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A 38 Week Trial Comparing Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification

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ClinicalTrials.gov Identifier: NCT02906917
Recruitment Status : Completed
First Posted : September 20, 2016
Results First Posted : September 28, 2018
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
Trial comparing effect and safety of insulin degludec/insulin aspart vs. insulin glargine plus insulin aspart in subjects with type 2 diabetes treated with basal insulin with or without oral antidiabetic treatment in need of treatment intensification.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: Insulin degludec/insulin aspart Drug: Insulin glargine Drug: Insulin aspart Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 532 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: This Trial is Conducted Globally. The Aim of This Trial is to Compare the Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification.
Actual Study Start Date : September 20, 2016
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : December 24, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IDegAsp Drug: Insulin degludec/insulin aspart
Administered subcutaneously (s.c. under the skin) once daily.

Active Comparator: IGlar + IAsp Drug: Insulin glargine
Administered subcutaneously (s.c. under the skin) once daily.

Drug: Insulin aspart
Administered subcutaneously (s.c. under the skin) once daily.




Primary Outcome Measures :
  1. Change in HbA1c (%) - Week 26 [ Time Frame: Week 0, week 26 ]
    Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated 26 weeks after randomisation.


Secondary Outcome Measures :
  1. Change in HbA1c (%) - Week 38 [ Time Frame: Week 0, week 38 ]
    Change from baseline (week 0) in HbA1c was evaluated 38 weeks after randomisation.

  2. Responder (Yes/No) for HbA1c < 7% [ Time Frame: Week 26 and week 38 ]
    Participants achieving (yes/no) HbA1c <7% was evaluated 26 and 38 weeks after randomisation, respectively.

  3. Responder (Yes/No) for HbA1c <7% Without Severe or BG Confirmed Symptomatic Hypoglycaemia [ Time Frame: Week 26 and week 38 ]
    Participants achieving (yes/no) HbA1c <7% without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia, was evaluated 26 and 38 weeks after randomisation, respectively. Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.

  4. Change in FPG [ Time Frame: Week 0, week 26, week 38 ]
    Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated 26 and 38 weeks after randomisation, respectively.

  5. Change in Pre-breakfast SMPG (Used for Titration) [ Time Frame: Week 1, week 26, week 38 ]
    Reported results are observed pre-breakfast self-measured plasma glucose (SMPG; used for titration) values at week 1 (baseline) and 26 and 38 weeks after randomisation.

  6. Change in Postprandial SMPG Increment (From 9-point Profile) [ Time Frame: Week 0, week 26, week 38 ]
    Change from baseline (week 0) in postprandial SMPG increment (from 9-point profile) was evaluated 26 and 38 weeks after randomisation, respectively. 9-point SMPG profiles were measured starting in the morning 2 days prior to the scheduled visit at the time points described below: 1) Before breakfast (2 days prior to visit) 2) 90 minutes after start of the breakfast 3) Before lunch 4) 90 minutes after start of the lunch 5) Before dinner/main evening meal 6) 90 minutes after start of the dinner/main evening meal 7) At bedtime (2 days or 1 day prior to visit depending on actual clock time) 8) At 4 a.m. (1 day prior to visit) 9) Before breakfast at the following day (1 day prior to the visit).

  7. Number of Nocturnal, Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes [ Time Frame: Weeks 0-26, weeks 16-26, weeks 0-38 ]
    Number of nocturnal, treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were analysed during the following periods: weeks 0-26, weeks 16-26 and weeks 0-38. Nocturnal hypoglycaemic episodes: episodes occurring between 00:01 and 05:59 both inclusive. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product.

  8. Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes [ Time Frame: Weeks 0-26, weeks 16-26, weeks 0-38 ]
    Number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were analysed during the following periods: weeks 0-26, weeks 16-26 and weeks 0-38. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product.

  9. Total Insulin Dose [ Time Frame: Week 26 and week 38 ]
    Total insulin dose was evaluated 26 and 38 weeks after randomisation, respectively.

  10. Change in Body Weight [ Time Frame: Week 0, week 26, week 38 ]
    Change from baseline (week 0) in body weight was evaluated 26 and 38 weeks after randomisation, respectively.

  11. Incidence of TEAEs [ Time Frame: Weeks 0-26, weeks 26-38, weeks 0-38 ]
    Number of treatment emergent adverse events (TEAEs) were analysed during the following periods: weeks 0-26, weeks 26-38 and weeks 0-38. Treatment emergent: An adverse event that had an 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. If an event had an onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period, or if it had an onset date within 7 days after the last drug date, then this event was also to be considered as a TEAE.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
  • Male or female, age at least 18 years at the time of signing informed consent Algeria: Male or female, age at least 19 years at the time of signing informed consent
  • Diagnosed with type 2 diabetes mellitus
  • Treated with any basal insulin for at least 90 days prior to the day of screening
  • Subject not on any OAD(s) prior to trial participation OR subjects on stable daily dose(s) of OAD(s) for at least 90 days prior to screening visit (V1). The OAD(s) include any of the following anti-diabetic drug s)/regimen: a. Biguanides (metformin at least 1500 mg or maximum tolerated dose documented in the subject medical record) b. Other OADs (at least half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record): i. Insulin secretagogues (SU and glinides) ii. Di-peptidyl-peptidase IV (DPP-4) inhibitors iii. α-glucosidase inhibitors iv. Sodium/glucose co-transporter 2 (SGLT-2) inhibitors v. Oral combination products (of the allowed individual OADs above)
  • HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) by central laboratory analysis
  • Body mass index (BMI) equal to or below 45.0 kg/m^2

Exclusion Criteria:

  • Participation in any clinical trial of an approved or non-approved investigational medicinal product within four weeks prior to the day of screening (V1)
  • Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
  • Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g. diabetes ketoacidosis) equal or below 90 days prior to the day of the screening and between screening and randomisation
  • Any of the following: myocardial infarction, stroke or hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and between screening and randomisation
  • Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of below 60 ml/min/1.73 m^2 as defined by KDIGO 2012 classification using isotope dilution mass spectrometry (IDMS) for serum creatinine measured at screening
  • Impaired liver function, defined as alanine aminotransferase (ALT) equal to or above 2.5 times upper normal limit (UNL) at screening.
  • Subjects presently classified as being in New York Heart Association (NYHA) Class IV
  • Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
  • 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) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906917


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  Study Documents (Full-Text)

Documents provided by Novo Nordisk A/S:
Study Protocol  [PDF] June 22, 2018
Statistical Analysis Plan  [PDF] June 22, 2018

Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02906917    
Other Study ID Numbers: NN5401-4266
2015-004768-12 ( EudraCT Number )
U1111-1175-7895 ( Other Identifier: WHO )
First Posted: September 20, 2016    Key Record Dates
Results First Posted: September 28, 2018
Last Update Posted: November 13, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs