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

ConjuChem122 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

122

Conditions

Type 2 Diabetes Mellitus

Interventions

CJC-1134-PCDRUG

1.5 or 2.0 mg CJC-1134-PC

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 25 Years

Medical Language ↔ Plain English

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%

Locations (1)

ConjuChem Biotechnologies Inc.

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Reduction of HbA1c From Baseline

Change from Baseline

Time frame: Screening and Day 85

Secondary Outcomes

Reduction in FPG From Baseline

Change from Baseline

Time frame: Screening and Day 85

Reduction in Fasting Body Weight From Baseline

Change from Baseline

Time frame: Screening and Day 85

Data from ClinicalTrials.gov

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