Phase 3
Completed N=1,012
A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02501161 ↗Enrolled (actual)
1,012
Serious AEs
10.2%
Results posted
Nov 2019
Primary outcomePrimary: Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification — NA; 104.3; 106.7; 90.3 Weeks — p=<.0001
◆ Published Evidence
Established
67citations · ~10 / year
Durability of insulin degludec plus liraglutide versus insulin glargine U100 as initial injectable therapy in type 2 diabetes (DUAL VIII): a multicentre, open-label, phase 3b, randomised controlled trial.
Summary
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.
Linked Publications (2)
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Durability of insulin degludec plus liraglutide versus insulin glargine U100 as initial injectable therapy in type 2 diabetes (DUAL VIII): a multicentre, open-label, phase 3b, randomised controlled trial.
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Higher Derived Time in Range With IDegLira Versus Insulin Glargine U100 in People With Type 2 Diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification |
NA; 104.3; 106.7; 90.3; NA; 64.6 | <.0001 sig |
| SECONDARY Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits |
NA; 64.1; 90.1; 26.6; 64.1; 26.6 | <.0001 sig |
| SECONDARY Change in HbA1c |
-1.99; -1.69 | — |
| SECONDARY Change in Body Weight |
0.5; 2.2; 1.2; 3.0 | — |
| SECONDARY Insulin Dose |
34.6; 48.6; 36.1; 50.6 | — |
| SECONDARY Participants Who Achieved (Yes/no): HbA1c <7.0% |
78.7; 55.7; 21.3; 44.3; 55.5; 28.5 | — |
| SECONDARY Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain |
38.5; 15.4; 61.5; 84.6; 20.9; 6.3 | — |
| SECONDARY Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes |
71.3; 44.9; 28.7; 55.1; 51.8; 25.5 | — |
| SECONDARY Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain |
35.2; 13.6; 64.8; 86.4; 20.0; 6.1 | — |
| SECONDARY Participants Who Achieved (Yes/no): HbA1c ≤6.5% |
63.6; 35.4; 36.4; 64.6; 43.3; 21.7 | — |
| SECONDARY Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain |
33.2; 9.9; 66.8; 90.1; 17.6; 5.7 | — |
| SECONDARY Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes |
57.9; 27.9; 42.1; 72.1; 40.1; 19.2 | — |
| SECONDARY Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain |
30.2; 8.7; 69.8; 91.3; 16.6; 5.5 | — |
| SECONDARY Change in FPG |
-3.97; -3.79; -3.93; -3.73 | — |
| SECONDARY SMPG-9-point Profile (Individual Points in the Profile) |
5.59; 5.58; 8.34; 8.76; 6.03; 6.43 | — |
| SECONDARY Change in SMPG-mean 9-point Profile |
-3.34; -3.32; -3.27; -2.76 | — |
| SECONDARY Change in SMPG-mean Postprandial Increment Over All Meals |
-0.28; 0.20; -0.47; 0.12 | — |
| SECONDARY Change in Blood Pressure (Systolic and Diastolic) |
-1.2; 0.5; 0.1; -0.3; 0.5; 0.9 | — |
| SECONDARY Change in Fasting C-peptide |
0.63; 0.57; 0.58; 0.54 | — |
| SECONDARY Change in Fasting Human Insulin |
0.67; 0.68; 0.60; 0.62 | — |
| SECONDARY Change in Fasting Total Cholesterol |
0.99; 0.99; 0.97; 0.97 | — |
| SECONDARY Change in Fasting LDL-cholesterol |
1.05; 1.02; 0.96; 0.98 | — |
| SECONDARY Change in Fasting HDL-cholesterol |
1.03; 1.02; 1.02; 1.03 | — |
| SECONDARY Change in Fasting VLDL-cholesterol |
0.85; 0.85; 0.90; 0.88 | — |
| SECONDARY Change in Fasting Triglycerides |
0.84; 0.85; 0.89; 0.89 | — |
| SECONDARY Change in Fasting Free Fatty Acids |
0.68; 0.75; 0.70; 0.78 | — |
| SECONDARY Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment |
143; 261 | — |
| SECONDARY Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment |
319; 642 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes During 26 Weeks of Treatment |
3190; 3806 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes During 104 Weeks of Treatment |
8934; 10658 | — |
| SECONDARY Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment |
27; 60 | — |
| SECONDARY Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment |
61; 164 | — |
| SECONDARY Number of TEAEs During 26 Weeks of Treatment |
718; 624 | — |
| SECONDARY Number of TEAEs During 104 Weeks of Treatment |
1788; 1368 | — |
| SECONDARY Eye Examination Category |
345; 341; 151; 155; 10; 8 | — |
| SECONDARY ECG Evaluation |
335; 335; 162; 165; 9; 4 | — |
| SECONDARY Change in Urine Albumin/Creatinine Ratio |
-1.09; -0.74 | — |
| SECONDARY Change in Pulse Rate |
2.0; -0.4; 1.7; -0.5 | — |
| SECONDARY Change in Biochemistry Parameter- Creatinine, Total Bilirubin |
-0.50; 0.25; 0.75; 2.20; -0.30; -0.32 | — |
| SECONDARY Change in Biochemistry Parameter- Albumin |
-0.03; -0.03; 0.01; 0.03 | — |
| SECONDARY Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase |
-4.16; -4.33; -1.35; -1.34; -5.45; -3.33 | — |
| SECONDARY Change in Biochemistry Parameter- Sodium, Potassium and Calcium |
0.89; 1.03; 1.22; 1.47; -0.05; -0.08 | — |
| SECONDARY Change in Haematological Parameter- Haemoglobin |
0.08; 0.08; -0.00; -0.03 | — |
| SECONDARY Change in Haematological Parameter- Haematocrit |
-0.33; -0.36; -0.71; -0.95 | — |
| SECONDARY Change in Haematological Parameter- Erythrocytes |
-0.02; -0.03; -0.12; -0.11 | — |
| SECONDARY Change in Haematological Parameter- Thrombocytes and Leukocytes |
8.77; 7.05; 16.87; 18.73; 0.49; 0.39 | — |
| SECONDARY Change in Haematological Parameter- Eosinophils |
0.10; 0.06; 0.32; 0.43 | — |
| SECONDARY Change in Haematological Parameter- Neutrophils |
1.86; 0.78; 1.25; 1.21 | — |
| SECONDARY Change in Haematological Parameter- Basophils |
0.00; -0.00; 0.20; 0.16 | — |
| SECONDARY Change in Haematological Parameter- Monocytes |
-0.10; 0.01; 0.49; 0.59 | — |
| SECONDARY Change in Haematological Parameter- Lymphocytes |
-1.87; -0.84; -2.25; -2.38 | — |
| SECONDARY Change in Calcitonin |
0; 0; 481; 472; 25; 32 | — |
| SECONDARY Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) |
1.2; 1.1; 0.7; 0.6; 1.4; 0.5 | — |
| SECONDARY Change in TRIM-D |
9.6; 7.3; 11.4; 9.5 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02501161) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.