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

Study Description

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Brief 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.

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	274 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Actual Study Start Date :	February 21, 2013
Actual Primary Completion Date :	January 9, 2014
Actual Study Completion Date :	January 9, 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: IDegAsp BID+/-OADs	Drug: insulin degludec/insulin aspart; Dose individually adjusted. For subcutaneous (s.c, under the skin) administration twice a day.
Experimental: IDeg OD plus IAsp +/-OADs	Drug: insulin degludec; Dose individually adjusted. For subcutaneous (s.c, under the skin) administration once daily. Drug: 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.

Outcome Measures

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Primary Outcome Measures :

1. Change From Baseline in HbA1c (%) [ Time Frame: Week 0, week 26 ]
   Change from baseline in HbA1c (%) after 26 weeks of treatment

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

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  Show 51 Study Locations

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director:	Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S

More Information

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Additional Information:

Clinical Trials at Novo Nordisk 

Publications of Results:

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, controlled phase III trial. Diabetes Obes Metab. 2016 Mar;18(3):274-80. doi: 10.1111/dom.12609. Epub 2016 Jan 11.

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 haemoglobin levels, disease duration or body mass index: A pooled meta-analysis of phase III studies in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Feb 16. doi: 10.1111/dom.13261. [Epub ahead of print]

Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT01713530 History of Changes
Other Study ID Numbers:	NN5401-3996; 2012-002346-20 ( EudraCT Number ); U1111-1130-7135 ( Other Identifier: WHO )
First Posted:	October 24, 2012
Results First Posted:	November 17, 2015
Last Update Posted:	April 2, 2018
Last Verified:	March 2018

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin, Globin Zinc	Insulin degludec, insulin aspart drug combination; Insulin; Insulin Aspart; Insulin, Long-Acting; Hypoglycemic Agents; Physiological Effects of Drugs