Phase 2
Completed N=90
A Study to Evaluate the Efficacy and Safety of CJC-1134-PC in Patients With Type 2 Diabetes Who Are Currently on Metformin Monotherapy
Source: ClinicalTrials.gov NCT00674466 ↗Enrolled (actual)
90
Serious AEs
2.3%
Results posted
Jun 2017
Primary outcomePrimary: Reduction of HbA1c From Baseline — -1.29; -0.55; -0.34 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 who are currently on metformin monotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction of HbA1c From Baseline |
-1.29; -0.55; -0.34 | — |
| SECONDARY Reduction in Fasting Plasma Glucose From Baseline |
-5.88; 4.12; 12.12 | — |
| SECONDARY Reduction in Fasting Body Weight From Baseline |
-1.17; -0.90; -0.39 | — |
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 (NCT00674466). 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.