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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00613951
First received: January 30, 2008
Last updated: November 7, 2013
Last verified: November 2013
  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:


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:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Biphasic Insulins
Insulin
Insulin Aspart
Insulin, Globin Zinc
Insulin, Long-Acting
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014