Evaluation of the Glycaemic Control With Insulin Detemir as an add-on to Current Oral Anti-diabetic Drug Treatment in Subjects With Type 2 Diabetes in Korea

This study has been completed.

Sponsor:

Information provided by:

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT00455858

First received: April 3, 2007

Last updated: June 26, 2012

Last verified: June 2012

History of Changes

Results First Received: December 16, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Diabetes Diabetes Mellitus, Type 2
Intervention:	Drug: insulin detemir

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 eight study sites in South Korea.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Between screening and treatment with study drug, subjects were assessed for eligibility. After start of treatment, all subjects were to have their dosage titrated individually based on SMPG (self-monitored plasma glucose) values during the 20-week titration and treatment period to reach and maintain pre-breakfast SMPG below 6.0 mmol/L (108 mg/dL).

Reporting Groups

	Description
Insulin Detemir	Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.

Participant Flow: Overall Study

	Insulin Detemir
STARTED	87 ^[1]
COMPLETED	81
NOT COMPLETED	6
Lost to Follow-up	2
Protocol Violation	1
Lack of Efficacy	1
Well controlled FPG without insulin	1
Withdrawal	1

[1]	Enrolled in study and exposed to study drug

Baseline Characteristics

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Reporting Groups

	Description
Insulin Detemir	Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.

Baseline Measures

	Insulin Detemir
Number of Participants [units: participants]	87
Age [units: years] Mean ± Standard Deviation	55.7 ± 9.5
Gender [units: participants]
Female	51
Male	36

Outcome Measures

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1. Primary:

Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20 [ Time Frame: week 0, week 20 ]

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2. Secondary:

Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12 [ Time Frame: week 0, week 12 ]

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3. Secondary:

Change in Fasting Plasma Glucose (FPG) [ Time Frame: week 0, week 12, week 20 ]

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4. Secondary:

Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0% [ Time Frame: week 12, week 20 ]

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5. Secondary:

Occurence of Hypoglycaemic Episodes [ Time Frame: weeks 0-20 ]

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Serious Adverse Events

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Time Frame	Adverse events were collected in a time span of 22 weeks.
Additional Description	Safety analysis set contains all enrolled subjects exposed to at least one dose of study drug.

Reporting Groups

	Description
Insulin Detemir	Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.

Serious Adverse Events

	Insulin Detemir
Total, serious adverse events
# participants affected / at risk	5/87 (5.75%)
Cardiac disorders
Angina pectoris ^{† 1}
# participants affected / at risk	1/87 (1.15%)
# events	1
Gastrointestinal disorders
Intestinal polyp ^{† 1}
# participants affected / at risk	1/87 (1.15%)
# events	1
Infections and infestations
Pyelonephritis acute ^{† 1}
# participants affected / at risk	1/87 (1.15%)
# events	1
Pneumonia mycoplasmal ^{† 1}
# participants affected / at risk	1/87 (1.15%)
# events	1
Nervous system disorders
Hepatic encephalopathy ^{† 1}
# participants affected / at risk	1/87 (1.15%)
# events	1

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA (12.0)

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 acknowledges the Investigator’s right to publish the entire results of the trial. Any such scientific paper, presentation, communication or other information concerning the investigation described in this protocol, should be submitted in writing to Novo Nordisk Trial Manager prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.

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:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00455858 History of Changes
Other Study ID Numbers:	NN304-1762
Study First Received:	April 3, 2007
Results First Received:	December 16, 2009
Last Updated:	June 26, 2012
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

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