Phase 2
Completed N=160
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
Source: ClinicalTrials.gov NCT00638716 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Reduction of HbA1c From Baseline — -0.85; -0.80; -0.46 Percent (%)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction of HbA1c From Baseline |
-0.85; -0.80; -0.46 | — |
| SECONDARY Reduction in FPG From Baseline |
-13.48; -18.76; -10.06 | — |
| SECONDARY Reduction in Fasting Body Weight From Baseline |
-1.98; -1.25; -1.58 | — |
Eligibility 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%
Data sourced from ClinicalTrials.gov (NCT00638716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.