Comparison of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT01272193

First received: January 6, 2011

Last updated: October 21, 2015

Last verified: October 2015

History of Changes

Results First Received: October 21, 2015

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Diabetes Diabetes Mellitus, Type 2
Interventions:	Drug: insulin degludec/insulin aspart Drug: insulin glargine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The trial was conducted at 48 sites in Japan.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects continued on not more than 2 oral antidiabetic drugs (excluding sulphonylureas/dipeptyl peptidase-4 [DPP-4] inhibitors/glinides) at the pre-randomisation dose level and dosing frequency.

Reporting Groups

	Description
IDegAsp OD	Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
IGlar OD	Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.

Participant Flow: Overall Study

	IDegAsp OD	IGlar OD
STARTED	147	149
COMPLETED	137	137
NOT COMPLETED	10	12
Adverse Event	1	1
Lack of Efficacy	0	3
Withdrawal Criteria	1	1
Unclassified	8	7

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
IDegAsp OD	Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
IGlar OD	Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
Total	Total of all reporting groups

Baseline Measures

	IDegAsp OD	IGlar OD	Total
Number of Participants [units: participants]	147	149	296
Age [units: years] Mean (Standard Deviation)	60.0 (10.0)	61.0 (9.6)	60.5 (9.8)
Gender [units: participants]
Female	57	50	107
Male	90	99	189
Glycosylated haemoglobin (HbA1c) [units: percentage of glycosylated haemoglobin] Mean (Standard Deviation)	8.3 (0.8)	8.5 (0.8)	8.4 (0.8)
Fasting plasma glucose (FPG) [units: mmol/L] Mean (Standard Deviation)	9.0 (1.6)	9.1 (1.9)	9.0 (1.7)
Body weight [units: kg] Mean (Standard Deviation)	66.2 (13.4)	66.4 (13.3)	66.3 (13.4)

Outcome Measures

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1. Primary:

Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, Week 26 ]

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2. Secondary:

Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal [ Time Frame: Week 26 ]

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3. Secondary:

Rate of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 26 + 7 days follow up ]

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4. Secondary:

Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 + 7 days follow up ]

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5. Secondary:

Rate of Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 + 7 days follow up ]

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6. Secondary:

Change in Body Weight [ Time Frame: Week 0, Week 26 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Novo Nordisk maintains the right to be informed of any Investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.

Results Point of Contact:

Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com

Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT01272193 History of Changes
Other Study ID Numbers:	NN5401-3896 U1111-1118-0124 ( Other Identifier: WHO ) JapicCTI-111385 ( Registry Identifier: JAPIC )
Study First Received:	January 6, 2011
Results First Received:	October 21, 2015
Last Updated:	October 21, 2015
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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