A Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes
A Dose-ranging, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes Mellitus.
2 other identifiers
interventional
315
1 country
1
Brief Summary
This study will assess the efficacy and safety/tolerability of 4 doses of Imeglimin versus placebo. The study will be performed in subjects with type 2 diabetes either naive of treatment or previously treated with an oral monotherapy excluding thiazolidinedione.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes-mellitus
Started Jan 2013
Typical duration for phase_2 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 19, 2013
CompletedFirst Posted
Study publicly available on registry
September 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedAugust 13, 2015
July 1, 2015
1.5 years
September 19, 2013
July 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c
Baseline and week 24
Secondary Outcomes (1)
Safety will be assessed by the incidence of adverse events (AEs), physical examination, relevant changes on laboratory tests, vital signs, and 12-lead electrocardiograms (ECG)
Baseline to week 24
Study Arms (5)
Imeglimin (Dose 1)
EXPERIMENTALImeglimin (Dose 2)
EXPERIMENTALImeglimin (Dose 3)
EXPERIMENTALImeglimin (Dose 4)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Subject has given written informed consent
- Male and female type 2 diabetic subjects, either naïve of antidiabetic agents or treated with an oral anti-diabetic monotherapy.
- Body mass index (BMI) : ≥ 24 to ≤ 40 kg/m²
- HbA1c criteria: ≥ 7% and ≤ 9.5%
- Creatinine clearance ≥ 50 mL/\[min\*1.73 m2\] at Screening Visit
- Effective contraception for women of child bearing potential
You may not qualify if:
- Any disease which in the investigator's opinion would exclude the subject from the study
- Acute cardiovascular event within 3 months before randomization
- Uncontrolled high blood pressure
- Impairment of hepatic function
- History of drug-induced Torsades de Pointes or a marked baseline prolongation of the QTc interval
- Pregnancy or lactation
- Use of any non-permitted medication
- Positive screen for viral hepatitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Poxel SAlead
Study Sites (1)
Pauls Stradins Clinical University Hospital
Riga, Latvia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valdis Pirags, MD
P. Stradins Clinical University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2013
First Posted
September 26, 2013
Study Start
January 1, 2013
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
August 13, 2015
Record last verified: 2015-07