Completed

JTT-851 Safety and Efficacy in Type 2 Diabetes Mellitus Patients

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Study Aim

This phase 2 study aims to evaluate the safety and effectiveness of JTT-851 in managing Type 2 Diabetes Mellitus by observing the change in your glycosylated hemoglobin (HbA1c) levels after taking JTT-851 once daily for 12 weeks.

What is being tested

JTT-851

+ Placebo for comparator

+ JTT-851

Drug
Who is being recruted

Endocrine System Diseases+3

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

From 18 to 70 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorAkros Pharma Inc.
Last updated: August 1, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

This is a randomized, double-blind, double-dummy, placebo and active-controlled (glimepiride), multi-center, parallel-group study to investigate the effect of JTT-851 on HbA1c and other ancillary efficacy parameters and to assess the safety, tolerability, and pharmacokinetics of JTT-851 in inadequately-controlled treatment-naïve or metformin-treated type 2 diabetic patients.

NCT01699737
Principal SponsorAkros Pharma Inc.
Last updated: August 1, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

325 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes MellitusDiabetes Mellitus, Type 2

Criteria

4 inclusion criteria required to participate
Body mass index (BMI) >= 23.0 kg/m^2 and <= 45.0 kg/m^2 at Visit 1
Glycosylated hemoglobin at Visit 1 between 7.5% and 10.0%, if on metformin and between 7.5% and 10.9%, if without treatment
Males and females with type 2 diabetes, 18-70 years of age at Visit 1
Managing diabetes with diet and exercise only or currently being treated with a stable dose of metformin (at least 1500 mg/day)
4 exclusion criteria prevent from participating
Acute coronary syndrome or uncontrolled hypertension
Does not meet all diet or previous/concomitant medication restriction criteria
Females who are pregnant or breast-feeding
Known medical history or presence of type 1 diabetes or acute metabolic diabetic complications, unstable or rapidly progressing retinopathy, nephropathy or neuropathy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

5 intervention groups are designated in this study

20% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks

Group II

Experimental
JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks

Group III

Experimental
JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks

Group IV

Active Comparator
Active Comparator Capsule and Placebo Tablets, administered once daily for 12 weeks

Group 5

Placebo
Placebo Tablets for study drug and Placebo Capsule for active comparator, administered once daily for 12 weeks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 79 locations

Birmingham, United StatesOpen in Google Maps

Dothan, United States

Huntsville, United States

Montgomery, United States
Completed79 Study Centers