Comparing the Efficacy and Safety of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 on Blood Sugar Control in Subjects With Type 2 Diabetes

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT00807092

First received: December 10, 2008

Last updated: June 15, 2012

Last verified: April 2012

History of Changes

Results First Received: November 12, 2010

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: biphasic insulin aspart 30 Drug: biphasic human insulin 30 Drug: metformin

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
A total of 10 sites across China

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All eligible subjects had their baseline blood glucose profiles monitored by continuous glucose monitoring system (CGMS) for 72 hours. Following CGMS uninstall and discontinuation of all previous oral anti-diabetic drug (OAD) treatment, subjects were randomised to one of two treatment groups.

Reporting Groups

Description

BIAsp 30

BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.

BHI 30

BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.

Participant Flow: Overall Study

	BIAsp 30	BHI 30
STARTED	72	73
Exposed to Drug	71 ^[1]	73
COMPLETED	71	69
NOT COMPLETED	1	4
Adverse Event	0	1
Protocol Violation	0	2
Withdrawal by Subject	1	0
CGMS data collection failed	0	1

[1]	Subject was randomised, but not exposed to any trial drug

Baseline Characteristics

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Reporting Groups

	Description
BIAsp 30	BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
BHI 30	BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
Total	Total of all reporting groups

Baseline Measures

	BIAsp 30	BHI 30	Total
Number of Participants [units: participants]	71	73	144
Age [units: years] Mean ± Standard Deviation	56.5 ± 9	54.4 ± 10.4	55.5 ± 9.8
Gender [units: participants]
Female	33	39	72
Male	38	34	72
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0	0	0
Asian	71	73	144
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	0	0	0
More than one race	0	0	0
Unknown or Not Reported	0	0	0
Weight [units: kg] Mean ± Standard Deviation	66.28 ± 12	65.49 ± 11.4	65.88 ± 11.7
Height at screening [units: m] Mean ± Standard Deviation	1.634 ± 0.09	1.623 ± 0.09	1.628 ± 0.09
BMI (Body Mass Index) [units: kg/m^2] Mean ± Standard Deviation	24.68 ± 3	24.74 ± 3	24.71 ± 3
Duration of diagnosed diabetes [units: years] Mean ± Standard Deviation	7.74 ± 5.5	7 ± 5.2	7.36 ± 5.3
HbA1c at screening [units: percentage of total haemoglobin] Mean ± Standard Deviation	9.19 ± 1.05	9.08 ± 1.08	9.13 ± 1.06
Metformin monotherapy or combination therapy at randomisation ^[1] [units: participants]
Metformin Monotherapy	20	18	38
Metformin Combination Therapy	51	55	106

[1]	OAD treatment at randomisation

Outcome Measures

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1. Primary:

Change in IAUC (Incremental Area Under the Curve) for Postprandial Glucose (0-4 Hours) Over 3 Main Meals [ Time Frame: Week 0, week 6 ]

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2. Secondary:

Change in Mean IAUC for Postprandial Glucose (0-4 Hours) After Each Meal (Breakfast, Lunch, Dinner) Assessed by CGMS [ Time Frame: Week 0, Week 6 ]

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3. Secondary:

Mean FBG (Fasting Blood Glucose) Assessed by CGMS [ Time Frame: Week 6 ]

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4. Secondary:

Change in Mean FBG Assessed by CGMS [ Time Frame: Week 0, week 6 ]

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5. Secondary:

Change in FPG (Fasting Plasma Glucose) [ Time Frame: Week 0, Week 6 ]

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6. Secondary:

Change in 8-point SMBG (Self-monitored Blood Glucose) Profiles [ Time Frame: Week 0, Week 6 ]

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7. Secondary:

Change in Prandial Blood Glucose Increment [ Time Frame: Week 0, Week 6 ]

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8. Secondary:

Change in MAGE (Mean Amplitude of Glycaemic Excursions) Assessed by CGMS [ Time Frame: Week 0, Week 6 ]

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9. Secondary:

Change in GA (Glycated Albumin) [ Time Frame: Week -2, week 6 ]

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10. Secondary:

Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week -2, week 6 ]

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11. Secondary:

Duration of Hypoglycaemic Events Based on CGMS [ Time Frame: 72-hour monitoring period at Week 0 and Week 6 ]

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12. Secondary:

Hypoglycaemia Based on Self-reported Episodes [ Time Frame: Weeks 0-6 ]

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Serious Adverse Events

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Time Frame	The adverse events were collected in a time span of 6 weeks (starting from the start of treatment to the end of treatment plus one day)
Additional Description	The safety analysis set contains all randomised subjects exposed to at least one dose of trial drug(s).

Reporting Groups

Description

BIAsp 30

BHI 30

Serious Adverse Events

	BIAsp 30	BHI 30
Total, serious adverse events
# participants affected / at risk	1/71 (1.41%)	3/73 (4.11%)
Injury, poisoning and procedural complications
Soft tissue injury ^{† 1}
# participants affected / at risk	0/71 (0.00%)	1/73 (1.37%)
# events	0	1
Musculoskeletal and connective tissue disorders
Loose body in joint ^{† 1}
# participants affected / at risk	1/71 (1.41%)	0/73 (0.00%)
# events	1	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic ^{† 1}
# participants affected / at risk	0/71 (0.00%)	1/73 (1.37%)
# events	0	1
Pancreatic carcinoma ^{† 1}
# participants affected / at risk	0/71 (0.00%)	1/73 (1.37%)
# events	0	1
Nervous system disorders
Hypoglycaemic coma ^{† 1}
# participants affected / at risk	0/71 (0.00%)	2/73 (2.74%)
# events	0	2

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA version 12.1

Other Adverse Events

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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 reserves the right to not release data until specified milestones. This includes the right to not release interim results of clinical trials. At the end of the trial, manuscripts for publication will be prepared collaboratively between Investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for less than 60 days to protect intellectual property.

Limitations and Caveats

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
No text entered.

Results Point of Contact:

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

No publications provided

Responsible Party:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00807092 History of Changes
Other Study ID Numbers:	BIASP-3681
Study First Received:	December 10, 2008
Results First Received:	November 12, 2010
Last Updated:	June 15, 2012
Health Authority:	China: Food and Drug Administration

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