A 24 Week, Phase IIa, Double blind, Randomized, Parallel Group, Placebo-controlled, Proof of Concept Study to Assess the Efficacy and Safety of Two Doses of 5 Aminolevulinic Acid Co-administered with Sodium Ferrous Citrate in Adult Patients with Type 2 Diabetes Mellitus - Phase IIa Double-blind Proof of Concept Study of Two Doses of 5-ALA Co-administered with SFC in T2DM

neopharma Japan Co., Ltd0 sites216 target enrollmentMay 7, 2018

ConditionsType 2 Diabetes Mellitus MedDRA version: 20.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Type 2 Diabetes Mellitus
Sponsor: neopharma Japan Co., Ltd
Enrollment: 216
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 7, 2018

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

neopharma Japan Co., Ltd

Eligibility Criteria

Inclusion Criteria

•1\. Male or female between 18 and 75 years old (age \<18 to age \=75\) at time of informed consent, with a documented diagnosis of T2DM for at least 6 weeks before enrolment.
•2\.Written and signed informed consent needs to be provided by patients who are legally capable before starting any protocol\-specific procedures.
•For patients treated with anti\-diabetic medication between 6\.5% and 9\.0% (both inclusive) at Screening (Visit 1\) and between 6\.5% and 9\.5%, inclusive, at Run\-in (Visit 3\) based on central laboratory results.
•For anti\-diabetic treatment free patients – between 6\.5% and 9\.5% at Screening (Visit 1\), based on central laboratory results
•4\. Currently treatment free patients for anti\-diabetic medication, or treated with a single therapy of oral anti\-diabetic treatment and willing and able to safely discontinue that OAD therapy (for at least 6 weeks prior to the first dose of study treatment) and for the duration of the study.
•5\. On a documented, recommended diet and exercise program for at least 6 weeks prior to Visit 1 and willing to continue this program for the duration of the study.
•6\. Patients willing to follow the CGM procedures.
•7\. BMI of \=40 kg/m2 at Visit 1
•8\.C\-peptide laboratory value of \=1\.5 ng/mL (0\.495 nmol/L) based on central laboratory results from Visit 1\.
•9\. Female patients of childbearing potential, who are sexually active who agree to routinely use adequate contraception from Screening throughout the duration of the study.

Exclusion Criteria

•1\.Any known complication of T2DM indicating a late disease state
•2\.History of Type I diabetes, maturity onset diabetes of the young, secondary DM or known presence of glutamate decarboxylase 65 antibodies.
•3\.History of diabetic ketoacidosis, hyperosmolar non\-ketotic coma, in the 6 months prior to Screening (Visit 1\).
•4\.History of photo\-hypersensitivity, porphyria, or hemochromatosis
•5\.Greater than 5% unexplained weight change (loss or gain) during the 3 months prior to enrolment
•6\.Fasting plasma glucose \>270 mg/dL (\>15 mmol/L) assessed based on central laboratory results from Visit 1 (can be repeated once during the Screening period)
•7\.Patients who take acetaminophen containing medications on a regular basis and are unable/unwilling to substitute it the day before placement of the sensor and throughout the 7\-day CGM periods
•8\.History of bariatric surgery or lap\-band surgery, or either procedure planned during the time period of the study. History of liposuction is allowed.
•9\.Patients with history of hypersensitivity to porphyrins and history of acute or chronic porphyria
•10\.History of any unstable endocrine, psychiatric, rapidly progressing or unstable renal disease, or rheumatic disorder