A Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes

• Sponsor: Poxel SA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01951235
• Collaborator: (none)
• Enrollment: 315
• Location: 1
• Arms: 5
• Duration (Months): 17.9
• Patients Per Site Per Month: 17.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: Imeglimin; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 315 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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.
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Imeglimin (Dose 1)	Drug: Imeglimin
Experimental: Imeglimin (Dose 2)	Drug: Imeglimin
Experimental: Imeglimin (Dose 3)	Drug: Imeglimin
Experimental: Imeglimin (Dose 4)	Drug: Imeglimin
Placebo Comparator: Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Change in HbA1c [Baseline and week 24]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject has given written informed consent

2. Male and female type 2 diabetic subjects, either naïve of antidiabetic agents or treated with an oral anti-diabetic monotherapy.

3. Body mass index (BMI) : ≥ 24 to ≤ 40 kg/m²

4. HbA1c criteria: ≥ 7% and ≤ 9.5%

5. Creatinine clearance ≥ 50 mL/[min*1.73 m2] at Screening Visit

6. Effective contraception for women of child bearing potential

Exclusion Criteria:

1. Any disease which in the investigator's opinion would exclude the subject from the study

2. Acute cardiovascular event within 3 months before randomization

3. Uncontrolled high blood pressure

4. Impairment of hepatic function

5. History of drug-induced Torsades de Pointes or a marked baseline prolongation of the QTc interval

6. Pregnancy or lactation

7. Use of any non-permitted medication

8. Positive screen for viral hepatitis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pauls Stradins Clinical University Hospital	Riga		Latvia

Sponsors and Collaborators

• Poxel SA

Investigators

• Principal Investigator: Valdis Pirags, MD, P. Stradins Clinical University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Poxel SA
• ClinicalTrials.gov Identifier: NCT01951235
• Other Study ID Numbers: PXL008-008; 2012-004045-33
• First Posted: Sep 26, 2013
• Last Update Posted: Aug 13, 2015
• Last Verified: Jul 1, 2015

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Aug 13, 2015