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Completed

NCT Number: NCT01713530

A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin

This trial is conducted in Africa, Europe and the United States of America (USA).

The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.

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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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Algiers, Algeria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of type 2 Diabetes Mellitus at the discretion of the investigator for at least 26 weeks prior to screening (visit 1)
  • Treatment with basal insulin for at least 12 weeks prior to randomisation with or without metformin, sulphonylurea (SU)/glinide, DPP-4 inhibitors, alfa-glucosidase-inhibitors
  • HbA1c 7.0% - 10.0%
  • Body mass index (BMI) less than or equal to 40.0 kg/m^2

Exclusion criteria

  • Treatment with glucose-lowering agent(s) other than those stated in the inclusion criteria
  • Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
  • Chronic disorder or disease which might jeopardise safety or compliance
  • Malignant neoplasms
  • Recurrent severe hypoglycaemia

Treatment and study plan

insulin degludec/insulin aspart

Drug

Dose individually adjusted. For subcutaneous (s.c, under the skin) administration twice a day.

insulin degludec

Drug

Dose individually adjusted. For subcutaneous (s.c, under the skin) administration once daily.

insulin aspart

Drug

Dose individually adjusted. For subcutaneous (s.c, under the skin) administration with the main meals 2-4 times daily in accordance with local labelling.

Primary outcomes

  1. Change From Baseline in HbA1c (%)

    Time frame: Week 0, week 26

    Change from baseline in HbA1c (%) after 26 weeks of treatment

Secondary outcomes

  1. Change From Baseline in Fasting Plasma Glucose (FPG)

    Time frame: Week 0, week 26

    Change from baseline in FPG after 26 weeks of treatment

  2. Number of Treatment Emergent Hypoglycaemic Episodes

    Time frame: During Weeks 0-26

    According to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured Plasma Glucose (PG) <3.1 mmol/L(56 mg/dL))

  3. Number of Treatment Emergent Hypoglycaemic Episodes

    Time frame: During Weeks 0-26

    According to the American Diabetes Association (ADA) definition following are the categories of hypoglycaemic episodes:

    Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Relative hypoglycaemia

  4. Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes

    Time frame: Weeks 0-26

    Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.

  5. Incidence of Treatment Emergent Adverse Events (TEAE)

    Time frame: Weeks 0-26

    A TEAE was defined as an event that has 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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 24, 2012
Registry last updated
Apr 2, 2018

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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