Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of SHR3824 in Type 2 Diabetes Mellitus Patients

NCT02346175 | Completed Phase 1

• 1 other identifier: SHR3824-103
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability following single and multiple oral doses of 5mg to 20 mg SHR3824 in Type 2 diabetes mellitus patients.

Conditions

Type 2 Diabetes Mellitus

Keywords

SHR3824 Type 2 diabetes mellitus SGLT2

Outcome Measures

Primary Outcomes (3)

• Plasma pharmacokinetic parameters of SHR3824

  up to Day 13

• Urine glucose concentration of SHR3824

  up to Day 11

• Plasma glucose concentration of SHR3824

  up to Day 11

Secondary Outcomes (1)

• The number and type of adverse events reported

  Up to Day 13

Study Arms (3)

Cohort1

EXPERIMENTAL

5-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.

Drug: SHR3824; Drug: Placebo

Cohort2

EXPERIMENTAL

10-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.

Drug: SHR3824; Drug: Placebo

Cohort3

EXPERIMENTAL

20-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.

Drug: SHR3824; Drug: Placebo

Interventions

SHR3824 DRUG

Cohort1; Cohort2; Cohort3

Placebo DRUG

Cohort1; Cohort2; Cohort3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI:20-35kg/m2;
• Medically stable based on physical examination, medical history, laboratory results, vital sign measurements, and 12-lead electrocardiogram (ECG) at screening;
• On a stable regimen of antihyperglycemic therapy for at least 8 weeks prior to screening and had fasting plasma glucose (FPG) concentration lower than 13.9 mmol/L at baseline;
• Stable antihyperglycemic regimens could include a single oral agent (eg, metformin, a sulfonylurea, a thiazolidinediones ketone, a benzoic acid derivatives, a dipeptidyl peptidase-4 inhibitor, or an α-glucosidase inhibitor) with glycated hemoglobin (HbA1c) between 7.0% and 10.0%.

You may not qualify if:

• History of clinically significant diabetic complications, type 1 diabetes mellitus, or repeated severe hypoglycemic episodes.
• Pregnancy or breastfeeding;
• Significant acute or chronic medical illness, including renal impairment, or recent surgery;
• Donation of blood or plasma within the 4 weeks prior to the start of the study;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

henagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: January 20, 2015
• First Posted: January 26, 2015
• Study Start: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 3, 2015

Record last verified: 2015-01