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TerminatedPhase 2Results posted

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

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

Lead sponsor

ConjuChem

Asset

Exenatide

GLP-1 agonist

Listed sites

22

Recruiting sites

Enrollment

73

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

BMI 27-45HbA1c 7-11%

Primary endpoint

HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01514149
Org study IDDM200-103

Timeline

Milestones

Study first posted2012-01-20estimated
Last update posted2017-07-19actual
Results first posted2017-07-19actual
Study start2011-09 (month precision)
Primary completion2012-05actual (month precision)
Study completion2013-03actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
2
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Fasting Body Weight CFB to Week 18

Time frame:CFB to Week 18

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), kg95% CI
Arm 1 - Weekly CJC-1134-PC-1.91
Arm 2 - Weekly CJC-1134-PC-0.14
Arm 3 - Weekly CJC-1134-PC-1.37
Arm 4 - Weekly CJC-1134-PC-0.92
Arm 5 - Weekly Placebo-1.85

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18

Time frame:CFB to Week 18

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), Percent (%)95% CI
Arm 1 - Weekly CJC-1134-PC-0.56
Arm 2 - Weekly CJC-1134-PC-0.56
Arm 3 - Weekly CJC-1134-PC-0.95
Arm 4 - Weekly CJC-1134-PC-0.95
Arm 5 - Weekly Placebo-0.13
Secondary/protocol endpoint

Time to Hyperglycemia Rescue

Time frame:18 weeks

time to event, event

Posted result

GroupValue (mean), days95% CI
Arm 1 - Weekly CJC-1134-PCNA
Arm 2 - Weekly CJC-1134-PC47.0
Arm 3 - Weekly CJC-1134-PCNA
Arm 4 - Weekly CJC-1134-PCNA
Arm 5 - Weekly Placebo57.0

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.