ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 39 for:    LY2189265

A Study to Evaluate the Effect of LY2189265 on the Speed at Which Food and Drink Leaves the Stomach in Patients With Type 2 Diabetes Mellitus

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: NCT01215968
Recruitment Status : Completed
First Posted : October 7, 2010
Results First Posted : October 7, 2014
Last Update Posted : October 7, 2014
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Biological: LY2189265
Drug: Placebo
Enrollment 38

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo LY2189265
Hide Arm/Group Description Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5. Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
Period Title: Overall Study
Started 13 25
Received at Least 1 Dose of Study Drug 13 24 [1]
Completed 11 18
Not Completed 2 7
Reason Not Completed
Adverse Event             0             2
Protocol Violation             2             4
Not received study drug             0             1
[1]
25 participants received placebo during Week 1.
Arm/Group Title Placebo LY2189265 Total
Hide Arm/Group Description Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5. Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5. Total of all reporting groups
Overall Number of Baseline Participants 13 25 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 25 participants 38 participants
52.0  (14.0) 58.9  (9.8) 56.5  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 25 participants 38 participants
Female
2
  15.4%
5
  20.0%
7
  18.4%
Male
11
  84.6%
20
  80.0%
31
  81.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 25 participants 38 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
13
 100.0%
25
 100.0%
38
 100.0%
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 13 participants 25 participants 38 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
  23.1%
1
   4.0%
4
  10.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
10
  76.9%
24
  96.0%
34
  89.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 13 participants 25 participants 38 participants
13 25 38
1.Primary Outcome
Title Time Required for 50% of Radioactivity To Be Emptied From the Stomach by Scintigraphy
Hide Description After at least 8 hours fasting, participants received a radiolabeled breakfast containing technetium-99m-tin colloid (99mTc-tin colloid). After which serial anterior and posterior scintigraphy images were taken. Data presented are the time required for 50% of radioactivity to be emptied from stomach. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for weeks.
Time Frame Days 3, 10,17, 24 and 31
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study drug, a radiolabeled breakfast, and had scintigraphy images taken. Those who violated protocol were excluded.
Arm/Group Title Placebo LY2189265
Hide Arm/Group Description:
Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
Overall Number of Participants Analyzed 10 15
Geometric Mean (90% Confidence Interval)
Unit of Measure: hours
Day 3
1.44
(1.22 to 1.69)
1.72
(1.43 to 2.06)
Day 10
1.41
(1.20 to 1.66)
3.77
(3.15 to 4.51)
Day 17 (n=9, 14)
1.60
(1.36 to 1.89)
3.32
(2.76 to 4.00)
Day 24 (n=9, 14)
1.47
(1.25 to 1.73)
3.28
(2.72 to 3.94)
Day 31 (n=10, 13)
1.46
(1.24 to 1.71)
3.15
(2.61 to 3.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2189265
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Linear effects model analyses
Comments Ratio is the Geometric LS Means of Day 10 over Day 3.
Method of Estimation Estimation Parameter Ratio of Geometric LS Mean
Estimated Value 2.19
Confidence Interval (2-Sided) 90%
1.83 to 2.62
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY2189265
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Linear effects model analyses
Comments Ratio is the Geometric LS Means of Day 17 over Day 3.
Method of Estimation Estimation Parameter Ratio of Geometric LS Mean
Estimated Value 1.94
Confidence Interval (2-Sided) 90%
1.61 to 2.33
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LY2189265
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Linear effects model analyses
Comments Ratio is the Geometric LS Means of Day 24 over Day 3.
Method of Estimation Estimation Parameter Ratio of Geometric LS Mean
Estimated Value 1.91
Confidence Interval (2-Sided) 90%
1.59 to 2.29
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LY2189265
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Linear effects model analyses
Comments Ratio is the Geometric LS Means of Day 31 over Day 3.
Method of Estimation Estimation Parameter Ratio of Geometric LS Mean
Estimated Value 1.84
Confidence Interval (2-Sided) 90%
1.52 to 2.22
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Area Under the Curve (AUC) of Metformin
Hide Description Metformin was used as a secondary marker in the study to correlate the effect of LY2189265 on gastric emptying to the pharmacokinetics (PK) (measured as AUC) of concomitant medications. Participants taking metformin for treatment of Type 2 Diabetes Mellitus (T2DM) underwent PK assessments for metformin in parallel to their scintigraphy assessments for gastric emptying. AUC of metformin was calculated during one dosing interval.
Time Frame Days 3, 17 and 31
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received both study drug and immediate release metformin, and had PK data. Those who violated protocol were excluded.
Arm/Group Title Placebo LY2189265
Hide Arm/Group Description:
Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
Overall Number of Participants Analyzed 6 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms*hour/milliliter (ng*h/mL)
Day 3
13600
(11228% to 16824%)
13700
(40%)
Day 17
14600
(12523% to 18766%)
15300
(43%)
Day 31 (n=6, 11)
14600
(12941% to 19429%)
15800
(43%)
3.Secondary Outcome
Title Maximum Concentration (Cmax) of Metformin
Hide Description Metformin was used as a secondary marker in the study to correlate the effect of LY2189265 on gastric emptying to the pharmacokinetics (PK) (measured as Cmax) of concomitant medications. Participants taking metformin for treatment of Type 2 Diabetes Mellitus (T2DM) underwent PK assessments for metformin in parallel to their scintigraphy assessments for gastric emptying.
Time Frame Days 3, 17 and 31
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received both study drug and immediate release metformin, and had pharmacokinetic (PK) data. Those who violated protocol were excluded.
Arm/Group Title Placebo LY2189265
Hide Arm/Group Description:
Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
Overall Number of Participants Analyzed 6 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms/milliliter (ng/mL)
Day 3
1610
(48%)
1690
(47%)
Day 17
1690
(48%)
1500
(53%)
Day 31 (n=6, 11)
1770
(46%)
1680
(44%)
4.Secondary Outcome
Title Time to Maximum Concentration (Tmax) of Metformin
Hide Description Metformin was used as a secondary marker in the study to correlate the effect of LY2189265 on gastric emptying to the pharmacokinetics (PK) (measured as Tmax) of concomitant medications. Participants taking metformin for treatment of Type 2 Diabetes Mellitus (T2DM) underwent PK assessments for metformin in parallel to their scintigraphy assessments for gastric emptying.
Time Frame Days 3, 17 and 31
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received both study drug and immediate release metformin, and had pharmacokinetic (PK) data. Those who violated protocol were excluded.
Arm/Group Title Placebo LY2189265
Hide Arm/Group Description:
Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
Overall Number of Participants Analyzed 6 12
Median (Full Range)
Unit of Measure: hour
Day 3
1.00
(1.00 to 2.03)
2.02
(1.00 to 4.10)
Day 17
2.02
(1.02 to 8.00)
2.05
(0.96 to 4.02)
Day 31 (n=6, 11)
1.53
(0.98 to 4.00)
2.02
(1.00 to 4.03)
5.Secondary Outcome
Title Number of Participants With Clinically Significant Effects
Hide Description Adverse events (AEs) were considered clinically significant effects. A summary of serious adverse events (SAEs) and other nonserious AEs are located in the Reported Adverse Event section.
Time Frame Baseline through 5 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug.
Arm/Group Title Placebo Placebo (Week 1) LY2189265
Hide Arm/Group Description:
Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
Participants received placebo on Week 1 and went on to receive once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
Participants received placebo on Week 1 and once-weekly doses of 1.5 mg LY2189265 on Weeks 2 to 5.
Overall Number of Participants Analyzed 13 25 24
Measure Type: Number
Unit of Measure: participants
SAEs 0 0 0
Other nonserious AEs 7 11 20
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Placebo (Week 1) LY2189265
Hide Arm/Group Description Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5. Participants received placebo on Week 1 and went on to receive once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5. Participants received placebo on Week 1 and once-weekly doses of 1.5 mg LY2189265 on Weeks 2 to 5.
All-Cause Mortality
Placebo Placebo (Week 1) LY2189265
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Placebo (Week 1) LY2189265
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/25 (0.00%)      0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Placebo (Week 1) LY2189265
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/13 (53.85%)      11/25 (44.00%)      20/24 (83.33%)    
Eye disorders       
Eye irritation  1  1/13 (7.69%)  1 0/25 (0.00%)  0 0/24 (0.00%)  0
Gastrointestinal disorders       
Abdominal discomfort  1  0/13 (0.00%)  0 0/25 (0.00%)  0 3/24 (12.50%)  3
Abdominal distension  1  1/13 (7.69%)  1 0/25 (0.00%)  0 4/24 (16.67%)  8
Abdominal pain upper  1  2/13 (15.38%)  2 0/25 (0.00%)  0 2/24 (8.33%)  2
Diarrhoea  1  1/13 (7.69%)  1 2/25 (8.00%)  2 7/24 (29.17%)  19
Dyspepsia  1  0/13 (0.00%)  0 1/25 (4.00%)  1 7/24 (29.17%)  18
Eructation  1  1/13 (7.69%)  1 0/25 (0.00%)  0 5/24 (20.83%)  7
Gastrooesophageal reflux disease  1  0/13 (0.00%)  0 0/25 (0.00%)  0 3/24 (12.50%)  6
Nausea  1  3/13 (23.08%)  4 1/25 (4.00%)  1 12/24 (50.00%)  25
Toothache  1  1/13 (7.69%)  1 0/25 (0.00%)  0 0/24 (0.00%)  0
Vomiting  1  1/13 (7.69%)  1 0/25 (0.00%)  0 6/24 (25.00%)  11
General disorders       
Injection site pain  1  1/13 (7.69%)  1 0/25 (0.00%)  0 0/24 (0.00%)  0
Vessel puncture site haematoma  1  0/13 (0.00%)  0 2/25 (8.00%)  2 2/24 (8.33%)  4
Infections and infestations       
Bronchitis  1  1/13 (7.69%)  1 0/25 (0.00%)  0 0/24 (0.00%)  0
Lower respiratory tract infection  1  1/13 (7.69%)  1 0/25 (0.00%)  0 1/24 (4.17%)  1
Nasopharyngitis  1  0/13 (0.00%)  0 1/25 (4.00%)  1 4/24 (16.67%)  4
Injury, poisoning and procedural complications       
Limb injury  1  1/13 (7.69%)  1 0/25 (0.00%)  0 0/24 (0.00%)  0
Procedural nausea  1  1/13 (7.69%)  5 1/25 (4.00%)  1 0/24 (0.00%)  0
Metabolism and nutrition disorders       
Decreased appetite  1  1/13 (7.69%)  1 0/25 (0.00%)  0 8/24 (33.33%)  12
Increased appetite  1  2/13 (15.38%)  3 0/25 (0.00%)  0 1/24 (4.17%)  1
Musculoskeletal and connective tissue disorders       
Back pain  1  0/13 (0.00%)  0 0/25 (0.00%)  0 3/24 (12.50%)  5
Nervous system disorders       
Dizziness  1  1/13 (7.69%)  1 2/25 (8.00%)  2 4/24 (16.67%)  4
Headache  1  2/13 (15.38%)  3 4/25 (16.00%)  4 5/24 (20.83%)  7
Lethargy  1  0/13 (0.00%)  0 0/25 (0.00%)  0 3/24 (12.50%)  4
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal pain  1  1/13 (7.69%)  1 1/25 (4.00%)  1 2/24 (8.33%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
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
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01215968     History of Changes
Other Study ID Numbers: 13598
2009-017305-11 ( EudraCT Number )
H9X-EW-GBDM ( Other Identifier: Eli Lilly and Company )
First Submitted: October 5, 2010
First Posted: October 7, 2010
Results First Submitted: October 3, 2014
Results First Posted: October 7, 2014
Last Update Posted: October 7, 2014