A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: biphasic insulin aspart 30; Drug: insulin degludec/insulin aspart

• Registration Number: NCT01059812
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Asia. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with biphasic insulin aspart (BIAsp) 30 in patients with type 2 diabetes not optimally controlled on once or twice daily insulin with or without metformin.

Detailed Description

Not available

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

Study Timeline

• Study First Submitted: 2010-01-29
• Study First Submitted QC: 2010-01-29
• Study Start: 2010-02-01
• Study First Posted: 2010-02-01
• Primary Completion: 2010-12-23
• Study Completion: 2010-12-23
• Disposition First Submitted: 2011-02-23
• Disposition First Submitted QC: 2011-02-23
• Disposition First Posted: 2011-03-01
• Results First Submitted: 2015-10-19
• Results First Submitted QC: 2015-10-19
• Results First Posted: 2015-11-20
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-30
• Last Update Posted: 2018-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 424

Inclusion Criteria

• Male or female at least 18 years of age (at least 20 years for Japan)
• Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
• Subject on basal human or analogue insulin, once daily (OD) or twice daily (BID) with or without metformin for at least 3 months or subject on premixed human or analogue insulin or self-mixed insulin regimen, containing 20-40% fast/rapid-acting component, OD or BID, with or without metformin, for at least 3 months
• HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
• Body mass index (BMI) maximum 35.0 kg/m^2

Read More

Exclusion Criteria

• Treatment with oral antidiabetic drugs (OADs) (except metformin) within the last 8 weeks prior to Visit 1
• Treatment with thiazolidinediones (TZDs) or glucagon like peptide 1 (GLP-1) receptor agonists within 3 months prior to Visit 1
• Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
• Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
• Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
• Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIAsp 30 BID	biphasic insulin aspart 30	-
IDegAsp BID	insulin degludec/insulin aspart	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26	Week 26	Mean of SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.
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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol.
Change in Body Weight	Week 0, Week 26	Change from baseline in body weight after 26 weeks of treatment.
Rate of Nocturnal 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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇳 Taipei, Taiwan