Clinical Trials Register

Summary
EudraCT Number:	2011-001712-61
Sponsor's Protocol Code Number:	NN5401-3940
National Competent Authority:	Bulgarian Drug Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-09-03
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Bulgarian Drug Agency

A.2

EudraCT number

2011-001712-61

A.3

Full title of the trial

A 26-week, randomised, open-label, multinational, treat-to-target trial comparing efficacy and safety of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) and BIAsp 30 BID both with metformin in insulin naïve subjects with type 2 diabetes mellitus inadequately controlled on metformin monotherapy or metformin in combination with one additional oral antidiabetic drug (OAD).

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A trial comparing efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 in insulin naïve subjects with type 2 diabetes

A.3.2

Name or abbreviated title of the trial where available

BOOST™

A.4.1

Sponsor's protocol code number

NN5401-3940

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1120-5633

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Novo Nordisk A/S
B.1.3.4	Country	Denmark
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Novo Nordisk A/S
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novo Nordisk A/S
B.5.2	Functional name of contact point	Global Clinical Registry (GCR,1452)
B.5.3	Address:
B.5.3.1	Street Address	Vandtaarnsvej 114,VTB
B.5.3.2	Town/ city	Soeborg
B.5.3.3	Post code	DK-2860
B.5.3.4	Country	Denmark
B.5.6	E-mail	clinicaltrials@novonordisk.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	IDegAsp 30 PDS290
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	insulin degludec
D.3.9.1	CAS number	844439-96-9
D.3.10	Strength
D.3.10.1	Concentration unit	nmol/ml nanomole(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	420
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	insulin aspart
D.3.9.1	CAS number	116094-23-6
D.3.10	Strength
D.3.10.1	Concentration unit	nmol/ml nanomole(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	180
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	NovoMix® 30
D.2.1.1.2	Name of the Marketing Authorisation holder	Novo Nordisk A/S
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	NovoMix 30
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INSULIN ASPART
D.3.9.1	CAS number	116094-23-6
D.3.9.4	EV Substance Code	SUB08195MIG
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Type 2 diabetes mellitus

E.1.1.1

Medical condition in easily understood language

Type 2 diabetes mellitus

E.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	LLT
E.1.2	Classification code	10045242
E.1.2	Term	Type II diabetes mellitus
E.1.2	System Organ Class	10027433 - Metabolism and nutrition disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To confirm the efficacy of IDegAsp twice daily (BID) added to metformin in controlling glycaemia with respect to change from baseline in HbA1c after 26 weeks of treatment. This is done by comparing the difference in change from baseline in HbA1c after 26 weeks of treatment between IDegAsp and BIAsp 30 both BID added to metformin, to a non-inferiority limit of 0.4%, and if noninferiority is confirmed, to a superiority limit of 0%.

E.2.2

Secondary objectives of the trial

To confirm superiority of IDegAsp BID added to metformin against BIAsp 30 BID added to metformin after 26 weeks of treatment in terms of:
- Fasting plasma glucose (FPG) from central laboratory
- Nocturnal hypoglycaemic episodes (severe and minor)
- Hypoglycaemic episodes (severe and minor)
- Body weight
- Frequency of responders for HbA1c (<7.0 %) without severe or minor hypoglycaemic episodes

To compare efficacy and safety of IDegAsp BID added to metformin against BIAsp 30 BID added to metformin after 26 weeks of treatment in terms of:
- 9-point profile self measured plasma glucose (SMPG)
- 2-point profile (SMPG) for dose adjustments
- Frequency of responders for HbA1c targets
- Adverse Events (AEs)
- Hypoglycaemic episodes
- Clinical and laboratory assessments
- Insulin dose

E.2.3

Trial contains a sub-study

E.3

Principal 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.)
- Male or female ≥ 18 years of age
- Type 2 diabetes mellitus (diagnosed clinically) for ≥ 24 weeks

- Current treatment: metformin monotherapy or metformin in any combination with one of the following OADs: insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPPIV) inhibitor, α-glucosidase inhibitors for at least 12 weeks prior to randomisation (Visit 2) with the minimum doses stated:
- Metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily)
- Insulin secretagogue (sulphonylurea or glinide): minimum half of the daily maximum dose according to local labelling
- DPP-IV inhibitor: minimum 100 mg daily or according to local labelling
- α-glucosidase-inhibitors: minimum half of the daily maximum dose or maximum tolerated dose

- Insulin naïve subject; allowed is:
- Previous short term insulin treatment up to 14 days
- Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)

- HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
- Body mass index (BMI) ≤ 40.0 kg/m2

E.4

Principal exclusion criteria

- Treatment with thiazolidinedione (TZDs) or GLP-1 receptor agonists within 12 weeks prior to Visit 1
- Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers and MAO inhibitors
- Anticipated significant lifestyle changes during the trial according to the discretion of the investigator, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits
- Cardiovascular disease, within the last 24 weeks prior to visit 1, defined as: stroke; decompensated heart failure NYHA1 class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
- Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the Investigator’s opinion could interfere with the results of the trial
- Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period
- Known or suspected hypersensitivity to trial products or related products

E.5 End points

E.5.1

Primary end point(s)

Change from baseline in HbA1c (%) after 26 weeks of treatment (central laboratory)

E.5.1.1

Timepoint(s) of evaluation of this end point

After 26 weeks of treatment

E.5.2

Secondary end point(s)

1. Change from baseline in FPG after 26 weeks of treatment (central laboratory)
2. Number of treatment emergent nocturnal (00:01-05:59 am) severe or minor hypoglycaemic episodes
3. Number of severe and minor treatment emergent hypoglycaemic episodes
4. Change from baseline in body weight after 26 weeks of treatment
5. Responder without hypoglycaemic episodes (HbA1c <7.0% at end of trial and no severe or minor hypoglycaemic episodes during the last 12 weeks of treatment including only subjects
exposed for at least 12 weeks)

E.5.2.1

Timepoint(s) of evaluation of this end point

1. After 26 weeks of treatment
2. On or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product
3. On or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product
4. After 26 weeks of treatment
5. After 26 weeks of treatment

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Treat To Target trial

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Algeria

Bulgaria

Croatia

Czech Republic

Germany

Poland

Romania

Slovakia

Turkey

Ukraine

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

319

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

259

F.4.2.2

In the whole clinical trial

394

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

N/A

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-09-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-12-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-11-19

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