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Completed

NCT Number: NCT01984489

Efficacy and Safety Study of SHR117887 in Combination With Metformin in Patients With Type 2 Diabetes

SHR117887 is a new dipeptidyl peptidase(DPP)-4 inhibitor. This study aims to evaluate the efficacy and safety of SHR117887 in combination therapy with Metformin in patients with Type 2 Diabetes in Metformin monotherapy Who have Inadequate Glycemic Control

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with type 2 diabetes mellitus
  • Patients have been treated with metformin for at least 8 weeks and be on a stable dose of at least 1500mg daily prior to the screening visit
  • HbA1C：≥7.5% and ≤11.0% at screeing visit and at the end of run-in period
  • Age:≥20 and ≤70 years
  • BMI(body mass index):≥20 and ≤35 kg/m2

Exclusion criteria

-

Treatment and study plan

Placebo

Drug

SHR117887

Drug

Primary outcomes

  1. Change From Baseline in HbA1c (Hemoglobin A1C) at Week 12

    Time frame: 12 weeks

Secondary outcomes

  1. Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels

    Time frame: 12 weeks

  2. Change From Baseline in Fasting Plasma Glucose,insulin and C-peptide at Week 12

    Time frame: 12 weeks

  3. Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 12

    Time frame: 12 weeks

  4. Change From Baseline in Body Weight at Week 12

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Multicenter Randomized, Double-blind, Placebo Controlled ,Parallel Group ,Phase II Study to Access the Efficacy and Safety of SHR117887 in Combination Therapy With Metformin in Patients With Type 2 Diabetes Patients

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 14, 2013
Registry last updated
Nov 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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