Effect of Liraglutide or Exenatide Added to an Ongoing Treatment on Blood Glucose Control in Subjects With Type 2 Diabetes (LEAD-6)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00518882
First received: August 20, 2007
Last updated: June 19, 2012
Last verified: June 2012
Results First Received: February 23, 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: liraglutide
Drug: exenatide

  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 133 centres in 15 countries: Austria (4), Denmark (6), Finland (5), France (5), Germany (14), Ireland (4), Macedonia (1), Norway (4), Poland (9), Romania (3), Slovenia (3), Spain (4), Sweden (2), Switzerland (4) and United States (65).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible subjects were subjects with type 2 diabetes being treated with oral anti-diabetic (OAD) therapy(ies) for at least 3 months prior to the study. Three subjects were exposed to study drug prior to randomisation, and thus only included in safety analysis set.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide -> Liraglutide -> Liraglutide Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)

Participant Flow for 2 periods

Period 1:   Double-Blind, Week 0-26
    Liraglutide -> Liraglutide -> Liraglutide     Exenatide -> Liraglutide -> Liraglutide  
STARTED     235 [1]   232 [2]
Randomised     233     231  
COMPLETED     202     187  
NOT COMPLETED     33     45  
Adverse Event                 23                 31  
Lack of Efficacy                 1                 0  
Protocol Violation                 4                 3  
Withdrawal criteria                 1                 1  
Lost to follow up                 2                 1  
Subject decision                 1                 1  
Withdrawal of consent                 1                 3  
Loss of trust                 0                 1  
Fear of hypoglycaemia                 0                 1  
Hypoglycaemia                 0                 2  
Mutual consent                 0                 1  
[1] 2 subjects exposed to study drug before randomisation. Subjects only included in safety analysis set
[2] 1 subject exposed to study drug before randomisation. Subject only included in safety analysis set

Period 2:   Open-Label Extension, Week 26-78
    Liraglutide -> Liraglutide -> Liraglutide     Exenatide -> Liraglutide -> Liraglutide  
STARTED     202     187  
COMPLETED     161     138  
NOT COMPLETED     41     49  
Adverse Event                 3                 9  
Lack of Efficacy                 6                 5  
Protocol Violation                 3                 4  
Withdrawel criteria                 1                 2  
Hypoglycaemia                 0                 1  
Lost to follow up                 1                 1  
Consent withdrawn                 2                 1  
Change in treatment                 1                 1  
Creatine increased                 1                 0  
Decreased kidney function                 1                 0  
Exclusion criteria                 2                 0  
Subject decision                 2                 0  
Completed extension 1 (weeks 26-40)                 18                 25  



  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.
No text entered.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide -> Liraglutide -> Liraglutide Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Total Total of all reporting groups

Baseline Measures
    Liraglutide -> Liraglutide -> Liraglutide     Exenatide -> Liraglutide -> Liraglutide     Total  
Number of Participants  
[units: participants]
  233     231     464  
Age  
[units: years]
Mean ± Standard Deviation
  56.3  ± 9.8     57.1  ± 10.8     56.7  ± 10.3  
Gender  
[units: participants]
     
Female     119     104     223  
Male     114     127     241  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     32     25     57  
Not Hispanic or Latino     201     206     407  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     1     1  
Asian     0     4     4  
Native Hawaiian or Other Pacific Islander     1     1     2  
Black or African American     13     12     25  
White     216     210     426  
More than one race     0     0     0  
Unknown or Not Reported     3     3     6  
Previous OAD treatment [1]
[units: participants]
     
Metformin/Sulphonylurea Combination     145     147     292  
Sulphonylurea     24     21     45  
Metformin     64     63     127  
BMI [2]
[units: kg/m2]
Mean ± Standard Deviation
  32.9  ± 5.5     32.9  ± 5.7     32.9  ± 5.6  
Duration of diabetes [3]
[units: years]
Mean ± Standard Deviation
  8.5  ± 6.2     7.9  ± 5.9     8.2  ± 6.0  
HbA1c [4]
[units: percentage of total haemoglobin]
Mean ± Standard Deviation
  8.4  ± 1.0     8.2  ± 1.0     8.3  ± 1.0  
Height  
[units: m]
Mean ± Standard Deviation
  1.68  ± 0.10     1.68  ± 0.10     1.68  ± 0.10  
Weight  
[units: kg]
Mean ± Standard Deviation
  93.1  ± 20.1     93.0  ± 19.5     93.1  ± 19.8  
[1] OAD = Oral Anti-diabetic Drug
[2] Body Mass Index
[3] Number of years since diagnosis
[4] Glycosylated Haemoglobin at screening



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Glycosylated A1c (HbA1c) at Week 26   [ Time Frame: week 0, week 26 ]

2.  Secondary:   Change in Glycosylated A1c (HbA1c), Weeks 26-78   [ Time Frame: week 26, week 78 ]

3.  Secondary:   Change in Glycosylated A1c (HbA1c) at Week 78   [ Time Frame: week 0, week 78 ]

4.  Secondary:   Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26   [ Time Frame: week 0, week 26 ]

5.  Secondary:   Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78   [ Time Frame: week 0, week 78 ]

6.  Secondary:   Change in Body Weight at Week 26   [ Time Frame: week 0, week 26 ]

7.  Secondary:   Change in Body Weight, Weeks 26-78   [ Time Frame: week 26, week 78 ]

8.  Secondary:   Change in Body Weight at Week 78   [ Time Frame: week 0, week 78 ]

9.  Secondary:   Change in Fasting Plasma Glucose at Week 26   [ Time Frame: week 0, week 26 ]

10.  Secondary:   Change in Fasting Plasma Glucose, Weeks 26-78   [ Time Frame: week 26, week 78 ]

11.  Secondary:   Change in Fasting Plasma Glucose at Week 78   [ Time Frame: week 0, week 78 ]

12.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26   [ Time Frame: week 0, week 26 ]

13.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26   [ Time Frame: week 0, week 26 ]

14.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26   [ Time Frame: week 0, week 26 ]

15.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78   [ Time Frame: week 26, week 78 ]

16.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78   [ Time Frame: week 26, week 78 ]

17.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78   [ Time Frame: week 26, week 78 ]

18.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78   [ Time Frame: week 0, week 78 ]

19.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78   [ Time Frame: week 0, week 78 ]

20.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78   [ Time Frame: week 0, week 78 ]

21.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26   [ Time Frame: week 0, week 26 ]

22.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26   [ Time Frame: week 0. week 26 ]

23.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26   [ Time Frame: week 0, week 26 ]

24.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78   [ Time Frame: week 26, week 78 ]

25.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78   [ Time Frame: week 26, week 78 ]

26.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78   [ Time Frame: week 26, week 78 ]

27.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78   [ Time Frame: week 0, week 78 ]

28.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78   [ Time Frame: week 0, week 78 ]

29.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78   [ Time Frame: week 0, week 78 ]

30.  Secondary:   Change in Beta-cell Function at Week 26   [ Time Frame: week 0, week 26 ]

31.  Secondary:   Change in Beta-cell Function, Weeks 26-78   [ Time Frame: week 26, week 78 ]

32.  Secondary:   Change in Beta-cell Function at Week 78   [ Time Frame: week 0, week 78 ]

33.  Secondary:   Change in Total Cholesterol at Week 26   [ Time Frame: week 0, week 26 ]

34.  Secondary:   Change in Total Cholesterol, Weeks 26-78   [ Time Frame: week 26, week 78 ]

35.  Secondary:   Change in Total Cholesterol at Week 78   [ Time Frame: week 0, week 78 ]

36.  Secondary:   Change in Low-density Lipoprotein-cholesterol at Week 26   [ Time Frame: week 0, week 26 ]

37.  Secondary:   Change in Low-density Lipoprotein-cholesterol, Weeks 26-78   [ Time Frame: week 26, week 78 ]

38.  Secondary:   Change in Low-density Lipoprotein-cholesterol at Week 78   [ Time Frame: week 0, week 78 ]

39.  Secondary:   Change in Very Low-density Lipoprotein-cholesterol at Week 26   [ Time Frame: week 0, week 26 ]

40.  Secondary:   Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78   [ Time Frame: week 26, week 78 ]

41.  Secondary:   Change in Very Low-density Lipoprotein-cholesterol at Week 78   [ Time Frame: week 0, week 78 ]

42.  Secondary:   Change in High-density Lipoprotein-cholesterol at Week 26   [ Time Frame: week 0, week 26 ]

43.  Secondary:   Change in High-density Lipoprotein-cholesterol, Weeks 26-78   [ Time Frame: week 26, week 78 ]

44.  Secondary:   Change in High-density Lipoprotein-cholesterol at Week 78   [ Time Frame: week 0, week 78 ]

45.  Secondary:   Change in Triglyceride at Week 26   [ Time Frame: week 0, week 26 ]

46.  Secondary:   Change in Triglyceride, Weeks 26-78   [ Time Frame: week 26, week 78 ]

47.  Secondary:   Change in Triglyceride at Week 78   [ Time Frame: week 0, week 78 ]

48.  Secondary:   Change in Free Fatty Acid at Week 26   [ Time Frame: week 0, week 26 ]

49.  Secondary:   Change in Free Fatty Acid, Weeks 26-78   [ Time Frame: week 26, week 78 ]

50.  Secondary:   Change in Free Fatty Acid at Week 78   [ Time Frame: week 0, week 78 ]

51.  Secondary:   Change in Apolipoprotein B at Week 26   [ Time Frame: week 0, week 26 ]

52.  Secondary:   Change in Apolipoprotein B, Weeks 26-78   [ Time Frame: week 26, week 78 ]

53.  Secondary:   Change in Apolipoprotein B at Week 78   [ Time Frame: week 0, week 78 ]

54.  Secondary:   Hypoglycaemic Episodes at Week 26   [ Time Frame: weeks 0-26 ]

55.  Secondary:   Hypoglyceamic Episodes, Weeks 26-78   [ Time Frame: weeks 26-78 ]


  Serious Adverse Events
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Time Frame The adverse events were collected in a time span of 78 weeks.
Additional Description The safety analysis set included all subjects who had been exposed to at least one dose of the study products.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide -> Liraglutide -> Liraglutide Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)

Serious Adverse Events
    Liraglutide -> Liraglutide -> Liraglutide     Exenatide -> Liraglutide -> Liraglutide  
Total, serious adverse events      
# participants affected / at risk     23/235 (9.79%)     23/232 (9.91%)  
Blood and lymphatic system disorders      
Haemorrhagic anaemia † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Cardiac disorders      
Acute coronary syndrome † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Acute myocardial infarction † 1    
# participants affected / at risk     1/235 (0.43%)     1/232 (0.43%)  
# events     1     1  
Angina pectoris † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Cardiac artery disease † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Cardiac failure † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Cardiac failure congestive † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Coronary artery occlusion † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Coronary artery stenosis † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Myocardial infarction † 1    
# participants affected / at risk     1/235 (0.43%)     2/232 (0.86%)  
# events     1     2  
Supraventricular tachycardia † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     2     0  
Endocrine disorders      
Autoimmune thyroiditis † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Goitre † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Hyperthyroidism † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Eye disorders      
Cataract † 1    
# participants affected / at risk     0/235 (0.00%)     3/232 (1.29%)  
# events     0     3  
Diplopia † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Gastrointestinal disorders      
Inguinal hernia † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Intra-abdominal haematoma † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Pancreatitis acute † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
General disorders      
Chest discomfort † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Non-cardiac chest pain † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Hepatobiliary disorders      
Cholelithiasis † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Portal vein thrombosis † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Infections and infestations      
Campylobacter gastroenteritis † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Cellulitis † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Diverticulitis † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Epstein-Barr virus infection † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Lobar pneumonia † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Lower respiratory tract infection † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Moraxella infection † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Pneumonia † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Injury, poisoning and procedural complications      
Jaw fracture † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Lumbar vertebral fracture † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Rib fracture † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Tibia fracture † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Investigations      
Intraocular pressure increased † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Metabolism and nutrition disorders      
Hypoglycaemia † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Musculoskeletal and connective tissue disorders      
Arthralgia † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Adenocarcinoma pancreas † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Brain neoplasm † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Lung adenocarcinoma † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Multiple myeloma † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Neoplasm prostate † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Rectal cancer † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Nervous system disorders      
Cerebellar infarction † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Cerebral infarction † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Cerebrovascular accident † 1    
# participants affected / at risk     1/235 (0.43%)     1/232 (0.43%)  
# events     1     1  
Sciatica † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Transient ischaemic attack † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Psychiatric disorders      
Bipolar disorder † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Renal and urinary disorders      
Nephrolithiasis † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Reproductive system and breast disorders      
Postmenopausal haemorrhage † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Respiratory, thoracic and mediastinal disorders      
Chronic obstructive pulmonary disease † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     3  
Dyspnoea † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Nasal polyps † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Pleurisy † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Pulmonary embolism † 1    
# participants affected / at risk     1/235 (0.43%)     0/232 (0.00%)  
# events     1     0  
Surgical and medical procedures      
Blood product transfusion † 1    
# participants affected / at risk     0/235 (0.00%)     1/232 (0.43%)  
# events     0     1  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (12.0)




  Other Adverse Events


  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:
unchecked 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.
unchecked 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.


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 A/S

Publications automatically indexed to this study:


Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00518882     History of Changes
Other Study ID Numbers: NN2211-1797, 2006-006092-21
Study First Received: August 20, 2007
Results First Received: February 23, 2010
Last Updated: June 19, 2012
Health Authority: United States: Food and Drug Administration
Finland: Finnish Medicines Agency
Switzerland: Swissmedic
Germany: Federal Institute for Drugs and Medical Devices
Ireland: Irish Medicines Board
Austria: Federal Ministry for Health and Women
Poland: The Office for Registration of Medicinal Products, Medical Devices; and Biocides, Central Evidence of Clinical Trials
Denmark: Danish Medicines Agency
Macedonia, The Former Yugoslav Republic of: Drug Agency, Ministry of Health
Slovenia: Agency of Drugs and Medicinal Products of the Slovenian Republic
Romania: National Medicines Agency
Sweden: Medical Products Agency