Phase 3 · Liraglutide

DUAL VIII trial results

A Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus

Participants
1,012
Status
completed
Completed
2018-10-03
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT02501161), updated at source Nov 27, 2019. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What DUAL VIII measured first

Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment IntensificationWeeks · Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2 · median
MeasureInsulin Degludec/Liraglutiden=506Insulin Glarginen=506
Baseline HbA1c <8.5% + Non-SU usersNA(104.0 to NA)104.3(38.1 to NA)
Baseline HbA1c <8.5% + SU users106.7(89.9 to NA)90.3(26.4 to 105.1)
Baseline HbA1c >=8.5% + Non-SU usersNA(39.7 to NA)64.6(26.1 to 105.1)
Baseline HbA1c >=8.5% + SU users104.0(26.4 to NA)26.6(26.1 to 91.1)
Side effects by arm

Side effects in DUAL VIII

Percent of participants affected, Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2. The most common events the registry lists.

EventInsulin Degludec/LiraglutideInsulin Glargine
Any serious event11.9%8.5%
Headache11.5%8.9%
Nasopharyngitis11.3%8.7%
Diarrhoea7.7%2.4%
Influenza7.1%5.6%
Upper respiratory tract infection5.5%7.1%
Nausea6.1%1.6%
Arthralgia4.7%5.8%
Back pain4.9%5.4%
Secondary outcomes

What else it measured

Time From Randomisation to HbA1c >6.5% at 2 Consecutive VisitsWeeks · Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2 · median
MeasureInsulin Degludec/Liraglutiden=506Insulin Glarginen=506
Baseline HbA1c <8.5% + Non-SU usersNA(52.1 to NA)64.1(26.1 to 104.3)
Baseline HbA1c <8.5% + SU users90.1(27.0 to NA)26.6(26.1 to 89.9)
Baseline HbA1c >=8.5% + Non-SU users64.1(26.1 to NA)26.6(26.1 to 90.1)
Baseline HbA1c >=8.5% + SU users52.1(26.1 to 104.1)26.1(26.1 to 38.1)
Change in HbA1cPercentage of HbA1c · Week 0, week 26 · mean
Insulin Degludec/Liraglutiden=506Insulin Glarginen=506
-1.99(1.14)-1.69(1.10)
Change in Body WeightKilogram (kg) · Week 0, week 26, week 104 · mean
MeasureInsulin Degludec/Liraglutiden=506Insulin Glarginen=506
Week 260.5(3.3)2.2(3.6)
Week 1041.2(4.9)3.0(4.9)
Insulin DoseUnits · Week 26, week 104 · mean
MeasureInsulin Degludec/Liraglutiden=506Insulin Glarginen=504
Week 2634.6(13.4)48.6(28.2)
Week 10436.1(12.9)50.6(31.5)
Participants Who Achieved (Yes/no): HbA1c <7.0%Percentage of participants · Week 26, week 104 · number
MeasureInsulin Degludec/Liraglutiden=506Insulin Glarginen=506
Week 26: Yes78.755.7
Week 26: No21.344.3
Week 104: Yes55.528.5
Week 104: No44.571.5
Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight GainPercentage of participants · Week 26, week 104 · number
MeasureInsulin Degludec/Liraglutiden=506Insulin Glarginen=506
Week 26: Yes38.515.4
Week 26: No61.584.6
Week 104: Yes20.96.3
Week 104: No79.193.7
Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic EpisodesPercentage of participants · Week 26, week 104 · number
MeasureInsulin Degludec/Liraglutiden=506Insulin Glarginen=506
Week 26: Yes71.344.9
Week 26: No28.755.1
Week 104: Yes51.825.5
Week 104: No48.274.5
Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight GainPercentage of participants · Week 26, week 104 · number
MeasureInsulin Degludec/Liraglutiden=506Insulin Glarginen=506
Week 26: Yes35.213.6
Week 26: No64.886.4
Week 104: Yes20.06.1
Week 104: No80.093.9
Participants Who Achieved (Yes/no): HbA1c ≤6.5%Percentage of participants · Week 26, week 104 · number
MeasureInsulin Degludec/Liraglutiden=506Insulin Glarginen=506
Week 26: Yes63.635.4
Week 26: No36.464.6
Week 104: Yes43.321.7
Week 104: No56.778.3
Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight GainPercentage of participants · Week 26, week 104 · number
MeasureInsulin Degludec/Liraglutiden=506Insulin Glarginen=506
Week 26: Yes33.29.9
Week 26: No66.890.1
Week 104: Yes17.65.7
Week 104: No82.494.3
Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic EpisodesPercentage of participants · Week 26, week 104 · number
MeasureInsulin Degludec/Liraglutiden=506Insulin Glarginen=506
Week 26: Yes57.927.9
Week 26: No42.172.1
Week 104: Yes40.119.2
Week 104: No59.980.8
Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight GainPercentage of participants · Week 26, week 104 · number
MeasureInsulin Degludec/Liraglutiden=506Insulin Glarginen=506
Week 26: Yes30.28.7
Week 26: No69.891.3
Week 104: Yes16.65.5
Week 104: No83.494.5
The trial

How DUAL VIII was run

This trial is conducted in Africa, Asia, Europe, North America and South America. The purpose is to compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) in insulin naïve subjects with type 2 diabetes mellitus inadequately controlled with oral anti diabetics.

  • Insulin degludec/liraglutide QD + OAD(s)
  • insulin glargine QD + OAD(s)
Who could join the trial

Inclusion Criteria: * Male or female, age greater than or equal to 18 years at the time of signing informed consent * Subjects diagnosed with type 2 diabetes mellitus * HbA1c 7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis * Body mass index greater than or equal to 20 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 is prior insulin treatment for gestational diabetes * Stable daily dose(s) including any of the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening: a) Biguanides (metformin greater than or equal to 1500 mg or maximum tolerated dose documented in the subject medical record), b) Other OAD(s) allowed: sulphonylurea, glinides, pioglitazone, and DPP4-inhibitors (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subjects medical record) Exclusion Criteria: * Screening calcitonin greater than or equal to 50 ng/L * Renal impairment estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73 m2 as per CKD-EPI value to be defined as listed in the classification CKD-EPI using IDMS for serum creatinine measurement on the day of screening * Impaired liver function, defined as ALAT or ASAT greater than or equal to 2.5 times upper limit of normal * Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma * History of pancreatitis (acute or chronic) * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening * Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)

Published papers

Papers from DUAL VIII

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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