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

NCT ID: NCT00613951

Last Updated: 2017-03-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-08-31

Brief Summary

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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.

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Investigation of the Response Relationship of NN5401 in Type 1 Diabetics

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SIAC 30 (B)

Group Type EXPERIMENTAL

insulin degludec/insulin aspart

Intervention Type DRUG

Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily

metformin

Intervention Type DRUG

Tablets, 1500-2000 mg/daily

SIAC 45 (B)

Group Type EXPERIMENTAL

insulin degludec/insulin aspart

Intervention Type DRUG

Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily

metformin

Intervention Type DRUG

Tablets, 1500-2000 mg/daily

BIAsp 30

Group Type ACTIVE_COMPARATOR

biphasic insulin aspart

Intervention Type DRUG

Treat-to-target dose titration scheme, injection s.c., twice daily

metformin

Intervention Type DRUG

Tablets, 1500-2000 mg/daily

Interventions

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insulin degludec/insulin aspart

Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily

Intervention Type DRUG

insulin degludec/insulin aspart

Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily

Intervention Type DRUG

biphasic insulin aspart

Treat-to-target dose titration scheme, injection s.c., twice daily

Intervention Type DRUG

metformin

Tablets, 1500-2000 mg/daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Helsinki, , Finland

Site Status

Novo Nordisk Investigational Site

Kuopio, , Finland

Site Status

Novo Nordisk Investigational Site

Lahti, , Finland

Site Status

Novo Nordisk Investigational Site

Pori, , Finland

Site Status

Novo Nordisk Investigational Site

Bar-le-Duc, , France

Site Status

Novo Nordisk Investigational Site

Grenoble, , France

Site Status

Novo Nordisk Investigational Site

Hayange, , France

Site Status

Novo Nordisk Investigational Site

La Rochelle, , France

Site Status

Novo Nordisk Investigational Site

Nanterre, , France

Site Status

Novo Nordisk Investigational Site

Nevers, , France

Site Status

Novo Nordisk Investigational Site

Pointe à Pitre, , France

Site Status

Novo Nordisk Investigational Site

Berlin, , Germany

Site Status

Novo Nordisk Investigational Site

Pirna, , Germany

Site Status

Novo Nordisk Investigational Site

Riesa, , Germany

Site Status

Novo Nordisk Investigational Site

Saarbrücken, , Germany

Site Status

Novo Nordisk Investigational Site

Saint Ingbert, , Germany

Site Status

Novo Nordisk Investigational Site

Völklingen, , Germany

Site Status

Novo Nordisk Investigational Site

Wangen, , Germany

Site Status

Novo Nordisk Investigational Site

Bydgoszcz, , Poland

Site Status

Novo Nordisk Investigational Site

Gniewkowo, , Poland

Site Status

Novo Nordisk Investigational Site

Nysa, , Poland

Site Status

Novo Nordisk Investigational Site

Płock, , Poland

Site Status

Novo Nordisk Investigational Site

Szczecin, , Poland

Site Status

Novo Nordisk Investigational Site

Tychy, , Poland

Site Status

Novo Nordisk Investigational Site

Warsaw, , Poland

Site Status

Novo Nordisk Investigational Site

Wroclaw, , Poland

Site Status

Novo Nordisk Investigational Site

Almería, , Spain

Site Status

Novo Nordisk Investigational Site

Barcelona, , Spain

Site Status

Novo Nordisk Investigational Site

Granada, , Spain

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

San Juan, , Spain

Site Status

Countries

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Finland France Germany Poland Spain

References

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Niskanen L, Leiter LA, Franek E, Weng J, Damci T, Munoz-Torres M, Donnet JP, Endahl L, Skjoth TV, Vaag A. Comparison of a soluble co-formulation of insulin degludec/insulin aspart vs biphasic insulin aspart 30 in type 2 diabetes: a randomised trial. Eur J Endocrinol. 2012 Aug;167(2):287-94. doi: 10.1530/EJE-12-0293. Epub 2012 Jun 1.

Reference Type RESULT
PMID: 22660026 (View on PubMed)

Ma Z, Parkner T, Christiansen JS, Laursen T. IDegAsp: a novel soluble insulin analogs combination. Expert Opin Biol Ther. 2012 Nov;12(11):1533-40. doi: 10.1517/14712598.2012.722203. Epub 2012 Sep 4.

Reference Type RESULT
PMID: 22946603 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2007-002462-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN5401-1792

Identifier Type: -

Identifier Source: org_study_id

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