Phase 3
Completed N=420
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
Source: ClinicalTrials.gov NCT02773368 ↗Enrolled (actual)
420
Serious AEs
3.1%
Results posted
Oct 2018
Primary outcomePrimary: Change in HbA1c (Glycosylated Haemoglobin) — 8.20; 8.36; -1.94; -1.68 Percentage of glycosylated haemoglobin
◆ Published Evidence
Established
66citations · ~9 / year
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.
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.
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c (Glycosylated Haemoglobin) |
8.20; 8.36; -1.94; -1.68 | — |
| SECONDARY Change in Body Weight |
89.3; 87.2; -0.0; 2.0 | — |
| SECONDARY Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes |
38; 95 | — |
| SECONDARY Insulin Dose, Total Daily Dose (U) |
36.2; 53.5 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) |
9.51; 9.57; -3.72; -3.50 | — |
| SECONDARY Number of Treatment-emergent Adverse Events |
450; 386 | — |
| SECONDARY Responder (Yes/No) for HbA1c Below 7.0% |
167; 144; 30; 58 | — |
| SECONDARY Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain |
91; 38; 106; 164 | — |
| SECONDARY 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 |
156; 114; 41; 88 | — |
| SECONDARY 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 |
83; 34; 114; 168 | — |
| SECONDARY Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% |
147; 100; 50; 102 | — |
| SECONDARY Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain |
84; 26; 113; 176 | — |
| SECONDARY 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 |
137; 79; 60; 123 | — |
| SECONDARY 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 |
77; 24; 120; 178 | — |
| SECONDARY Change From Baseline After 26 Weeks in Waist Circumference |
105.9; 104.7; -0.6; 0.7 | — |
| SECONDARY Change From Baseline in Fasting Lipid Profile: Cholesterol |
4.42; 4.45; 4.27; 4.27 | — |
| SECONDARY Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol) |
2.28; 2.28; 2.20; 2.31 | — |
| SECONDARY Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol) |
1.14; 1.14; 1.17; 1.17 | — |
| SECONDARY Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol) |
0.75; 0.80; 0.70; 0.67 | — |
| SECONDARY Change From Baseline in Fasting Lipid Profile: Triglycerides |
1.67; 1.73; 1.55; 1.47 | — |
| SECONDARY Change From Baseline in Fasting Lipid Profile: Free Fatty Acids |
0.58; 0.61; 0.38; 0.42 | — |
| SECONDARY Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile |
9.01; 9.00; 11.79; 11.77; 8.93; 9.20 | — |
| SECONDARY Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile |
9.98; 10.06; -3.47; -2.98 | — |
| SECONDARY 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 |
2.38; 2.28; -0.86; -0.09 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure |
130.5; 128.9; -3.0; 0.6 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure |
79.4; 78.9; -1.2; -1.1 | — |
| SECONDARY Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks |
6; 13 | — |
| SECONDARY Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks |
1; 0; 239; 419; 850; 902 | — |
| SECONDARY Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) |
142; 141; 66; 69; 1; 0 | — |
| SECONDARY Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography |
134; 131; 68; 74; 7; 4 | — |
| SECONDARY Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate |
76.1; 75.0; 2.0; -0.4 | — |
| SECONDARY Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2) |
51.3; 51.5; 53.2; 54.6; 53.3; 53.3 | — |
| SECONDARY Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Treatment Related Impact Measure for Diabetes (TRIM-D) |
75.9; 75.9; 84.4; 83.9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02773368) 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.