Type 2 Diabetes
Conditions
Brief summary
evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.
Interventions
Sponsors
Intarcia Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* type 2 diabetes \>6 months * stable diet & exercise, metformin, TZD or met + TZD HbA1c \>6.5% \<10.0%
Exclusion criteria
* prior treatment with exenatide * history of pancreatitis * history of medullary thyroid cancer or multiple endocrine neoplasia 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects With Study Drug-Related Adverse Events | 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus | 4 weeks | Change in HbA1c from baseline |
| Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline | 4 weeks | — |
| Change in Weight From Baseline to 4 Weeks | 4 weeks | — |
Countries
United States
Participant flow
Recruitment details
Initiated February 2009 completed 15 May 2009
Participants by arm
| Arm | Count |
|---|---|
| 10 Mcg/Day ITCA 650 (exenatide in DUROS) | 12 |
| 20 Mcg/Day ITCA 650 (exenatide in DUROS) | 11 |
| 40 Mcg/Day ITCA 650 (exenatide in DUROS) | 10 |
| 80 Mcg/Day ITCA 650 (exenatide in DUROS) | 11 |
| Total | 44 |
Baseline characteristics
| Characteristic | 10 Mcg/Day | 20 Mcg/Day | 40 Mcg/Day | 80 Mcg/Day | Total |
|---|---|---|---|---|---|
| Age Continuous | 56.3 years STANDARD_DEVIATION 6.74 | 57.2 years STANDARD_DEVIATION 6.1 | 52.6 years STANDARD_DEVIATION 9.54 | 56.5 years STANDARD_DEVIATION 4.84 | 55.7 years STANDARD_DEVIATION 6.92 |
| Region of Enrollment United States | 12 participants | 11 participants | 10 participants | 11 participants | 44 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 6 Participants | 4 Participants | 18 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 4 Participants | 7 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 12 | 11 / 11 | 9 / 10 | 11 / 11 |
| serious Total, serious adverse events | 0 / 12 | 0 / 11 | 0 / 10 | 0 / 11 |
Outcome results
Primary
Number of Subjects With Study Drug-Related Adverse Events
Time frame: 4 weeks
Population: Number of subjects reporting study drug-related adverse events
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10 Mcg/Day | Number of Subjects With Study Drug-Related Adverse Events | 9 participants |
| 20 Mcg/Day | Number of Subjects With Study Drug-Related Adverse Events | 11 participants |
| 40 Mcg/Day | Number of Subjects With Study Drug-Related Adverse Events | 9 participants |
| 80 Mcg/Day | Number of Subjects With Study Drug-Related Adverse Events | 11 participants |
Secondary
Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10 Mcg/Day | Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline | -5.6 mg/dL | Standard Deviation 34.33 |
| 20 Mcg/Day | Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline | -31.2 mg/dL | Standard Deviation 24.2 |
| 40 Mcg/Day | Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline | -42.0 mg/dL | Standard Deviation 33.16 |
| 80 Mcg/Day | Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline | -28.8 mg/dL | Standard Deviation 33.5 |
Secondary
Change in Weight From Baseline to 4 Weeks
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10 Mcg/Day | Change in Weight From Baseline to 4 Weeks | -0.3 kg | Standard Deviation 0.91 |
| 20 Mcg/Day | Change in Weight From Baseline to 4 Weeks | -0.3 kg | Standard Deviation 1.51 |
| 40 Mcg/Day | Change in Weight From Baseline to 4 Weeks | -1.1 kg | Standard Deviation 1.6 |
| 80 Mcg/Day | Change in Weight From Baseline to 4 Weeks | -3.1 kg | Standard Deviation 2.13 |
Secondary
To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus
Change in HbA1c from baseline
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10 Mcg/Day | To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus | -0.5 percentage | Standard Deviation 0.39 |
| 20 Mcg/Day | To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus | -0.6 percentage | Standard Deviation 0.31 |
| 40 Mcg/Day | To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus | -0.5 percentage | Standard Deviation 0.31 |
| 80 Mcg/Day | To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus | -0.7 percentage | Standard Deviation 0.36 |