Trial Outcomes & Findings for Dose-Ranging Study to Evaluate Efficacy and Safety of Weekly CJC-1134-PC in Patients With T2DM on Metformin Monotherapy (NCT NCT01514149)
NCT ID: NCT01514149
Last Updated: 2017-07-19
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
73 participants
Primary outcome timeframe
CFB to Week 18
Results posted on
2017-07-19
Participant Flow
Participant milestones
| Measure |
Arm 1 - Weekly CJC-1134-PC
CJC-1134-PC, 1.5 mg. weekly subcutaneous injection
|
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
|
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
|
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
|
Arm 5 - Weekly Placebo
Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
14
|
14
|
15
|
|
Overall Study
COMPLETED
|
12
|
14
|
11
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
3
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arm 1 - Weekly CJC-1134-PC
n=15 Participants
CJC-1134-PC, 1.5 mg. weekly subcutaneous injection
|
Arm 2 - Weekly CJC-1134-PC
n=15 Participants
CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection
|
Arm 3 - Weekly CJC-1134-PC
n=14 Participants
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
|
Arm 4 - Weekly CJC-1134-PC
n=14 Participants
CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection
|
Arm 5 - Weekly Placebo
n=15 Participants
Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
18 to 70 years
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
14 Participants
n=14 Participants
|
14 Participants
n=14 Participants
|
15 Participants
n=15 Participants
|
73 Participants
n=73 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=15 Participants
|
7 Participants
n=15 Participants
|
6 Participants
n=14 Participants
|
8 Participants
n=14 Participants
|
4 Participants
n=15 Participants
|
31 Participants
n=73 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=15 Participants
|
8 Participants
n=15 Participants
|
8 Participants
n=14 Participants
|
6 Participants
n=14 Participants
|
11 Participants
n=15 Participants
|
42 Participants
n=73 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: CFB to Week 18Population: Completed Population
Outcome measures
| Measure |
Arm 1 - Weekly CJC-1134-PC
n=12 Participants
CJC-1134-PC, 1.5 mg. weekly subcutaneous injection
|
Arm 2 - Weekly CJC-1134-PC
n=14 Participants
CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection
|
Arm 3 - Weekly CJC-1134-PC
n=11 Participants
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
|
Arm 4 - Weekly CJC-1134-PC
n=13 Participants
CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection
|
Arm 5 - Weekly Placebo
n=14 Participants
Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
|
|---|---|---|---|---|---|
|
Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18
|
-0.56 Percent (%)
Standard Deviation 0.597
|
-0.56 Percent (%)
Standard Deviation 0.627
|
-0.95 Percent (%)
Standard Deviation 0.746
|
-0.95 Percent (%)
Standard Deviation 0.828
|
-0.13 Percent (%)
Standard Deviation 0.811
|
SECONDARY outcome
Timeframe: CFB to Week 18Population: Completed Population
Outcome measures
| Measure |
Arm 1 - Weekly CJC-1134-PC
n=12 Participants
CJC-1134-PC, 1.5 mg. weekly subcutaneous injection
|
Arm 2 - Weekly CJC-1134-PC
n=14 Participants
CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection
|
Arm 3 - Weekly CJC-1134-PC
n=11 Participants
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
|
Arm 4 - Weekly CJC-1134-PC
n=13 Participants
CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection
|
Arm 5 - Weekly Placebo
n=14 Participants
Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
|
|---|---|---|---|---|---|
|
Fasting Body Weight CFB to Week 18
|
-1.91 kg
Standard Deviation 1.624
|
-0.14 kg
Standard Deviation 4.122
|
-1.37 kg
Standard Deviation 2.182
|
-0.92 kg
Standard Deviation 1.999
|
-1.85 kg
Standard Deviation 4.083
|
SECONDARY outcome
Timeframe: 18 weeksPopulation: Completed Population
Outcome measures
| Measure |
Arm 1 - Weekly CJC-1134-PC
n=12 Participants
CJC-1134-PC, 1.5 mg. weekly subcutaneous injection
|
Arm 2 - Weekly CJC-1134-PC
n=14 Participants
CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection
|
Arm 3 - Weekly CJC-1134-PC
n=11 Participants
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
|
Arm 4 - Weekly CJC-1134-PC
n=13 Participants
CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection
|
Arm 5 - Weekly Placebo
n=14 Participants
Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
|
|---|---|---|---|---|---|
|
Time to Hyperglycemia Rescue
|
NA days
Standard Deviation NA
0 patient with hyperglycemia rescue
|
47.0 days
Standard Deviation 53.74
|
NA days
Standard Deviation NA
0 patient with hyperglycemia rescue
|
NA days
Standard Deviation NA
0 patient with hyperglycemia rescue
|
57.0 days
Standard Deviation NA
Only 1 patient with hyperglycemia rescue
|
Adverse Events
Arm 1 - Weekly CJC-1134-PC
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 2 - Weekly CJC-1134-PC
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Arm 3 - Weekly CJC-1134-PC
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm 4 - Weekly CJC-1134-PC
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm 5 - Weekly Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1 - Weekly CJC-1134-PC
n=12 participants at risk
CJC-1134-PC, 1.5 mg. weekly subcutaneous injection
|
Arm 2 - Weekly CJC-1134-PC
n=15 participants at risk
CJC-1134-PC, start at 1.5 mg and titrate 0.5 mg weekly to 3-mg fixed weekly subcutaneous injection
|
Arm 3 - Weekly CJC-1134-PC
n=13 participants at risk
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
|
Arm 4 - Weekly CJC-1134-PC
n=13 participants at risk
CJC-1134-PC, start at 1.0 mg and titrate 1.0 mg weekly to 6.0-mg fixed weekly subcutaneous injection
|
Arm 5 - Weekly Placebo
n=14 participants at risk
Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • 18 weeks
|
46.7%
7/15 • 18 weeks
|
38.5%
5/13 • 18 weeks
|
46.2%
6/13 • 18 weeks
|
7.1%
1/14 • 18 weeks
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • 18 weeks
|
13.3%
2/15 • 18 weeks
|
7.7%
1/13 • 18 weeks
|
38.5%
5/13 • 18 weeks
|
0.00%
0/14 • 18 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • 18 weeks
|
0.00%
0/15 • 18 weeks
|
7.7%
1/13 • 18 weeks
|
23.1%
3/13 • 18 weeks
|
14.3%
2/14 • 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • 18 weeks
|
6.7%
1/15 • 18 weeks
|
7.7%
1/13 • 18 weeks
|
7.7%
1/13 • 18 weeks
|
7.1%
1/14 • 18 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • 18 weeks
|
13.3%
2/15 • 18 weeks
|
0.00%
0/13 • 18 weeks
|
7.7%
1/13 • 18 weeks
|
7.1%
1/14 • 18 weeks
|
|
General disorders
Influenza like illness
|
8.3%
1/12 • 18 weeks
|
6.7%
1/15 • 18 weeks
|
0.00%
0/13 • 18 weeks
|
7.7%
1/13 • 18 weeks
|
0.00%
0/14 • 18 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • 18 weeks
|
13.3%
2/15 • 18 weeks
|
0.00%
0/13 • 18 weeks
|
0.00%
0/13 • 18 weeks
|
7.1%
1/14 • 18 weeks
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/12 • 18 weeks
|
6.7%
1/15 • 18 weeks
|
7.7%
1/13 • 18 weeks
|
7.7%
1/13 • 18 weeks
|
0.00%
0/14 • 18 weeks
|
Additional Information
Associate Director of Regulatory Affairs
ConjuChem Biotechnologies Inc.
Phone: 310-405-7549
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place