A 24-week, Phase IIa, Double blind, Randomized, Parallel Group, Placebo controlled, Exploratory Study to Evaluate the Efficacy and Safety of 5 Aminolevulinic Acid Co-administered with Sodium Ferrous Citrate Compared with Placebo in the Treatment of Adult Type 2 Diabetes Mellitus Patients who have not Achieved Adequate Glycaemic Control with Maximum Tolerated Dose of Metformin Daily or Sulfonylurea - Phase IIa Double-blind Exploratory Study of 5 ALA Co-administered with SFC in T2DM

neopharma Japan Co., Ltd0 sites100 target enrollmentMay 7, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Type 2 Diabetes Mellitus in Patients who have not Achieved Adequate Glycemic Control with Maximum Tolerated Dose of Metformin Daily or Sulfonylurea
Sponsor: neopharma Japan Co., Ltd
Enrollment: 100
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

May 7, 2018

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

neopharma Japan Co., Ltd

•1\.Male or female between 18 and 75 years old (age \>18 to \=75\) at time of informed consent, with a documented diagnosis of T2DM.
•2\.Written and signed informed consent needs to be provided by patients who are legally capable before starting any protocol\-specific procedures.
•3\.HbA1c between 6\.5% and 9% (both inclusive) based on central laboratory results from Visit 1, with individual need for therapy escalation (not to be re\-assessed at Randomization Visit 3\).
•4\.Currently treated with a stable MTD of metformin (immediate\-release and extended\-release) therapy \=1500 mg/day or a SU for at least 12 weeks prior to enrolment visit. The patient should remain on therapy with metformin or SU will remain on the same dose for the duration of the study for both treatment arms indicated.
•5\.Patients willing to follow the CGM procedures.
•6\.BMI of \=40 kg/m2 at Visit 1\.
•7\.C\-peptide laboratory value of \=1\.5 ng/mL (0\.495 nmol/L) based on central laboratory results from Visit 1\.
•8\.Female patients of childbearing potential who are sexually active who agree to routinely use adequate contraception from Screening throughout the duration of the study.
•Women must be one of the following:
•a.Naturally postmenopausal defined as \=1 year without menstruation and \=55 years, or

•1\.Any known complication of T2DM indicating a late disease state
•2\.History of Type 1 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 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 or history of acute or chronic porphyria
•10\.History of any unstable endocrine, psychiatric, rapidly progressing or unstable renal disease, or rheumatic disorder