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Dose-Ranging Study to Evaluate Efficacy and Safety of Weekly CJC-1134-PC in Patients With T2DM on Metformin Monotherapy

Primary Purpose

Type 2 Diabetes Mellitus (T2DM)

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CJC-1134-PC Injection
Weekly placebo for CJC-1134-PC Injection
Sponsored by
ConjuChem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus (T2DM) focused on measuring Type 2 Diabetes Mellitus, T2DM, diabetes, ConjuChem, GLP-1, Glucagon-like peptide-1, exendin-4, modified exendin-4

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

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

Arm Description

Outcomes

Primary Outcome Measures

Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18

Secondary Outcome Measures

Fasting Body Weight CFB to Week 18
Time to Hyperglycemia Rescue

Full Information

First Posted
October 20, 2011
Last Updated
June 21, 2017
Sponsor
ConjuChem
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1. Study Identification

Unique Protocol Identification Number
NCT01514149
Brief Title
Dose-Ranging Study to Evaluate Efficacy and Safety of Weekly CJC-1134-PC in Patients With T2DM on Metformin Monotherapy
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
Business decision
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ConjuChem

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus (T2DM)
Keywords
Type 2 Diabetes Mellitus, T2DM, diabetes, ConjuChem, GLP-1, Glucagon-like peptide-1, exendin-4, modified exendin-4

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 - Weekly CJC-1134-PC
Arm Type
Experimental
Arm Title
Arm 2 - Weekly CJC-1134-PC
Arm Type
Experimental
Arm Title
Arm 3 - Weekly CJC-1134-PC
Arm Type
Experimental
Arm Title
Arm 4 - Weekly CJC-1134-PC
Arm Type
Experimental
Arm Title
Arm 5 - Weekly Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CJC-1134-PC Injection
Other Intervention Name(s)
metformin
Intervention Description
CJC-1134-PC administered weekly by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Weekly placebo for CJC-1134-PC Injection
Other Intervention Name(s)
metformin
Intervention Description
Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
Primary Outcome Measure Information:
Title
Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18
Time Frame
CFB to Week 18
Secondary Outcome Measure Information:
Title
Fasting Body Weight CFB to Week 18
Time Frame
CFB to Week 18
Title
Time to Hyperglycemia Rescue
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Soon-Shiong, MD
Organizational Affiliation
Chief Executive Officer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Robert Henry, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Research Site
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Research Site
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Research Site
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Research Site
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Research Site
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Research Site
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Research Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
Research Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Research Site
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Research Site
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02915
Country
United States
Facility Name
Research Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Research Site
City
Taylors
State/Province
South Carolina
ZIP/Postal Code
29687
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Research Site
City
Henrico
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Smiths Falls
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Dose-Ranging Study to Evaluate Efficacy and Safety of Weekly CJC-1134-PC in Patients With T2DM on Metformin Monotherapy

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