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

NCTId: NCT01713530

Official Title

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

Summary

This trial is conducted in Africa, Asia, 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.

Eligibility

Eligibility Criteria

Gender Minimum Age Maximum Age Healthy Volunteers?
Both 18 Years N/A False

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

Interventions & Outcomes

Study Interventions & Types

Drug Intervention(s)

insulin aspart - Dose individually adjusted. For subcutaneous (s.c, under the skin) administration with the main meals 2-4 times daily in accordance with local labelling.
insulin degludec - Dose individually adjusted. For subcutaneous (s.c, under the skin) administration once daily.
insulin degludec/insulin aspart - Dose individually adjusted. For subcutaneous (s.c, under the skin) administration twice a day.

Study Outcomes

Primary Outcome(s)

Timeframe: Week 0, week 26
Measure: Change from baseline in HbA1c (%)
Safety Issue? No

Secondary Outcome(s)

Measure: Change from baseline in fasting plasma glucose (FPG)
Timeframe: Week 0, week 26
Safety Issue? No

Measure: Incidence of treatment emergent adverse events (TEAE)
Timeframe: Weeks 0-26
Safety Issue? No

Measure: Number of treatment emergent hypoglycaemic episodes
Timeframe: Weeks 0-26
Safety Issue? No

Measure: Number of treatment emergent hypoglycaemic episodes. Number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes
Timeframe: Weeks 0-26
Safety Issue? No

Facility Locations

Research Study Facility Map

Map of facility locations for this research study.

Facility is recruiting
Facility is not yet recruiting
Unknown status
First 15 facilities are shown on map

Clinical Research Study Facility Locations

Recruiting


Kongsvinger, 2212 Norway


Le Creusot, 71200 France


Graz, 8036 Austria

Novo Nordisk Clinical Trial Call Center
Tacoma, Washington 98405 United States

Novo Nordisk Clinical Trial Call Center
Renton, Washington 98057 United States

Novo Nordisk Clinical Trial Call Center
San Antonio, Texas 78224 United States

Novo Nordisk Clinical Trial Call Center
San Antonio, Texas 78215 United States

Novo Nordisk Clinical Trial Call Center
Dallas, Texas 75246 United States

Novo Nordisk Clinical Trial Call Center
Dallas, Texas 75230 United States

Novo Nordisk Clinical Trial Call Center
Kingsport, Tennessee 37660 United States

Novo Nordisk Clinical Trial Call Center
Pittsburgh, Pennsylvania 15220-1203 United States

Novo Nordisk Clinical Trial Call Center
Whiteville, North Carolina 28472 United States

Novo Nordisk Clinical Trial Call Center
Toms River, New Jersey 08755-8050 United States

Novo Nordisk Clinical Trial Call Center
Lawrenceville, New Jersey 08648 United States

Novo Nordisk Clinical Trial Call Center
Rockville, Maryland 20852 United States

Novo Nordisk Clinical Trial Call Center
Slidell, Louisiana 70461-4231 United States

Novo Nordisk Clinical Trial Call Center
Avon, Indiana 46123-7877 United States

Novo Nordisk Clinical Trial Call Center
Kissimmee, Florida 34741 United States

Novo Nordisk Clinical Trial Call Center
Mission Hills, California 91345 United States

Novo Nordisk Clinical Trial Call Center
Los Angeles, California 90057 United States

Novo Nordisk Clinical Trial Call Center
Greenbrae, California 94904 United States

Not yet recruiting

Novo Nordisk Clinical Trial Call Center
Martinsburg, West Virginia 25401 United States

Related Keywords & Studies

Conditions and Diseases with Related Research Studies

  1. Diabetes
  2. Diabetes Mellitus, Type 2

Other Related Condition Keywords

  1. Diabetes Mellitus

Related Intervention Keywords

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