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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT01713530
Other study ID #	NN5401-3996
Secondary ID	2012-002346-20U1
Status	Completed
Phase	Phase 3
First received	October 22, 2012
Last updated	March 6, 2018
Start date	February 21, 2013
Est. completion date	January 9, 2014

Study information
Verified date	March 2018
Source	Novo Nordisk A/S
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status	Completed
Enrollment	274
Est. completion date	January 9, 2014
Est. primary completion date	January 9, 2014
Accepts healthy volunteers	No
Gender	All
Age group	18 Years and older
Eligibility	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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• insulin degludec/insulin aspart
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration twice a day.
• insulin degludec
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration once daily.
• 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.

Locations
Country	Name	City	State
Algeria	Novo Nordisk Investigational Site	Algiers
Algeria	Novo Nordisk Investigational Site	Annaba
Algeria	Novo Nordisk Investigational Site	Constantine
Algeria	Novo Nordisk Investigational Site	Oran
Austria	Novo Nordisk Investigational Site	Graz
Austria	Novo Nordisk Investigational Site	Innsbruck
Austria	Novo Nordisk Investigational Site	Linz
Austria	Novo Nordisk Investigational Site	Mödling
Austria	Novo Nordisk Investigational Site	Salzburg
Austria	Novo Nordisk Investigational Site	Wien
Austria	Novo Nordisk Investigational Site	Wien
France	Novo Nordisk Investigational Site	Caen
France	Novo Nordisk Investigational Site	LA ROCHE-sur-YON cedex 9
France	Novo Nordisk Investigational Site	LA ROCHELLE cedex
France	Novo Nordisk Investigational Site	Le Creusot
France	Novo Nordisk Investigational Site	Montpellier
France	Novo Nordisk Investigational Site	Montpellier
France	Novo Nordisk Investigational Site	Saint Herblain
France	Novo Nordisk Investigational Site	Venissieux
Norway	Novo Nordisk Investigational Site	Hamar
Norway	Novo Nordisk Investigational Site	Kongsvinger
Norway	Novo Nordisk Investigational Site	Kristiansand S
Norway	Novo Nordisk Investigational Site	Oslo
Norway	Novo Nordisk Investigational Site	Skedsmokorset
Norway	Novo Nordisk Investigational Site	Stavanger
United States	Novo Nordisk Investigational Site	Austin	Texas
United States	Novo Nordisk Investigational Site	Buckley	Michigan
United States	Novo Nordisk Investigational Site	Chicago	Illinois
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Greenbrae	California
United States	Novo Nordisk Investigational Site	Greensboro	North Carolina
United States	Novo Nordisk Investigational Site	Hillsborough	New Jersey
United States	Novo Nordisk Investigational Site	Houston	Texas
United States	Novo Nordisk Investigational Site	Indianapolis	Indiana
United States	Novo Nordisk Investigational Site	Kettering	Ohio
United States	Novo Nordisk Investigational Site	Kingsport	Tennessee
United States	Novo Nordisk Investigational Site	Kissimmee	Florida
United States	Novo Nordisk Investigational Site	Lawrenceville	New Jersey
United States	Novo Nordisk Investigational Site	Martinsburg	West Virginia
United States	Novo Nordisk Investigational Site	Mission Hills	California
United States	Novo Nordisk Investigational Site	Pittsburgh	Pennsylvania
United States	Novo Nordisk Investigational Site	Rockville	Maryland
United States	Novo Nordisk Investigational Site	Round Rock	Texas
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	San Diego	California
United States	Novo Nordisk Investigational Site	Slidell	Louisiana
United States	Novo Nordisk Investigational Site	Tacoma	Washington
United States	Novo Nordisk Investigational Site	Toms River	New Jersey
United States	Novo Nordisk Investigational Site	Wadsworth	Ohio
United States	Novo Nordisk Investigational Site	Whiteville	North Carolina

Sponsors *(1)*
Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States, Algeria, Austria, France, Norway,

References & Publications (2)

Haluzík M, Fulcher G, Pieber TR, Bardtrum L, Tutkunkardas D, Rodbard HW. The co-formulation of insulin degludec and insulin aspart lowers fasting plasma glucose and rates of confirmed and nocturnal hypoglycaemia, independent of baseline glycated haemoglob — View Citation

Rodbard HW, Cariou B, Pieber TR, Endahl LA, Zacho J, Cooper JG. Treatment intensification with an insulin degludec (IDeg)/insulin aspart (IAsp) co-formulation twice daily compared with basal IDeg and prandial IAsp in type 2 diabetes: a randomized, control — View Citation

Outcome
Type	Measure	Description	Time frame
Primary	Change From Baseline in HbA1c (%)	Change from baseline in HbA1c (%) after 26 weeks of treatment	Week 0, week 26
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG)	Change from baseline in FPG after 26 weeks of treatment	Week 0, week 26
Secondary	Number of Treatment Emergent Hypoglycaemic Episodes	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))	During Weeks 0-26
Secondary	Number of Treatment Emergent Hypoglycaemic Episodes	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	During Weeks 0-26
Secondary	Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes	Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.	Weeks 0-26
Secondary	Incidence of Treatment Emergent Adverse Events (TEAE)	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	Weeks 0-26

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Not yet recruiting	`NCT05029804` - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes	N/A
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External Links

Clinical Trials at Novo Nordisk

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

Clinical Trial Details — Status: Completed

Administrative data

Study information

Clinical Trial Summary

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (1)

Countries where clinical trial is conducted

References & Publications (2)

Outcome

External Links