscow, 123423
Novo Nordisk Investigational Site
Novosibirsk, 630047
Novo Nordisk Investigational Site
Saint Petersburg, 191119
Novo Nordisk Investigational Site
Saint Petersburg, 194354
Novo Nordisk Investigational Site
Saint Petersburg, 194358
Novo Nordisk Investigational Site
Saint-Petesburg, 195257
Spain7 sites
Novo Nordisk Investigational Site
Almería, 04001
Novo Nordisk Investigational Site
Antequera, 29200
Novo Nordisk Investigational Site
Barcelona, 08035
Novo Nordisk Investigational Site
Boadilla del Monte, 28660
Novo Nordisk Investigational Site
Seville, 41003
Novo Nordisk Investigational Site
Seville, 41009
Novo Nordisk Investigational Site
Villamartín, 11650
Canada6 sites
Novo Nordisk Investigational Site
Burlington, Ontario, L7M 4Y1
Novo Nordisk Investigational Site
London, Ontario, N6G 2M1
Novo Nordisk Investigational Site
Moncton, New Brunswick, E1G 1A7
Novo Nordisk Investigational Site
Montreal, Quebec, H4A 3T2
Novo Nordisk Investigational Site
Smiths Falls, Ontario, K7A 4W8
Novo Nordisk Investigational Site
Winnipeg, Manitoba, R2V 4W3
Finland6 sites
Novo Nordisk Investigational Site
Helsinki, 00100
Novo Nordisk Investigational Site
Lahti, 15110
Novo Nordisk Investigational Site
Oulu, FI-90220
Novo Nordisk Investigational Site
Rovaniemi, 96400
Novo Nordisk Investigational Site
Tampere, 33520
Novo Nordisk Investigational Site
Turku, 20520
Hungary6 sites
Novo Nordisk Investigational Site
Budapest, 1042
Novo Nordisk Investigational Site
Debrecen, 4043
Novo Nordisk Investigational Site
Komárom, 2900
Novo Nordisk Investigational Site
Salgótarján, 3100
Novo Nordisk Investigational Site
Szekszárd, 7100
Novo Nordisk Investigational Site
Zalaegerszeg, 8900
Slovakia5 sites
Novo Nordisk Investigational Site
Košice, 040 01
Novo Nordisk Investigational Site
Lučenec, 984 01
Novo Nordisk Investigational Site
Nitra, 94901
Novo Nordisk Investigational Site
Prešov, 080 01
Novo Nordisk Investigational Site
Trnava, 91701
Slovenia5 sites
Novo Nordisk Investigational Site
Celje, SI-3000
Novo Nordisk Investigational Site
Koper, SI-6000
Novo Nordisk Investigational Site
Kranj, 4000
Novo Nordisk Investigational Site
Murska Sobota, SI-9000
Novo Nordisk Investigational Site
Trbovlje, 1420
Argentina4 sites
Novo Nordisk Investigational Site
Buenos Aires, C1425AGC
Novo Nordisk Investigational Site
CABA, C1120AAC
Novo Nordisk Investigational Site
CABA, C1180AAX
Novo Nordisk Investigational Site
Mendoza, 5500
About this study
Official title: 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. DUALTM IX - Add-on to SGLT2i
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.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- insulin degludec/liraglutide, insulin glargine
- 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
IDegLira will be given subcutaneously ( s.c., under the skin) once daily.
insulin glargineDrug
IGlar will be given subcutaneously ( s.c., under the skin) once daily.
| Study group | Role | What they receive |
|---|---|---|
| IDegLira | Experimental | Not described Receives: Drug: insulin degludec/liraglutide |
| IGlar | Active comparator | Not described Receives: Drug: insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c (Glycosylated Haemoglobin)
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.
Measured: Week 0, Week 26
Secondary outcomes (32)
Change in Body Weight
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.
Measured: Week 0, Week 26
Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes
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.
Measured: Week 0-26
Insulin Dose, Total Daily Dose (U)
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.
Measured: After 26 weeks
Change in Fasting Plasma Glucose (FPG)
Change from baseline (week 0) in FPG was evaluated after 26 weeks of randomised treatment.
Measured: Week 0, Week 26
Number of Treatment-emergent Adverse Events
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.
Measured: Week 0-26
Responder (Yes/No) for HbA1c Below 7.0%
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.
Measured: After 26 weeks
Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain
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.
Measured: After 26 weeks
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
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.
Measured: After 26 weeks
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
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.
Measured: After 26 weeks
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5%
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.
Measured: After 26 weeks
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain
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.
Measured: After 26 weeks
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
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.
Measured: After 26 weeks
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
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.
Measured: After 26 weeks
Change From Baseline After 26 Weeks in Waist Circumference
Mean change from baseline in waist circumference after 26 weeks of randomised treatment.
Measured: After 26 weeks
Change From Baseline in Fasting Lipid Profile: Cholesterol
The values of total cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
Measured: After 26 weeks
Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol)
The values of LDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
Measured: After 26 weeks
Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol)
The values of HDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
Measured: After 26 weeks
Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol)
The values of VLDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
Measured: After 26 weeks
Change From Baseline in Fasting Lipid Profile: Triglycerides
The values of triglycerides from fasting lipid profile after 26 weeks of randomised treatment.
Measured: After 26 weeks
Change From Baseline in Fasting Lipid Profile: Free Fatty Acids
The values of free fatty acids from fasting lipid profile after 26 weeks of randomised treatment.
Measured: After 26 weeks
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile
Change in 9-point SMPG profile was evaluated after 26 weeks of randomised treatment. SMPG measurements at baseline and week 26 are presented here at the following mentioned time points:1) Before breakfast, 2) 90 mins after the start of Breakfast, 3) Before lunch, 4) 90 mins after the start of lunch, 5) Before dinner, 6) 90 mins after the start of dinner, 7) At bedtime, 8) At 4 AM, 9) Before breakfast the following day.
Measured: After 26 weeks
Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile
Change in mean of the 9-point profile SMPG was evaluated after 26 weeks of randomised treatment. 9-point profile SMPG was measured at the following mentioned time points:1) Before breakfast, 2) 90 mins after the start of Breakfast, 3) Before lunch, 4) 90 mins after the start of lunch, 5) Before dinner, 6) 90 mins after the start of dinner, 7) At bedtime, 8) At 4 AM, 9) Before breakfast the following day.
Measured: After 26 weeks
Change From Baseline in SMPG 9-point Profile: Prandial Plasma Glucose Increments (From Before Meal to 90 Min After Breakfast, Lunch and Dinner). The Mean Increment Over All Meals Will be Derived as the Mean of All Available Meal Increments
Mean prandial plasma glucose increments for each meal (from before meal to 90 min after breakfast, lunch and dinner) was evaluated after 26 weeks of randomised treatment. The mean increment over all meals was derived as the mean of all available meal increments are presented here.
Measured: After 26 weeks
Change From Baseline in Systolic Blood Pressure
Change from baseline (week 0) in systolic blood pressure (BP) was evaluated after 26 weeks of randomised treatment.
Measured: After 26 weeks
Change From Baseline in Diastolic Blood Pressure
Change from baseline (week 0) in diastolic blood pressure was evaluated after 26 weeks of randomised treatment.
Measured: After 26 weeks
Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks
Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes (00:01-05:59 - inclusive) during 26 weeks of randomised treatment.
Measured: Week 0-26
Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks
American Diabetes Association (ADA) classification of hypoglycaemic episodes: 1)Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo: PG >3.9 mmol/L with symptoms. 6) Unclassifiable.
Measured: Week 0-26
Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG)
Reported results are ECG findings at screening and week 26 of randomised treatment. Since the values measured at the baseline (week 0) were not collected, the screening data (week -2, which is <= 2 weeks before baseline) is presented here. The findings are categorised as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 4) Missing.
Measured: After 26 weeks
Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography
Reported results are fundus photography/fundoscopy (for both left and right eye) findings at screening and week 26 of randomised treatment. Since the values measured at the baseline (week 0) were not collected, the screening data (week -2, which is <= 2 weeks before baseline) is presented here. The findings are categorised as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 4) Missing.
Measured: After 26 weeks
Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate
Change from baseline (week 0) in pulse rate was evaluated after 26 weeks of randomised treatment.
Measured: After 26 weeks
Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2)
The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject's overall health related quality of life (HRQoL). PRO questionnaire (SF-36v2™) measured the HRQoL which contains 36 items covering 8 domains of physical and mental health status. The raw scale scores from the SF-36 were transformed to a 0-100 scale scores (where higher scores indicated a better health status) which is further converted to norm-based scores using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 2009 reference population . The total/overall (SF-36v2™) scores for physical and mental health from baseline to week 26 are presented here.
Measured: After 26 weeks
Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Treatment Related Impact Measure for Diabetes (TRIM-D)
The patient reported outcomes are calculated based on TRIM-D questionnaire. The TRIM-D questionnaire consists of 5 sub-domains (treatment burden, daily life, diabetes management, compliance and psychological health), where each question is scored to a 1-5-point scale with a higher score indicating a better health state (less negative impact). Mean TRIM-D domain scores and the total scores are later transformed to a 0-100 scale for analysis. Summary scores from baseline and week 26 for total/overall scores are presented here.
Measured: After 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study start23 May 2016
- Primary completion26 Sep 2017
- Study completion23 Oct 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 420 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
- NCT02773368
- Sponsor's protocol ID
- NN9068-4229
- Other IDs
- 2015-001596-48, U1111-1168-9343, REec-2016-2248, 2015
- Acronym
- DUALTM IX
- Status last verified
- Aug 2020
- First submitted
- 13 May 2016
- Last updated
- 11 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Philis-Tsimikas A, Billings LK, Busch R, Portillo CM, Sahay R, Halladin N, Eggert S, Begtrup K, Harris S. 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. Diabetes Obes Metab. 2019 Jun;21(6):1399-1408. doi: 10.1111/dom.13666. Epub 2019 Apr 4.
PubMed 30761720
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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. DUALTM IX - Add-on to SGLT2i
- ClinicalTrials.gov ID
- NCT02773368
- Acronym / sponsor ID
- DUALTM IX / NN9068-4229
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 23 May 2016 (actual)
- Primary completion
- 26 Sep 2017 (actual)
- Study completion
- 23 Oct 2017 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Posted 23 Oct 2018
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDegLira | Experimental | Drug: insulin degludec/liraglutide |
| IGlar | Active comparator | Drug: insulin glargine |
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/liraglutideIDegLira will be given subcutaneously ( s.c., under the skin) once daily. | Drug | IDegLira |
| insulin glargineIGlar will be given subcutaneously ( s.c., under the skin) once daily. | Drug | IGlar |
Primary outcome
Change in HbA1c (Glycosylated Haemoglobin)
Time frame: Week 0, Week 26
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.
32 secondary outcomes
Change in Body Weight
Time frame: Week 0, Week 26
Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes
Time frame: Week 0-26
Insulin Dose, Total Daily Dose (U)
Time frame: After 26 weeks
Change in Fasting Plasma Glucose (FPG)
Time frame: Week 0, Week 26
Number of Treatment-emergent Adverse Events
Time frame: Week 0-26
Responder (Yes/No) for HbA1c Below 7.0%
Time frame: After 26 weeks
Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain
Time frame: After 26 weeks
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
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
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5%
Time frame: After 26 weeks
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain
Time frame: After 26 weeks
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
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
Change From Baseline After 26 Weeks in Waist Circumference
Time frame: After 26 weeks
Change From Baseline in Fasting Lipid Profile: Cholesterol
Time frame: After 26 weeks
Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol)
Time frame: After 26 weeks
Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol)
Time frame: After 26 weeks
Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol)
Time frame: After 26 weeks
Change From Baseline in Fasting Lipid Profile: Triglycerides
Time frame: After 26 weeks
Change From Baseline in Fasting Lipid Profile: Free Fatty Acids
Time frame: After 26 weeks
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile
Time frame: After 26 weeks
Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile
Time frame: After 26 weeks
Change From Baseline in SMPG 9-point Profile: Prandial Plasma Glucose Increments (From Before Meal to 90 Min After Breakfast, Lunch and Dinner). The Mean Increment Over All Meals Will be Derived as the Mean of All Available Meal Increments
Time frame: After 26 weeks
Change From Baseline in Systolic Blood Pressure
Time frame: After 26 weeks
Change From Baseline in Diastolic Blood Pressure
Time frame: After 26 weeks
Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks
Time frame: Week 0-26
Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks
Time frame: Week 0-26
Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG)
Time frame: After 26 weeks
Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography
Time frame: After 26 weeks
Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate
Time frame: After 26 weeks
Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2)
Time frame: After 26 weeks
Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Treatment Related Impact Measure for Diabetes (TRIM-D)
Time frame: After 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30761720Philis-Tsimikas A, Billings LK, Busch R, Portillo CM, Sahay R, Halladin N, Eggert S, Begtrup K, Harris S. 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. Diabetes Obes Metab. 2019 Jun;21(6):1399-1408. doi: 10.1111/dom.13666. Epub 2019 Apr 4.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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
88 sites in 11 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 glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 88 sites in 11 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 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 88 sites in United States, India, Switzerland, Russia, Spain and 6 more countries. 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 23 Oct 2018). 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 (Glycosylated Haemoglobin) (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?
On the ClinicalTrials.gov record for NCT02773368, which also lists 1 linked publication.
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 11 Aug 2020.