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:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00613951
First Posted: February 13, 2008
Last Update Posted: March 20, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S
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Purpose
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.
| 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 Intervention Model: Parallel Assignment Masking: None (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 |
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Further study details as provided by Novo Nordisk A/S:
Primary Outcome Measures:
- Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, Week 16 ]Change from baseline in HbA1c after 16 weeks of treatment
Secondary Outcome Measures:
- Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) [ Time Frame: Week 16 ]Estimate of the overall 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, before bedtime, at 4 am and before breakfast.
- Rate of Major and Minor Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 16 + 5 days follow up ]Observed 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.
- Rate of Nocturnal Major and Minor Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 16 + 5 days follow up ]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 05:59 (included).
- Rate of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 16 + 5 days follow up ]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.
- Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) [ Time Frame: Week -4, Week 16 ]Laboratory values at screening (Week -4) and at Week 16
- Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) [ Time Frame: Week -4, Week 16 ]Laboratory values at screening (Week -4) and at Week 16
- Laboratory Safety Parameters (Biochemistry): Serum Creatinine [ Time Frame: Week -4, Week 16 ]Laboratory values at screening (Week -4) and at Week 16
- Vital Signs: Diastolic Blood Pressure (BP) [ Time Frame: Week 0, Week 16 ]Values at baseline (Week 0) and at Week 16
- Vital Signs: Systolic Blood Pressure (BP) [ Time Frame: Week 0, Week 16 ]Values at baseline (Week 0) and at Week 16
- Vital Signs: Pulse [ Time Frame: Week 0, Week 16 ]Values at baseline (Week 0) and at Week 16
- Physical Examination [ Time Frame: Week -4, Week 8, Week 16 ]Physical examination was performed at screening (week -4), 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.
| 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
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00613951
Locations
| Finland | |
| Novo Nordisk Investigational Site | |
| Helsinki, Finland, 00260 | |
| Novo Nordisk Investigational Site | |
| Kuopio, Finland, 70210 | |
| Novo Nordisk Investigational Site | |
| Lahti, Finland, 15110 | |
| Novo Nordisk Investigational Site | |
| Pori, Finland, FI-28100 | |
| France | |
| Novo Nordisk Investigational Site | |
| Bar-Le-Duc, France, 55000 | |
| Novo Nordisk Investigational Site | |
| GRENOBLE cedex, France, 38043 | |
| Novo Nordisk Investigational Site | |
| Hayange, France, 57700 | |
| Novo Nordisk Investigational Site | |
| LA ROCHELLE cedex, France, 17019 | |
| Novo Nordisk Investigational Site | |
| Nanterre, France, 92014 | |
| Novo Nordisk Investigational Site | |
| NEVERS cedex, France, 58033 | |
| Novo Nordisk Investigational Site | |
| Pointe à Pitre, France, 97159 | |
| Germany | |
| Novo Nordisk Investigational Site | |
| Berlin, Germany, 12163 | |
| Novo Nordisk Investigational Site | |
| Pirna, Germany, 01796 | |
| Novo Nordisk Investigational Site | |
| Riesa, Germany, 01587 | |
| Novo Nordisk Investigational Site | |
| Saarbrücken, Germany, 66121 | |
| Novo Nordisk Investigational Site | |
| St. Ingbert, Germany, 66386 | |
| Novo Nordisk Investigational Site | |
| Völklingen, Germany, 66333 | |
| Novo Nordisk Investigational Site | |
| Wangen, Germany, 88239 | |
| Poland | |
| Novo Nordisk Investigational Site | |
| Bydgoszcz, Poland, 85-822 | |
| Novo Nordisk Investigational Site | |
| Gniewkowo, Poland, 88-140 | |
| Novo Nordisk Investigational Site | |
| Nysa, Poland, 48-300 | |
| Novo Nordisk Investigational Site | |
| Plock, Poland, 09-400 | |
| Novo Nordisk Investigational Site | |
| Szczecin, Poland, 70-483 | |
| Novo Nordisk Investigational Site | |
| Tychy, Poland, 43-100 | |
| Novo Nordisk Investigational Site | |
| Warszawa, Poland, 02-507 | |
| Novo Nordisk Investigational Site | |
| Wroclaw, Poland, 50-127 | |
| Spain | |
| Novo Nordisk Investigational Site | |
| Almería, Spain, 04001 | |
| Novo Nordisk Investigational Site | |
| Barcelona, Spain, 08035 | |
| Novo Nordisk Investigational Site | |
| Granada, Spain, 18012 | |
| Novo Nordisk Investigational Site | |
| Madrid, Spain, 28034 | |
| Novo Nordisk Investigational Site | |
| San Juan, Spain, 03550 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
More Information
Additional Information:
Publications:
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00613951 History of Changes |
| Other Study ID Numbers: |
NN5401-1792 2007-002462-35 ( EudraCT Number ) |
| First Submitted: | January 30, 2008 |
| First Posted: | February 13, 2008 |
| Results First Submitted: | October 16, 2015 |
| Results First Posted: | December 1, 2015 |
| Last Update Posted: | March 20, 2017 |
| Last Verified: | February 2017 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin, Globin Zinc Insulin degludec, insulin aspart drug combination Insulin aspart, insulin aspart protamine drug combination 30:70 |
Insulin Metformin Insulin Aspart Insulin, Long-Acting Biphasic Insulins Hypoglycemic Agents Physiological Effects of Drugs |