Efficacy and Safety of Insulin Degludec/Insulin Aspart in Insulin-naïve Subjects With Type 2 Diabetes Using Two Dosing Regimens

Phase 3

Completed

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

• Registration Number: NCT01365507
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Asia and North America. The aim of this trial is to compare the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily in insulin-naïve subjects with type 2 diabetes mellitus when using two different titration algorithms (dose individually adjusted) as add-on to subject's ongoing treatment with metformin.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2011-05-31
• Study Start: 2011-06
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-03
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Disposition First Submitted: 2012-05-09
• Disposition First Submitted QC: 2012-05-09
• Disposition First Posted: 2012-05-10
• Results First Submitted: 2015-10-19
• Results First Submitted QC: 2015-10-19
• Results First Posted: 2015-11-20
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

Inclusion Criteria

• Type 2 diabetes (diagnosed clinically) for 24 weeks or longer prior to randomisation (visit 2)
• Insulin naïve subjects (Allowed are: Previous short term insulin treatment no longer than or equal to 14 days in total; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days in total)
• Current treatment: Metformin alone or metformin in any combination of 1 or 2 additional OADs (oral anti-diabetic drug) including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors or thiazolidinediones (TZDs) - all with unchanged dosing for at least 12 weeks prior to randomisation (visit 2). Metformin dose, alone or in combination (including fixed combination), must be at least 1000 mg daily
• HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive)
• BMI (Body Mass Index) below or equal to 45 kg/m^2
• Ability and willingness to adhere to the protocol including self measurement of plasma glucose

Read More

Exclusion Criteria

• Treatment with GLP-1 (glucagon like peptide) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
• Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial physician)
• Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period
• Known or suspected hypersensitivity to trial products or related products
• The receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)
• Anticipated significant lifestyle changes during the study, e.g. shift work (including permanent night/evening shift workers) as well as highly variable eating habits

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IDegAsp Simple	insulin degludec/insulin aspart	-
IDegAsp Step wise	insulin degludec/insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Change in Glycosylated Haemoglobin (HbA1c)	Week 0, week 26	Change from baseline in HbA1c after 26 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Change in Fasting Plasma Glucose (FPG)	Week 0, week 26	Change from baseline in FPG after 26 weeks of treatment.
Rate of Nocturnal Confirmed Hypoglycaemic Episodes	Week 0 to Week 26 + 7 days follow up	Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.
Rate of Treatment Emergent Adverse Events (AEs)	Week 0 to Week 26 + 7 days follow up	Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Rate of Confirmed Hypoglycaemic Episodes	Week 0 to Week 26 + 7 days follow up	Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇹🇷 Istanbul, Turkey