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Trial record 57 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

A Long-term Study for the Treatment of Painful Diabetic Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00641719
Recruitment Status : Completed
First Posted : March 24, 2008
Results First Posted : March 31, 2011
Last Update Posted : March 31, 2011
Sponsor:
Collaborator:
Shionogi
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetic Neuropathies
Intervention Drug: Duloxetine hydrochloride
Enrollment 258
Recruitment Details This study, F1J-JE-HMFY (Study HMFY), is an open-label, long-term extension study of double-blind placebo-controlled study F1J-JE-HMFX (Study HMFX) (NCT00552175).
Pre-assignment Details Prior to start of extension study (HMFY), all participants in Study HMFX were re-randomized to duloxetine 40 or 60 mg regardless of the treatment they received in Study HMFX. Baseline values for the extension study HMFY represent those of 40- and 60-mg groups after re-randomization of participants.
Arm/Group Title Duloxetine 40 mg Duloxetine 60 mg
Hide Arm/Group Description Duloxetine 40 mg once daily (QD), orally (PO), 1 year Duloxetine 60 mg QD, PO, 1 year
Period Title: Overall Study
Started 129 129
Completed 99 92 [1]
Not Completed 30 37
Reason Not Completed
Lack of Efficacy             1             2
Adverse Event             24             29
Withdrawal by Subject             4             4
Reason Not Specified             1             2
[1]
1 participant discontinued during taper phase, not during treatment phase.
Arm/Group Title Duloxetine 40 mg Duloxetine 60 mg Total
Hide Arm/Group Description Duloxetine 40 mg once daily (QD), orally (PO), 1 year Duloxetine 60 mg QD, PO, 1 year Total of all reporting groups
Overall Number of Baseline Participants 129 129 258
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 129 participants 129 participants 258 participants
60.2  (10.5) 60.0  (9.6) 60.1  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 129 participants 258 participants
Female
40
  31.0%
22
  17.1%
62
  24.0%
Male
89
  69.0%
107
  82.9%
196
  76.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 129 participants 129 participants 258 participants
129 129 258
[1]
Measure Description: All participants were Japanese.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 129 participants 129 participants 258 participants
129 129 258
Duration of Diabetes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 129 participants 129 participants 258 participants
Less Than 5 Years 23 25 48
5 to 10 Years 27 23 50
Greater Than or Equal to 10 Years 76 79 155
Unknown 3 2 5
Type of Diabetes   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 129 participants 129 participants 258 participants
Type I 8 4 12
Type II 121 125 246
[1]
Measure Description: Type I diabetes is insulin dependent diabetes. Type II diabetes is non-insulin dependent diabetes.
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters (cm)
Number Analyzed 129 participants 129 participants 258 participants
163.69  (9.04) 165.12  (7.75) 164.41  (8.44)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 129 participants 129 participants 258 participants
63.91  (12.13) 64.98  (11.57) 64.45  (11.84)
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms/meters squared (kg/m^2)
Number Analyzed 129 participants 129 participants 258 participants
23.79  (3.77) 23.77  (3.49) 23.78  (3.62)
[1]
Measure Description: Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared (kg/m^2).
Duration of Diabetic Neuropathy  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 129 participants 129 participants 258 participants
3.91  (3.16) 4.29  (3.91) 4.10  (3.55)
Patient's Global Impressions of Improvement (PGI-I) Rate   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 129 participants 129 participants 258 participants
3.0  (1.1) 3.1  (1.1) 3.1  (1.1)
[1]
Measure Description: A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Beck Depression Inventory - II (BDI-II)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 129 participants 129 participants 258 participants
6.1  (6.4) 6.1  (6.4) 6.1  (6.4)
[1]
Measure Description: A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Brief Pain Inventory (BPI) Interference   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 129 participants 129 participants 258 participants
General Activity 2.5  (2.4) 2.7  (2.2) 2.6  (2.3)
Mood 2.3  (2.3) 2.4  (2.2) 2.3  (2.2)
Walking Ability 2.2  (2.4) 2.3  (2.1) 2.3  (2.2)
Normal Work 2.3  (2.3) 2.3  (2.2) 2.3  (2.3)
Relation to People 1.6  (2.1) 1.9  (2.1) 1.8  (2.1)
Sleep 2.2  (2.3) 2.5  (2.4) 2.3  (2.4)
Enjoyment of Life 1.9  (2.1) 2.1  (2.1) 2.0  (2.1)
Average Interference Score 2.14  (2.09) 2.32  (2.06) 2.23  (2.07)
[1]
Measure Description: Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Brief Pain Inventory (BPI) - Pain Severity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 129 participants 129 participants 258 participants
Worst Pain 4.7  (2.0) 4.9  (2.0) 4.8  (2.0)
Least Pain 2.8  (2.0) 3.1  (2.1) 3.0  (2.0)
Average Pain 3.8  (1.9) 4.0  (1.9) 3.9  (1.9)
Pain Right Now 3.4  (2.1) 3.6  (2.1) 3.5  (2.1)
[1]
Measure Description: A self-reported scale that measures the severity of pain based on the average pain, least pain, and worst pain experienced over the past 24 hours, and the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
1.Primary Outcome
Title Number of Participants Who Experienced an Adverse Event (AE)
Hide Description See the Reported Adverse Events section for details.
Time Frame baseline through 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug.
Arm/Group Title Duloxetine 40 mg Duloxetine 60 mg
Hide Arm/Group Description:
Duloxetine 40 mg once daily (QD), orally (PO), 1 year
Duloxetine 60 mg QD, PO, 1 year
Overall Number of Participants Analyzed 129 129
Measure Type: Number
Unit of Measure: participants
Serious Adverse Events 11 22
Adverse Events 126 121
2.Secondary Outcome
Title Patient Global Impression of Improvement (PGI-I) Scale at One Year Endpoint.
Hide Description A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
Arm/Group Title Duloxetine 40 mg Duloxetine 60 mg
Hide Arm/Group Description:
Duloxetine 40 mg once daily (QD), orally (PO), 1 year
Duloxetine 60 mg QD, PO, 1 year
Overall Number of Participants Analyzed 129 128
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.1  (0.9) 2.1  (1.0)
3.Secondary Outcome
Title Change From Baseline to One Year Endpoint for Patient Global Impression of Improvement (PGI-I) Scale
Hide Description A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Time Frame baseline, 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
Arm/Group Title Duloxetine 40 mg Duloxetine 60 mg
Hide Arm/Group Description:
Duloxetine 40 mg once daily (QD), orally (PO), 1 year
Duloxetine 60 mg QD, PO, 1 year
Overall Number of Participants Analyzed 129 128
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.9  (1.1) -1.0  (1.1)
4.Secondary Outcome
Title Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint
Hide Description A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
Arm/Group Title Duloxetine 40 mg Duloxetine 60 mg
Hide Arm/Group Description:
Duloxetine 40 mg once daily (QD), orally (PO), 1 year
Duloxetine 60 mg QD, PO, 1 year
Overall Number of Participants Analyzed 129 128
Mean (Standard Deviation)
Unit of Measure: units on a scale
Worst Pain 2.4  (1.9) 2.6  (2.0)
Least Pain 1.3  (1.5) 1.5  (1.5)
Average Pain 1.8  (1.5) 1.9  (1.6)
Pain Right Now 1.7  (1.6) 1.7  (1.6)
5.Secondary Outcome
Title Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores
Hide Description A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now.
Time Frame baseline, 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
Arm/Group Title Duloxetine 40 mg Duloxetine 60 mg
Hide Arm/Group Description:
Duloxetine 40 mg once daily (QD), orally (PO), 1 year
Duloxetine 60 mg QD, PO, 1 year
Overall Number of Participants Analyzed 129 128
Mean (Standard Deviation)
Unit of Measure: units on a scale
Worst Pain -2.2  (1.8) -2.3  (1.9)
Least Pain -1.6  (1.6) -1.6  (1.6)
Average Pain -2.1  (1.7) -2.1  (1.6)
Pain Right Now -1.8  (1.7) -1.8  (1.6)
6.Secondary Outcome
Title Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint
Hide Description Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
Arm/Group Title Duloxetine 40 mg Duloxetine 60 mg
Hide Arm/Group Description:
Duloxetine 40 mg once daily (QD), orally (PO), 1 year
Duloxetine 60 mg QD, PO, 1 year
Overall Number of Participants Analyzed 129 128
Mean (Standard Deviation)
Unit of Measure: units on a scale
General Activities 1.4  (1.7) 1.4  (1.6)
Mood 1.2  (1.5) 1.3  (1.6)
Walking Ability 1.4  (1.7) 1.3  (1.5)
Normal Work 1.2  (1.7) 1.3  (1.5)
Relation to People 1.0  (1.5) 1.1  (1.4)
Sleep 1.2  (1.5) 1.3  (1.6)
Enjoyment of Life 1.2  (1.6) 1.3  (1.5)
Average Score 1.21  (1.52) 1.28  (1.48)
7.Secondary Outcome
Title Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores
Hide Description Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time Frame baseline, 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
Arm/Group Title Duloxetine 40 mg Duloxetine 60 mg
Hide Arm/Group Description:
Duloxetine 40 mg once daily (QD), orally (PO), 1 year
Duloxetine 60 mg QD, PO, 1 year
Overall Number of Participants Analyzed 129 128
Mean (Standard Deviation)
Unit of Measure: units on a scale
General Activities -1.1  (1.8) -1.3  (1.8)
Mood -1.1  (1.8) -1.0  (1.7)
Walking Ability -0.8  (1.8) -1.0  (1.6)
Normal Work -1.0  (1.8) -1.0  (1.6)
Relation to People -0.6  (1.6) -0.7  (1.6)
Sleep -1.0  (2.1) -1.1  (2.0)
Enjoyment of Life -0.8  (1.7) -0.8  (1.5)
Average Score -0.93  (1.57) -1.00  (1.48)
8.Secondary Outcome
Title Beck Depression Inventory-II (BDI-II) Total Score at One Year Endpoint
Hide Description A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
Arm/Group Title Duloxetine 40 mg Duloxetine 60 mg
Hide Arm/Group Description:
Duloxetine 40 mg once daily (QD), orally (PO), 1 year
Duloxetine 60 mg QD, PO, 1 year
Overall Number of Participants Analyzed 129 128
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.3  (7.1) 5.4  (5.8)
9.Secondary Outcome
Title Change From Baseline to One Year Endpoint in Beck Depression Inventory-II (BDI-II) Total Score
Hide Description A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Time Frame baseline, 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
Arm/Group Title Duloxetine 40 mg Duloxetine 60 mg
Hide Arm/Group Description:
Duloxetine 40 mg once daily (QD), orally (PO), 1 year
Duloxetine 60 mg QD, PO, 1 year
Overall Number of Participants Analyzed 129 128
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.2  (4.4) -0.7  (3.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duloxetine 40 mg Duloxetine 60 mg
Hide Arm/Group Description Duloxetine 40 mg once daily (QD), orally (PO), 1 year Duloxetine 60 mg QD, PO, 1 year
All-Cause Mortality
Duloxetine 40 mg Duloxetine 60 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Duloxetine 40 mg Duloxetine 60 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/129 (8.53%)      22/129 (17.05%)    
Cardiac disorders     
Acute myocardial infarction  1  0/129 (0.00%)  0 2/129 (1.55%)  2
Angina pectoris  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Cardiac failure  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Cardiac failure congestive  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Myocardial ischaemia  1  1/129 (0.78%)  1 0/129 (0.00%)  0
Eye disorders     
Glaucoma  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Gastrointestinal disorders     
Colonic polyp  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Ileus  1  0/129 (0.00%)  0 1/129 (0.78%)  1
General disorders     
Generalised oedema  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Infections and infestations     
Bronchopneumonia  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Diabetic gangrene  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Infected epidermal cyst  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Pyonephrosis  1  1/129 (0.78%)  1 0/129 (0.00%)  0
Injury, poisoning and procedural complications     
Clavicle fracture  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Femoral neck fracture  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Foot fracture  1  1/129 (0.78%)  1 0/129 (0.00%)  0
Lung injury  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Pelvic fracture  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Rib fracture  1  0/129 (0.00%)  0 2/129 (1.55%)  2
Spinal compression fracture  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Subdural haematoma  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Thoracic vertebral fracture  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Vertebral injury  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Metabolism and nutrition disorders     
Hypoglycaemia  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  1/129 (0.78%)  1 0/129 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer  1  1/129 (0.78%)  1 0/129 (0.00%)  0
Gastric cancer  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Hepatic neoplasm malignant  1  0/129 (0.00%)  0 2/129 (1.55%)  2
Lymphoma  1  2/129 (1.55%)  3 0/129 (0.00%)  0
Metastases to liver  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Metastases to lung  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Pancreatic carcinoma  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Tumour embolism  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Tumour invasion  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Nervous system disorders     
Carotid artery stenosis  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Cerebral infarction  1  1/129 (0.78%)  1 0/129 (0.00%)  0
Loss of consciousness  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Reproductive system and breast disorders     
Uterine prolapse  1  1/129 (0.78%)  1 0/129 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Nasal cyst  1  1/129 (0.78%)  1 0/129 (0.00%)  0
Pneumonia aspiration  1  1/129 (0.78%)  1 0/129 (0.00%)  0
Pneumothorax  1  0/129 (0.00%)  0 1/129 (0.78%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Duloxetine 40 mg Duloxetine 60 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   126/129 (97.67%)      121/129 (93.80%)    
Eye disorders     
Diabetic retinopathy  1  8/129 (6.20%)  8 3/129 (2.33%)  3
Gastrointestinal disorders     
Constipation  1  17/129 (13.18%)  19 17/129 (13.18%)  19
Diarrhoea  1  9/129 (6.98%)  10 7/129 (5.43%)  7
Nausea  1  14/129 (10.85%)  16 13/129 (10.08%)  15
Stomach discomfort  1  4/129 (3.10%)  7 7/129 (5.43%)  7
Vomiting  1  9/129 (6.98%)  11 10/129 (7.75%)  12
General disorders     
Oedema peripheral  1  7/129 (5.43%)  9 8/129 (6.20%)  8
Thirst  1  5/129 (3.88%)  5 8/129 (6.20%)  9
Infections and infestations     
Nasopharyngitis  1  36/129 (27.91%)  52 31/129 (24.03%)  39
Pharyngitis  1  5/129 (3.88%)  6 11/129 (8.53%)  12
Injury, poisoning and procedural complications     
Contusion  1  10/129 (7.75%)  11 12/129 (9.30%)  20
Investigations     
Alanine aminotransferase increased  1  12/129 (9.30%)  12 13/129 (10.08%)  15
Aspartate aminotransferase increased  1  13/129 (10.08%)  13 12/129 (9.30%)  14
Blood alkaline phosphatase increased  1  6/129 (4.65%)  6 7/129 (5.43%)  8
Blood creatine phosphokinase increased  1  12/129 (9.30%)  13 12/129 (9.30%)  12
Blood creatinine increased  1  3/129 (2.33%)  4 8/129 (6.20%)  9
Blood glucose decreased  1  14/129 (10.85%)  22 8/129 (6.20%)  9
Blood glucose increased  1  14/129 (10.85%)  21 12/129 (9.30%)  14
Blood lactate dehydrogenase increased  1  7/129 (5.43%)  7 5/129 (3.88%)  5
Blood potassium increased  1  7/129 (5.43%)  8 7/129 (5.43%)  10
Blood triglycerides increased  1  9/129 (6.98%)  11 10/129 (7.75%)  10
Blood urea increased  1  7/129 (5.43%)  7 4/129 (3.10%)  4
Blood uric acid increased  1  6/129 (4.65%)  7 8/129 (6.20%)  8
Blood urine present  1  4/129 (3.10%)  4 7/129 (5.43%)  8
Gamma-glutamyltransferase increased  1  10/129 (7.75%)  10 11/129 (8.53%)  11
Glycosylated haemoglobin increased  1  31/129 (24.03%)  32 29/129 (22.48%)  29
Urine albumin/creatinine ratio increased  1  10/129 (7.75%)  11 15/129 (11.63%)  15
Weight increased  1  12/129 (9.30%)  13 11/129 (8.53%)  11
White blood cell count increased  1  13/129 (10.08%)  16 8/129 (6.20%)  8
Metabolism and nutrition disorders     
Diabetes mellitus  1  12/129 (9.30%)  13 11/129 (8.53%)  11
Hypoglycaemia  1  14/129 (10.85%)  34 11/129 (8.53%)  18
Musculoskeletal and connective tissue disorders     
Back pain  1  5/129 (3.88%)  5 9/129 (6.98%)  10
Nervous system disorders     
Dizziness  1  10/129 (7.75%)  12 8/129 (6.20%)  11
Headache  1  11/129 (8.53%)  31 9/129 (6.98%)  13
Somnolence  1  17/129 (13.18%)  17 18/129 (13.95%)  18
Psychiatric disorders     
Insomnia  1  11/129 (8.53%)  11 5/129 (3.88%)  5
Respiratory, thoracic and mediastinal disorders     
Upper respiratory tract inflammation  1  9/129 (6.98%)  14 3/129 (2.33%)  6
Skin and subcutaneous tissue disorders     
Eczema  1  8/129 (6.20%)  9 10/129 (7.75%)  14
Vascular disorders     
Hypertension  1  9/129 (6.98%)  12 8/129 (6.20%)  8
Orthostatic hypotension  1  4/129 (3.10%)  4 8/129 (6.20%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00641719     History of Changes
Other Study ID Numbers: 12194
F1J-JE-HMFY ( Other Identifier: Eli Lilly and Company )
First Submitted: March 19, 2008
First Posted: March 24, 2008
Results First Submitted: March 3, 2011
Results First Posted: March 31, 2011
Last Update Posted: March 31, 2011