Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus Who Are Currently on Metformin Monotherapy (NCT NCT00638716)
NCT ID: NCT00638716
Last Updated: 2017-06-02
Results Overview
Change from Baseline
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
122 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
12 weekly doses of 1.5 mg CJC-1134-PC
CJC-1134-PC: 1.5 mg CJC-1134-PC
|
1.5 or 2.0 mg CJC-1134-PC
4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC
CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC
|
Placebo
12 weekly doses of placebo
Placebo: Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
52
|
58
|
|
Overall Study
COMPLETED
|
43
|
37
|
46
|
|
Overall Study
NOT COMPLETED
|
7
|
15
|
12
|
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 Mellitus Who Are Currently on Metformin Monotherapy
Baseline characteristics by cohort
| Measure |
1.5 mg CJC-1134-PC
n=49 Participants
12 weekly doses of 1.5 mg CJC-1134-PC
CJC-1134-PC: 1.5 mg CJC-1134-PC
|
1.5 or 2.0 mg CJC-1134-PC
n=49 Participants
4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC
CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC
|
Placebo
n=57 Participants
12 weekly doses of placebo
Placebo: Placebo
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 10.46 • n=5 Participants
|
55.1 years
STANDARD_DEVIATION 12.24 • n=7 Participants
|
57.2 years
STANDARD_DEVIATION 13.05 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 11.99 • n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
138 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
18 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
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
103 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 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=44 Participants
12 weekly doses of 1.5 mg CJC-1134-PC
CJC-1134-PC: 1.5 mg CJC-1134-PC
|
1.5 or 2.0 mg CJC-1134-PC
n=38 Participants
4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC
CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC
|
Placebo
n=47 Participants
12 weekly doses of placebo
Placebo: Placebo
|
|---|---|---|---|
|
Reduction of HbA1c From Baseline
|
-0.85 Percent (%)
Standard Deviation 0.883
|
-0.80 Percent (%)
Standard Deviation 0.827
|
-0.46 Percent (%)
Standard Deviation 0.744
|
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=42 Participants
12 weekly doses of 1.5 mg CJC-1134-PC
CJC-1134-PC: 1.5 mg CJC-1134-PC
|
1.5 or 2.0 mg CJC-1134-PC
n=38 Participants
4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC
CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC
|
Placebo
n=45 Participants
12 weekly doses of placebo
Placebo: Placebo
|
|---|---|---|---|
|
Reduction in FPG From Baseline
|
-13.48 mg/dL
Standard Deviation 34.579
|
-18.76 mg/dL
Standard Deviation 36.736
|
-10.06 mg/dL
Standard Deviation 34.137
|
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=44 Participants
12 weekly doses of 1.5 mg CJC-1134-PC
CJC-1134-PC: 1.5 mg CJC-1134-PC
|
1.5 or 2.0 mg CJC-1134-PC
n=38 Participants
4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC
CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC
|
Placebo
n=46 Participants
12 weekly doses of placebo
Placebo: Placebo
|
|---|---|---|---|
|
Reduction in Fasting Body Weight From Baseline
|
-1.98 kg
Standard Deviation 2.438
|
-1.25 kg
Standard Deviation 2.106
|
-1.58 kg
Standard Deviation 2.374
|
Adverse Events
1.5 mg CJC-1134-PC
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
1.5 or 2.0 mg CJC-1134-PC
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1.5 mg CJC-1134-PC
n=49 participants at risk
12 weekly doses of 1.5 mg CJC-1134-PC
CJC-1134-PC: 1.5 mg CJC-1134-PC
|
1.5 or 2.0 mg CJC-1134-PC
n=49 participants at risk
4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC
CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC
|
Placebo
n=57 participants at risk
12 weekly doses of placebo
Placebo: Placebo
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
22.4%
11/49 • 16 weeks
|
30.6%
15/49 • 16 weeks
|
15.8%
9/57 • 16 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
12.2%
6/49 • 16 weeks
|
12.2%
6/49 • 16 weeks
|
5.3%
3/57 • 16 weeks
|
|
Gastrointestinal disorders
Vomiting
|
12.2%
6/49 • 16 weeks
|
4.1%
2/49 • 16 weeks
|
3.5%
2/57 • 16 weeks
|
|
General disorders
Injection site bruising
|
0.00%
0/49 • 16 weeks
|
0.00%
0/49 • 16 weeks
|
5.3%
3/57 • 16 weeks
|
|
Infections and infestations
Nasopharyngitis
|
4.1%
2/49 • 16 weeks
|
4.1%
2/49 • 16 weeks
|
5.3%
3/57 • 16 weeks
|
|
Infections and infestations
Urinary tract infection
|
6.1%
3/49 • 16 weeks
|
2.0%
1/49 • 16 weeks
|
3.5%
2/57 • 16 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
2.0%
1/49 • 16 weeks
|
0.00%
0/49 • 16 weeks
|
5.3%
3/57 • 16 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
4.1%
2/49 • 16 weeks
|
6.1%
3/49 • 16 weeks
|
0.00%
0/57 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/49 • 16 weeks
|
6.1%
3/49 • 16 weeks
|
1.8%
1/57 • 16 weeks
|
|
Nervous system disorders
Headache
|
10.2%
5/49 • 16 weeks
|
4.1%
2/49 • 16 weeks
|
15.8%
9/57 • 16 weeks
|
|
Nervous system disorders
Dizziness
|
4.1%
2/49 • 16 weeks
|
4.1%
2/49 • 16 weeks
|
7.0%
4/57 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/49 • 16 weeks
|
2.0%
1/49 • 16 weeks
|
5.3%
3/57 • 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