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

Purpose

This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (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.

Condition	Intervention	Phase
Diabetes Diabetes Mellitus, Type 2	Drug: insulin degludec/insulin aspart Drug: biphasic insulin aspart Drug: metformin	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines

Drug Information available for: Metformin Metformin hydrochloride Insulin Insulin human Insulin aspart

U.S. FDA Resources

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:

Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Rate of Major and Minor Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 16 + 5 days follow up ] [ Designated as safety issue: No ]
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 16 + 5 days follow up ] [ Designated as safety issue: No ]
Rate of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 16 + 5 days follow up ] [ Designated as safety issue: No ]
Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) [ Time Frame: Week -4, Week 16 ] [ Designated as safety issue: No ]
Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) [ Time Frame: Week -4, Week 16 ] [ Designated as safety issue: No ]
Laboratory Safety Parameters (Biochemistry): Serum Creatinine [ Time Frame: Week -4, Week 16 ] [ Designated as safety issue: No ]
Vital Signs: Diastolic Blood Pressure (BP) [ Time Frame: Week 0, Week 16 ] [ Designated as safety issue: No ]
Vital Signs: Systolic Blood Pressure (BP) [ Time Frame: Week 0, Week 16 ] [ Designated as safety issue: No ]
Vital Signs: Pulse [ Time Frame: Week 0, Week 16 ] [ Designated as safety issue: No ]
Physical Examination [ Time Frame: Week -4, Week 8, Week 16 ] [ Designated as safety issue: No ]


Enrollment:	182
Study Start Date:	January 2008
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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
Active Comparator: BIAsp 30	Drug: biphasic insulin aspart Treat-to-target dose titration scheme, injection s.c., twice daily Drug: metformin Tablets, 1500-2000 mg/daily

Eligibility


Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613951

Locations


Finland

Lahti, Finland, 15110
France

Narbonne, France, 11108
Germany

Riesa, Germany, 01587
Poland

Warszawa, Poland, 02-507
Spain

Madrid, Spain, 28034

Sponsors and Collaborators

Novo Nordisk A/S

Investigators


Study Director:	Benedikte J. Lertoft, DVM	Novo Nordisk A/S

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Niskanen L, Leiter LA, Franek E, Weng J, Damci T, Muñoz-Torres M, Donnet JP, Endahl L, Skjøth 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. Erratum in: Eur J Endocrinol. 2012 Sep;167(3):453.


Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00613951 History of Changes
Other Study ID Numbers:	NN5401-1792, 2007-002462-35
Study First Received:	January 30, 2008
Last Updated:	November 7, 2013
Health Authority:	Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Spain: Spanish Agency of Medicines Germany: Federal Institute for Drugs and Medical Devices Poland: Ministry of Health

Additional relevant MeSH terms:


Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Biphasic Insulins Insulin	Insulin Aspart Insulin, Globin Zinc Insulin, Long-Acting Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 03, 2015