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Completed

NCT Number: NCT00842361

Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus

This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue/intermediate-acting insulin or pre-mixed insulin/pre-mixed insulin analogue on a twice daily regimen to NN5401 (SIAC, insulin degludec/insulin aspart) on a twice daily regimen in subjects with type 2 diabetes mellitus.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Chuo-ku, Tokyo, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with type 2 diabetes mellitus
  • Current treatment using a long-acting insulin analogue/intermediate-acting insulin preparation (except insulin glargine) or a pre-mixed insulin/insulin analogue preparation (except Mix30) on a twice daily regimen for at least 12 weeks, with stable insulin dose for the last 4 weeks (a brand of insulin preparation and dosing regimen has not been changed in the preceding 12 weeks)
  • HbA1c below 10.0%
  • Body Mass Index (BMI) < 30.0 kg/m^2

Exclusion criteria

  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia
  • Current treatment with total insulin dose of more than 100 U or IU/day
  • Current treatment or expected to start treatment with systemic corticosteroid
  • Treatment with oral anti-diabetic drugs (OADs: including alpha-glucosidase inhibitor and insulin sensitizer [thiazolidinedione: TZD]) within the last 12 weeks prior to screening

Treatment and study plan

insulin degludec/insulin aspart

Drug

The insulin NN5401 (insulin degludec/insulin aspart) injected subcutaneously immediately before breakfast and dinner.

biphasic insulin aspart 30

Drug

The insulin (biphasic insulin aspart 30) injected subcutaneously immediately before breakfast and dinner.

Primary outcomes

  1. Rate of Major and Minor Hypoglycaemic Episodes

    Time frame: Week 0 to Week 6 + 5 days follow up

    Rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL.

  2. Rate of Nocturnal Major and Minor Hypoglycaemic Episodes

    Time frame: Week 0 to Week 6 + 5 days follow up

    Rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 (both inclusive).

Secondary outcomes

  1. Number of Treatment Emergent Adverse Events (AEs)

    Time frame: Week 0 to Week 6 + 5 days follow up

    Corresponds to number of adverse events. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.

  2. Change in Body Weight

    Time frame: Week 0, Week 6

    Change from baseline in body weight after 6 weeks of treatment

  3. Electrocardiogram (ECG) Worsening

    Time frame: Week 0, Week 6

    The number of subjects having an electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.

  4. Diastolic BP (Blood Pressure)

    Time frame: Week 0, Week 6

    Values at baseline (Week 0) and at Week 6

  5. Systolic BP (Blood Pressure)

    Time frame: Week 0, Week 6.

    Values at baseline (Week 0) and at Week 6

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A 6-week, Randomised, Multi-centre, Open-labelled, Parallel Group, Exploratory Trial to Investigate the Safety of SIAC Compared to Mix30 (NovoRapid®30Mix) on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 12, 2009
Registry last updated
Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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