Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of CJC-1134-PC in Patients With Type 2 Diabetes Who Are Currently on Metformin Monotherapy (NCT NCT00674466)
NCT ID: NCT00674466
Last Updated: 2017-06-02
Results Overview
Change from baseline
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
Screening and Day 85
Results posted on
2017-06-02
Participant Flow
Participant milestones
| Measure |
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
|
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
|
Placebo
Twice-a-week placebo for CJC-1134-PC
Placebo: twice-a-week
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
23
|
22
|
21
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of CJC-1134-PC in Patients With Type 2 Diabetes Who Are Currently on Metformin Monotherapy
Baseline characteristics by cohort
| Measure |
1.5 mg CJC-1134-PC
n=30 Participants
Twice-a-week dose of 1.5 mg CJC-1134-PC
1.5 mg CJC-1134-PC: twice-a-week
|
1.5 mg or 2.0 mg CJC-1134-PC
n=30 Participants
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
|
Placebo
n=29 Participants
Twice-a-week placebo for CJC-1134-PC
Placebo: twice-a-week
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 8.05 • n=5 Participants
|
55.5 years
STANDARD_DEVIATION 11.06 • n=7 Participants
|
55.2 years
STANDARD_DEVIATION 8.26 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 9.14 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Screening and Day 85Population: Modified Intent-to-Treat Population
Change from baseline
Outcome measures
| Measure |
1.5 mg CJC-1134-PC
n=27 Participants
Twice-a-week dose of 1.5 mg CJC-1134-PC
1.5 mg CJC-1134-PC: twice-a-week
|
1.5 mg or 2.0 mg CJC-1134-PC
n=27 Participants
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
|
Placebo
n=26 Participants
Twice-a-week placebo for CJC-1134-PC
Placebo: twice-a-week
|
|---|---|---|---|
|
Reduction of HbA1c From Baseline
|
-1.29 Percent (%)
Standard Deviation 1.226
|
-0.55 Percent (%)
Standard Deviation 0.672
|
-0.34 Percent (%)
Standard Deviation 0.697
|
SECONDARY outcome
Timeframe: Screening and Day 85Population: Modified Intent-to-Treat Population
Change from baseline
Outcome measures
| Measure |
1.5 mg CJC-1134-PC
n=27 Participants
Twice-a-week dose of 1.5 mg CJC-1134-PC
1.5 mg CJC-1134-PC: twice-a-week
|
1.5 mg or 2.0 mg CJC-1134-PC
n=27 Participants
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
|
Placebo
n=26 Participants
Twice-a-week placebo for CJC-1134-PC
Placebo: twice-a-week
|
|---|---|---|---|
|
Reduction in Fasting Plasma Glucose From Baseline
|
-5.88 mg/dL
Standard Deviation 62.369
|
4.12 mg/dL
Standard Deviation 46.803
|
12.12 mg/dL
Standard Deviation 33.210
|
SECONDARY outcome
Timeframe: Screening and Day 85Population: Modified Intent-to-Treat Population
Change from baseline
Outcome measures
| Measure |
1.5 mg CJC-1134-PC
n=27 Participants
Twice-a-week dose of 1.5 mg CJC-1134-PC
1.5 mg CJC-1134-PC: twice-a-week
|
1.5 mg or 2.0 mg CJC-1134-PC
n=27 Participants
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
|
Placebo
n=26 Participants
Twice-a-week placebo for CJC-1134-PC
Placebo: twice-a-week
|
|---|---|---|---|
|
Reduction in Fasting Body Weight From Baseline
|
-1.17 kg
Standard Deviation 1.976
|
-0.90 kg
Standard Deviation 1.873
|
-0.39 kg
Standard Deviation 2.467
|
Adverse Events
1.5 mg CJC-1134-PC
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
1.5 mg or 2.0 mg CJC-1134-PC
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1.5 mg CJC-1134-PC
n=30 participants at risk
Twice-a-week dose of 1.5 mg CJC-1134-PC
1.5 mg CJC-1134-PC: twice-a-week
|
1.5 mg or 2.0 mg CJC-1134-PC
n=30 participants at risk
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
|
Placebo
n=29 participants at risk
Twice-a-week placebo for CJC-1134-PC
Placebo: twice-a-week
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
1/30 • 16 weeks
|
0.00%
0/30 • 16 weeks
|
0.00%
0/29 • 16 weeks
|
|
Infections and infestations
Eye infection staphylococcal
|
0.00%
0/30 • 16 weeks
|
0.00%
0/30 • 16 weeks
|
3.4%
1/29 • 16 weeks
|
Other adverse events
| Measure |
1.5 mg CJC-1134-PC
n=30 participants at risk
Twice-a-week dose of 1.5 mg CJC-1134-PC
1.5 mg CJC-1134-PC: twice-a-week
|
1.5 mg or 2.0 mg CJC-1134-PC
n=30 participants at risk
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
|
Placebo
n=29 participants at risk
Twice-a-week placebo for CJC-1134-PC
Placebo: twice-a-week
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
26.7%
8/30 • 16 weeks
|
23.3%
7/30 • 16 weeks
|
13.8%
4/29 • 16 weeks
|
|
Gastrointestinal disorders
Vomiting
|
23.3%
7/30 • 16 weeks
|
16.7%
5/30 • 16 weeks
|
17.2%
5/29 • 16 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
3/30 • 16 weeks
|
13.3%
4/30 • 16 weeks
|
20.7%
6/29 • 16 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
3/30 • 16 weeks
|
3.3%
1/30 • 16 weeks
|
6.9%
2/29 • 16 weeks
|
|
Gastrointestinal disorders
Constipation
|
10.0%
3/30 • 16 weeks
|
3.3%
1/30 • 16 weeks
|
6.9%
2/29 • 16 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.3%
1/30 • 16 weeks
|
6.7%
2/30 • 16 weeks
|
3.4%
1/29 • 16 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
2/30 • 16 weeks
|
0.00%
0/30 • 16 weeks
|
3.4%
1/29 • 16 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
2/30 • 16 weeks
|
3.3%
1/30 • 16 weeks
|
0.00%
0/29 • 16 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/30 • 16 weeks
|
0.00%
0/30 • 16 weeks
|
6.9%
2/29 • 16 weeks
|
|
Nervous system disorders
Headache
|
26.7%
8/30 • 16 weeks
|
30.0%
9/30 • 16 weeks
|
24.1%
7/29 • 16 weeks
|
|
Nervous system disorders
Dizziness
|
10.0%
3/30 • 16 weeks
|
6.7%
2/30 • 16 weeks
|
6.9%
2/29 • 16 weeks
|
|
General disorders
Injection site reaction
|
6.7%
2/30 • 16 weeks
|
13.3%
4/30 • 16 weeks
|
10.3%
3/29 • 16 weeks
|
|
General disorders
Fatigue
|
13.3%
4/30 • 16 weeks
|
10.0%
3/30 • 16 weeks
|
3.4%
1/29 • 16 weeks
|
|
General disorders
Edema peripheral
|
0.00%
0/30 • 16 weeks
|
6.7%
2/30 • 16 weeks
|
3.4%
1/29 • 16 weeks
|
|
Infections and infestations
Urinary tract infection
|
3.3%
1/30 • 16 weeks
|
0.00%
0/30 • 16 weeks
|
10.3%
3/29 • 16 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
2/30 • 16 weeks
|
10.0%
3/30 • 16 weeks
|
3.4%
1/29 • 16 weeks
|
|
Injury, poisoning and procedural complications
Skin laceration
|
3.3%
1/30 • 16 weeks
|
0.00%
0/30 • 16 weeks
|
6.9%
2/29 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/30 • 16 weeks
|
10.0%
3/30 • 16 weeks
|
3.4%
1/29 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.3%
1/30 • 16 weeks
|
0.00%
0/30 • 16 weeks
|
10.3%
3/29 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/30 • 16 weeks
|
6.7%
2/30 • 16 weeks
|
3.4%
1/29 • 16 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
3.3%
1/30 • 16 weeks
|
6.7%
2/30 • 16 weeks
|
3.4%
1/29 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
6.7%
2/30 • 16 weeks
|
0.00%
0/30 • 16 weeks
|
3.4%
1/29 • 16 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