Type 2 Diabetes Mellitus
Conditions
Keywords
GLP-1, incretin, type 2 diabetes
Brief summary
This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study. The objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment with CJC-1134-PC in patients who are currently on metformin monotherapy.
Interventions
DRUG1.5 mg or 2.0 mg CJC-1134-PC
twice-a-week
DRUGPlacebo
twice-a-week
Sponsors
ConjuChem
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Major Inclusion Criteria: * BMI: 27 to 45 kg/m2 * Stable Type 2 diabetes mellitus for at least 3 months, as defined by the Investigator * Stable life-style, i.e. diet & physical activity, as determined by the Investigator * Stable metformin daily dose ≥1000 mg for at least 3 months * Glycosylated hemoglobin (HbA1c) at screening ≥ 7.1% and ≤ 11%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of HbA1c From Baseline | Screening and Day 85 | Change from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Fasting Plasma Glucose From Baseline | Screening and Day 85 | Change from baseline |
| Reduction in Fasting Body Weight From Baseline | Screening and Day 85 | Change from baseline |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1.5 mg CJC-1134-PC Twice-a-week dose of 1.5 mg CJC-1134-PC
1.5 mg CJC-1134-PC: twice-a-week | 30 |
| 1.5 mg or 2.0 mg CJC-1134-PC Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo
1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week | 30 |
| Placebo Twice-a-week placebo for CJC-1134-PC
Placebo: twice-a-week | 29 |
| Total | 89 |
Baseline characteristics
| Characteristic | 1.5 mg CJC-1134-PC | 1.5 mg or 2.0 mg CJC-1134-PC | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 56.2 years STANDARD_DEVIATION 8.05 | 55.5 years STANDARD_DEVIATION 11.06 | 55.2 years STANDARD_DEVIATION 8.26 | 55.7 years STANDARD_DEVIATION 9.14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 10 Participants | 9 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 20 Participants | 20 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 3 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 25 Participants | 23 Participants | 26 Participants | 74 Participants |
| Sex: Female, Male Female | 13 Participants | 17 Participants | 19 Participants | 49 Participants |
| Sex: Female, Male Male | 17 Participants | 13 Participants | 10 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 29 |
| other Total, other adverse events | 18 / 30 | 19 / 30 | 20 / 29 |
| serious Total, serious adverse events | 1 / 30 | 0 / 30 | 1 / 29 |
Outcome results
Primary
Reduction of HbA1c From Baseline
Change from baseline
Time frame: Screening and Day 85
Population: Modified Intent-to-Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1.5 mg CJC-1134-PC | Reduction of HbA1c From Baseline | -1.29 Percent (%) | Standard Deviation 1.226 |
| 1.5 mg or 2.0 mg CJC-1134-PC | Reduction of HbA1c From Baseline | -0.55 Percent (%) | Standard Deviation 0.672 |
| Placebo | Reduction of HbA1c From Baseline | -0.34 Percent (%) | Standard Deviation 0.697 |
Secondary
Reduction in Fasting Body Weight From Baseline
Change from baseline
Time frame: Screening and Day 85
Population: Modified Intent-to-Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1.5 mg CJC-1134-PC | Reduction in Fasting Body Weight From Baseline | -1.17 kg | Standard Deviation 1.976 |
| 1.5 mg or 2.0 mg CJC-1134-PC | Reduction in Fasting Body Weight From Baseline | -0.90 kg | Standard Deviation 1.873 |
| Placebo | Reduction in Fasting Body Weight From Baseline | -0.39 kg | Standard Deviation 2.467 |
Secondary
Reduction in Fasting Plasma Glucose From Baseline
Change from baseline
Time frame: Screening and Day 85
Population: Modified Intent-to-Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1.5 mg CJC-1134-PC | Reduction in Fasting Plasma Glucose From Baseline | -5.88 mg/dL | Standard Deviation 62.369 |
| 1.5 mg or 2.0 mg CJC-1134-PC | Reduction in Fasting Plasma Glucose From Baseline | 4.12 mg/dL | Standard Deviation 46.803 |
| Placebo | Reduction in Fasting Plasma Glucose From Baseline | 12.12 mg/dL | Standard Deviation 33.21 |