Investigating Efficacy and Safety of Biphasic Insulin Aspart 50 Twice Daily Versus Biphasic Human Insulin 50 Twice Daily Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions:	Diabetes; Diabetes Mellitus, Type 2
Interventions:	Drug: biphasic insulin aspart 50; Drug: biphasic human insulin 50

  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
This trial was conducted in 14 sites in one country (China).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were no significant events following enrolment of subjects, and prior to randomization.

Reporting Groups

	Description
Group A (BIAsp 50 - BHI 50)	In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences. Group A received BIAsp 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BHI 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG).
Group B (BHI 50 - BIAsp 50)	In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences. Group B received BHI 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BIAsp 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG).

Participant Flow for 2 periods

Period 1:   Period 1

	Group A (BIAsp 50 - BHI 50)	Group B (BHI 50 - BIAsp 50)
STARTED	81	80
COMPLETED	78	74
NOT COMPLETED	3	6
Adverse Event	1	1
Protocol Violation	2	4
Unclassified	0	1

Period 2:   Period 2

	Group A (BIAsp 50 - BHI 50)	Group B (BHI 50 - BIAsp 50)
STARTED	78	74
COMPLETED	77	74
NOT COMPLETED	1	0
Protocol Violation	1	0

  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

All Subjects

In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences. Group A received BIAsp 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BHI 50 BID for further 4 weeks (period 2). Group B received BHI 50 BID during the first 4 weeks (period 1), then switched to BIAsp 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG).

Baseline Measures

	All Subjects
Overall Participants Analyzed; [Units: Participants]	161
Age; [Units: Years]; Mean (Standard Deviation)	59.1 (8.5)
Gender; [Units: Participants]
Female	88
Male	73

  Outcome Measures

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1. Primary:

2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test [ Time Frame: After 4 weeks of treatment in each treatment sequence ]

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2. Secondary:

­1-hour PPG Increment Following a Standard Meal Test [ Time Frame: After 4 weeks of treatment in each treatment sequence ]

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3. Secondary:

­IAUC (Incremental Area Under the Curve) for PPG (0-2 Hours) Following a Standard Meal Test [ Time Frame: After 4 weeks of treatment in each treatment sequence ]

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4. Secondary:

2-hour PPG Increments Over Each of the 3 Main Meals in 8-point SMPG (Self-measured Plasma Glucose) Profile [ Time Frame: After 4 weeks of treatment in each treatment sequence ]

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5. Secondary:

The Mean 2-hour PPG Increments of the 3 Main Meals in 8-point SMPG Profile [ Time Frame: After 4 weeks of treatment in each treatment sequence ]

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6. Secondary:

Incidence of Hypoglycemic Episodes [ Time Frame: During 4 weeks of treatment in each treatment sequence ]

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7. Secondary:

Incidence of AEs (Adverse Event) [ Time Frame: During 4 weeks of treatment in each treatment sequence ]

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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: Authorship of publications should be in accordance with the Uniform Requirements of the International Committee of Medical Journal Editors. The Investigators offered authorship will be asked to comment and approve the publication. No permission to publish will be granted to any clinical research organization involved in the trial described in trial protocol.

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:	NCT01892020 History of Changes
Other Study ID Numbers:	BIASP-4058; U1111-1137-2342 ( Other Identifier: WHO )
First Submitted:	June 28, 2013
First Posted:	July 3, 2013
Results First Submitted:	May 4, 2015
Results First Posted:	July 9, 2015
Last Update Posted:	July 9, 2015