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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 (DM200-101)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00638716
First Posted: March 19, 2008
Last Update Posted: June 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ConjuChem
Results First Submitted: May 2, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: CJC-1134-PC
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    1.5 mg CJC-1134-PC   1.5 or 2.0 mg CJC-1134-PC   Placebo
STARTED   50   52   58 
COMPLETED   43   37   46 
NOT COMPLETED   7   15   12 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   1.5 mg CJC-1134-PC   1.5 or 2.0 mg CJC-1134-PC   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 49   49   57   155 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.2  (10.46)   55.1  (12.24)   57.2  (13.05)   55.9  (11.99) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      21  42.9%      28  57.1%      30  52.6%      79  51.0% 
Male      28  57.1%      21  42.9%      27  47.4%      76  49.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      4   8.2%      8  16.3%      5   8.8%      17  11.0% 
Not Hispanic or Latino      45  91.8%      41  83.7%      52  91.2%      138  89.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      1   2.0%      1   1.8%      2   1.3% 
Asian      4   8.2%      5  10.2%      9  15.8%      18  11.6% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      9  18.4%      9  18.4%      7  12.3%      25  16.1% 
White      34  69.4%      33  67.3%      36  63.2%      103  66.5% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      2   4.1%      1   2.0%      4   7.0%      7   4.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Reduction of HbA1c From Baseline   [ Time Frame: Screening and Day 85 ]

2.  Secondary:   Reduction in FPG From Baseline   [ Time Frame: Screening and Day 85 ]

3.  Secondary:   Reduction in Fasting Body Weight From Baseline   [ Time Frame: Screening and Day 85 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Associate Director of Regulatory Affairs
Organization: ConjuChem Biotechnologies Inc.
phone: 310-405-7549
e-mail: Aleece.Nolasco@nantbio.com



Responsible Party: ConjuChem
ClinicalTrials.gov Identifier: NCT00638716     History of Changes
Other Study ID Numbers: DM200-101
First Submitted: March 13, 2008
First Posted: March 19, 2008
Results First Submitted: May 2, 2017
Results First Posted: June 2, 2017
Last Update Posted: June 2, 2017