Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes

February 9, 2017 updated by: Novo Nordisk A/S

A 16 Week Randomised, Open Labelled, 3-armed, Parallel Group, Treat-to-target Trial Comparing Twice Daily (BID) Injections of SIAC 30 (B), SIAC 45 (B) and NovoMix®30, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment

This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble Insulin Analogue Combination [SIAC], insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive subjects with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00260
        • Novo Nordisk Investigational Site
      • Kuopio, Finland, 70210
        • Novo Nordisk Investigational Site
      • Lahti, Finland, 15110
        • Novo Nordisk Investigational Site
      • Pori, Finland, FI-28100
        • Novo Nordisk Investigational Site
  • France
      • Bar-Le-Duc, France, 55000
        • Novo Nordisk Investigational Site
      • GRENOBLE cedex, France, 38043
        • Novo Nordisk Investigational Site
      • Hayange, France, 57700
        • Novo Nordisk Investigational Site
      • LA ROCHELLE cedex, France, 17019
        • Novo Nordisk Investigational Site
      • NEVERS cedex, France, 58033
        • Novo Nordisk Investigational Site
      • Nanterre, France, 92014
        • Novo Nordisk Investigational Site
      • Pointe à Pitre, France, 97159
        • Novo Nordisk Investigational Site
  • Germany
      • Berlin, Germany, 12163
        • Novo Nordisk Investigational Site
      • Pirna, Germany, 01796
        • Novo Nordisk Investigational Site
      • Riesa, Germany, 01587
        • Novo Nordisk Investigational Site
      • Saarbrücken, Germany, 66121
        • Novo Nordisk Investigational Site
      • St. Ingbert, Germany, 66386
        • Novo Nordisk Investigational Site
      • Völklingen, Germany, 66333
        • Novo Nordisk Investigational Site
      • Wangen, Germany, 88239
        • Novo Nordisk Investigational Site
  • Poland
      • Bydgoszcz, Poland, 85-822
        • Novo Nordisk Investigational Site
      • Gniewkowo, Poland, 88-140
        • Novo Nordisk Investigational Site
      • Nysa, Poland, 48-300
        • Novo Nordisk Investigational Site
      • Plock, Poland, 09-400
        • Novo Nordisk Investigational Site
      • Szczecin, Poland, 70-483
        • Novo Nordisk Investigational Site
      • Tychy, Poland, 43-100
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 02-507
        • Novo Nordisk Investigational Site
      • Wroclaw, Poland, 50-127
        • Novo Nordisk Investigational Site
  • Spain
      • Almería, Spain, 04001
        • Novo Nordisk Investigational Site
      • Barcelona, Spain, 08035
        • Novo Nordisk Investigational Site
      • Granada, Spain, 18012
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28034
        • Novo Nordisk Investigational Site
      • San Juan, Spain, 03550
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
  • Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximum 14 days within the last 3 months)
  • Treatment with one or two oral anti-diabetic drugs (OADs): metformin, sulfonylurea, other insulin secretagogue (e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 months at a stable maximally tolerated dose or at least half maximally allowed dose according to locally approved summary of product characteristics (SPC)
  • HbA1c, 7.0-11.0 % (both inclusive)
  • Body Mass Index (BMI), 25.0-37.0 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Metformin contraindication according to local practice
  • Thiazolidinedione (TZD) treatment within previous 3 months prior to Visit 1
  • Any systemic treatment with products, which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) within 3 months prior to randomisation
  • Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system (except for conditions associated with type 2 diabetes) that, in the opinion of the investigator, may confound the results of the trial or pose additional risk in administering trial product

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BIAsp 30
Drug: metformin
Tablets, 1500-2000 mg/daily
Drug: biphasic insulin aspart
Treat-to-target dose titration scheme, injection s.c., twice daily
Experimental: SIAC 30 (B)
Drug: insulin degludec/insulin aspart
Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily
Drug: metformin
Tablets, 1500-2000 mg/daily
Experimental: SIAC 45 (B)
Drug: insulin degludec/insulin aspart
Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily
Drug: metformin
Tablets, 1500-2000 mg/daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycosylated Haemoglobin (HbA1c)
Time Frame: Week 0, Week 16
Change from baseline in HbA1c after 16 weeks of treatment
Week 0, Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
Time Frame: Week 0 to Week 16 + 5 days follow up
Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 05:59 (included).
Week 0 to Week 16 + 5 days follow up
Rate of Treatment Emergent Adverse Events (AEs)
Time Frame: Week 0 to Week 16 + 5 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.
Week 0 to Week 16 + 5 days follow up
Vital Signs: Diastolic Blood Pressure (BP)
Time Frame: Week 0, Week 16
Values at baseline (Week 0) and at Week 16
Week 0, Week 16
Vital Signs: Systolic Blood Pressure (BP)
Time Frame: Week 0, Week 16
Values at baseline (Week 0) and at Week 16
Week 0, Week 16
Vital Signs: Pulse
Time Frame: Week 0, Week 16
Values at baseline (Week 0) and at Week 16
Week 0, Week 16
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
Time Frame: Week 16
Estimate of the overall mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, before bedtime, at 4 am and before breakfast.
Week 16
Rate of Major and Minor Hypoglycaemic Episodes
Time Frame: Week 0 to Week 16 + 5 days follow up
Observed rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.
Week 0 to Week 16 + 5 days follow up
Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
Time Frame: Week -4, Week 16
Laboratory values at screening (Week -4) and at Week 16
Week -4, Week 16
Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
Time Frame: Week -4, Week 16
Laboratory values at screening (Week -4) and at Week 16
Week -4, Week 16
Laboratory Safety Parameters (Biochemistry): Serum Creatinine
Time Frame: Week -4, Week 16
Laboratory values at screening (Week -4) and at Week 16
Week -4, Week 16
Physical Examination
Time Frame: Week -4, Week 8, Week 16
Physical examination was performed at screening (week -4), and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.
Week -4, Week 8, Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

January 30, 2008

First Submitted That Met QC Criteria

January 30, 2008

First Posted (Estimate)

February 13, 2008

Study Record Updates

Last Update Posted (Actual)

March 20, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN5401-1792
  • 2007-002462-35 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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