NCT00613951|CompletedPhase 2Results

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

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

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN5401-17922007-002462-35

Study Type

interventional

Target

182

Locations

5 countries

Sites

Timeline

RegisteredFeb 2008

StartedJan 2008

CompletionAug 2008

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

182

participants targeted

Target at P75+ for phase_2 diabetes

Timeline

Completed

Started Jan 2008

Shorter than P25 for phase_2 diabetes

Geographic Reach

5 countries

31 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7 months study duration

Study Start

First participant enrolled

January 1, 2008

Completed

29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2008

Completed

14 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed

7.3 years until next milestone

Results Posted

Study results publicly available

December 1, 2015

Completed

Last Updated

March 20, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

January 30, 2008

Results QC Date

October 16, 2015

Last Update Submit

February 9, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in Glycosylated Haemoglobin (HbA1c)
Change from baseline in HbA1c after 16 weeks of treatment
Week 0, Week 16

Secondary Outcomes (11)

Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
Week 16
Rate of Major and Minor Hypoglycaemic Episodes
Week 0 to Week 16 + 5 days follow up
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
Week 0 to Week 16 + 5 days follow up
Rate of Treatment Emergent Adverse Events (AEs)
Week 0 to Week 16 + 5 days follow up
Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
Week -4, Week 16
+6 more secondary outcomes

Study Arms (3)

SIAC 30 (B)

EXPERIMENTAL

Drug: insulin degludec/insulin aspartDrug: metformin

SIAC 45 (B)

EXPERIMENTAL

Drug: insulin degludec/insulin aspartDrug: metformin

BIAsp 30

ACTIVE COMPARATOR

Drug: biphasic insulin aspartDrug: metformin

Interventions

insulin degludec/insulin aspartDRUG

Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily

SIAC 30 (B)

biphasic insulin aspartDRUG

Treat-to-target dose titration scheme, injection s.c., twice daily

BIAsp 30

metforminDRUG

Tablets, 1500-2000 mg/daily

BIAsp 30SIAC 30 (B)SIAC 45 (B)

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

You may not qualify if:

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

Contact the study team to confirm eligibility.