Comparison of Two NN5401 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes | RxWiki

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

Overview[ - collapse ][ - ]

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 insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.
Condition	Diabetes Diabetes Mellitus, Type 2
Intervention	Drug: insulin degludec/insulin aspart Drug: insulin degludec/insulin aspart Drug: insulin glargine Drug: metformin
Phase	Phase 2
Sponsor	Novo Nordisk A/S
Responsible Party	Novo Nordisk A/S
ClinicalTrials.gov Identifier	NCT00614055
First Received	January 30, 2008
Last Updated	November 7, 2013
Last verified	November 2013

Tracking Information[ + expand ][ + ]

First Received Date	January 30, 2008
Last Updated Date	November 7, 2013
Start Date	January 2008
Estimated Primary Completion Date	July 2008
Current Primary Outcome Measures	Change in Glycosylated Haemoglobin (HbA1c) [Time Frame: Week 0, Week 16] [Designated as safety issue: No]
Current Secondary Outcome Measures	Change in Fasting Plasma Glucose (FPG) [Time Frame: Week 0, Week 16] [Designated as safety issue: No] Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) [Time Frame: Week 16] [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] 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] 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 0, Week 8, Week 16] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Comparison of Two NN5401 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes
Official Title	A 16 Week Randomised, Open Labelled, 3 Armed, Parallel Group, Treat-to-target Trial Comparing Once Daily Injection of SIAC 30 (B), SIAC 45 (B) and Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment
Brief Summary	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 insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Diabetes Diabetes Mellitus, Type 2
Intervention	Drug: insulin degludec/insulin aspart Formulation 1: Treat-to-target dose titration scheme, injection s.c., once daily Drug: insulin degludec/insulin aspart Formulation 2: Treat-to-target dose titration scheme, injection s.c., once daily Drug: insulin glargine Treat-to-target dose titration scheme, injection s.c., once daily Drug: metformin Tablets, 1500-2000 mg/day
Study Arm (s)	Active Comparator: Insulin glargine Experimental: SIAC 30 (B) Experimental: SIAC 45 (B)

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	178
Estimated Completion Date	July 2008
Estimated Primary Completion Date	July 2008
Eligibility 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 month at a stable maximum tolerated dose or at least half maximum 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) treatments within the previous three 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 that, in the opinion of the investigator, may confound the results of the trial or pose additional risk in administering trial product
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	France, Germany, Norway, Romania, Spain

Administrative Information[ + expand ][ + ]

NCT Number	NCT00614055
Other Study ID Numbers	NN5401-1791
Has Data Monitoring Committee	No
Information Provided By	Novo Nordisk A/S
Study Sponsor	Novo Nordisk A/S
Collaborators	Not Provided
Investigators	Study Director: Benedikte J. Lertoft, DVM Novo Nordisk A/S
Verification Date	November 2013

Locations[ + expand ][ + ]