Observational Study to Evaluate the Safety of Levemir® in Diabetes - Study Results

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Conditions:	Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2
Intervention:	Drug: insulin detemir

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study conducted globally in 26 countries. Some countries participated for only 3 months, while others extended their participation to 6 and 12 months, respectively.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects with type 1 or type 2 diabetes including newly diagnosed subjects who had never received insulin or an insulin analogue at the prescribing physician's discretion.

Reporting Groups

	Description
Type 1 Diabetes	Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
Type 2 Diabetes	Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.

Participant Flow: Overall Study

	Type 1 Diabetes	Type 2 Diabetes
STARTED	13529	37641
COMPLETED	10821	32038
NOT COMPLETED	2708	5603

Baseline Characteristics

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Reporting Groups

	Description
Type 1 Diabetes	Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
Type 2 Diabetes	Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.

Baseline Measures

	Type 1 Diabetes	Type 2 Diabetes	Total
Number of Participants [units: participants]	13529	37641	51170
Age ^[1] [units: years] Mean ± Standard Deviation
Austria, n=331, 430	41.9 ± 13.8	60.8 ± 11.5	52.6 ± 12.5
Brazil, n=962, 1136	29.6 ± 15.5	60.3 ± 12.9	46.2 ± 14.1
Denmark, n=312, 77	45.6 ± 13.3	61.4 ± 10.9	48.7 ± 12.8
Germany, n=2640, 7526	45.0 ± 15.7	62.3 ± 10.4	57.8 ± 11.8
Israel, n=295, 722	36.5 ± 20.0	60.2 ± 11.1	53.3 ± 13.7
Lebanon, n=63, 192	27.6 ± 10.3	58.2 ± 11.6	50.6 ± 11.3
Russia, n=1121, 2515	28.5 ± 15.8	58.7 ± 9.8	49.4 ± 11.6
Slovenia, n=91, 209	42.3 ± 14.5	59.1 ± 10.0	54.0 ± 11.4
Turkey, n=622, 2132	28.9 ± 15.2	55.9 ± 10.5	49.8 ± 11.6
Age ^[2] [units: years] Mean ± Standard Deviation
Belgium/Luxembourg, n=330, 38	45.2 ± 15.4	62.4 ± 9.6	47.0 ± 14.8
Czech Republic, n=861, 820	45.3 ± 16.8	59.4 ± 10.7	52.2 ± 13.8
Greece, n=125, 923	31.6 ± 16.3	64.9 ± 11.2	60.9 ± 11.8
, n=142, 3162	31.4 ± 17.0	52.6 ± 10.1	51.7 ± 10.4
Italy, n=177, 1297	44.6 ± 16.0	64.9 ± 9.8	62.5 ± 11.5
Netherlands, n=92, 324	39.9 ± 16.6	59.7 ± 13.0	55.3 ± 13.8
Saudi Arabia, n=104, 503	25 ± 13.1	50 ± 10.5	45.7 ± 10.9
South Africa, n=207, 247	33.6 ± 16.0	53.3 ± 11.9	44.3 ± 13.8
South Korea, n=224, 8854	36 ± 16.0	56.9 ± 12.4	56.4 ± 12.5
Sweden, n=553, 95	42 ± 17.5	61.3 ± 11.2	44.8 ± 16.6
Tunisia, n=21, 316	24.5 ± 15.9	57.6 ± 11.1	55.5 ± 11.4
United Kingdom/Ireland, n=2292, 1832	35.5 ± 17.6	59.2 ± 11.7	46.0 ± 15.0
Age ^[3] [units: years] Mean ± Standard Deviation
Finland, n=809, 249	41.9 ± 14.3	58.8 ± 10.7	45.9 ± 13.5
France, n=641, 1127	47.1 ± 16.1	62.6 ± 11.9	57.0 ± 13.4
Japan, n=490, 2801	50.5 ± 16.1	61.9 ± 12.8	60.2 ± 13.3
Gender, Customized [units: participants]
Female	6865	19175	26040
Male	6658	18453	25111
Not specified	6	13	19
Duration of diabetes (3 months' participation) [units: years] Mean ± Standard Deviation
Austria, n=330, 428	18.5 ± 13.6	12.5 ± 8.5	15.1 ± 10.7
Brazil, n=959, 1141	12.6 ± 9.7	13.7 ± 9.0	13.2 ± 9.3
Denmark, n=312, 76	20.4 ± 12.6	11.8 ± 6.6	18.7 ± 11.4
Germany, n=2607, 7468	17.2 ± 12.5	10.6 ± 7.2	12.3 ± 8.6
Israel, n=286, 721	14.3 ± 12.4	15.7 ± 9.1	15.3 ± 10.0
Lebanon, n=63, 192	11.4 ± 7.7	12.2 ± 7.1	12.0 ± 7.2
Russia, n=1112, 2509	8.5 ± 8.2	9.5 ± 5.8	9.2 ± 6.5
Slovenia, n=90, 208	18.1 ± 13.0	13.7 ± 8.0	15.0 ± 9.5
Turkey, n=612, 2127	8.2 ± 6.7	10.6 ± 6.6	10.1 ± 6.6
Duration of diabetes (6 months' participation) [units: years] Mean ± Standard Deviation
Belgium/Luxembourg, n=329, 38	17.7 ± 12.3	14 ± 9.2	17.3 ± 12.0
Czech Republic, n=856, 807	14.5 ± 11.1	12.8 ± 7.8	13.7 ± 9.5
Greece, n=129, 956	11.9 ± 9.9	13.4 ± 7.6	13.2 ± 7.9
India, n=139, 3178	6.6 ± 6.2	8.5 ± 5.5	8.4 ± 5.5
Italy, n=175, 1292	14.6 ± 11.6	14.7 ± 8.6	14.7 ± 9.0
Netherlands, n=88, 318	16.0 ± 14.5	9.6 ± 6.9	11.0 ± 8.5
Saudi Arabia, n=96, 494	7.2 ± 6.3	9.1 ± 5.6	8.8 ± 5.7
South Africa, n=196, 243	11.3 ± 9.4	9.9 ± 7.4	10.5 ± 8.3
South Korea, n=214, 8701	9.4 ± 7.7	10.1 ± 6.8	10.1 ± 6.8
Sweden, n=547, 96	19.6 ± 14.2	13.6 ± 7.4	18.7 ± 13.2
Tunisia, n=21, 316	8.2 ± 7.7	11.5 ± 6.4	11.3 ± 6.5
United Kingdom/Ireland, n=2260, 1827	15.2 ± 12.3	11.3 ± 7.7	13.5 ± 10.2
Duration of diabetes (12 months' participation) [units: years] Mean ± Standard Deviation
Finland, n=796, 245	19.8 ± 12.3	13.3 ± 7.6	18.3 ± 11.2
France, n=628, 1117	17.0 ± 12.0	14.6 ± 8.9	15.5 ± 10.0
Japan, n=420, 2240	12.1 ± 10.0	14.2 ± 8.9	13.9 ± 9.1

[1]	Age: 3 months' participation
[2]	Age: 6 months' participation
[3]	Age: 12 months' participation

Outcome Measures

1. Primary:

Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events [ Time Frame: Months 0-12 ]

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Serious Adverse Events

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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 physician’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, must 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
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Results Point of Contact:

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

No publications provided by Novo Nordisk

Publications automatically indexed to this study:

Niskanen L, Virkamäki A, Hansen JB, Saukkonen T. Fasting plasma glucose variability as a marker of nocturnal hypoglycemia in diabetes: evidence from the PREDICTIVE study. Diabetes Res Clin Pract. 2009 Nov;86(2):e15-8. Epub 2009 Sep 10.

Fontaine P, Gin H, Pinget M, Thivolet C, Hanaire H, Robert JJ, Marre M, Venkatanarasimhachar S. Effect of insulin detemir dose frequency on clinical outcomes in patients with diabetes in PREDICTIVE. Adv Ther. 2009 May;26(5):535-51. Epub 2009 Jun 2.

Yenigun M, Honka M. Switching patients from insulin glargine-based basal-bolus regimens to a once daily insulin detemir-based basal-bolus regimen: results from a subgroup of the PREDICTIVE study. Int J Clin Pract. 2009 Mar;63(3):425-32.

Sreenan S, Virkamäki A, Zhang K, Hansen JB; PREDICTIVE study group. Switching from NPH insulin to once-daily insulin detemir in basal-bolus-treated patients with diabetes mellitus: data from the European cohort of the PREDICTIVE study. Int J Clin Pract. 2008 Dec;62(12):1971-80.

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00659295 History of Changes
Other Study ID Numbers:	NN304-1677
Study First Received:	April 10, 2008
Results First Received:	June 16, 2011
Last Updated:	July 20, 2011
Health Authority:	Denmark: Danish Medicines Agency United Kingdom: Medicines and Healthcare Products Regulatory India: Ministry of Health Germany: Federal Institute for Drugs and Medical Devices Russia: Federal Ethics Committee South Africa: Medicines Control Council South Korea: Korea Food and Drug Administration (KFDA) Sweden: Medical Products Agency Ireland: Irish Medicines Board Italy: Ethics Committee Japan: Ministry of Health, Labour and Welfare (MHLW) Belgium: Federal Agency for Medicines and Health Products Austria: Agency for Health and Food Safety Brazil: National Committee of Ethics in Research Czech Republic: State Institute for Drug Control Finland: Ethics Committee France: French National Agency for Health Israel: Ministry of Health Luxembourg: Le Gouvernement du Grand-Duché de Luxembourg Slovenia: Agency for Medicinal Products Tunisia: Direction of Pharmacy and Medicines Turkey: Ethics Committee Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)