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A Study to Examine the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension

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ClinicalTrials.gov Identifier: NCT01104701
Recruitment Status : Completed
First Posted : April 15, 2010
Results First Posted : July 17, 2014
Last Update Posted : August 20, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes
Interventions Drug: exenatide once weekly
Drug: exenatide once monthly suspension
Enrollment 121

Recruitment Details Study initiated 22-May-2010; completed 27-Dec-2010. Once weekly arm: first dose of exenatide administered at study-site on Day 1; self-administered on a weekly basis over subsequent 20 weeks. Once monthly arm: first dose of exenatide administered at study-site on Day 1;self-administered on monthly basis by participants over next 20 weeks.
Pre-assignment Details  
Arm/Group Title 2 mg Exenatide Weekly 5 mg Exenatide Monthly 8 mg Exenatide Monthly 11 mg Exenatide Monthly
Hide Arm/Group Description 2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks. 5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. 8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. 11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
Period Title: Overall Study
Started 30 30 31 30
Completed 30 27 29 28
Not Completed 0 3 2 2
Reason Not Completed
Withdrawal by Subject             0             1             2             1
Adverse Event             0             0             0             1
Physician Decision             0             2             0             0
Arm/Group Title 2 mg Exenatide Weekly 5 mg Exenatide Monthly 8 mg Exenatide Monthly 11 mg Exenatide Monthly Total
Hide Arm/Group Description 2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC). 5 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides. 8 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides. . 11 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides. Total of all reporting groups
Overall Number of Baseline Participants 30 30 31 30 121
Hide Baseline Analysis Population Description
All participants who were randomized and received at least one dose of study study drug were analyzed in the intent to treat (ITT) population.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 31 participants 30 participants 121 participants
Less than (<) 65 years of age 28 29 26 27 110
Greater than, equal to (≥) 65 years of age 2 1 5 3 11
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 31 participants 30 participants 121 participants
Female
10
  33.3%
13
  43.3%
7
  22.6%
13
  43.3%
43
  35.5%
Male
20
  66.7%
17
  56.7%
24
  77.4%
17
  56.7%
78
  64.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 31 participants 30 participants 121 participants
Asian 0 1 0 2 3
Black or African American 1 4 2 5 12
White 28 24 29 23 104
Other 1 1 0 0 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 30 participants 31 participants 30 participants 121 participants
30 30 31 30 121
Mean Hemoglobin A1c (HbA1c)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent of hemoglobin
Number Analyzed 30 participants 30 participants 31 participants 30 participants 121 participants
8.64  (1.19) 8.54  (1.18) 8.54  (1.18) 8.37  (1.34) 8.52  (1.21)
[1]
Measure Description: HbA1c is measured as a percent (%) of all hemoglobin.
Category of HbA1c  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 31 participants 30 participants 121 participants
HbA1c < 9.0% 20 18 19 21 78
HbA1c ≥ 9.0% 10 12 12 9 43
1.Primary Outcome
Title Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population
Hide Description HbA1c was measured as a percent of total hemoglobin at screening, Baseline, and during treatment on Weeks 4, 8, 12, 16, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. The Evaluable population was defined as participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.
Time Frame Baseline (Day 1) to 20 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value on the specified week were included in the analysis of the evaluable population. n=number of participants with measurement value.
Arm/Group Title 2 mg Exenatide Weekly 5 mg Exenatide Monthly 8 mg Exenatide Monthly 11 mg Exenatide Monthly
Hide Arm/Group Description:
2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
Overall Number of Participants Analyzed 29 26 28 27
Mean (Standard Error)
Unit of Measure: Percent of Hemoglobin
Change from baseline at Week 4 (n=29, 26, 28, 27) -0.52  (0.095) -0.33  (0.127) -0.24  (0.139) -0.34  (0.074)
Change from baseline at Week 8 (n=25, 22, 25, 27) -1.15  (0.157) -0.89  (0.200) -1.03  (0.218) -0.91  (0.110)
Change from baseline at Week 12 (n=29, 26, 28, 27) -1.43  (0.223) -1.30  (0.209) -1.19  (0.246) -1.26  (0.156)
Change from baseline at Week 16 (n=29, 26, 28, 27) -1.58  (0.216) -1.40  (0.215) -1.41  (0.271) -1.43  (0.177)
Change from baseline at Week 20 (n=29, 26, 28, 27) -1.54  (0.234) -1.29  (0.210) -1.31  (0.313) -1.45  (0.179)
2.Secondary Outcome
Title Percentage of Participants Achieving HbA1c Target Values at Week 20 - Evaluable Population
Hide Description HbA1c was measured as a percent (%) of total hemoglobin. The Target values for HbA1c were <7% and ≤ 6.5% at Week 20. Evaluable population was defined as participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.
Time Frame Week 20
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value for Week 20 were included in the analysis of the evaluable population. n=number of participants with measurement value.
Arm/Group Title 2 mg Exenatide Weekly 5 mg Exenatide Monthly 8 mg Exenatide Monthly 11 mg Exenatide Monthly
Hide Arm/Group Description:
2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
Overall Number of Participants Analyzed 29 26 28 27
Measure Type: Number
Unit of Measure: percentage of Participants
< 7.0% HbA1c 48.3 50.0 57.1 70.4
≤ 6.5% HbA1c 44.8 26.9 39.3 48.1
3.Secondary Outcome
Title Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population
Hide Description Body weight was measured in kilograms (kg) at Baseline, and during treatment at Weeks 2, 4, 6, 8, 9-11, 12, 13, 14, 15, 16, 17-19, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. Evaluable population was defined as all participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.
Time Frame Baseline (Day 1) to Week 20
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value on the specified week were included in the analysis. n=number of participants with measurement value.
Arm/Group Title 2 mg Exenatide Weekly 5 mg Exenatide Monthly 8 mg Exenatide Monthly 11 mg Exenatide Monthly
Hide Arm/Group Description:
2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
Overall Number of Participants Analyzed 29 26 28 27
Mean (Standard Error)
Unit of Measure: kg
Change from baseline to Week 2 (n=29,26,28,27) -0.31  (0.274) 0.32  (0.232) 0.31  (0.234) 0.35  (0.204)
Change from baseline to Week 4 (n=29,26,28,27) -0.66  (0.321) -0.04  (0.249) 0.32  (0.299) 0.03  (0.226)
Change from baseline to Week 6 (n=29,26,28,27) -1.26  (0.359) -0.74  (0.304) -0.45  (0.409) -0.74  (0.326)
Change from baseline to Week 8 (n=28,26,28,27) -1.36  (0.455) -0.85  (0.395) -0.33  (0.482) -0.70  (0.466)
Change from baseline to Weeks 9-11 (n=29,26,28,27) -1.73  (0.565) -0.57  (0.469) -0.49  (0.498) -0.83  (0.563)
Change from baseline to Week 12 (n=28,26,28,27) -1.49  (0.573) -0.91  (0.453) -0.33  (0.578) -0.76  (0.502)
Change from baseline to Week 13 (n=29,26,28,27) -1.96  (0.505) -1.20  (0.572) -0.56  (0.591) -0.97  (0.551)
Change from baseline to Week 14 (n=29,26,28,27) -1.91  (0.643) -0.96  (0.611) -0.76  (0.589) -0.81  (0.563)
Change from baseline to Week 15 (n=29,26,28,26) -1.84  (0.511) -1.34  (0.648) -0.80  (0.581) -1.24  (0.581)
Change from baseline to Week 16 (n=29,26,28,27) -1.85  (0.590) -1.33  (0.673) -0.26  (0.551) -1.02  (0.574)
Change from baseline to Weeks 17-19(n=29,26,28,27) -1.63  (0.592) -1.17  (0.697) -0.58  (0.629) -1.72  (0.700)
Change from baseline to Week 20 (n=29,26,28,27) -1.36  (0.641) -1.10  (0.774) -0.41  (0.559) -1.14  (0.676)
4.Secondary Outcome
Title Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population
Hide Description Fasting glucose was measured in milligrams per deciliter (mg/dL) at screening, Baseline, and during treatment at Weeks 2, 4, 6, 8, 9-11, 12, 13, 14, 15, 16, 17-19, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. Evaluable population was defined as all participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.
Time Frame Baseline (Day 1) to Week 20
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value on the specified week were included in the analysis of the evaluable population. n=number of participants with measurement value.
Arm/Group Title 2 mg Exenatide Weekly 5 mg Exenatide Monthly 8 mg Exenatide Monthly 11 mg Exenatide Monthly
Hide Arm/Group Description:
2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
Overall Number of Participants Analyzed 29 26 28 27
Mean (Standard Error)
Unit of Measure: mg/dL
Change from baseline to Week 2 (n=29, 26, 28,27) -1.16  (8.54) -12.9  (7.57) -14.6  (6.36) -23.5  (5.17)
Change from baseline to Week 4 (n=29, 25, 28,27) -21.7  (7.97) -18.0  (5.96) -14.2  (8.57) -23.1  (7.83)
Change from baseline to Week 6 (n=28, 26, 28,27) -32.8  (8.58) -42.6  (5.72) -39.5  (9.49) -48.8  (7.67)
Change from baseline to Week 8 (n=28, 26, 28,27) -40.8  (8.70) -45.7  (6.44) -36.8  (7.45) -44.0  (7.24)
Change from baseline to Weeks 9-11 (n=29,26,27,27) -32.8  (8.77) -40.2  (8.25) -44.3  (7.71) -48.1  (7.60)
Change from baseline to Weeks 12 (n=29,26,27,27) -44.8  (10.28) -37.4  (8.61) -45.4  (6.78) -44.9  (7.53)
Change from baseline to Weeks 13 (n=29,26,28,27) -42.0  (8.60) -38.0  (7.52) -48.6  (6.21) -45.7  (8.60)
Change from baseline to Weeks 14 (n=29,26,28,27) -36.3  (10.51) -37.3  (7.75) -47.5  (7.83) -51.6  (8.68)
Change from baseline to Weeks 15 (n=29,26,28,26) -38.0  (11.09) -37.3  (7.65) -46.9  (7.35) -53.1  (8.96)
Change from baseline to Weeks 16 (n=29,26,28,27) -34.5  (9.96) -31.6  (9.24) -43.3  (10.14) -46.3  (7.90)
Change from baseline to Weeks17-19 (n=29,26,28,27) -33.3  (8.58) -42.4  (7.16) -34.6  (9.32) -55.1  (8.92)
Change from baseline to Week 20 (n=29,26,28,27) -34.2  (8.99) -25.1  (8.49) -29.8  (9.88) -48.9  (9.35)
5.Secondary Outcome
Title Time Weighted Average Concentration and Peak to Trough of Exenatide From Week 12 Through Week 16 - Pharmacokinetic Evaluable - Steady State Population
Hide Description All participants received an initial blood draw prior to the first dose and a single blood sample was collected at all other subsequent visits, for plasma exenatide assessments and the characterization of pharmacokinetic (PK) parameters following multiple monthly doses over the study period. Exenatide was measured using a validated enzyme-linked immunosorbent assay (ELISA). Time weighted average concentration (Cave (2016-2688 h) and Peak to Trough were measured in picograms per milliliter (pg/mL).
Time Frame Day 1 to Week 20
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Evaluable- Steady-State: from trough to trough following Week 12 through Week 16, 3 or more values.
Arm/Group Title 2 mg Exenatide Weekly 5 mg Exenatide Monthly 8 mg Exenatide Monthly 11 mg Exenatide Monthly
Hide Arm/Group Description:
2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
Overall Number of Participants Analyzed 25 24 25 23
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg/mL
Cave(2016-2688h) pg/mL
262.92
(83.54%)
127.13
(69.34%)
247.38
(81.63%)
218.07
(73.77%)
Peak-Trough (2016-2688h) pg/mL
171.27
(73.85%)
198.06
(86.76%)
424.47
(70.27%)
328.52
(86.30%)
6.Secondary Outcome
Title Mean Change From Baseline in Diastolic and Systolic Blood Pressure at Week 20 - Intent to Treat (ITT) Population
Hide Description Baseline was Day 1, or last measurement prior to first dose of study drug. Vital signs were measured after the participant had rested for approximately 5 minutes and with the participant in a sitting position. Measurement was recorded in millimeters of mercury (mmHg). The blood pressure measurement was repeated after at least 30 seconds and the average of the two readings recorded. ITT population was defined as all participants who received at least one dose of the study drug.
Time Frame Baseline (Day 1), Week 20
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study drug were analyzed in the Intent to Treat (ITT) population.
Arm/Group Title 2 mg Exenatide Weekly 5 mg Exenatide Monthly 8 mg Exenatide Monthly 11 mg Exenatide Monthly
Hide Arm/Group Description:
2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
Overall Number of Participants Analyzed 30 30 31 30
Mean (Standard Deviation)
Unit of Measure: mmHg
Diastolic Blood Pressure -1.7  (8.55) 3.4  (8.54) 1.8  (9.61) 1.9  (8.17)
Systolic Blood Pressure -2.3  (13.64) 4.4  (18.68) 0.5  (13.97) 5.0  (12.04)
7.Secondary Outcome
Title Mean Change From Baseline in Heart Rate at Week 20 - Intent to Treat (ITT) Population
Hide Description Baseline was Day 1, or last measurement prior to first dose of study drug. Heart rate was measured after the participant had rested for approximately 5 minutes and with the participant in a sitting position. Measurement was recorded in beats per minute (bpm). The measurement was repeated after at least 30 seconds and the average of the two readings recorded. ITT population was defined as all participants who received at least one dose of the study drug.
Time Frame Baseline (Day 1), Week 20
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study drug were analyzed in the ITT population.
Arm/Group Title 2 mg Exenatide Weekly 5 mg Exenatide Monthly 8 mg Exenatide Monthly 11 mg Exenatide Monthly
Hide Arm/Group Description:
2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
Overall Number of Participants Analyzed 30 30 31 30
Mean (Standard Deviation)
Unit of Measure: bpm
2.8  (9.58) 3.9  (10.69) 5.6  (10.84) -0.3  (11.55)
8.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population
Hide Description AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. All participants who received at least one dose of study drug were included in the ITT analysis. Treatment-emergent (TE) adverse events were defined as those with onset at or after initiation of study medication on Day 1 through study termination or early termination.
Time Frame Day 1 to Study Termination (24 Weeks) or early Termination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug were included in the ITT analysis.
Arm/Group Title 2 mg Exenatide Weekly 5 mg Exenatide Monthly 8 mg Exenatide Monthly 11 mg Exenatide Monthly
Hide Arm/Group Description:
2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
Overall Number of Participants Analyzed 30 30 31 30
Measure Type: Number
Unit of Measure: participants
Treatment-Emergent AES 27 25 20 24
Treatment-Emergent SAEs 0 2 0 0
Treatment-Emergent AEs Leading to Discontinuation 0 0 0 1
9.Secondary Outcome
Title Number of Participants With Injection Site Reaction Treatment Emergent Adverse Events - ITT Population
Hide Description

AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Injection site related adverse events were defined as the adverse events with 'injection site' phrase in preferred term excluding 'injection site nodule'. The following events were Injection Site Reaction AEs: erythema, hematoma, hemorrhage, site pain, site papule, site pruritus, site warmth.

Participants receiving study drug monthly received 5 injections with last injection at Week 16; Participants receiving study drug weekly received 20 injections with last injection at Week 19.

Time Frame Day 1 through study termination (Week 24) or early termination.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug were analyzed in the ITT population.
Arm/Group Title 2 mg Exenatide Weekly 5 mg Exenatide Monthly 8 mg Exenatide Monthly 11 mg Exenatide Monthly
Hide Arm/Group Description:
2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
Overall Number of Participants Analyzed 30 30 31 30
Measure Type: Number
Unit of Measure: participants
6 8 3 6
10.Secondary Outcome
Title Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population
Hide Description Serum titers of antibodies to exenatide were evaluated using a validated enzyme-linked immunosorbent assay (Covance Method No. ELISA-0308). Positive antibody to exenatide titer: observed at the indicated visit following a negative or missing titer at baseline, or a positive titer that has increased by at least 3 dilutions at the indicated visit from a detectable baseline. Baseline=Day 1.
Time Frame Day 1 to Study Termination (24 weeks) or early termination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
n=all participants who received at least one dose of study drug and had available titer.
Arm/Group Title 2 mg Exenatide Weekly 5 mg Exenatide Monthly 8 mg Exenatide Monthly 11 mg Exenatide Monthly
Hide Arm/Group Description:
2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
Overall Number of Participants Analyzed 30 30 30 30
Measure Type: Number
Unit of Measure: participants
Week 2 Negative (n=30,30,30,30) 27 30 30 29
Week 2 Low Titer (<625)(n=30,30,30,30) 3 0 0 1
Week 2 High Titer (≥625)(n=30,30,30,30) 0 0 0 0
Week 20 Negative (n=30,26,29,28) 7 8 9 9
Week 20 Low Titer (<625)(n=30,26,29,28) 15 10 15 15
Week 20 High Titer (≥625)(n=30,26,29,28) 8 8 5 4
11.Secondary Outcome
Title Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population
Hide Description Potential clinical importance are the following: Hematocrit values for males less than (<) 36%, females < 30%; hemoglobin for males <12 grams per deciliter (g/dL), females < 10 g/dL; low platelet values <75,000/micro liter (µL), high values greater than (>) 500,000 µL. Laboratory samples were obtained at baseline (Day 1 or if unavailable, last measurement prior to first study drug dose), Weeks 6, 12, 20, and at study termination (Week 24) or early termination. Number of laboratory values of potential clinical importance presented for Weeks 6 - Week 24 or early termination.
Time Frame Day 1 to study termination (24 weeks) or early termination
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Hide Analysis Population Description
n= all participants who received at least one dose of study drug and had available laboratory measurements.
Arm/Group Title 2 mg Exenatide Weekly 5 mg Exenatide Monthly 8 mg Exenatide Monthly 11 mg Exenatide Monthly
Hide Arm/Group Description:
2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
Overall Number of Participants Analyzed 30 30 30 30
Measure Type: Number
Unit of Measure: laboratory values
Week 6 Hematocrit (n=30,30,30,30) 0 1 0 0
Hematocrit at study termination (n=30,27,29,28) 0 1 0 0
Week 12 Platelets (n=30, 29, 30, 28) 0 1 0 0
12.Secondary Outcome
Title Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population
Hide Description Potential clinical importance (PCI): triacylglycerol lipase high values were > 3* upper limit of normal (ULN); creatinine high values in males >1.6 mg/dL, females >1.4 mg/dL; gamma glutamyl transferase (GGT) high value >3* ULN; bilirubin high value > 2 mg/dL; Urate high values > 10 (males), >8 (females) mg/dL; potassium low value < 3 milliequivalents per liter (mEq/L), high value >5.5 mEq/L; calcium low value < 8 mg/dL and high value > 11 mg/dL. Laboratory samples were obtained at baseline (Day 1 or if unavailable, last measurement prior to first study drug dose), Weeks 6, 12, 20, and at study termination (Week 24) or early termination. Number of laboratory values of potential clinical importance (values could be either low or high) are presented for Weeks 6 - Week 24 or early termination. Note: those tests with no values meeting the PCI criteria, ie, 0 values observed across all treatment arms, are not presented.
Time Frame Day 1 to Study Termination (Week24) or early termination
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Hide Analysis Population Description
All participants who were randomized and received at least one dose of study drug were analyzed in the intent to treat (ITT) population. n= all participants who received at least one dose of study drug and had available laboratory measurements.
Arm/Group Title 2 mg Exenatide Weekly 5 mg Exenatide Monthly 8 mg Exenatide Monthly 11 mg Exenatide Monthly
Hide Arm/Group Description:
2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
Overall Number of Participants Analyzed 30 30 31 30
Measure Type: Number
Unit of Measure: laboratory values
triacylglycerol lipase Week 12 (n=30,29,29,28) 1 1 0 0
triacylglycerol lipase Week 20 (n=30,27,29,28) 1 0 0 1
Creatinine Week 6 (n=30,30,30,30) 0 1 0 0
Creatinine Week 12 (n=30,29,30,28) 1 0 0 0
Creatinine Week 20 (n=30,26,28,28) 0 1 0 0
Creatinine at study termination (n=30,26,29,28) 0 0 1 0
GGT Week 6 (n=30,30,30,30) 2 0 0 0
GGT Week 20 (n=30,26,28,28) 1 0 1 0
GGT study termination (n=30,26,29,28) 1 0 1 0
Bilirubin Week 6 (n=30,30,30,30) 0 1 0 0
Bilirubin Week 12 (n=30,29,30,28) 0 1 0 0
Urate Week 6 (n=30,30,30,30) 1 1 2 2
Urate Week 12 (n=30,29,30,28) 0 3 1 2
Urate Week 20 (n=30,26,28,28) 0 1 2 2
Urate Study termination (n=30,26,29,28) 1 0 0 0
Potassium Week 6 (n=30,30,30,30) 1 0 0 0
Calcium Week 6 (n=30,30,30,30) 1 0 0 0
Time Frame Day 1 to Week 24 or early termination
Adverse Event Reporting Description Note: Injection site related adverse events were defined as adverse events with ‘injection site’ phrase in Preferred Term excluding ‘injection site nodule’.
 
Arm/Group Title 2 mg Exenatide Weekly 5 mg Exenatide Monthly 8 mg Exenatide Monthly 11 mg Exenatide Monthly
Hide Arm/Group Description 2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC). 5 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides. 8 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides. . 11 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides.
All-Cause Mortality
2 mg Exenatide Weekly 5 mg Exenatide Monthly 8 mg Exenatide Monthly 11 mg Exenatide Monthly
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
2 mg Exenatide Weekly 5 mg Exenatide Monthly 8 mg Exenatide Monthly 11 mg Exenatide Monthly
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      2/30 (6.67%)      0/31 (0.00%)      0/30 (0.00%)    
Cardiac disorders         
Acute Coronary Syndrome * 1  0/30 (0.00%)  0 1/30 (3.33%)  1 0/31 (0.00%)  0 0/30 (0.00%)  0
Acute myocardial infarction * 1  0/30 (0.00%)  0 1/30 (3.33%)  1 0/31 (0.00%)  0 0/30 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
2 mg Exenatide Weekly 5 mg Exenatide Monthly 8 mg Exenatide Monthly 11 mg Exenatide Monthly
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/30 (90.00%)      25/30 (83.33%)      20/31 (64.52%)      24/30 (80.00%)    
Gastrointestinal disorders         
Nausea * 1  4/30 (13.33%)  5/30 (16.67%)  7/31 (22.58%)  7/30 (23.33%) 
Diarrhea * 1  8/30 (26.67%)  2/30 (6.67%)  4/31 (12.90%)  5/30 (16.67%) 
Vomiting * 1  3/30 (10.00%)  2/30 (6.67%)  4/31 (12.90%)  5/30 (16.67%) 
Dyspepsia * 1  3/30 (10.00%)  1/30 (3.33%)  5/31 (16.13%)  3/30 (10.00%) 
Eructation * 1  0/30 (0.00%)  2/30 (6.67%)  4/31 (12.90%)  4/30 (13.33%) 
Abdominal distension * 1  0/30 (0.00%)  1/30 (3.33%)  1/31 (3.23%)  3/30 (10.00%) 
Abdominal Pain * 1  0/30 (0.00%)  1/30 (3.33%)  0/31 (0.00%)  2/30 (6.67%) 
Constipation * 1  1/30 (3.33%)  1/30 (3.33%)  0/31 (0.00%)  2/30 (6.67%) 
Flatulence * 1  1/30 (3.33%)  1/30 (3.33%)  3/31 (9.68%)  1/30 (3.33%) 
General disorders         
Injection site pruritus * 1  5/30 (16.67%)  4/30 (13.33%)  1/31 (3.23%)  2/30 (6.67%) 
Injection site erythema * 1  4/30 (13.33%)  2/30 (6.67%)  1/31 (3.23%)  2/30 (6.67%) 
Fatigue * 1  1/30 (3.33%)  1/30 (3.33%)  3/31 (9.68%)  3/30 (10.00%) 
Injection site Hematoma * 1  2/30 (6.67%)  0/30 (0.00%)  0/31 (0.00%)  1/30 (3.33%) 
Injection site hemorrhage * 1  0/30 (0.00%)  1/30 (3.33%)  1/31 (3.23%)  2/30 (6.67%) 
Injection site pain * 1  1/30 (3.33%)  1/30 (3.33%)  0/31 (0.00%)  2/30 (6.67%) 
Pain * 1  2/30 (6.67%)  0/30 (0.00%)  0/31 (0.00%)  0/30 (0.00%) 
Infections and infestations         
Gastroenteritis * 1  2/30 (6.67%)  1/30 (3.33%)  1/31 (3.23%)  2/30 (6.67%) 
Sinusitis * 1  2/30 (6.67%)  1/30 (3.33%)  1/31 (3.23%)  0/30 (0.00%) 
Metabolism and nutrition disorders         
Decreased Appetite * 1  4/30 (13.33%)  1/30 (3.33%)  3/31 (9.68%)  6/30 (20.00%) 
Diabetes mellitus inadequate control * 1  3/30 (10.00%)  0/30 (0.00%)  2/31 (6.45%)  0/30 (0.00%) 
Increased appetite * 1  2/30 (6.67%)  1/30 (3.33%)  1/31 (3.23%)  1/30 (3.33%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  2/30 (6.67%)  1/30 (3.33%)  0/31 (0.00%)  1/30 (3.33%) 
Back pain * 1  2/30 (6.67%)  1/30 (3.33%)  0/31 (0.00%)  2/30 (6.67%) 
Muscle spasms * 1  0/30 (0.00%)  1/30 (3.33%)  2/31 (6.45%)  0/30 (0.00%) 
Nervous system disorders         
Headache * 1  9/30 (30.00%)  5/30 (16.67%)  7/31 (22.58%)  8/30 (26.67%) 
Dysgeusia * 1  1/30 (3.33%)  0/30 (0.00%)  3/31 (9.68%)  1/30 (3.33%) 
Anxiety * 1  0/30 (0.00%)  2/30 (6.67%)  1/31 (3.23%)  1/30 (3.33%) 
Respiratory, thoracic and mediastinal disorders         
Nasal Congestion * 1  4/30 (13.33%)  0/30 (0.00%)  3/31 (9.68%)  1/30 (3.33%) 
Upper respiratory tract infection * 1  1/30 (3.33%)  4/30 (13.33%)  1/31 (3.23%)  1/30 (3.33%) 
Cough * 1  3/30 (10.00%)  3/30 (10.00%)  0/31 (0.00%)  0/30 (0.00%) 
Dyspnea * 1  0/30 (0.00%)  2/30 (6.67%)  0/31 (0.00%)  0/30 (0.00%) 
Oropharyngeal pain * 1  2/30 (6.67%)  2/30 (6.67%)  0/31 (0.00%)  0/30 (0.00%) 
Respiratory Tract Congestion * 1  1/30 (3.33%)  2/30 (6.67%)  0/31 (0.00%)  0/30 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Name/Title: AstraZeneca
Organization: Clinical Trial Transparency
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01104701     History of Changes
Other Study ID Numbers: BCB111
First Submitted: April 13, 2010
First Posted: April 15, 2010
Results First Submitted: June 17, 2014
Results First Posted: July 17, 2014
Last Update Posted: August 20, 2015