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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614055
• Other study ID #: NN5401-1791
• Secondary ID: 2007-002476-33
• Status: Completed
• Phase: Phase 2
• First received: January 30, 2008
• Last updated: December 10, 2015
• Start date: January 2008
• Est. completion date: July 2008

Study information

• Verified date: December 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesNorway: Norwegian Medicines AgencyRomania: National Medicines AgencySpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin degludec/insulin aspart
Formulation 1: Treat-to-target dose titration scheme, injection s.c., once daily
• insulin degludec/insulin aspart
Formulation 2: Treat-to-target dose titration scheme, injection s.c., once daily
• insulin glargine
Treat-to-target dose titration scheme, injection s.c., once daily
• metformin
Tablets, 1500-2000 mg/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

France,  Germany,  Norway,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycosylated Haemoglobin (HbA1c)	Change from baseline in HbA1c after 16 weeks of treatment	Week 0, Week 16	No
Secondary	Change in Fasting Plasma Glucose (FPG)	Change from baseline in FPG after 16 weeks of treatment	Week 0, Week 16	No
Secondary	Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)	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, bedtime, at 4 am and before breakfast.	Week 16	No
Secondary	Rate of Treatment Emergent Adverse Events (AEs)	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	No
Secondary	Rate of Major and Minor Hypoglycaemic Episodes	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	No
Secondary	Rate of Nocturnal Major and Minor Hypoglycaemic Episodes	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 06:00 (excluded).	Week 0 to Week 16 + 5 days follow up	No
Secondary	Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)	Values at screening (Week -4) and at Week 16	Week -4, Week 16	No
Secondary	Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)	Values at screening (Week -4) and at Week 16	Week -4, Week 16	No
Secondary	Laboratory Safety Parameters (Biochemistry): Serum Creatinine	Values at screening (Week -4) and at Week 16	Week -4, Week 16	No
Secondary	Vital Signs: Diastolic Blood Pressure (BP)	Values at baseline (Week 0) and at Week 16	Week 0, Week 16	No
Secondary	Vital Signs: Systolic Blood Pressure (BP)	Values at baseline (Week 0) and at Week 16	Week 0, Week 16	No
Secondary	Vital Signs: Pulse	Values at baseline (Week 0) and at Week 16	Week 0, Week 16	No
Secondary	Physical Examination	Physical examination is performed at baseline (Week 0) 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 0, Week 8, Week 16	No

External Links

•   Clinical Trials at Novo Nordisk