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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

A Randomized, Double-blind, Placebo-controlled, Multiple-dose, Phase II Study to Evaluate the Efficacy and Safety of 3 Months of Weekly Injections of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus on Metformin Monotherapy

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00638716
Acronym
DM200-101
Enrollment
122
Registered
2008-03-19
Start date
2008-02-29
Completion date
2008-11-30
Last updated
2017-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus, incretins, GLP-1, HbA1c, metformin

Brief summary

This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study. The objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment with CJC-1134-PC in patients with type 2 diabetes mellitus who are currently on metformin monotherapy.

Interventions

DRUGCJC-1134-PC

1.5 or 2.0 mg CJC-1134-PC

DRUGPlacebo

Placebo

Sponsors

ConjuChem
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Major Inclusion Criteria: * BMI: 27 to 45 kg/m2 * Stable Type 2 diabetes mellitus for at least 3 months, as defined by the Investigator * Stable life-style, i.e. diet & physical activity, as determined by the Investigator * Stable metformin daily dose ≥1000 mg for at least 3 months * Glycosylated hemoglobin (HbA1c) at screening ≥ 7.1% and ≤ 11%

Design outcomes

Primary

MeasureTime frameDescription
Reduction of HbA1c From BaselineScreening and Day 85Change from Baseline

Secondary

MeasureTime frameDescription
Reduction in FPG From BaselineScreening and Day 85Change from Baseline
Reduction in Fasting Body Weight From BaselineScreening and Day 85Change from Baseline

Countries

Canada

Participant flow

Participants by arm

ArmCount
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
49
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
49
Placebo
12 weekly doses of placebo Placebo: Placebo
57
Total155

Baseline characteristics

Characteristic1.5 mg CJC-1134-PC1.5 or 2.0 mg CJC-1134-PCPlaceboTotal
Age, Continuous55.2 years
STANDARD_DEVIATION 10.46
55.1 years
STANDARD_DEVIATION 12.24
57.2 years
STANDARD_DEVIATION 13.05
55.9 years
STANDARD_DEVIATION 11.99
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants8 Participants5 Participants17 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
45 Participants41 Participants52 Participants138 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants2 Participants
Race (NIH/OMB)
Asian
4 Participants5 Participants9 Participants18 Participants
Race (NIH/OMB)
Black or African American
9 Participants9 Participants7 Participants25 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants1 Participants4 Participants7 Participants
Race (NIH/OMB)
White
34 Participants33 Participants36 Participants103 Participants
Sex: Female, Male
Female
21 Participants28 Participants30 Participants79 Participants
Sex: Female, Male
Male
28 Participants21 Participants27 Participants76 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 490 / 490 / 57
other
Total, other adverse events
36 / 4930 / 4934 / 57
serious
Total, serious adverse events
0 / 490 / 490 / 57

Outcome results

Primary

Reduction of HbA1c From Baseline

Change from Baseline

Time frame: Screening and Day 85

Population: Modified Intent-to-Treat Population

ArmMeasureValue (MEAN)Dispersion
1.5 mg CJC-1134-PCReduction of HbA1c From Baseline-0.85 Percent (%)Standard Deviation 0.883
1.5 or 2.0 mg CJC-1134-PCReduction of HbA1c From Baseline-0.80 Percent (%)Standard Deviation 0.827
PlaceboReduction of HbA1c From Baseline-0.46 Percent (%)Standard Deviation 0.744
Secondary

Reduction in Fasting Body Weight From Baseline

Change from Baseline

Time frame: Screening and Day 85

Population: Modified Intent-to-Treat Population

ArmMeasureValue (MEAN)Dispersion
1.5 mg CJC-1134-PCReduction in Fasting Body Weight From Baseline-1.98 kgStandard Deviation 2.438
1.5 or 2.0 mg CJC-1134-PCReduction in Fasting Body Weight From Baseline-1.25 kgStandard Deviation 2.106
PlaceboReduction in Fasting Body Weight From Baseline-1.58 kgStandard Deviation 2.374
Secondary

Reduction in FPG From Baseline

Change from Baseline

Time frame: Screening and Day 85

Population: Modified Intent-to-Treat Population

ArmMeasureValue (MEAN)Dispersion
1.5 mg CJC-1134-PCReduction in FPG From Baseline-13.48 mg/dLStandard Deviation 34.579
1.5 or 2.0 mg CJC-1134-PCReduction in FPG From Baseline-18.76 mg/dLStandard Deviation 36.736
PlaceboReduction in FPG From Baseline-10.06 mg/dLStandard Deviation 34.137

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026