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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Drug: insulin degludec/insulin aspart; Drug: insulin degludec; Drug: insulin aspart

• Registration Number: NCT01713530
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-22
• Study First Submitted QC: 2012-10-22
• Study First Posted: 2012-10-24
• Study Start: 2013-02-21
• Primary Completion: 2014-01-09
• Study Completion: 2014-01-09
• Disposition First Submitted: 2014-01-24
• Disposition First Submitted QC: 2014-01-24
• Disposition First Posted: 2014-02-24
• Results First Submitted: 2015-10-16
• Results First Submitted QC: 2015-10-16
• Results First Posted: 2015-11-17
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 274

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IDegAsp BID+/-OADs	insulin degludec/insulin aspart	-
IDeg OD plus IAsp +/-OADs	insulin degludec	-
IDeg OD plus IAsp +/-OADs	insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c (%)	Week 0, week 26	Change from baseline in HbA1c (%) after 26 weeks of treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇳🇴 Stavanger, Norway