Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study in Adolescents With Schizophrenia or Bipolar Disorder

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: NCT00982020
Recruitment Status : Completed
First Posted : September 22, 2009
Results First Posted : December 17, 2014
Last Update Posted : December 17, 2014
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Bipolar I Disorder
Schizophrenia
Interventions Drug: Olanzapine
Behavioral: Standard behavioral weight intervention
Behavioral: Intense behavioral weight intervention
Enrollment 203
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Olanzapine/Standard Behavioral Weight Intervention Olanzapine/Intense Behavioral Weight Intervention
Hide Arm/Group Description Olanzapine: 2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
Period Title: Overall Study
Started 102 101
Received at Least 1 Dose of Study Drug 102 101
Completed 45 37
Not Completed 57 64
Reason Not Completed
Adverse Event             19             15
Withdrawal by Subject             11             14
Lost to Follow-up             5             11
Lack of Efficacy             10             4
Parent/Caregiver Decision             5             5
Treatment Non-compliance             3             6
Physician Decision             2             5
Entry Criteria Not Met             2             1
Protocol Violation             0             2
Clinical Relapse             0             1
Arm/Group Title Olanzapine/Standard Behavioral Weight Intervention Olanzapine/Intense Behavioral Weight Intervention Total
Hide Arm/Group Description

Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.

Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only

Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.

Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits

Total of all reporting groups
Overall Number of Baseline Participants 102 101 203
Hide Baseline Analysis Population Description
All randomized participants who received at least one dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 101 participants 203 participants
15.86  (1.49) 15.66  (1.52) 15.76  (1.51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 101 participants 203 participants
Female
50
  49.0%
47
  46.5%
97
  47.8%
Male
52
  51.0%
54
  53.5%
106
  52.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 101 participants 203 participants
Hispanic or Latino
15
  14.7%
9
   8.9%
24
  11.8%
Not Hispanic or Latino
87
  85.3%
92
  91.1%
179
  88.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 101 participants 203 participants
American Indian or Alaska Native
0
   0.0%
1
   1.0%
1
   0.5%
Asian
2
   2.0%
1
   1.0%
3
   1.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
12
  11.8%
14
  13.9%
26
  12.8%
White
84
  82.4%
80
  79.2%
164
  80.8%
More than one race
4
   3.9%
5
   5.0%
9
   4.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 102 participants 101 participants 203 participants
Germany 2 1 3
Poland 6 12 18
Russian Federation 28 27 55
United States 53 54 107
Puerto Rico 13 7 20
1.Primary Outcome
Title Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants
Hide Description [Not Specified]
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology used.
Arm/Group Title Olanzapine/Standard Behavioral Weight Intervention Olanzapine/Intense Behavioral Weight Intervention
Hide Arm/Group Description:
Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
Overall Number of Participants Analyzed 102 101
Least Squares Mean (Standard Error)
Unit of Measure: kilograms per meter squared (kg/m^2)
3.64  (.39) 2.83  (.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olanzapine/Standard Behavioral Weight Intervention, Olanzapine/Intense Behavioral Weight Intervention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.150
Comments The threshold for statistical significance was 0.05.
Method Mixed Models Analysis
Comments Mixed model repeated measures analysis terms included baseline BMI, baseline age, gender, intervention group, visit, region, intervention group*visit.
2.Secondary Outcome
Title Mean Change From Baseline to Endpoint in Body Mass Index (BMI) for Participants With Duration of Treatment of at Least 6 Months
Hide Description [Not Specified]
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and who had at least 6 months of data. Last observation carried forward (LOCF) methodology.
Arm/Group Title Olanzapine/Standard Behavioral Weight Intervention Olanzapine/Intense Behavioral Weight Intervention
Hide Arm/Group Description:
Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
Overall Number of Participants Analyzed 54 55
Least Squares Mean (Standard Error)
Unit of Measure: kg/m^2
3.36  (0.41) 2.99  (0.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olanzapine/Standard Behavioral Weight Intervention, Olanzapine/Intense Behavioral Weight Intervention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.520
Comments The threshold for statistical significance was 0.05.
Method ANCOVA
Comments ANCOVA model terms included: baseline, baseline age, gender, intervention group, and region.
3.Secondary Outcome
Title Time to Event for 7%, 15%, and 25% Weight Gain for All Participants
Hide Description Kaplan-Meier methodology used to estimate time to event. Participants who never reached the target weight gain contributed to the set of patients at risk up to the point at which they discontinued from the study and were then censored (i.e., removed from the risk set).
Time Frame Baseline up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

65 participants (32%; 34% in Standard Group [SG], 30% in Intense Group [IG]) did not meet 7% weight gain criterion [WGC] by the time they discontinued.

122 participants (60%; 58% in SG, 62% in IG) did not meet 15% WGC by the time they discontinued.

161 participants (79%; 76% in SG, 82% in IG) did not meet 25% WGC by the time they discontinued.

Arm/Group Title Olanzapine/Standard Behavioral Weight Intervention Olanzapine/Intense Behavioral Weight Intervention
Hide Arm/Group Description:

Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.

Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only

Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.

Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits

Overall Number of Participants Analyzed 102 101
Median (95% Confidence Interval)
Unit of Measure: days
Time to First 7% Weight Gain
57
(44.00 to 84.00)
57
(44.00 to 84.00)
Time to First 15% Weight Gain
197
(140.00 to 359.00)
198 [1] 
(141.00 to NA)
Time to First 25% Weight Gain
NA [2] 
(NA to NA)
NA [3] 
(NA to NA)
[1]
There was an insufficient number of events of 15% weight gain in the Intense group to compute this statistic.
[2]
There was an insufficient number of events of 25% weight gain in the Standard group to compute these statistics.
[3]
There was an insufficient number of events of 25% weight gain in the Intense group to compute these statistics.
4.Secondary Outcome
Title Mean Change From Baseline to 52 Weeks in Adolescent Structured Young Mania Rating Scale (YMRS) for Participants With Bipolar I Disorder
Hide Description The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 (symptom not present) to 60 (symptom extremely severe).
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with bipolar I disorder, who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.
Arm/Group Title Olanzapine/Standard Behavioral Weight Intervention Olanzapine/Intense Behavioral Weight Intervention
Hide Arm/Group Description:

Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.

Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only

Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.

Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits.

Overall Number of Participants Analyzed 58 58
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-17.66  (1.75) -12.05  (1.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olanzapine/Standard Behavioral Weight Intervention, Olanzapine/Intense Behavioral Weight Intervention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments Threshold for statistical significance was 0.05
Method Mixed Models Analysis
Comments MMRM analysis terms included baseline, intervention group, visit, region, and intervention group*visit.
5.Secondary Outcome
Title Mean Clinical Global Impression of Improvement (CGI-I) at 52 Weeks for All Participants
Hide Description The Clinical Global Impression of Improvement (CGI-I) is used by the clinician to record the improvement of illness at the time of assessment. The score ranges from 1 (very much improved) to 7 (very much worse).
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.
Arm/Group Title Olanzapine/Standard Behavioral Weight Intervention Olanzapine/Intense Behavioral Weight Intervention
Hide Arm/Group Description:
Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
Overall Number of Participants Analyzed 102 101
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.04  (0.15) 2.29  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olanzapine/Standard Behavioral Weight Intervention, Olanzapine/Intense Behavioral Weight Intervention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.266
Comments The threshold for statistical significance was 0.05
Method Mixed Models Analysis
Comments MMRM analysis terms included intervention group, visit, region, and intervention group*visit.
6.Secondary Outcome
Title Mean Change From Baseline to 52 Weeks in Waist Circumference for All Participants
Hide Description [Not Specified]
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Olanzapine/Standard Behavioral Weight Intervention Olanzapine/Intense Behavioral Weight Intervention
Hide Arm/Group Description:
Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
Overall Number of Participants Analyzed 102 101
Least Squares Mean (Standard Error)
Unit of Measure: centimeters (cm)
7.22  (1.06) 7.31  (1.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olanzapine/Standard Behavioral Weight Intervention, Olanzapine/Intense Behavioral Weight Intervention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.954
Comments The threshold for statistical significance was 0.05.
Method Mixed Models Analysis
Comments MMRM analysis terms included baseline, baseline age, gender, intervention group, visit, region, and intervention group*visit.
7.Secondary Outcome
Title Mean Change From Baseline to 52 Weeks in Clinical Global Impression - Severity (CGI-S) for All Participants
Hide Description The CGI-S is used by the clinician to record the severity of illness at the time of assessment. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill.
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.
Arm/Group Title Olanzapine/Standard Behavioral Weight Intervention Olanzapine/Intense Behavioral Weight Intervention
Hide Arm/Group Description:
Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
Overall Number of Participants Analyzed 102 101
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.06  (0.14) -1.74  (0.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olanzapine/Standard Behavioral Weight Intervention, Olanzapine/Intense Behavioral Weight Intervention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.103
Comments Threshold for statistical significance was 0.05
Method Mixed Models Analysis
Comments MMRM analysis terms included baseline, intervention group, visit, region, and intervention group*visit.
8.Secondary Outcome
Title Mean Change From Baseline to 52 Weeks in Anchored Version of the Brief Psychiatric Rating Scale for Children (BPRS-C) for Participants With Schizophrenia
Hide Description The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with schizophrenia who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.
Arm/Group Title Olanzapine/Standard Behavioral Weight Intervention Olanzapine/Intense Behavioral Weight Intervention
Hide Arm/Group Description:
Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
Overall Number of Participants Analyzed 44 43
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-28.00  (2.83) -30.96  (2.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olanzapine/Standard Behavioral Weight Intervention, Olanzapine/Intense Behavioral Weight Intervention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.436
Comments The threshold for statistical significance was 0.05
Method Mixed Models Analysis
Comments MMRM analysis terms included baseline, intervention group, visit, region, and intervention group*visit.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Olanzapine/Standard Behavioral Weight Intervention Olanzapine/Intense Behavioral Weight Intervention
Hide Arm/Group Description

Olanzapine: 2.5mg to 20mg given orally, daily for 52 weeks

Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only

Olanzapine: 2.5mg to 20mg given orally, daily for 52 weeks

Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits.

All-Cause Mortality
Olanzapine/Standard Behavioral Weight Intervention Olanzapine/Intense Behavioral Weight Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Olanzapine/Standard Behavioral Weight Intervention Olanzapine/Intense Behavioral Weight Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/102 (12.75%)      20/101 (19.80%)    
Gastrointestinal disorders     
Gastroduodenitis  1  0/102 (0.00%)  0 1/101 (0.99%)  1
General disorders     
Irritability  1  0/102 (0.00%)  0 1/101 (0.99%)  2
Infections and infestations     
Gastroenteritis viral  1  1/102 (0.98%)  1 0/101 (0.00%)  0
Injury, poisoning and procedural complications     
Acetabulum fracture  1  0/102 (0.00%)  0 1/101 (0.99%)  1
Clavicle fracture  1  0/102 (0.00%)  0 1/101 (0.99%)  1
Craniocerebral injury  1  0/102 (0.00%)  0 1/101 (0.99%)  1
Facial bones fracture  1  0/102 (0.00%)  0 1/101 (0.99%)  1
Fall  1  0/102 (0.00%)  0 1/101 (0.99%)  1
Hip fracture  1  0/102 (0.00%)  0 1/101 (0.99%)  1
Humerus fracture  1  1/102 (0.98%)  1 0/101 (0.00%)  0
Jaw fracture  1  0/102 (0.00%)  0 1/101 (0.99%)  1
Multiple injuries  1  0/102 (0.00%)  0 1/101 (0.99%)  1
Overdose  1  1/102 (0.98%)  1 0/101 (0.00%)  0
Rib fracture  1  0/102 (0.00%)  0 1/101 (0.99%)  1
Traumatic liver injury  1  0/102 (0.00%)  0 1/101 (0.99%)  1
Traumatic lung injury  1  0/102 (0.00%)  0 1/101 (0.99%)  1
Nervous system disorders     
Neuroleptic malignant syndrome  1  1/102 (0.98%)  1 0/101 (0.00%)  0
Psychiatric disorders     
Abnormal behaviour  1  0/102 (0.00%)  0 1/101 (0.99%)  2
Aggression  1  0/102 (0.00%)  0 1/101 (0.99%)  1
Bipolar disorder  1  0/102 (0.00%)  0 2/101 (1.98%)  2
Bipolar i disorder  1  0/102 (0.00%)  0 4/101 (3.96%)  4
Drug abuse  1  1/102 (0.98%)  1 0/101 (0.00%)  0
Hallucination, auditory  1  0/102 (0.00%)  0 1/101 (0.99%)  1
Mental disorder  1  0/102 (0.00%)  0 1/101 (0.99%)  1
Psychotic disorder  1  1/102 (0.98%)  1 4/101 (3.96%)  5
Schizophrenia  1  1/102 (0.98%)  1 0/101 (0.00%)  0
Schizophrenia, paranoid type  1  1/102 (0.98%)  1 0/101 (0.00%)  0
Suicidal ideation  1  3/102 (2.94%)  3 2/101 (1.98%)  2
Suicide attempt  1  2/102 (1.96%)  2 0/101 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pneumothorax  1  1/102 (0.98%)  1 0/101 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Olanzapine/Standard Behavioral Weight Intervention Olanzapine/Intense Behavioral Weight Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   81/102 (79.41%)      81/101 (80.20%)    
Gastrointestinal disorders     
Dry mouth  1  6/102 (5.88%)  6 4/101 (3.96%)  4
Vomiting  1  7/102 (6.86%)  8 4/101 (3.96%)  7
General disorders     
Fatigue  1  9/102 (8.82%)  10 6/101 (5.94%)  6
Infections and infestations     
Nasopharyngitis  1  14/102 (13.73%)  16 11/101 (10.89%)  11
Investigations     
Blood creatine phosphokinase increased  1  7/102 (6.86%)  9 5/101 (4.95%)  6
Blood insulin increased  1  10/102 (9.80%)  11 7/101 (6.93%)  7
Weight increased  1  31/102 (30.39%)  31 21/101 (20.79%)  21
Metabolism and nutrition disorders     
Increased appetite  1  16/102 (15.69%)  16 13/101 (12.87%)  14
Nervous system disorders     
Dizziness  1  7/102 (6.86%)  7 2/101 (1.98%)  2
Headache  1  19/102 (18.63%)  49 20/101 (19.80%)  30
Sedation  1  8/102 (7.84%)  8 3/101 (2.97%)  5
Somnolence  1  19/102 (18.63%)  22 24/101 (23.76%)  28
Psychiatric disorders     
Anxiety  1  6/102 (5.88%)  6 3/101 (2.97%)  4
Reproductive system and breast disorders     
Dysmenorrhoea  1  3/50 (6.00%)  18 1/47 (2.13%)  4
Respiratory, thoracic and mediastinal disorders     
Cough  1  7/102 (6.86%)  8 3/101 (2.97%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00982020     History of Changes
Other Study ID Numbers: 12117
F1D-MC-HGMX ( Other Identifier: Eli Lilly and Company )
First Submitted: September 15, 2009
First Posted: September 22, 2009
Results First Submitted: April 18, 2014
Results First Posted: December 17, 2014
Last Update Posted: December 17, 2014