Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
Type 2 Diabetes Mellitus, T2DM, diabetes, ConjuChem, GLP-1, Glucagon-like peptide-1, exendin-4, modified exendin-4
Brief summary
DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus on metformin monotherapy.
Detailed description
DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus (T2DM) on metformin monotherapy. This study will be a randomized, double-blind comparison of CJC-1134-PC versus placebo. Patients taking metformin will continue to take their metformin at the same dose for the duration of the study. Patients with T2DM, who meet all the inclusion criteria and none of the exclusion criteria, will be randomly assigned to a treatment arm. All patients will undergo weekly clinic visits to receive 17 weeks of study treatment, including the titration period. CJC-1134-PC or placebo treatment will be administered weekly by subcutaneous injection in the abdomen to patients in a fasting state. Patients will be closely monitored and evaluated for toxicity on an ongoing basis.
Interventions
CJC-1134-PC administered weekly by subcutaneous injection
DRUGWeekly placebo for CJC-1134-PC Injection
Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
Sponsors
ConjuChem
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Men or women 18 to 70 years of age, inclusive * Body mass index of 27 to 45 kg/m2 * Diagnosed with T2DM for at least 6 months before screening * Stable daily dose of metformin monotherapy of ≥1000 mg for at least 3 months before screening * FPG ≤240 mg/dL at screening * HbA1c ≥7.0% and ≤11% at screening * A 12-lead electrocardiogram recording without clinically significant arrhythmia, left bundle-branch block, or corrected QT interval
Exclusion criteria
* Pregnant or breastfeeding women * Use of a weight control treatment, including over-the-counter medications (includes herbal supplements), or a significant change in body weight (at least ±10%) in the 3 months before screening * Treatment with any oral antidiabetic agent other than metformin within the 3 months before screening * Treatment with insulin for longer than 1 week within the 3 months before screening or any treatment with insulin within the 2 weeks before screening * Previous treatment with a glucagon-like peptide 1 (GLP-1) analog or other incretin therapy * Receipt of any experimental drug in a clinical trial within 30 days before administration of study drug or receipt of any investigational antidiabetic product within 3 months before screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18 | CFB to Week 18 |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Body Weight CFB to Week 18 | CFB to Week 18 |
| Time to Hyperglycemia Rescue | 18 weeks |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 - Weekly CJC-1134-PC CJC-1134-PC, 1.5 mg. weekly subcutaneous injection | 15 |
| Arm 2 - Weekly CJC-1134-PC CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection | 15 |
| Arm 3 - Weekly CJC-1134-PC CJC-1134-PC, start at 1.5 mg and titrate weekly to 2-, 2.5-, 3-, 3.5-, and 4.5-mg fixed weekly subcutaneous injection | 14 |
| Arm 4 - Weekly CJC-1134-PC CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection | 14 |
| Arm 5 - Weekly Placebo Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection | 15 |
| Total | 73 |
Baseline characteristics
| Characteristic | Arm 1 - Weekly CJC-1134-PC | Arm 2 - Weekly CJC-1134-PC | Arm 3 - Weekly CJC-1134-PC | Arm 4 - Weekly CJC-1134-PC | Arm 5 - Weekly Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Customized 18 to 70 years | 15 Participants | 15 Participants | 14 Participants | 14 Participants | 15 Participants | 73 Participants |
| Race and Ethnicity Not Collected | — | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 6 Participants | 8 Participants | 4 Participants | 31 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 8 Participants | 6 Participants | 11 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 15 | 0 / 13 | 0 / 13 | 0 / 14 |
| other Total, other adverse events | 3 / 12 | 11 / 15 | 8 / 13 | 8 / 13 | 5 / 14 |
| serious Total, serious adverse events | 0 / 12 | 0 / 15 | 0 / 13 | 0 / 13 | 0 / 14 |
Outcome results
Primary
Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18
Time frame: CFB to Week 18
Population: Completed Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Weekly CJC-1134-PC | Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18 | -0.56 Percent (%) | Standard Deviation 0.597 |
| Arm 2 - Weekly CJC-1134-PC | Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18 | -0.56 Percent (%) | Standard Deviation 0.627 |
| Arm 3 - Weekly CJC-1134-PC | Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18 | -0.95 Percent (%) | Standard Deviation 0.746 |
| Arm 4 - Weekly CJC-1134-PC | Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18 | -0.95 Percent (%) | Standard Deviation 0.828 |
| Arm 5 - Weekly Placebo | Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18 | -0.13 Percent (%) | Standard Deviation 0.811 |
Secondary
Fasting Body Weight CFB to Week 18
Time frame: CFB to Week 18
Population: Completed Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Weekly CJC-1134-PC | Fasting Body Weight CFB to Week 18 | -1.91 kg | Standard Deviation 1.624 |
| Arm 2 - Weekly CJC-1134-PC | Fasting Body Weight CFB to Week 18 | -0.14 kg | Standard Deviation 4.122 |
| Arm 3 - Weekly CJC-1134-PC | Fasting Body Weight CFB to Week 18 | -1.37 kg | Standard Deviation 2.182 |
| Arm 4 - Weekly CJC-1134-PC | Fasting Body Weight CFB to Week 18 | -0.92 kg | Standard Deviation 1.999 |
| Arm 5 - Weekly Placebo | Fasting Body Weight CFB to Week 18 | -1.85 kg | Standard Deviation 4.083 |
Secondary
Time to Hyperglycemia Rescue
Time frame: 18 weeks
Population: Completed Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Weekly CJC-1134-PC | Time to Hyperglycemia Rescue | NA days | — |
| Arm 2 - Weekly CJC-1134-PC | Time to Hyperglycemia Rescue | 47.0 days | Standard Deviation 53.74 |
| Arm 3 - Weekly CJC-1134-PC | Time to Hyperglycemia Rescue | NA days | — |
| Arm 4 - Weekly CJC-1134-PC | Time to Hyperglycemia Rescue | NA days | — |
| Arm 5 - Weekly Placebo | Time to Hyperglycemia Rescue | 57.0 days | — |