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Clinical Trials/NCT02773368
NCT02773368CompletedPhase 3

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

Novo Nordisk A/S1 site in 1 country420 target enrollmentStarted: May 23, 2016Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
420
Locations
1
Primary Endpoint
Change in HbA1c (Glycosylated Haemoglobin)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

IDegLira

Experimental

Intervention: insulin degludec/liraglutide (Drug)

IGlar

Active Comparator

Intervention: insulin glargine (Drug)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate(After 26 weeks)
  • Change in Body Weight(Week 0, Week 26)
  • Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes(Week 0-26)
  • Insulin Dose, Total Daily Dose (U)(After 26 weeks)
  • Change in Fasting Plasma Glucose (FPG)(Week 0, Week 26)
  • Number of Treatment-emergent Adverse Events(Week 0-26)
  • Responder (Yes/No) for HbA1c Below 7.0%(After 26 weeks)
  • Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain(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(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(After 26 weeks)
  • Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5%(After 26 weeks)
  • Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain(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(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(After 26 weeks)
  • Change From Baseline After 26 Weeks in Waist Circumference(After 26 weeks)
  • Change From Baseline in Fasting Lipid Profile: Cholesterol(After 26 weeks)
  • Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol)(After 26 weeks)
  • Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol)(After 26 weeks)
  • Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol)(After 26 weeks)
  • Change From Baseline in Fasting Lipid Profile: Triglycerides(After 26 weeks)
  • Change From Baseline in Fasting Lipid Profile: Free Fatty Acids(After 26 weeks)
  • Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile(After 26 weeks)
  • Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile(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(After 26 weeks)
  • Change From Baseline in Systolic Blood Pressure(After 26 weeks)
  • Change From Baseline in Diastolic Blood Pressure(After 26 weeks)
  • Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks(Week 0-26)
  • Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks(Week 0-26)
  • Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG)(After 26 weeks)
  • Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography(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)(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)(After 26 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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